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1. In your word document click File and go down HE View Insert Format Tools Table Window Help wos New CrN e the list to Send To gt Mail Recipient for E e mae Review and click on this option ose Save Ctrl 5 Save As Save as Web Page a exch Hoe e An e mail will be created with an Versio p od automatically generated message Sore E yr oe soe Page Setup K requesting the recipient to review the rera Z ah 7 vi d d 2 A attached document 5 eit cue Pe gt A Send To gt e Mail Recipient for Review j Properties G Mail Recipient as Attachment The document for review will already be 1D Lead Site Guidelines for QH CR fa Routing Recipient attached to the e mail 2 G OHMR REGU where_do_I_submit en sl 3G Quarterly Update Meeting Ag amp Fax Recipient 4D userdata BrosnaKa Desktop New colour ecg Microsoft PowerPoint Include any other message for the aa and ie Gu id recipient 6 F Lead Site Guidelines For QH CRCS Regu Mail To Ee File Edit View Actions Tools Window Help Kil Send 3 Cancel E Address al fae ons Spell Check em gea a view it and add any relevant message to the email BC Please review Lead Site Guidelines For QH CRCs 10 08 10b 10 BZ u i i dE te Please review the attached document Open this document as normal and when you have finished editing please click on the red Reply w
2. Click on Authorise Form A pop up box will appear requesting that you insert your username which is your log in e mail your password and other identifying details Complete the text boxes and click on Sign Queensland Health Guidelines for The Management of Investigator Initiated Multi centre Research Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health qld gov au ohmr ohmr health qld gov au 3405 6121 48 of 50 HOME My PROJECTS My CON a We had a lovely day at the seaside last Sunday Form Type NEAF Status Submission Code AU I F 41707 HREC Reference None Owner Form Section WA Created On 24 03 2010 Signatures This form is attached with electronic AuthoriseForm S Last Modified On 0309 2010 11 13 00 a fim My Project on Please enter your username and password and the details relevant H to this authorisation NEAF E Username pgneaith qld gov au A Your full e mail address 11 14 that you sign this form as Principal Researcher Electronic al te for downloadable step by step instructions on electronic al Password eecccee P Job Title Post ajksdf button A Organisation asdf tion submenu to authorise the form I Email ptheaitn qia gov au Your full e mail address usually the same as above A pop up box will appear asking if you are sure you want to sign the
3. Click here to begin completing reviewing the form or click on the number for a specific section Navigate by question numbers v Status Oenabled O disabled Page completed SECTION QUESTION NUMBER 1 TITLE and SUMMARY of Project 1 2 2 RESEARCHERS INVESTIGATORS 1 2 3 4 SSe 67a 3 RESOURCES id 5 9 4 PRIOR REVIEWS 1 3 45 6 7 8 9 10 11 The new screen will give you two options to authorise the form or reject the request HOME a We had a lovely day at the seaside last Sunday Form Type NEAF Status Submission Code AU 1 F41707 HREC Reference None Owner Form Section WA Created On 24 03 2010 Signatures This form is attached with electronic signatures any changes to the form will invalidate the signatures Last Modified On 03 09 2010 11 13 00 a My Project NEAF Authorisation Electronic authorisations requested for this NEAF form A request for authorisation was sent by Ms Margaret Morton on 03 09 2010 11 14 that you sign this form as Principal Researcher Electronic authorisation is available as an alternative to ink signatures Please click here for downloadable step by step instructions on electronic authorisations Please check the data in this form by clicking the Review Requested Form button After reviewing the form click the Navigate icon and then go to the Authorisation submenu to authorise the form Authorise Form Reject Request
4. the Reviewing QH HREC their Local RGO the CPI Please note for local SAEs SUSARs the local PI is to submit directly to the QH Reviewing HREC and local RGO with a copy of this correspondence to the CPI The Reviewing HREC should correspond directly with the PI at whose site the SAE SUSAR occurred and it is the responsibility of the site to send copies of the HREC correspondence to the CPI in the normal manner If the Reviewing HREC sends the Acknowledgement Letter to the CPI rather than to the PI the letter is scanned and e mailed to the appropriate PI and the Acknowledgement Letter is filed in the CPI folder If the RGO from the site at which the SAE SUSAR occurred wishes to discuss the SAE SUSAR with the Reviewing HREC they should contact the Reviewing HREC directly It is the responsibility of the CPI to ensure all other Safety Reports are submitted for HREC review As per the May 2009 version of the NHMRC Position Statement for Monitoring and Reporting of Safety for Clinical Trials involving Therapeutic Products the Reviewing HREC must be notified in a prompt manner of any material which impacts the continued ethical acceptability of a trial or information that requires or indicates a need for a change to the trial protocol including changed safety monitoring in the view of the Investigator or Sponsor For further information please go to www nhmrc gov au health_ ethics hrecs hrecalerts htm
5. For a summary of how and where to submit research applications please see Appendix 13 3 3 Answering NEAF Questions Under the single ethical review process you may have some concerns regarding answering the NEAF questions The following guidance is provided Q2 2 Principal Researchers You are required to insert the contact details of ALL Pls participating in the study not just the Pls at sites covered by your CPI responsibilities N S 5 3 4 Q2 3 Associate Researchers At this stage you only need to insert details for the Associate Investigators at the QH sites over which you have CPI responsibilities With the introduction of the HoMER processes this requirement will include all Associate Investigators from all Australian sites You do not need to obtain signatures on the NEAF from Associate Investigators at Accepting Sites they will be collected on the SSA Form Q2 5 Other personne relevant to the research project You do not need to name individuals in this section Please just insert the professional category to which these personnel belong e g Pharmacist Neuropsychologist Nuclear Medicine Radiographer Q2 6 Certification of Researchers Investigators The SSA Form section 4 1 requires the Medical Officer Investigator to make a statement regarding their Queensland certification so for this question in the NEAF your response should outline any credentialing or certification requirements for the conduct of the study
6. Q2 7 Training of Researchers In this section again the response should be general outlining any extra training required for the conduct of the study A detailed response re training required at specific sites is covered in the SSA Form Q3 7 Does any member of the research team have a financial interest in the study You must ascertain the response to this question from every researcher for whom you have CPI responsibilities The question has been inserted into the First Communication between CPI and Participating Sites letter Appendix 1 Q4 6 Reviewing HREC s In this question you must insert all the Australian HRECs that are reviewing the study However at this time you will not know which QH HREC will be allocated to review the study If you leave this question unanswered until after you have contacted QH CCS and attempt to insert the allocated QH HREC all the electronic signatures you have collected will be voided If you do not obtain your submission code until AFTER you have been allocated the Reviewing HREC by QH CCS you may not have enough time to collect all the required signatures Therefore it is suggested that you insert the QH HREC that you consider is most likely to be allocated the project and comment on this in your HREC cover letter if the allocated QH Reviewing HREC is different from the one you nominated in the NEAF If the allocated HREC is different from the one you have inserted into the NEAF you should
7. Office of Health and Medical Research Queensland Health Guidelines for the Management of Investigator Initiated Multi Centre Research conducted at Queensland Health sites A tool for Coordinating Principal Investigators and their research team Research Ethics and Governance Unit Office of Health and Medical Research Queensland Health December 2010 ane Queensland SAT Government Table of contents Table of contents Abbreviations Purpose and scope Contact Us Introduction Section 1 Dot Point Summaries 1 The First Approach 2 Setting Up 3 Preparing the HREC Application 4 CaSS Applications Guardianship Applications and PHA Applications within Queensland 4 1 Clinical and Statewide Services CaSS Applications 4 2 Queensland Civil and Administration Tribunal QCAT Applications 4 3 Queensland Public Health Act PHA Applications 5 Research Governance Review 6 Post Approval Amendments 7 HREC Reporting Post Approval 7 1 SAEs and SUSARs 7 2 Other Safety Updates 7 3 Annual Reports 8 Study Termination Section 2 Step by Step Guidelines 1 The First Approach 2 Setting Up 2 1 Develop a Communication Strategy 2 2 Preparing your Group e mail 2 3 Preparing the CPI Communications and Documents Folder 2 4 First Communication 2 5 Setting up your calendar for reminders 3 Preparing the HREC Application 3 1 The Protocol 3 2 NEAF Requirements 3 3 Answering NEAF Que
8. 03 09 2070 11 73 00 Al g Q Page 1 of 62 Read Only oO oO Navigate Print Incomplete 134567891011 Previous Next Within which Jurisdictions will your research application be submitted to tick aif that appi C New South Wales E Queensland OVvictoria HREC Application Reference Nurnber 1 TITLE AND SUMMARY OF PROJECT 1 Title What is the formal title of this research proposal We had a lovely day at the seaside last Sunday beg z When you ready to authorise the document click on the Navigate icon top left side of the page Queensland Health Guidelines for The Management of Investigator Initiated Multi centre Research 47 of 50 Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health qld gov au ohmr ohmr health qld gov au 3405 6121 This will take you to the Index page where the Authorisation tab appears Click on the Authorisation HOME MY PROJECTS MY CONTACTS HELP tab CONTACT US a We had a lovely day at the seaside last Sunday Form Type NEAF Status Submission Code AU 1 F41707 HREC Reference None Owner Form Section N A Created On 24 03 2010 Signatures This form is attached with electronic signatures any changes to the form will W alidate the signatures Last Modified On 03 09 2010 11 13 00 E My Project ear Navigate Documents Authorisation
9. CPI Studies File Edit View Help oy 3 a R p 2 _ Ne Details Delete Action e Click Ok 3 Online The new address book should now E Novell GroupWise Address Book appear on the left hand side of your neve Der Addes Bosk j K E Frequent Contact New Groupwise screen In this address i i Frequent Contacts Hee book you will set up all your groups 8 Logan ROS amp Logan ROS amp Payroll Supp relating to the studies for which you 0417883317 04 31395664 NIGHT Ph 0417889317 health qld a the CPI 0417939288 04 31395664 DAY Phon 0417939288 health qld g are e 5 TOUpS F 100Creek CR 1 100Creek CR 14 pax hea g Research Groups 9 100Creek MR2 100Creek MR2 8 pax he CPI Studies P 100Creek MR3 100Creek MR3 8 pax he 9 100Creek MR4 100Creek MR4 5 pax infor Queensland Health Guidelines for The Management of Investigator Initiated Multi centre Research 36 of 50 Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health qld gov au ohmr ohmr health qid gov au 3405 6121 Appendix 6 Creating a New E mail Group in Groupwise To set up a new E mail Group do the following t Address Book e Click on the Address book icon in Groupwise p ee upper left side of the toolbar Tn E Details BB osete A Action e Select the Address Book in which you want the group to appear e g CPI Studies Novell GroupWis
10. Select the folder you wish to save it in by clicking Browse find the folder in the list and click OK X Cose G Reply ap Forward 8 O amp 8 A eh B x Repeat this for all the components of ATES Items to save the e mail you wish to save Ciccseeee HTML Message Attachment IMAGE jpg Attachment Where do submit my Research Study for HREC reviev Browse For Folder Select Folder S O Networks Save to Disk Combined HREC amp RGO Saved message format E CR Access website info 2 CRC Network amp 2008 Save file as E 2009 Greetings tf O 2010 including Forur y lt gt Rich text RTF Current directory CAWINDOWS system32 Folder CRC Network v Report file name conflicts Make New Folder cancel Queensland Health Guidelines for The Management of Investigator Initiated Multi centre Research 40 of 50 Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health qld gov au ohmr ohmr health qld gov au 3405 6121 Appendix 9 Setting up a document to Track Changes This tool is only available in Word documents Open the document in Word Simultaneously press on Control Shift E OR Click on Tools 4 Normal ug Documenti Microsoft Word File Edit Yiew Insert Format Table Window Help DEHA R N Spelling a
11. Book S amp CPI Studies E Mail Address Office Phone A i Nei 8 Poppins Mary Mary Poppins nanniesRu 07 1234 5678 E Frequent Contacts Queensland Health Guidelines for The Management of Investigator Initiated Multi centre Research Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health qld gov au ohmr ohmr health qid gov au 3405 6121 39 of 50 Appendix 8 Saving an E mail Text as a Word document Open the e mail you wish to save and click on File ae Save the selected items and attachments Edit View Actions Tools Window Help Forward gt B amp amp amp A k BG Attachments TE Properties Alt Enter 21 07 2010 3 32 pm Print Ctrl P 7 save emails and emails with attachments Close Click on Save As and you should see the following screen Message Where dol submit m X close l Reply Forward 3 Ad foe B BIE kense 21 07 2010 3 32 pm dy cree Select the part of the e mail you wish to Attachment Where do submit my Research Study for HREC review save and click Save Ensure that the suffix of the document om contains the descriptor rtf If you do not Saved message format include this you will not be able to open the d S VE Tile Ss document when you have saved it TT rse Current directory C AWINDOWS system32 v Report file name conflicts
