IRB+ User Manual for Online Submissions
Contents
1. 3 3 4 Documents Tab The Documents tab indicates which documents must accompany this submission As you complete the various online forms the list of documents may change depending on your answers Hence frequently return to the Documents tab to check what documents you need to submit IRB New Test Study Microsoft Internet Explorer provided by Verizon Online Go i e https www irbplus com eSubmission asp nStudyId 37 196 amp nSubmissionId 152 i Q 4 X orade forms 6 pre block Pe 7 n me di TR8 New Test Study RE ab E Pace iG Tools TPO on rt PS Protocol Title New Test Study Principal Inv Email Go to My Studies Study Coord Email Document Status Instructions Complete research proposal or project Click here to upload the document description Abstract Summary of Research Click here to upload the document Advertising Materials flyers newspaper ads Click here to upload the document etc Consent Form Click here to upload the document Consent Form for Non English Speakers Click here to upload the document 3 3 4 1 Uploading Supporting Documents Documents that are required for submission should be uploaded on the Documents tab in electronic format e g Microsoft Word PDF Excel etc To upload a document use the Click here to upload the document link The Upload Document screen will be displaye2. RB IRB Online Submissions User Manual IRB User Manual for Online Submissions Updated April 15 2007 Third Sky Page 1 of 35 RB IRB Online Submissions User Manual 1 Contents L MIN TINT ER EE N EE EE EE EE EE EE 2 2 MIN 6 DAL OE O6 AE EE EE EE 3 Ki AD Ea OR ache ET EE EE N ET EE RE ED d EN ie ce is ME OE EE EE EE EE A 3 1 1 TS O E e E EE N A ET 4 Ie ARSC CIN eor EE E EE 5 3 3 MANAGING PROTOCOLS amp SUBMISSIONS esse ese ss ss sesse ss ss ee ee ed de Ge GEE Ee ee de Gee GE EE ee 6 3 3 1 Submitting A new protocol APPLICATION ees ee Ee ee RR ee ee ee RE ee ee ee ee ee ee 6 3 3 2 FORCO de TER ER EA OA A EE OE RE OE EN 7 3 3 3 Online T NE ORE EE EE N EER ER NE EE N 8 3 3 3 1 Complenne Online HOF ees ed ee eed ee EE de GE E e E eS ee EE IG 9 e Ae ie Sudy sir Onine FO aeei r S N 12 3 3 3 3 Demographic Information Online Form iese sesse see EE ee ee ee ee AR Re ee ee ee ee ee ee Ee 13 3 3 4 AE T EK ON NE EE EET EN N HOL NEE IE KON 14 3 3 4 1 Uploading Supporting Doeminie es HEER ie Ee EER Oe Ke Ee ee ie EG NE N ee Ee Nee 14 3 3 5 aal ele oi MR N OR EN EE EE EE EI OE EI N 15 3 3 6 Erge ME RE OE EE RR nue ve yaa eps Eaves US ea 17 5 3 7 OI bel ME E TA EE EE RE encase 19 3 3 8 Creating Non Initial SubmiSSIONS ee ee ee ee ee ee ee Re ee ee ee EE ee ee ee 20 EE EE EO TE E OE EE EI EE OE NE Ee 22 IG Correspondence TaD isisi risette ee de ee EE Ge Ee Ge ge ee Ge ee 2 A IRBADMINISTRA TORS sessies dees
3. www irbplus com RuleEdit asp nRuleId 253 If the value of the field is Yes Make the following field mandatory Explain why not using alternatives h Add the following form document to the protocol Cancel Delete M Internet 100 7 2 The rule will be triggered based on a specific answer When the rule triggers there are two possible actions make another field mandatory OR add a form document to the protocol If you choose the first radio button you will need to select which field becomes mandatory Since the field has to exist before you can create the rule the recommended process is to create all the fields first then go back and create the rules If you choose the second radio button you will need to select which form document to add to the protocol Again since the form document must already exist in order for you to create the rule it is recommended that you create all the forms documents first before creating the rules Third Sky Page 32 of 35 RB IRB Online Submissions User Manual You can create as many rules as you want for a given field and a given value For example if two fields become mandatory when the answer to the current field is Yes you can create two rules for the Yes answer To change an existing rule just click on the rule on the Edit Field screen Back on the Edit Field screen the next box under the rule section is the Indent box The indent box let
4. Pending IRB Action section of the My Studies screen If the IRB office returns the submission you will receive email notification and the submission will be moved to the Planned Submissions section of the My Studies screen to allow you to make changes The email will outline the changes that are required to the submission before you can resubmit to the IRB office You will receive email notification when the IRB office accepts your protocol The IRB office will schedule the submission for IRB review and you may view the meetings the submission is scheduled for and the activity letters for the submission on the Meetings and Correspondence tabs 3 3 8 Creating Non Initial Submissions Non initial submissions such as continuing reviews amendments adverse events unanticipated problems and project closures can be created on protocols in IRB To create a submission click appropriate New link in the My Studies screen e g the New Continuing Review link The New Submission screen will be displayed Third Sky Page 20 of 35 RB IRB Online Submissions User Manual IRB Microsoft Internet Explorer provided by Verizon Online ETES OO Erina nMsteeseg MRIEI ee e EIE IE 2 Planned Submissions Study Number Submission Type P l Protocol Title Delete New Protocol not assigned Initial Application M
5. if you check that the there is an Consent Change IRB will add a Third Sky Page 10 of 35 RB IRB Online Submissions User Manual Clean Consent Form and Consent Form with Changes Highlighted to the Documents tab For this reason it is important to check the Online Forms and Document tabs regularly to ensure the submission has been completed Description of Change Microsoft Internet Explorer provided by Yerizon Online El httnss fwww irbplus com WebForm asp ninstanceld 547 Identify the type of change requested check all that apply gt L Protocol Amendment Change Version Date Po Consent Change Version Date Version 2 1 dated 4 14 2007 How will currently enrolled subjects be informed of this revision i e verbally with documentation of notification in the medical record or by re consenting with a written consent Re consenting with a written consent Cl Study Personnel Change IRB HSR 06 001 SWOG 9999 A Double Blind Randomized Study of XYZ in Patients with AML Microsoft Internet Explorer provided b Go v https www irbplus com eSubmission asp nStudyId 24726 amp nSubmissionId 99 v 3 XI orade forms 6 pre block p z i vr di TR8 HSR 06 001 SWOG 9999 A Double Bind Rando EE dh Fp Pae Took EES E Study HSR 06 001 Expedited oe daad Protocol Title SWOG 9999 A Double Blind Randomized St
6. Email jdoe google com Go to My Studies Study Coord Phone Email Instructions If you would like a hard copy of your online forms click on this document and press the Printer icon in the toobar Please print and make sure the appropriate people sign this document Mail in this document with any other support documents Printable Single Project Approval Form Project Approval Sign off Sheet Page 16 of 35 Third Sky IRB Printable Submission Printable Form Microsoft Internet Explorer provided by Verizon Online IRB Online Submissions User Manual KEk CAZ https www irbplus com PrintForm asp nSubmis V E 4 X ile lek abe E Printable Form BR Do Bh o E e Tose Initial Application Study Number Study Title not yet assigned New Test Study Principal Investigator Area of research Address 1 Address 2 City Anytown State CA Dr John Doe D Div 222 Main Street Zip 12345 Dr Douglas Gorman M D 288 Sutter Street Co Investigator Address 1 Address 2 Suite 4B City Anytown State CA Zip 95007 Nhat type of review are you applying for Exempt Review Expedited Review Full Review Done Sign off Fax