12. HREC application such as the Protocol IB HREC Approval letter Master PICF s local site PICF s all study questionnaires advertisements etc Ensure you include in the footer detail of the local PICF the Master PICF version number and date as well as the site specific version number and dates as per the Sponsor CRO HREC requirements The Site PICF footer should contain the following details Master Participant Information amp Informed Consent Form Version x Dated DD MMM YYYY Page 1 of X Site Name Participant Information and Informed Consent Form Version x Dated DD MMM YYYY 5 3 Contracts The CPI is responsible for the preparation of contracts for Accepting Sites Under the process of Single Ethical Review there should only be one legal review of Research Contracts for each study However if standard contracts are used as indicated on the Queensland Health REGU website http www medicinesaustralia com au pages page39 asp there should be no need for legal review If a non standard contract is used the CPI is to organise the legal review of the contract through their site RGO Notify the other Accepting QH sites that you are organising the legal review of the non standard contract through your site RGO Once the contract is approved by the QH District Solicitor it will be sent back to the CPI for collection of signatures Each site requires a minimum of 3 original signed contracts Original signatures are required on
13. HREC for ethical review For HREC jurisdictional boundaries refer to Where do I submit my single site research study for HREC review located at http www health qld gov au ohmr documents regu hrec_subm _locn_sngl pdf Queensland Health Guidelines for The Management of Investigator Initiated Multi centre Research Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health qld gov au ohmr ohmr health qld gov au 3405 6121 50 of 50
14. Investigators at other participating sites for which the CPI has responsibility will be denoted as Accepting PIs The document is divided into three sections Section 1 contains dot point quick reference summaries Section 2 provides greater detail to guide the researcher through the processes required Section 3 contains the Appendices referenced throughout the document Section 1 Dot Point Summaries h 2 The First Approach Consider the number of sites involved in the study Have all the sites have been chosen and signed up What contract or agreement is required If there is a Commercial Sponsor involved to what extent will they be involved What equipment resources will be required e g scanner fax machine Consider the level of experience of the CPI team members who will be undertaking the majority of the CPI tasks Setting Up To start your study Start Up preparation you need e Contact phone numbers and e mail addresses of all Accepting Principal Investigators Pls and their nominated Site Contact Person e CPI Communications and Documents Folders see Appendix 4 e Agreement of roles and responsibilities and level of support provided to CPI team members outlined in dot point below Create an e mail group for the study for communication with all sites Scan and e mail all outgoing correspondence for ease of communication Send out an Introductory e mail to the group as per Appen
15. Name E Mail A E NovellGroupWise Address Book QH10302773 QH102 te 38 Novell LDAP Address Book QH10302774 QH102 E CPI Studies Qh30549519 loan QH305 w Frequent Contact New QHB 11 CR QHB al E3 Frequent Contacts QHB 12 CR QHB 1 CAT 1234 CPI Studies QHB 13 CR QHB 1 inma Details QHB 14 Video CR QHB 1 Name QHB 16 Reception CAT 1234 Comments eo 2150000000 Remove Members 0 Contacts 0 Groups 0 Resources By hts ees e Double click on the new group or right click and select details e Select Add e Anew window will appear called Select Group Members Cancel e Click on the QH employees one at a time from the Groupwise address book Ensure they appear in the right hand pane of the Select Group Members window then click OK in the same window The person s name should then appear in the New Group window on the right F Select Group Members 7 CAT 1234 CPI Studies Summary Details Look in Novell GroupWise Address Book v us Look for Match Last Name Selected Nemes CAT 1234 Address List O To QHB 17 CR pa Comments ae oe Sorne QH10302773 QH102 QHBM AS QH10302774 QH102 Qh30549519 loan QH30 amp Add To GHB 17 CR A gt Fa O To GHB 13 CR Members O Contacts 0 Groups 2 Resources QHB 12 CR QHB 14 Video CR QHB 16 Reception AUD 49
16. and NEAF e HREC Approval Letter Notification of Commencement of Study 2 Essential Documents e CTIN Indemnity HREC only e Protocol and Protocol Amendments e Master ICFs and ICF Amendments e Investigator Brochure 3 State Specific Approvals classified by State eg e QCAT Application Approval if required e Pathology Queensland Application Approval if required e PHA Approval if required 10 SAEs SUSARs and Safety Reports 11 Annual Reports You may also find it helpful to have separate sections for each participating site in which to file separate site specific communications Appendix 5 Creating a New Address Book in Groupwise To set up a new Address Book you should only need to do this once e Click on the Address book icon in Groupwise upper left side of the toolbar Mailbox Regu Home Mailbox 10 Q amp Sent Items x gt oo Calendar bad Documents SJ Wi Checklist YY Work In Progress F Cabinet Junk Mail P Trash 249 fg Address Book File Edit View Help ia New Details 3 Delete g Action Online e Click on file and select New book A new window will appear called Create New Address Book Office Phone Title 32718787 n a fe H E z3 zij e Type in the name of your new address book we suggest i Address Book something like
17. any new sites being added to a study check the status of the HREC that originally approved the study to see if that HREC is approved to review and manage multi centre research projects For studies changing from single site to multi centre research a new HREC number may be issued when the protocol is re allocated to the HREC through QH CCS A new application may need to be made to a different Reviewing HREC if the original HREC is not approved to review and manage multi centre research projects The addition of the new site may only need to be treated as an amendment to the study if the Reviewing HREC has approval to review and manage multi centre research 7 HREC Reporting Post Approval 7 1 SAEs and SUSARs Participating sites must report all local SAEs SUSARs to the CPI Reviewing HREC and local RGO within 24 hours of finding out about the SAE or SUSAR The Reviewing HREC should correspond directly with the PI at whose site the SAE SUSAR occurred and the site should send copies of the HREC Acknowledgement letter to the CPI If the Reviewing HREC sends the Acknowledgement Letter to the CPI it is scanned and e mailed to the appropriate site contact as per the usual process Ensure the HREC Acknowledgement Letter indicates the sites at which the reported events occurred or some other method of linking the Acknowledgement to the events If the RGO at the site where the SAE SUSAR occurred wishes to discuss the incident with the Re
18. authorisation is the owner of the NEAF To obtain the signatures from Pls at other sites there are two options electronic authorisation of the NEAF or signed hard copy If Pls are registered on the Online Forms website they will be able to sign the NEAF electronically Please note that only the Principal Investigators and Chief Researcher can sign the NEAF electronically If Pls are not registered on the Online Forms they will have to sign hard copies of the NEAF This is the process that you should follow when obtaining authorisations consider sending a copy of Appendix 12 Once the NEAF is completed send it for electronic authorisation first and when all electronic signatures are in place obtain the submission code Save the NEAF as a PDF and email it to the remaining PIs who will be signing the paper copy To create a PDF of the NEAF without the word Draft written on it the NEAF must have a submission code Then click on the Submission tab again and select the option to create a PDF of the NEAF Select the option to generate a PDF Without the last 3 text changes and follow the prompts In doing this the electronic signatures will be included on the NEAF that has the submission code Hard copy signatures will be collected later on the pages with the same submission code If you attempt to print the NEAF prior to obtaining the submission code you can only print a draft version and the
19. content of the CV please see QH GCP SOP No 1 at this website http www health qid gov au ohmr documents regu gcp sop _v1 pdf Uploading of the CVs should be performed by the Accepting site contact person when the NEAF is sent out for electronic authorisation from the PI The CVs of Associate Investigators do not get uploaded to the NEAF These CVs are attached to the SSA Form for submission to the site RGO 3 10 Electronically Attaching Supporting Documentation to the NEAF For information on electronically attaching documents to the NEAF go to Section 4 2 of the Online Forms User Manual at Help section at https ethicsform org Au Help AU 20Online 20Forms 20for 20Research 20User 20Manual 20v1 pdf At this time documents electronically uploaded to the NEAF are NOT automatically transferred to the SSA Forms created Therefore you will need to ensure that you e mail these documents to all Accepting Sites for which you have CPI responsibility to enable them to upload the documents to their SSA Forms once they have been created If you decide to attach the documents to all the SSA Forms yourself you will have to upload all documents to each SSA Form individually You cannot do this as a single operation for multiple SSA forms 3 11 Participant Information Sheets and Consent Forms Some sites may have specific clauses to be inserted into the Participant Information Sheet and Consent form PICF such as clauses relating to contra
20. enable them to sign a hard copy of the signature page that will have the submission code at the base of the page Once signed the Accepting PI should scan the signature page and upload it into the Online Forms site with the NEAF or post the signature page to the CPI for uploading electronically and insertion in the NEAF prior to photocopying The Protocol Signature page if required for HREC submission should be e mailed to all Accepting Pls for signing and either uploading with the NEAF or e mailing back to the CPI to enable the CPI to upload it with the NEAF The Protocol Signature page is really only required by the Sponsor Do not make any changes to the NEAF after the electronic signatures have been obtained or after the submission code has been generated as any amendment to the NEAF will void the electronic signatures Contact the Central Coordinating Service for allocation of the project to the first available appropriately certified Reviewing HREC Contact the Reviewing HREC regarding their preferred templates for Annual Reports SAE reports and any other site specific requirements If applicable CTN Forms for all participating sites are sent to the Reviewing HREC for signing before being signed by PIl s at participating sites Negotiations with the Sponsor regarding publication of study data on the QH Database of Research Activity Q20 on the SSA Form will be undertaken by the CPI and the outcome notified to Accepting
21. mail group Place a copy in the CPI Correspondence and Documents File Scan and e mail any correspondence from the HREG including the requests for amendments to any study documentation Ensure that any amended documents are sent electronically to your e mail group including the cover letters created by you and that copies of all correspondence are filed in your CPI Correspondence Folder As soon as you receive the Approval Letter from the Reviewing HREC scan it and e mail it to the Study Group and file in your CPI Documents Folder This will enable them to finalise their Site Specific Applications It is also prudent to update Accepting QH sites about the progress of any CaSS PHA or QCAT applications Remind all sites that their Annual HREC Reports are due in on the anniversary of the HREC approval date NOT the date on which they receive site authorisation to conduct the research Please note that all QH HREC Approvals are for a maximum of three years If an extension to the approval date is required ther CPI must write a cover letter from the CPI explaining why the extension is required eg low recruitment rates and include an updated literature review updated safety data for all clinical trials involving this investigational product and an assurance that there is adequate financial support as per NEAF Q3 1 3 4 3 16 QH Database of Research Activity DORA Permission must be obtained regarding publication of study informatio
22. manually cross out the HREC on the NEAF and write in the correct one Q4 8 Have you previously submitted an application for ethical review of this research project to any other HRECs This question does not ask if the research project has been submitted to other HRECs it asks if YOU have submitted the research project to other HRECs for review The answer to this question in most cases is No Under single ethical review of multi centre research as the CPI you should not have submitted this research proposal to any other HREC The only exception to this is if this was previously a single site study and you are now adding additional sites and changing it to multi centre research Q6 1 Participants When answering this question if you need assistance in answering later questions Q 9 7 regarding Aboriginal and Torres Strait Islander peoples please contact QH REGU to obtain contact details for the External Expert in this field Q6 7 Relationships between members of the research team and possible participants For this question you should assume that all Accepting Sites will have similar categories of team members involved in the research project so your answer should refer to a possible clinician patient relationship Q6 13 Recruitment processes In this section write generally about the types of recruitment processes likely to be used Site specific processes are addressed in the SSA Form Section 10 Signatures in the NEA
23. new screen will have a message text box in which you can type a message When you are ready to send the NEAF back simply click on Send Back and the NEAF will automatically transfer back to the owner Queensland Health Guidelines for The Management of Investigator Initiated Multi centre Research 45 of 50 Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health qld gov au ohmr ohmr health qld gov au 3405 6121 Appendix 12 How to Electronically Authorise an Online Forms document To electronically authorise an Online Forms document you must be registered on the Online Forms site You will receive an e mail notification to the e mail address you have nominated as your log in e mail instructing you to log into the Online Forms site Once logged in you will see on the Requests for Authorisation tab that there is number in brackets indicating the number of requests you have currently for electronic authorisation MY CONTACTS HELP CONTACT US HOME MY PROJECTS a My Projects Import xml NEAF amp otter forms sl Lo Project Categories pn z Create New Project New Projects 29 Form Type Training forms 4 L Duffer ones 4 L Submitted and completed 5 Redundant forms 4 Projects Form Title Project Created On i Demonstration project NEAF 26 08 2010 Transferred In In
24. of each site to contact their own participants and notify them of the termination Section 3 Appendices Appendix 1 First Communication between CPI and Accepting Sites Caution If you are copying and pasting this letter paste it into a Word document and attach it to an e mail If you paste it directly into an e mail the formatting may be corrupted Salutation of choice My name is insert name your name and am your contact from the CPI site for the Study name study The purpose of this e mail is to outline some of the reporting procedures for this study and proposed study timelines Study communications have set up an e mail group listing the e mail addressed of all the Principal Investigators and nominated Site Contact Persons for this study will be communicating with you by e mail only for this study Please contact me by e mail In this way we all have a copy of study communications THE HREC Application The NEAF will be completed on the Online Forms version of NEAF You will need to be registered on this site If you are not registered please go to the website and create your account https Awww ethicsform org au Signin aspx Your Pl and Heads of Departments will need to be registered on the site too to enable them to electronically sign the NEAF Please be aware that after registering on the Online Forms site you must activate your account in order to be recognised as a user You must also se
25. responsibilities Accepting Site A site that is participating in a multi centre research project but which has not taken on CPI responsibility CaSS Clinical and Statewide Services including Pathology Queensland and Medication Services Queensland Go to http www health qld gov au ghcss CCS CPI Queensland Health Central Coordinating Service for Multi Centre Research Go to http Awww health qld gov au ohmr html regu cen_ coord serv asp Coordinating Principal Investigator The CPI Team is responsible for coordinating all HREC processes throughout the study on behalf of the Accepting PI s over which the CPI has CPI responsibilities CRC Clinical Research Coordinator May also be referred to as Study Coordinator Clinical Trials Coordinator or Research Coordinator CTA or CTRA Clinical Trials Research Agreement Go to http Awww medicinesaustralia com au pages page39 asp or for device trials http www mtaa org au pages page283 asp CRA The Clinical Research Associate CRA is a Sponsor or Clinical Research Organisation CRO representative employed to monitor clinical trials The CRA ensures compliance with the clinical trial protocol checks site activities reviews case report forms CRFs and acts as a communication conduit between sites and the sponsor organisation CRO Contract Research Organisation A research organisation which is contracted by the Sponsor to undertake m
26. they can delete information relating to all researchers other than researchers from their own site Record on your communication planner record that you have sent the SSA Form out to each of the Accepting Sites Please note that only people who have registered on the Online Forms site can accept and access the SSA Form If an extension to the ethical approval period has been granted the CPI must send a copy of the HREC approval extension letter to Pls who will forward this to their local site RGO along with a updated study budget 5 2 Participant Information Sheets and Consent Forms Once the Reviewing HREC has approved the Master PICF the only changes Accepting Sites can make to the PICF are research governance changes unless as otherwise indicated in the HREC Approval Letter This Site Specific Consent Document must contain the name of the site from which recruitment is to occur this may be on the relevant institutional letterhead the relevant site specific contact details such as the local principal investigator who to contact if injury is sustained the contact details of the person identified by the institution to receive complaints etc the name and contact details of the Reviewing HREC the approved Master Consent Document version number amp date and e the Site Specific Consent Document version number amp date You will also need to upload any documents that have been e mailed to you from the
27. to another member of the research team such as a CRC the responsibility for the study ultimately rests with the CPI For this reason all references in this document regarding workloads and allocations of duties are directed to the CPI Contact Us Research Ethics and Governance Unit Office of Health and Medical Research 13 Floor Queensland Health Building 147 163 Charlotte Street Brisbane 4000 GPO Box 48 Brisbane 4001 T 07 3234 0034 F 07 3234 0107 E REGU health qld gov au E ohmr health qld gov au Central Coordinating Service T 1300 753 227 1300 QLD CCS E QHCCS health qld gov au W http Awww health qld gov au ohmr html requ cen coord serv asp Feedback on this document E requ health qld gov au Introduction This document is designed as a reference guide to assist a Coordinating Principal Investigator CPI or delegate of an Investigator initiated multi centre research study in developing a work plan to ensure the study is coordinated in an organised and informed manner from study start up to completion Using this guide the workload placed on a CPI or delegate when taking on the responsibilities of coordinating a multi centre research project should not be significantly greater than the workload experienced prior to the introduction of single ethical review of multi centre studies In this guide the Coordinating Principal Investigator CPI or delegate is denoted as CPI the Principal
28. you will Tarma taina cine see the Microsoft Word amendments in the 2 Wig inte my Resear Study for IRE reve was sert fo raven Do you mark to merce changes i Were do submit ny Research eee ee merged into your _ Nov and dort askasin_ original document and tracked as changes Gil Lead Site Guidelines for QH CRCs 10 08 10b Microsoft Word Eile Edit View Insert Format Tools Table Window Help O8B8 6RY avo 808 4 Doument Title Arial BT A Finalshowing Markup Showy Up lt Z ae r 4 Wi Fia z Queensland Health Guidelines adfsdfg The Management of Commercially Soonsored 5 gt a Save the document in the normal manner Queensland Health Guidelines for The Management of Investigator Initiated Multi centre Research 43 of 50 Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health qld gov au ohmr ohmr health qld gov au 3405 6121 Appendix 11 Accepting an Online Forms document for Review This information may be copied and e mailed to Accepting Sites to assist them with the process of accepting an Online Forms document that you have sent them for review It is best to copy and paste it into a new document and attach that document to an e mail It you paste it directly into an e mail the formatting may be lost How to Accept an Online Forms Doc
29. AF is to be used to enable creation of the SSA Form https Awww ethicsform org Au Forms NeafFormList aspx Please note that for some research projects the Low and Negligible Risk application form only may be required This form will soon be available from the Online Forms website but currently is only available from the QH REGU website Go to http www health qld gov au ohmr documents low_risk_app doc Complete all required sections of the NEAF and include the Accepting PIs from all participating sites Electronically upload all study documentation including Protocol Investigator Brochure Participant Information Sheets and Informed Consent Forms PICFs Investigator CVs but not Associate Investigator CVs questionnaires participant diaries advertisements etc Ensure that you complete identifier details in the Description box to differentiate between documents of the same name eg Investigator CVs questionnaires If you create the NEAF on the NHMRC version of NEAF documents cannot be uploaded and electronic signatures are not possible However it is a simple process to import the NHMRC NEAF into the Online Forms version Please see the Researcher User Guide Section 1 1 7 http www health qld gov au ohmr documents requ resrch_user guide _v1 pdf Do not open the file once you have saved it as an xml file as this will corrupt the file and you will not be able to import it into the Online Forms
30. CD New Contact fig 0 en 200 0 0 O08 MOO e Repeat this process for all QH personnel participating in the project e f an entry to the group is made in error simply click on the incorrect entry to highlight it e The word Remove will appear in the left hand pane Click on Remove to delete the incorrect entry Queensland Health Guidelines for The Management of Investigator Initiated Multi centre Research 38 of 50 Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health qld gov au ohmr ohmr health qid gov au 3405 6121 Appendix 7 Adding Non QH Contacts into Groupwise To add in names of people who are not QH employees take the following steps Address Book e Select the File Edit View Help correct Group from your CPI Studies address 2 wis I CPI Studies book Novell GroupWise Address Book BA Novell LDAP Address Book CPI Studies J Name Office Phone Department g CAT 1234 Frequent Contact New rr New Details 3 Delete Action Address Book File Edit View Help e Go to the upper left side of the tool bar as S z and click on New then select Contact lt e E ostais Dette Zaton CPI Studies e Click OK Novell Groupwise Address Book 4 3 Novell LDAP Address Book E CPI Studies gS CAT 1234 Select the entr e Anew window will appear with prom
31. F There are three separate signature sections in the NEAF 10a Principal Investigators and Associate Investigators The Pls signatures from all Accepting Sites are required Associate Investigators are only required to sign the SSA Form even though their name will appear in the NEAF Signature section 10b Student Supervisors Signatures are required from student supervisors at all sites where a student is participating in the research 10c Head of Department Only the signature from the Head of Department from the CPI site is required Heads of Department from Accepting Sites will sign the SSA Form Please note Where a researcher is also the Head of Department the researcher cannot sign as the Head of Department Their line manager must sign as the Head of Department in both the NEAF and the SSA Form 3 4 Transferring the NEAF for Review by Principal Investigators at Accepting Sites The completed NEAF should be sent for review by Principal Investigators at all Accepting Sites for which you have CPI responsibility If you try to do this via the Transfer option in the Online Forms site you can only send the NEAF to one PI at a time This will create long delays if there are many participating sites and therefore Pls for which you have CPI responsibility The most efficient way to send the NEAF out for review is to save it as a PDF document and e mail it out to all Accepting Sites with a message giving them
32. F will need to be made to the site specific PICF at a local level All amended documents must be forwarded to the Site RGO along with the HREC approval letter for those amendments A copy of the RGO Approval Letter is forwarded to the CPI for filing in the Documents folder under the specific sites 6 2 Adding a New Accepting Site Scenario A A study was approved prior to 01 July 2010 and now additional sites are to be added The original reviewing HREC is now a certified HREC for multi centre research MCR If only one additional site is to be added the new site will be treated as though it is a single site and will submit their own application to the original Reviewing QH HREC If more than one extra site will be added eg 2 new sites original site a new NEAF must be created and submitted via the QH CCS where a new HREC number will be allocated Where possible the original reviewing HREC will be used to review the study Scenario B A single site study is being conducted at only one QH site and the study was reviewed and approved by an HREC that is not certified to review and manage MCR Extra sites are to be added to the study A new NEAF will need to be submitted via the QH CCS to an HREC that has been approved to review and manage MCR A new HREC number will be generated for the study The original PI can continue to conduct the trial and will continue to report to their local HREC until such time as the study has been a
33. Investigator Initiated Multi centre Research 33 of 50 Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health qld gov au ohmr ohmr health qid gov au 3405 6121 Appendix 3 Spreadsheet for Tracking SAEs and SUSARs EA Microsoft Excel Lead Site Communication Spreadsheet File Edit View Insert Format Tools Data Window Help Calibri u BZU FS3S2H8 S 53 EE aA OBES 64Y Be Jno A2 hy Bor B_ H21 X me D E F G H Serious Adverse Event Record Australian Master Copy Date of Name of Event HRECmeeting Copy of HREC Follow up Copy of HREC Final Report HREC Meeting Copy of HREC event for Initial acknowledgement reports Acknowledgement date for Final Acknowledgement Report sent to Lead CRA dates sent to Lead CRA Report sent to Lead CRA Sitel example 29 Jul 10 Fractured Hip Aug 10 Aug 10 Nil 31 Aug 10 Sep 10 28 Sep 10 Site 2 Site 3 Site 4 site 5 Site 6 site 7 Queensland Health Guidelines for The Management of Investigator Initiated Multi centre Research 34 of 50 Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health qld gov au ohmr ohmr health qld gov au 3405 6121 Appendix 4 CPI File Index example CPI File Index Correspondence Folder 1 Correspondence General 2 Correspondence HREC Documents Folder 1 HREC Application documents including e Copy of HREC submission
34. LP a We had a lovely day at the seaside last Sunday Form Type NEAF Status Submission Code AU 1 F41707 HREC Reference None Owner Form Section WA Created On 24 03 2010 Signatures None Last Modified On 03 09 2010 11 13 00 3 E my Project Navigate Documents Authorisation NAF Electronic authorisations requested for this NEA YA Margaret Morton on 03 09 9010 11 14 that you sign this form as Principal Researcher Electronic e to ink signatures Please cli k here for downloadable step by step instructions on electronic A request for authorisation was sent by authorisation is available as an alterng authorisations Please check the data in thi After reviewing the form ch form by clicking the Review Requesfed Form button the Navigate icon and then go to th Authorisation submenu to authorise the form Reject Request Review requested form Click on Review Requested Form The document will open as a Read Only copy Although you will be able to type text into the document you will not be able to save any entries HOME a We had a lovely day at the seaside last Sunday Form Type NEAF Status Submission Code AU 1 F41707 HREC Reference None Owner Form Section 1 TITLE and SUMMARY of Project Created On 24 03 2010 Signatures This form is attached with electronic signatures any changes to the form will invalidate the signatures Last Modified On
35. Once the HoMER process commences there will be a standard reporting form for SAEs and SUSARs Until this time you may need to use the preferred reporting template for the Reviewing HREC Ensure you obtain a copy of this template when you make your first contact with the Reviewing HREC and send the template to all Accepting Sites For information on the preferred SAE reporting format for all QH HRECs go to the following website and look under Site Reporting Requirements http www health qid gov au ohmr html regu hrec_contacts asp It would be good practice to record all site SAEs SUSARs and any other safety reports received on a spreadsheet to enable you to keep track of all submitted safety information See Appendix 3 for an example of the CPI Record of Study SAEs and SUSARs As soon as the SAE or SUSAR Acknowledgement is received scan the Acknowledgement Letter and forward to the specific site s if not already sent to them and file it in the CPI File Ensure the HREC Acknowledgement Letter indicates at which sites the events occurred or some other method of linking the Acknowledgement to the events If the Acknowledgement Letter relates to submission of 3 6 monthly line listings if the research project involves a drug or device scan the Acknowledgement Letter and e mail a copy of the 3 6 monthly line listings and the Acknowledgement Letter to the E mail Group File the letter in the CPI file 7 2 3 6 Monthly Line Listings and ot
36. Progress Click on the Requests for Authorisation tab The details of the study will appear in a new text box Do NOT open the document by clicking on the document name Whilst this is possible you will not be able to authorise the document if you access it in this way The correct way to open the document is to click on the Open Request prompt HOME MYPROJECTS MYCONTACTS HELP CONTACTUS m My Projects i Le Project Categories a Create New Project Import xml NEAF amp other forms New Projects 29 Transfer Requests Training forms 4 Duffer ones 4 Submitted and completed 5 REQUESTS SIGNED LS Redundant forms 4 ea Form Accidently locked 1 Type L New Category 0 We had a lovely day at the seaside 03 09 2010 Principal last Sunday 11 14 NEAF Researcher Open Request Request L New Category 0 Projects Requests for Authorisation 1 Short Title Request By Request Date Signature Type Action Manage Categories Queensland Health Guidelines for The Management of Investigator Initiated Multi centre Research 46 of 50 Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health qld gov au ohmr ohmr health qld gov au 3405 6121 The next text box will prompt you to either review the form or reject the request CONTACT US MY CONTACTS HOME MY PROJECTS HE
37. Sites when the SSA Forms are created and sent out by the CPI See Appendix 13 for a summary of research project submission processes CaSS Applications Guardianship Applications and PHA Applications within Queensland 4 1 Clinical and Statewide Services CaSS Applications The CPI applies for CaSS Authorisation for participating QH sites only Accepting QH sites still need to contact their local Pathology Queensland Laboratory manager to negotiate the conduct of the project at their site The Authorisation to Proceed should be e mailed to all participating QH sites as soon as it is received to enable completion of the SSA at Accepting Sites 4 2 Queensland Civil and Administration Tribunal QCAT Applications Each PI is responsible for making his her own application to the Queensland Civil and Administration Tribunal for Guardianship approval of the study QCAT applications are made after HREC approval has been received and before RGO Authorisation can be granted Once received the QCAT Approval Letter should be processed at each site in the normal manner 4 3 Queensland Public Health Act PHA Applications The PHA application submission occurs after HREC Approval has been received and before RGO Authorisation can be granted One PHA Application will cover all participating QH sites Ol E mail the scanned Approval Letter to all relevant sites Research Governance Review The CPI creates the SSA forms for all t
38. TX Form as the Sponsor of the study but will still need to sign the CTN CTX as the PI for their own site Ideally the order of signing will be HREC Chair delegate e Local Site Principal Investigator Institutional Authority Approving The Conduct Of The Trial e Trial sponsor must always sign last as indicated on page 6 of the CTN CTX part 2 Form The Chairs of the QH certified HRECs have agreed to sign the CTN prior to the local Pls signing the document 3 14 Forms of Indemnity If the CPI and all Accepting Pls are QH employees a Form of Indemnity is not required as both the Sponsor CPI or Queensland Health and the Pls are all covered under QH indemnity If the CPI is a QH employee and one or more Pls are NOT QH employees the indemnification processes must be assessed on a case by case basis under consultation from the District Health Solicitor 3 15 The HREC Submission Ensure that all study documentation has been received either electronically or in hard copy It is sensible to create a study spreadsheet listing all the sites and all the study documentation sent or received Keep this up to date and refer to it regularly If there are some sites who have not returned all required paperwork in time for the HREC submission those sites may be added in as an amendment to the study at a later date If you receive an Acknowledgement Letter from the allocated HREC scan it and e mail it to the Study e
39. a specific time in which to review the document include a statement that if they have not responded by date you will assume they have no amendments to the NEAF Instruct Accepting Sites that any changes to the NEAF should be saved in a Word document since they will be unable to insert changes into the PDF document and e mailed to you but ensure that the Section and Page number of the change is included the e mail This way if any Pls wish to amend the NEAF they can contact you directly You can ascertain the importance of this proposed amendment discuss it with the relevant PI and CPI and a decision can be regarding implementing the change This is also a good time to remind Pls to register on the Online Forms website to enable electronic authorisation of the NEAF and to enable uploading of their Investigator CV s Ensure you file a copy of this e mail in the CPI Communications Binder If you do decide to send the NEAF for review via the Online Forms Transfer option the Pls must have registered on the Online Forms site in order to be able to receive the NEAF transfer Do not obtain the Submission Code prior to sending the NEAF out for review wait until all changes are made and you are sending the NEAF out for electronic authorisation before requesting a Submission Code Ensure you Clearly state in your NEAF Transfer Message Box that you will be retrieving the NEAF on a certain date and that no other chan
40. anagement and monitoring of a research project CTN A form used for notifying the TGA of a Clinical trial The Clinical Trial Notification Form Click on Clinical Trials Forms at http Awww tga gov au ct index htm CTX Clinical Trial Exemption Scheme A form used for notifying the TGA of a research project for which TGA approval is required Go to http www tga gov au ct ctglance htm and click on Clinical Trials at a Glance CV Curriculum Vitae For QH Guidance on CV s go to http www health qld gov au ohmr documents regu gcp sop v1 pdf DORA The QH Database Of Research Activity A QH sponsored website listing all research projects being conducted within QH sites Permission must be obtained from the Sponsor to publish details on the website The consent form is part of the SSA Form HOD Head of Department In the NEAF Section 10 this is the person who is supervising responsible for the researcher i e the PIs Head of Department either in the Institution or University etc In the SSA Form section 21B HOD refers to the Department Head s at the site where the actual research is taking place e g an antenatal clinic cardiac catheter laboratory etc SSA Section 21C refers to the Heads of Supporting Departments at the specific site where the research is being undertaken These are the departments that are providing services for the research study e g Medical I
41. anner Queensland Health Guidelines for The Management of Investigator Initiated Multi centre Research 44 of 50 Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health qld gov au ohmr ohmr health qld gov au 3405 6121 To transfer the NEAF back to the Owner e Once you have reviewed the NEAF and made any changes click on the Save icon top and bottom of each page right hand side e Click on the Navigate icon You will be taken to the Index Screen for that project e Click on the Transfer tab Australia gt A Online Forms Ss x x for Research My Account Logout HOME MY PROJECTS MY CONTACTS HELP CONTACT US jr just a test Form Type NEAF Status Transferred In Submission Code AUS 8095 256491 498 HREC Reference None Owner Form Section WA Created On Signatures This form is attached with electronic signatures any changes to the form will invalidate the Last Modified On 01 09 2010 13 34 55 signatures 3 PA my Project Navigate Documents Transfer Authorisation NEAF E This Form has been transferred to you sE You may edit and print this form You will need to get the original owner to reclaim this form to have any other action carried out such as transferring to another user Include personal message Send Back Application To Owner gt gt Send Back lt lt e The
42. any amendments requested by the Reviewing HREC during the HREC review and approval process Therefore each PI should sign the final SSA Declaration s and create a submission code for the SSA only after HREC approval has been given To create the SSA Forms open the NEAF at the Index page and click on the SSAs tab Insert the number of SSAs you wish to create and click on Create a new SSA Form Don t forget to include your own SSA Form in the number of SSAs to be created Select an SSA Form and indicate in the location tab which state the SSA will be submitted in and label the SSA with the relevant hospital name e g Townsville Hospital Gold Coast Hospital etc Once you have done this the tab bar options increase Select Transfer and insert the e mail address of site contact person that is specific to that particular SSA Click on transfer to user and answer yes to the prompt This action will permanently transfer the SSA to the nominated recipient Once the recipient has accepted the SSA Form the owner of the SSA form will alter from the person who created it to the recipient A copy of the NEAF will also be transferred with the SSA Repeat this for all SSA Forms except your own E mail electronic copies of study documentation including the HREC Approval Letter to all Accepting Sites to enable them to electronically attach these documents to their SSA forms Don t forget to inform the Accepting Sites that
43. ception particular cultural groups or consent to contact external medical personnel So as a priority e mail all sites as soon as possible and ask the sites to e mail you any specific clause s they want added Inform the group that you will deal with the clinical wording of the document Over time you can build a library of specific site clauses When you are inserting details into the Master PICF about the contacts for the study the following responses or insertions are suggested For queries regarding the research project insert a comment to say that the names and contact details of the Local Pls will be inserted by Accepting Sites prior to submission to their site RGO For queries about the approval process or complaints about a researcher or the research project contact the Reviewing HREC Administrator insert a name and contact details Rather than leaving the response date from Accepting Sites as a vague future time consider inserting a phrase that says If you have not responded by date e g 1 week forward I will assume that you have no site specific clauses for inclusion in the PICF The CPI will determine which additional clauses may be inserted into the PICF Therefore if you do receive any proposed clauses to the PICF include these into your Master PICF You may wish to annotate the clauses in such a way that it is clear they are specific to a particular site so that the CPI and Reviewing HREC can identify whi
44. ch site to discuss the clause with if there is a problem Ensure you have tracked changes and use the Comment icon to identify which site has requested which clause s Amend the clinical wording using the tracked changes tool Try to have at least 2 weeks between your nominated cut off date for the return of site specific clauses and the HREC submission date to enable the sponsor to review any changes to study documents When the PICF is ready for submission to the Reviewing HREC save as a clean copy without tracking or annotation Page1 of the Master PICF and the section relating to site contacts in the body of the Master PICF should have areas left blank for insertion of investigator name s site contact details and complaint contact details or contain a message indicating that these details will be completed by the sites for submission to their site Research Governance Officers RGO s The Master PICF footer should contain the following information Master Participant Information amp Informed Consent Form Version x Dated DD MMM YYYY Page 1 of X The footer should contain the word Master for HREC submission site specific version details will be added when submitting the approved Master version to the RGO at each site When submitting for HREC review ensure you submit the Study Master PICF with correct version details and date If the Reviewing HREC requests changes to the Master PICF the version details must be altered t
45. contracts Each site will send 3 signed contracts signed by the Sponsor QH and the PI to their site RGO with the SSA The site RGO will retain one contract and return two to the PI The PI will keep one contract and return the remaining contract to the sponsor CRO 5 4 Indemnity Forms The CPI will prepare Forms of Indemnity if required as outlined in Section 3 14 5 5 Study Budgets The CPI will determine the budget for each participating site and email those details to each Accepting PI to enable them to complete their SSA forms 5 6 RGO Authorisation Once Authorisation has been received from the Site RGO each site should ensure that the Authorisation Letter is mailed or scanned and e mailed to the CPI This letter will be filed in the Documents folder under the specific site 6 Post Approval Amendments 6 1 General Amendments The CPI will notify all sites of any impending amendments to the Protocol PICFs or any other study documents and will modify the study documents as appropriate electronically upload the documents into the Online Forms site via the NEAF that was submitted for the study and submit these to the Reviewing HREC for consideration and approval Version details should be modified and noted on all amended documents Once the Approval Letter is received back from the Reviewing HREG it is scanned and e mailed to the Study Group along with the amended documents Any changes to the Amended Master PIC
46. d gov au ohmr ohmr health qld gov au 3405 6121 Appendix 2 Spreadsheet for Tracking CPI and Accepting Site Communications EJ Microsoft Excel Lead Site Communication Spreadsheet Eile Edit View Insert Format Tools Data Window Help _ Calibri i yi BUS S23 BS 3 53 4 DOSER SRY BBS o c AA Ms oo B C21 X f Study Name Site 1 Site 2 Site 3 Site 4 Site 5 Site 6 Site 7 Site numbers 40003 Site Name RBWH Site Contact Person Jo Jackson Site Contact Email jo jackson health qld gov au Site Contact Phone 3333 3333 Introduction Email sent 24 Apr 10 insert date under site numbers Response recevied re Site specific 30 Apr 10 clauses for inclusion in PICF insert date under site numbers Protocol Signature page recieved 30 Apr 10 insert date under site numbers NEAF Signed by P I E E Electronic H Hardcopy P I CV received 30 Apr 10 insert date under site numbers Signed CTN Form received from 26 May 10 Sites insert date under site numbers HREC Approval Letter emailed out 30 May 10 insert date under site numbers Signed CTN Forms distributed 1 Jun L0 insert date under site numbers RGO Authorisation letter received 24 Jun 10 from Sites insert date under site numbers RGO Authorisation letters emailed 30 Jun 10 to Lead CRA insert date under site numbers Queensland Health Guidelines for The Management of
47. dix 1 Start setting up reminders in your calendar for future study related events 3 Preparing the HREC Application Ensure all supporting study documents for HREC review are electronically uploaded into the Online Forms site with the NEAF or LNR Form once this is available on line E mail all study documents to Accepting Sites to enable the Accepting Pls to electronically attach all documents to the SSA once the SSAs have been created Send the Participant Information sheet and Consent Form PICF to all Accepting Sites for review and amendment with site specific clauses If amending the PICF the new PICF should be uploaded into the NEAF Include the new version details when electronically attaching the amended documents Footer details for the PICF should be as follows Master Patient Information and Informed Consent Form Version x Dated DD MMM YYYY Page 1 of X Ensure that any sub studies or study addendums and their accompanying documentation are electronically attached to and included in the NEAF CVs of Pls only should be uploaded into the Online Forms site with the NEAF by the individual site contact persons and the investigators name and site name inserted into the Description box 4 If hard copies of signatures are to be used the CPI must wait until after all electronic signatures have been collected obtain the submission code then save the NEAF as a PDF document and email to Accepting Pl s to
48. e will include them prior to sending you the PICF for review You will have 5 days in which to review the PICF and insert any site specific clauses if you did not e mail them to me ahead of time will then liaise with the CPI to review the requested changes Study Contracts As the CPI our team will organise for the legal review of any non standard contracts or clauses CTN CTX Forms We will create the CTN Forms organise for the HREC to sign them and then send them to you for signing by thPI and the institution Please ensure you return the CTN forms to me so we can send them on to the TGA Site Contracts and Forms of Indemnity Where appropriate we will create the contracts and Forms of Indemnity and send them to you for signing When completed please return these to me The SSA Form will create your SSA Form and transfer it permanently to you to enable you to complete it and submit it to your site RGO You cannot submit the SSA Form until the HREC Approval has been granted will also send you the appropriate responses to Q20 of the SSA Form Site Authorisation Letter When you receive your Authorisation Letter from your site s RGO please send a copy to me SAEs SUSARs occurring at your site For any SAE or SUSAR occurring at your site you must report it to the CPI Reviewing HREC and site RGO within 24 hours of finding out about it will send you the reporting templates once the HREC process is completed The Reviewi
49. e Address Book i 3 Novell LDAP Address Book Frequent Contact New Frequent Contacts B PAH Medicatio Logan ROS amp J 8 0417983317 04 8 0417939288 04 E GH Groups E Research Groups j CPI Studies e Click on New upper left and select Group from the pop up window ni Address Book New Group CPI Studies e Click Ok File Edit View Herif Summary Details e Anew window will appear prompting you to q Name name the new group p A Comments e For simplicity use either the Protocol Number e g CAT 1234 of Study Acronym as the group E i Members O Contacts 0 Groups 0 Resources name Q Add x f cs ra QH Groups Research Gro E CPI Studies Summary Details Name Comments Members 0 Contacts 0 Groups 0 Resources Qs Add x e Click OK Queensland Health Guidelines for The Management of Investigator Initiated Multi centre Research 37 of 50 Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health qld gov au ohmr ohmr health qid gov au 3405 6121 e The Group should appear under the heading of CPI Studies gt Select Group Members Look in Novell GroupWise Address Book Y F i N ie El Detail 3 Delet Look for Match LastName Y Selected ne ae ie Address List a To oHe 17 cR Online
50. electronically The appropriate page must be printed out signed and either scanned and uploaded with the NEAF or posted back to me for insertion into the NEAF prior to photocopying If the PI or Student Supervisor is likely to be absent when the NEAF signatures are required please obtain a signed statement from them stating they are familiar with the protocol and are able to have the project undertaken at their site or in the case of a student they are able to provide suitable supervision This letter should be signed and either scanned and uploaded with the NEAF or posted to me for further processing Timeliness of Requested Responses For each communication send out to you where a response is requested will nominate a due by date for your reply If have not received all requested information back from you by the time the application is due to be submitted for HREC review your site may be deleted from the application so as to prevent unnecessary delays in the HREC review process Your site may be added to the study as a protocol amendment after the HREC review is completed You may be responsible for any additional HREC Fees incurred as a result of this protocol amendment as negotiated with the Sponsor Participant Information Sheets and Consent Forms PICFs will e mail you the Master PICF as soon as it is completed In the meantime if you have any clauses that you require to be inserted into the PICF please e mail them to m
51. endix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 Appendix 7 Appendix 8 Appendix 9 Appendix 10 Appendix 11 Appendix 12 Appendix 13 First Communication between CPI and Accepting Sites Spreadsheet for Tracking CPI and Accepting Site Communications Spreadsheet for Tracking SAEs and SUSARs CPI File Index example Creating a New Address Book in Groupwise Creating a New E mail Group in Groupwise Adding Non QH Contacts into Groupwise Saving an E mail Text as a Word document Setting up a document to Track Changes E mailing a Document for Review Accepting an Online Forms document for Review How to Electronically Authorise an Online Forms document Summary of Submission Process for Research Studies 21 22 22 23 23 23 24 24 24 24 24 24 25 25 26 26 26 26 26 26 28 28 29 29 29 30 30 33 34 35 36 37 39 40 41 42 44 46 50 Licensed under a Creative Commons Attribution 2 5 Australia licence To view a copy of this licence visit http creativecommons org licenses by 2 5 au State of Queensland Queensland Health 2010 You are free to copy communicate and adapt the work as long as you attribute the Research Ethics and Governance Unit Office of Health and Medical Research and the State of Queensland Queensland Health Abbreviations Accepting PI A Principal Investigator who is participating in the study but does not have the CPI
52. form Click OK HOME MY a We had a lovely day at the seaside last Sunday Form Type NEAF Status Submission Code AU 1 1F27015 HREC Reference None Owner Form Section A A r z Created On 24 03 2010 Signatures This form is attached with electronic Last Modified On 07 09 2010 09 29 22 Please enter your username and password and the details relevant to this authorisation a pO my Project NEAF Usernames ea EL ie 11 06 that you sign this form as Principal Researcher Electronic 2 Are you sure you want to sign this Form te for downloadable step by step instructions on electronic Password Job Title Post L button tion submenu to authorise the form T Email health qld gov au Cour full e mail address usually the same as above r E A al al P A AU Online Forms website version 2 0 Build 14841 08 09 2010 You have now electronically signed the document It will automatically send itself back to the owner Queensland Health Guidelines for The Management of Investigator Initiated Multi centre Research 49 of 50 Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health qld gov au ohmr ohmr health qld gov au 3405 6121 Appendix 13 Summary of Submission Process for Research Studies Submission of multi centre research applications to a QH HREC International am
53. g HREC to the external expert reviewer The Reviewing HREC will continue to oversee the study In those cases where a new site s is added to a previously single site study the PIs must determine between them as to who will take on the role of CPI In all cases where additional sites are added to an already established study the following steps should be taken The PIs should decide who will take on CPI responsibilities The CPI must write a letter to the Reviewing HREC informing them of the inclusion of the new site s The cover letter should also include a comment that the addition of the new site s may impact on the monitoring responsibilities of the Reviewing HREC Along with the cover letter from the CPI the following documents must be submitted CV of the new PI A letter from the new PI stating that they have read the protocol and can comply with the requirements for the conduct of the study at their site The CPI must also create an SSA and send it to the Accepting PI for completion and submission to their site RGO All other procedures required for the RGO submission as detailed in Section 5 above should be followed 7 HREC Reporting Post Approval 7 1 SAE and SUSARs Each Accepting site has the responsibility for reporting any Serious Adverse Events SAEs or Suspected Unexpected Serious Adverse Reactions SUSARs occurring at their sites within 24 hours of finding out about it to the following parties
54. gator and main CRC or site generic e mail address for each site and members of the study management team if any You may like to create a sub group consisting only of the site contact persons at the Accepting Sites When you agree to become undertake CPI responsibilities for a second study you would again set up an e mail group for the other study example protocol Galaxy 1 using the study acronym and this group would be saved in your CPI address book Eventually your CPI address book will be a record of the different studies for which you have taken on the CPI responsibilities One word of warning ensure you save or print all e mail correspondence in your e mail archive or whatever other method you use to save communication as in QH e mails only remain in your in box sent box and trash for 3 months After this time they are permanently deleted and cannot be retrieved For guidance on saving e mails see Appendix 8 2 3 Preparing the CP Communications and Documents Folder The best way to keep your documentation together is to obtain two folders One Folder is for Communications and one folder is for Documents These folders are separate from your own Investigator Site Binder See Appendix 4 for a suggested Index for these folders In your CPI Document folder there should be separate sections for all sites participating in the project including your own site Into each section copies of participating site s
55. ges will be made to the NEAF after that time including grammatical changes Once the documents have been sent back to you by the Local Pls or after you have retrieved them you can save them as a PDF Files with the tracked changes To do this open the NEAF and click on Print Draft Select Download NEAF for Printing and select the option of the PDF with last 3 text changes Save the PDF to your desktop and review For further information go to the Online Forms User Guide section 4 3 at https ethicsform org Au Help AU 20Online 20Forms 20for 20Research 20User 20Manual 20v1 pdf For information to send to Accepting Sites on how to accept transferred forms go to Appendix 11 3 5 Legislative Requirements For studies involving exposure of humans to ionizing radiation for Research researchers must obtain an independent assessment or verification by a Medical Physicist of the total effective dose and relevant organ doses for those radiological procedures that are performed specifically for the research protocol For studies involving access to identifiable or potentially re identifiable confidential health information without consent a Public Health Act application will need to be submitted to the Research Ethics and Governance Unit post HREC approval Studies involving access to coronial material must be referred to the Queensland Health Forensic and Scientific Services Human Ethics Committee FSS HEC for ethical a
56. give a time limit for the authorisations from the PIs and give yourself time to chase up those who have not responded If hard copy signatures are required i e if the PI is not registered on the Online Forms website the submission code should be obtained and the NEAF should be saved as a PDF the signature page printed signed scanned and uploaded into the Online Forms site with the NEAF before sending it back to the CPI In this way the Submission Code will appear on the signature page You will need to print this page for inclusion into your NEAF for submission In your covering letter to the HREC it is advisable that you inform the HREC that this page has been uploaded and a printed copy is attached to the NEAF The most preferred option is that all signatures are obtained electronically through the Online Forms authorisation process rather than hard copy signatures The only person able to make changes to the NEAF after it has been sent for Authorisation is the owner of the NEAF However if any changes ARE made to the NEAF by the owner after it has been electronically authorised all current electronic signatures are voided and will need to be sought again and a new submission code must be requested All investigators must be notified of any amendments to the NEAF after they have reviewed it and all signatures both electronic and hard copy will need to be obtained again on the correct version of the NEAF with the la
57. he sites including their own site and permanently transfers the SSAs to the relevant Accepting Pls If not previously emailed the CPI should email all supporting study documentation to the Pls to enable them to electronically upload supporting documentation to the SSA Form Inform the Accepting PI that the SSA should not be given a Submission Code until the Approval Letter from the Reviewing HREC has been issued as there may be changes to the Protocol NEAF and PICF that will affect the SSA Each site will localise the PICF by adding their site contact details inserting site specific footer information However the PICF footer should still retain the reference to the Master Copy version details and date see dot point below The site specific PICF footer details should be as follows Master Patient Information and Informed Consent Form Version x Date DD MMM YYYY Page 1 of X Site name Patient Information and Informed Consent Form Version x Dated DD MMM YYYY It is each site s responsibility to upload the localised PICF Master PICF and all other study documentation including the HREC Approval Letter onto the Online Forms SSA for submission to the RGO Ensure the Accepting PI s and Sponsor if applicable are aware of the DORA requirements SSA Q20 The CPI will arrange for any legal review of the contracts through their site RGO if non standard contracts are being used QH sites only The Medicines Au
58. her Safety Updates On receipt of the 3 6 monthly line listings from the Sponsor forward these with a cover letter to the Reviewing HREC On receipt of an Acknowledgement Letter from the Reviewing HREC scan all documents and send to your e mail group File a copy of all correspondence in the CPI Correspondence File 7 3 Annual Reports The annual report date is due on the anniversary of the date of the HREC Approval Determine from the Reviewing HREC the format in which they want the report submitted i e do they want all reports collated into one document or do they want each site s report individually but submitted collectively If the Reviewing HREC requests a collated report send a reminder to all Accepting Sites 4 weeks prior to the due date of the report Send additional reminders weekly to those sites who have not responded File all annual reports as they are received One week out start collating the individual reports into the main report File a copy of all correspondence in the CPI Correspondence File File a copy of the collated and individual if you have them Annual Reports in the CPI Documents File 8 Study Termination At particular end points in the study the CPI or delegate will notify the Reviewing HREC of the following Cessation of recruitment Completion of the final participant Formal closure of the study at all sites Formal End of Study report issued by the CPI It is the responsibility
59. hildren A new study is being conducted which will involve both children and adults It will be an MCR study If children are to be participants in an interventional study then the study will be allocated via the QH CCS to The Royal Children s Hospital HREC who will send the protocol to an external expert reviewer to review the study from the perspective of the adult participant If the study does involve children but is non interventional then the study will be allocated via the QH CCS to the most appropriate certified HREC and the protocol will be sent to an external expert reviewer to examine the study from the paediatric perspective Scenario G Research involving children If the study has been reviewed for adult participants only by an HREC certified for the review of MCR and at a later stage the study is expanded to include paediatric participants then two further options arise The addition of the paediatric participants into an interventional study means that the study will have to be reviewed by The Royal Children s Hospital HREC Whether the study is taken over by the children s HREC will need to be discussed between the original Reviewing HREC and the certified paediatric HREC If the addition of the paediatric participants is into a non interventional study then a notification is sent by the CPI to the Reviewing HREC to inform them of the new paediatric site The protocol and paediatric PICF will be sent by the Reviewin
60. ith Changes icon on the toolbar to send the document back to me Thank you i The recipient will be able to open the document Lead Ste and commence review and editing Guidelines After completing the 5 review the recipient sends amp Px me a the document back tothe jala pace oe sender by clicking on gt Reply with Changes icon on the toolbar Queensland Health Guidelines adfsdfg gt gt This will enable the recipient to send back to you with relevant changes and an e mail message Queensland Health Guidelines for The Management of Investigator Initiated Multi centre Research 42 of 50 Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health qld gov au ohmr ohmr health qld gov au 3405 6121 f Send J Cancel E address Fel See SS Spell e When the reviewed sends the document back to its owner the owner receives an e mail with the RE Please review Lead Site Guidelines for QH CRCs 10 08 10b amended document attached and an automated message viitov Bru g EES I ve reviewed the attached document e When you open the attachment you will be asked if you would like to merge the changes to your original document select whichever option suits you e lf you select Yes ACON Lt BE to merge the be e aes documents
61. maging Pharmacy Pathology HoMER Harmonisation of Multicentre Ethical Review The objective of the Harmonisation of Multi centre Ethical Review HoMER initiative is to enable the recognition of a single ethical and scientific review of multi centre health and medical research within and or across Australian jurisdictions Go to http www nhmrc gov au health_ethics homer index htm 1 HREC Human Research Ethics Committee LNR Low and Negligible Risk Research This application form will soon be accessible via the Online Forms site but is currently available at http www health qld gov au ohmr documents low_risk_app doc NEAF National Ethics Application Form NHMRC National Health and Medical Research Council Go to http www nhmrc gov au Online Forms The website containing the QH preferred version of the NEAF Go to https www ethicsform org au SignIn aspx PI Principal Investigator PHA Public Health Act For further information on the implications of the Public Health Act regarding Research go to http www health qld gov au ohmr html regu aces _conf hth_info asp PICF Participant Information Sheet and Consent form May also be referred to as the ICF Informed Consent Form QCAT Queensland Civil Administration Tribunal previously the Guardianship and Administration Tribunal Go to http www qcat qld gov au and search on Resea
62. n on the DORA website Although the questions relating to DORA are found on the SSA Form Q20 the CPI should ensure all Accepting Pis are aware of the research data to be published to enable them to answer the appropriate questions on the SSA Form 4 CaSS_ Applications Guardianship Applications and PHA Applications within Queensland 4 1 Clinical and Statewide Services CaSS Applications The CPI should take on responsibility for applying for CaSS Authorisation for participating QH sites only Participating QH Sites will still need to contact their local Pathology Queensland Laboratory manager to negotiate the conduct of the project at their site The Authorisation to Proceed should be e mailed to all participating QH sites as soon as it is received to enable the CRCs at those Accepting Sites to complete their site specific negotiations If anon QH Researcher is selected as the CPI they will need to negotiate with a participating QH site to take on partial CPI Responsibilities Negotiations should also include whether or not remuneration will be paid for this role 4 2 Queensland Civil and Administration Tribunal QCAT Applications Under current operating procedures at QCAT each site must make their own application to the Queensland Civil and Administration Tribunal for guardianship approval of studies The QCAT application requires a copy of the HREC Approval letter so QCAT applications are made once HREC approval has been granted O
63. name is already in use Your business manager or supervisor will need to send an e mail supporting your request and stating why a generic e mail address is required Include your proposed generic e mail name in this e mail Send the e mail to infoservicecentre health qld gov au If you discover that a QH employee in your e mail group has incorrect details in Groupwise please e mail them this link to enable them to update their details http connect health qld gov au SSC Authenticate aspx ReturnUrl 2fssc 2tServiceCalls 2fUpdate PersonInfo aspx 2 2 Preparing your Group e mail To set up for e mail communications you will need to create a new address book for each study for which you have accepted the CPI role which will allow you to keep your CPI e mail groups separate from any other groups or address books you may have Please see Appendices 5 7 for instructions on creating e mail groups Within the CPI address book you create your study specific e mail groups which contain the e mail addresses of all the parties you need to e mail during each study You should name the e mail group according to either the protocol number or the study acronym For example you could call your Address Book CPI Studies and create a group named for the protocol number CAT 1234 The names included in this e mail group would be the main contacts for each site participating in protocol CAT1234 Principal Investi
64. nce received the QCAT Approval Letter should be processed at Accepting Sites in the normal manner 4 3 Queensland Public Health Act PHA Applications The PHA application submission occurs after HREC Approval has been granted One PHA Application will cover all participating QH sites E mailing of the Approval Letter is as outlined above 5 Research Governance Review 5 1 The Site Specific Application Negotiations pertaining to the research governance processes should commence and run parallel to the HREC approval cycle Notify all Accepting Sites that you will be sending out their individual SSA Forms and give an expected date this will occur In order to generate the SSA Forms from the NEAF you must have permanent ownership of the NEAF Local Pls should begin negotiations with relevant QH personnel responsible for resources that will be required for the study as early as possible e g Heads of Departments or delegate s and Director of Finance or delegate The Reviewing HREC may request amendments to the Protocol or Master PICF may be altered before HREC approval is granted and these amendments could result in changes to the study documentation which in turn may impact on the content of the SSA Form e g study budget or resources required at the site Advise all Accepting Sites not to generate a submission code for the final SSA until the Reviewing HREC has granted approval for the application Do not forget to notify Accepting Sites of
65. nd Grammar F7 Language G Track Changes Ctrl Shift E gt Times New Roma Letters and Mailings gt Customize Options Select Track Changes and then click OK When you make any changes to the document they should appear in a different coloured font and an explanation of the change should appear in the side margins of the document If you want to alter the options in track changes click on Tools and select Options File Edit View Insert Format Tools Table Window Dees SRY LBAS o e Queensland Health Guidelines for The Management of Investigator Initiated Multi centre Research TimesNewRoman 12 B Z U User Information Compatibility File Locations General edt Print Save Spelling amp Grammar Track Changes E By author 7 Track Changes options Insertions orem coor Formatting none X Balloons I Use balloons in Print and Web Layout Preferred width Em Measure in centimeters 7 Margin Left x IV Show lines connecting to text Printing with Balloons Paper orientation Preserve kd Changed lines Mark Outside border x Color W auto z 41 of 50 Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health qld gov au ohmr ohmr health qld gov au 3405 6121 Appendix 10 E mailing a Document for Review
66. nd legal approvals For studies involving participants over the legal age of consent who are unable to give consent a written application to the Queensland Civil and Administrative Tribunal QCAT must be undertaken after HREC approval is given At this time each site must make their own application to QCAT For more information about Queensland State Legislative Requirements go to http Awww health gqld gov au ohmr html requ for_researcher asp 3 6 Sub studies Addendums These applications are included in the NEAF with the original application For all sub studies not contained in the NEAF a separate HREC application will need to be submitted and reviewed by an HREC The type of application form used will depend on the type of sub study There should be a separate PICF for all sub studies 3 7 Signatures and Electronic Authorisations Do not obtain the submission code for the NEAF prior to sending it out to the Pls for their authorisation When the NEAF is sent out for Review all parties are able to make changes to the NEAF When the NEAF is sent out for Authorisation it is automatically sent as a read only copy When sent for electronic authorisation although the authorising Pls can type text into the NEAF there is no save option and any text inserted by someone who has received the NEAF for authorisation will not be saved The only person who is able to make a change to the content of the NEAF after it has been sent for
67. nd me the email address that you have used for registering on the On Line Forms site Once the Reviewing HREC has been allocated will contact them to find out their preferred templates for SAE SUSAR reports and Annual reports and will send them to you All study documentation including the HREC Approval Letter will be uploaded into the Online Forms website and linked to the NEAF Your response please Please e mail me as soon as possible your responses to the following three questions Responses are required from every member of your research team 1 Does any member of your research team have a financial interest in the outcome of the research or any affiliation with the providers of funding support for the study NEAF Q 3 7 2 Does any other individual or organisation have an interest in the outcome of this research NEAF Q 3 8 3 Does any member of the research team have any other general competing interests NEAF Q 2 2 NEAF Signatures Only the PI and Student Supervisors if applicable from your site will be required to sign the NEAF The Head of Department signature for the NEAF is required from the CPI site only Associate Investigators and Heads of Departments from your site will sign your SSA Form only If there are any students participating in this research project at your site please inform them that their supervisors signature will be required in the NEAF This cannot be obtained
68. ng HREC will send the Acknowledgement Letter to you and you should send a copy to me However if the Acknowledgement Letter is sent to me instead will e mail it back to you If your RGO wishes to discuss the SAE SUSAR with the Reviewing HREC they should contact the HREC directly Safety Updates and Line Listings will be responsible for processing these through the HREC and will e mail correspondence to you Amendments will be responsible for processing study amendments Copies of the amended documentation and all HREC correspondence will be e mailed to you Annual Report Please use the Preferred Template for the Reviewing HREC I will send this to you This report will be due on the anniversary of the HREC Approval will send you a reminder 4 weeks prior Please check with your site RGO if they wish to receive a copy of your site specific Annual Report as well as a copy of the Collated Report All correspondence from your site RGO Please send a copy of all the correspondence to and from your site RGO to the CRA and to me for recording and tracking purposes Please let me know if you are unsure of any study processes or if you have any other queries Kind regards Insert your name Insert your position details Queensland Health Guidelines for The Management of Investigator Initiated Multi centre Research 32 of 50 Prepared by the Office of Health and Medical Research Dec 2010 Review date Jun 2011 http www health ql
69. o reflect the new document but always ensure the word Master remains in the footer Once the amendments are completed upload the PICF onto the NEAF in the usual manner Re submit to the HREC in the usual manner Attaching these documents will NOT impact on the submission code or negate the electronic signatures provided that no changes are made to the actual NEAF content no matter how minor those changes may seem 3 12 Central Coordinating Service For all multi centre studies involving more than one QH site the study must be submitted through the QH Central Coordinating Service CCS for allocation to a certified Reviewing HREC Do not ring the QH CCS until all signatures on the NEAF have been obtained all paperwork is approved and in order ready for submission and that you have reviewed and decided on the Research Category accessed at http www health qld gov au ohmr documents ccs cats vi pdf and the Field of Research accessed at http Awww health qld gov au ohmr documents ccs fields v1 pdf It takes approximately 15 20 minutes to complete the questions for central allocation For more information on the QH Central Coordinating Service go to http Awww health qld gov au ohmr html regu cen_coord serv asp or call 1300 753 227 1300 QLD CCS Once you have been allocated an HREC Reference Number by the CCS you should review the Site requirements for the Reviewing HREC on the REGU website Go to http ww
70. ou will soon be requesting Investigator CVs allows you to alert all the sites that access to the Online Forms NEAF is required by their sites Pls if the PI is willing to sign the NEAF electronically and the site CRC for electronically uploading CVs etc allows you to alert all the sites that access to the Online Forms is required by their sites Heads of Department HOD if the HOD is willing to sign the Site Specific Assessment Form SSA electronically it provides an opportunity to inform remind other site study staff of their reporting responsibilities see Section 6 allows you to notify the CRCs at the other Accepting QH sites that the CPI team will organise any legal review of the study contract if non standard contracts or Schedule 7 clauses are used it will test the efficacy of your e mail group and the correctness of your e mail addresses An example of this first communication letter can be found in Appendix 1 If you wish to use this letter copy and paste it into a word document and attach it to an e mail it may lose some of its formatting if pasted directly into an e mail 2 5 Setting up your calendar for reminders It is important that you have a system for reminding yourself of when required activities are due You should set yourself a reminder 1 week prior to the action being required For example Set a reminder in your diary 1 week prior to the Annual Report e mail notification being sent to Acce
71. ould compile a list containing the name e mail addresses and phone numbers of all site study contacts the site Principal Investigators Pls and the study management team This list is the Master Contact List for the study and should be saved with all other study data both on your computer and in hard copy Establish the manner in which you intend to communicate with the group The easiest and most efficient way to communicate directly to all parties is to set up an e mail group for the study By using e mail you can attach copies of all communications to an e mail and simply send it to the group In this way you are not spending a large amount of time attempting to fax documents and you are also able to communicate to a number of people in the one instance This also allows communication to continue if the Pls nominated coordinator is away for any period of time In addition you have a record of what correspondence has been sent and to whom You must have access to a scanner to use this method of communication Encourage Accepting Sites to set up a generic e mail address or alternate contact for their research site so that if the site contact person resigns from the site or takes leave you can continue to communicate with the site without interruption To create a generic e mail address follow these steps Determine what you want the generic name to be not too long though Search the Groupwise address book to see if the
72. p National studies International or National multi centre research study being conducted at only 1 QH site International or National multi centre research study being conducted at more than 1 QH site Researcher contacts QH Central Coordinating Service for allocation of the study to a QH certified HREC for ethical review Researcher contacts QH Central Coordinating Service for allocation of the study to a QH certified HREC for ethical review Queensland only studies study only being conducted within the State of Queensland Multi centre research study within the Multi centre research study outside the jurisdictional boundaries of 1 QH District and jurisdictional boundaries of 1 QH District but 1 QH HREC within the jurisdictional boundaries of 1 QH e g study being conducted at PAH Logan amp HREC Beaudesert Hospitals e g study being conducted at Townsville Bowen amp Mt Isa Hospitals Researcher submits directly to QH HREC in that Researcher submits directly to QH HREC HSD in example it would be to Townsville HREC in example it would be to Metro South HREC Multi centre research study outside the jurisdictional boundaries of 1 QH District and 1 QH HREC e g study being conducted at Townsville Cairns Gladstone amp Royal Brisbane amp Women s Hospitals l Researcher contacts QH Central Coordinating Service for allocation of the study to a QH certified
73. pecific documents should also be filed in chronological order In the front of this folder file the CPI Agreement for easy reference In your CPI Communications folder there should be separate sections for each Accepting site and copies of any correspondence created or received as part of the CPI role should be filed in chronological order It may also be helpful to create a spreadsheet to track correspondence created and received as part of the CPI role See Appendix 2 for an example Do not mix these folders up with your Investigator Site Binders You will still need to file your site specific documentation in your Investigator Site Binders as you would do normally 2 4 First Communication Consider sending out an Introductory e mail to your newly established e mail group This will serve a number of purposes enables you to introduce yourself as the CPI Team contact person for the study enables you to notify the sites of your full contact details including fax and telephone numbers and postal address enables you to inform the study centres of your role and responsibilities within the trial informs other study staff that they will need to be registered on the Online Forms web site in order to receive the NEAF https www ethicsform org au SignIn aspx and they must send you the email address that they have registered with so that you can share documents with them allows you to alert study staff from other sites that y
74. pproved by the new HREC The new PI cannot commence the study at their site until approval has been received from the new Reviewing HREC and they have received authorisation from their site RGO The Pls may negotiate between themselves as to who will undertake CPI responsibilities Once the study has received approval from the Reviewing HREC as a multi centre study the CPI must notify the original HREC that all HREC responsibilities for the study have now been transferred to the new Reviewing HREC The PI from the original site should also notify their site RGO that there has been a change in the reviewing HREC Scenario C As from 01 July 2010 if a new Accepting Site is added to a MCR study that is undergoing HREC review or has received HREC approval by an HREC certified to review and manage multi centre research the addition of a new site can be considered as an amendment to the study Scenario D Registry Studies A Registry Study was approved prior to 01 July 2010 The original Reviewing HREC is now certified to review and manage MCR projects Additional sites can be added as a protocol amendment Scenario E Registry Studies A Registry Study was approved prior to 01 July 2010 The original Reviewing HREC is NOT certified to review and manage MCR but additional sites are to be added A new NEAF is to be created and submitted to the CCS for allocation to an HREC that is certified to review and manage MCR Scenario F Research involving c
75. pting Sites 4 weeks prior to its due date e mail the Accepting Sites a notification that their annual report is due the date by which you want their completed report and attach the required Annual Report template that you will be using Ensure that you stipulate the due date for the return of this document It is important that you clarify whether the Annual Reports are to be returned to the CPI for collation prior to submission to the Reviewing HREC or whether they are to be returned to the Reviewing HREC individually with a copy to be sent to the CPI 2 weeks prior to the due date set a reminder in your diary to check which annual reports have been sent in by the Accepting Sites and issue a reminder to those sites who have not responded 1 week prior to the report being due commence collating your Annual Report if required for final signing off by the CPI 3 Preparing the HREC Application 3 1 The Protocol The CPI is responsible for the development of the study protocol For information regarding the content of a study protocol please go the REGU website to GCP SOPS no 4 Appendix 7 http Awww health gqld gov au ohmr html requ gcp sop asp It is not compulsory for the Protocol to contain a signature page as by signing the NEAF the PI is attesting they are able to conduct the study according to the protocol and all required legislation 3 2 NEAF Requirements For submission to QH HRECs the Online Forms version of NE
76. pts to ee insert details for the Non QH Contact aes person Organization a Address Book Fle Edt T new E etais Delte action e Insert the contact details for each non QH study G CPI Studies Name Completion Position Not searct Novel Gp Aer Book ocx Fox contact one at a time following the prompts GARD Novel LOAP Addiers Book a T E Mail Address Office Prone Department Ta EE marna dg S ae a E Frequent Contact New r BB Frequent Contacts New Contact CPI Studies i 5 Siren Corte oree Pena coman Advanced Contea e The contact will be stored in the CPI Studies Name address book E AH Groups Fit l Pref amp E Research Groups Middle Suffix x Lat Display x Email Address Phone Office Otome O Mobile O Fax OPage e When you click on Add and the Address Book window appears on the left go to the Look In tab and select the CPI address book All the non QH e mail addresses that you have just entered will appear Address Book mE File Edit Yiew Help e Import the contact details into the E mail b New Details 3 Delete Action Group for the correct study as per the Online instructions above T CPI Name Completion Position Not searched G E Novell GroupWise Address Book flees Rag dis He 4 3 Novell LDAP Address
77. rch QH Queensland Health REGU Research Ethics and Governance Unit For QH REGU go to http www health qld gov au ohmr html requ reqgu home asp Reviewing For multi centre studies the reviewing HREC is the NHMRC certified QH HREC HREC which under the single ethical review process has reviewed and ethically approved the study and has assumed responsibility for monitoring the conduct of the research being conducted at QH sites RGO Research Governance Office r SAE Serious Adverse Event SSA Site Specific Assessment Form SUSAR Suspected Unexpected Serious Adverse Reaction TGA Therapeutic Goods Administration The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access within a reasonable time to therapeutic advances Go to http www tga gov au about about htm Purpose and scope The purpose of this document is to provide guidance to Coordinating Principal Investigators CPI undertaking Investigator initiated multi centre research in Queensland Health research sites It is acknowledged that the CPI may delegate some duties to other research staff such as a Clinical Research Coordinator CRC Research Assistant or Project Officer and so this document also provides guidance to these research staff Although the majority of the work managing the study may be delegated
78. s are to contact their own participants and notify them of the termination or completion of the study and any follow up that may be required If there are changes to the role of CPI within the conduct of the study Accepting Sites must be notified of the change by the original CPI Section 2 Step by Step Guidelines 1 The First Approach To be a CPI the whole research team should consider their current and foreseeable workload and objectively appraise the implications of taking on this additional role In making this decision the following points need to be considered The number of sites involved in the study Whether all the sites have been chosen and signed up Is a contract required The pre approved Medicines Australia contracts are preferred and if used unchanged will not require legal review However if a non standard contract is required the services of the District Solicitor should be engaged What equipment resources will be required e g scanner fax machine The level of experience of the member of the research team who will be undertaking the majority of the CPI tasks It is suggested that for clinical trials this person should have at least 18 months experience as a clinical research coordinator who has experience in HREC processes before being delegated CPI responsibilities or should be mentored by such a person 2 Setting Up 2 1 Develop a Communication Strategy The CPI or delegate sh
79. stions 3 4 Transferring the NEAF for Review by Principal Investigators at Accepting Sites 3 5 Legislative Requirements 3 6 Sub studies Addendums 3 7 Signatures and Electronic Authorisations 3 8 Submission Codes 3 9 Investigator Curriculum Vitae s 3 10 Electronically Attaching Supporting Documentation to the NEAF oo O O O ON DD fF oe Oo O i i l k 4 o o N i i l l M M ar AROQ k ol PO N N a SS SS aS OO OWAOAN DD HO 3 11 Participant Information Sheets and Consent Forms 3 12C 3 13 C entral Coordinating Service TN CTX Forms 3 14 Forms of Indemnity 3 15 The HREC Submission 3 16 QH Database of Research Activity DORA 4 CaSS Applications Guardianship Applications and PHA Applications within Queensland 4 1 Clinical and Statewide Services CaSS Applications 4 2 Queensland Civil and Administration Tribunal QCAT Applications 4 3 Queensland Public Health Act PHA Applications 5 Research Governance Review 5 1 The Site Specific Application 5 2 Pa rticipant Information Sheets and Consent Forms 5 3 Contracts 5 4 Indemnity Forms 5 5 Study Budgets 5 6 RGO Authorisation 6 Post Approval Amendments 6 1 General Amendments 6 2 Adding a New Accepting Site 7 HREC Reporting Post Approval 7 1 SAE and SUSARs 7 2 3 7 3 An 6 Monthly Line Listings and other Safety Updates nual Reports 8 Study Termination Section 3 Appendices Appendix 1 App
80. stralia Forms of Indemnity are required and should be sent directly to the sites by the CPI and returned directly to the CPI If the CPI is a QH employee and all Accepting Pl s are QH employees a Form of Indemnity is not required Study budgets are contained in the contract and are dealt with at a site level not by the CPI Once the SSA and supporting documents have been reviewed and approved by the RGO the site will return a copy of the authorisation letter the original signed site CTN if required the original signed Contract and Indemnity Form if required to the CPI so the commencement of the study can proceed after these requirements have been fulfilled and completed Post Approval Amendments The CPI is to notify all sites of forth coming amendments to the Protocol PICFs or any other study documents The CPI will modify the study documents as appropriate electronically upload the documents into the Online Forms site via the NEAF that was submitted for the study and submit these to the Reviewing HREC for consideration and approval Ensure document version details are updated and noted on all amended documents Scan the Approval Letter once received and e mail to the Study Group along with the approved amended documents Remind Accepting Pl s that changes to the Amended Master PICF must be made to the site specific PICF at a local level and forwarded to the Site RGO along with the HREC approval letter For
81. test submission code Attaching documents to a NEAF with electronic authorisation does not void the signatures at any time 3 8 Submission Codes For information on obtaining a submission code go to the Online Forms User Manual section 4 5 https ethicsform org Au Help AU 20Online 20Forms 20for 20Research 20User 20Manual 20v1 odf_ or the Online Forms demonstration https ethicsform org au Help Demo aspx If you need to make amendments to the form after the submission code has been obtained amend the document and obtain a new submission code You do not need to duplicate the NEAF in order to make the changes In your covering letter ensure you supply the correct submission code to the Reviewing HREC Documents may be electronically attached to a NEAF at any time even after the submission code has been generated 3 9 Investigator Curriculum Vitae s The CPI and all Pls for whom you have CPI responsibility named in the NEAF are required to submit their Curriculum Vitae CV for HREC review unless they have already submitted their CVs to the Reviewing HREC within the last two years The CVs should be electronically uploaded with the NEAF When uploading the document ensure that an entry is made in the Description box so that the CV can be identified The name of the PI and their site should be sufficient e g Dr Smith Royal Queensland Hospital CVs should be no longer than 2 pages For guidance on the
82. ument that has been sent to you to Review e You must be registered on the Online Forms website e When a document is transferred to you for review you will receive a notification from the Online Forms site notifying you that you have been transferred a NEAF or SSA Form e Log into the Online Forms site It will open at the My Projects page e Note that the Transfer Requests tab will have a number in it in brackets indicating that you have that number of studies waiting to be accepted Create New Project Import xml NEAF amp other forms Projects Requests for Authorisation Transfer Requests 1 Form Title Form Type Project Created On Form Status Transferred In In Progress Demonstration project NEAF 26 08 2010 gt gt PENDING lt lt e Click on the Transfers tab Create New Project Import xml NEAF amp other forms Projects Requests for Authorisation Transfer Requests 1 RECIPIENT Application Title Created On Status Action Transferred In In Demonstration project 26 08 2010 Progress Accept Application gt gt PENDING lt lt Reject Application e The study details will appear in a box Go the Action column right hand side e Click on Accept Application Do not click on the study name to access the dgcument You now have access to the NEAF and can amend the text save the changes Online and upload documents in the normal m
83. viewing HREC they should contact the Reviewing HREC directly It is the responsibility of the CPI to submit all other Safety Reports for HREC review The Reviewing HREC may have preferred reporting templates and these should be used Please refer to the requirements on the REGU website http www health qld gov au ohmr html regu hrec_contacts asp Record the SAEs and SUSARs from all sites in a spreadsheet that includes a record of when the events were notified to the Reviewing HREC See Appendix 6 7 2 Other Safety Updates These are forwarded with a cover letter to the Reviewing HREC On receipt of an Acknowledgement Letter from the Reviewing HREC scan all documents and send to your e mail group File a copy of all correspondence in the CPI Correspondence File 7 3 Annual Reports The annual report date is due on the anniversary of the date of the HREC Approval Liaise with the Reviewing HREC as to their preferred reporting format or refer to the requirements on the REGU website http www health qld gov au ohmr html regu hrec_contacts asp File a copy of all correspondence in the CPI Correspondence File File a copy of the collated and individual if you have them Annual Reports in the CP Documents File Study Termination The CPI will notify the HREC of the following e Cessation of recruitment e Completion of the final patient e Formal closure of the study at all sites e Formal End of Study report Accepting Pl
84. w health gld gov au ohmr html regu hrec_contacts asp Contact the Reviewing HREC office to receive advice on submitting your application such as the preferred method of submission and their preferred templates for Annual Reports and SAEs When the Notification of Allocation notice is e mailed to you from the CCS forward the e mail to your Study e mail group immediately along with the Annual Report and SAE Reporting templates preferred by the Reviewing HREC File the Notification of Allocation notice in your CPI Documents Folder 3 13 CTN CTX Forms There is one CTN CTX Form for every QH site participating in the research project When these forms are required the CPI team is responsible for creating one for each participating site and for sending the completed forms to the TGA The Sponsor of clinical trials or research projects can either be individuals eg medical practitioners or bodies and organisations eg hospital area health service non government organisations or companies eg pharmaceutical companies The sponsor carries the medico legal responsibility for the study If the CPI initiates and organises a trial or study they may be defined as the Sponsor of the trial and will be responsible for the Sponsor s functions This includes where another party usually a pharmaceutical company used in the clinical trial but has no other involvement in the conduct of the trial Therefore the CPI may sign the CTN C
85. word Draft will appear across all pages Draft signature pages will not be acceptable to a reviewing HREC Student Supervisors where applicable must sign hard copies of the NEAF signature page scan the signature page and electronically attach it to the NEAF Alternatively they can post the hard copy to you for insertion into the NEAF prior to photocopying For instructions on how to obtain electronic authorisation of the NEAF go to Section 4 4 of the Online Forms User Manual https ethicsform org Au Help AU 20Online 20Forms 20for 20Research 20User 20Manual 20v1 pdf Appendix 12 of this document may be copied and pasted into a Word document and emailed to Pls to assist them with the electronic authorisation process Remember Multiple electronic signatures can be obtained simultaneously The Pls will have to be registered on the Online Forms website in order to be able to electronically authorise the NEAF The NEAF must be sent for Authorisation via the Authorisation option in the Online Forms site If you send it via the Transfer option the prompts for electronic authorisation of the NEAF do not appear When the NEAF is sent out for Authorisation the words Read Only appear in red font at the top of the document Whilst it may appear that text can be edited in the NEAF there is no Save option so any changes attempted by Pls will not be saved Ensure you

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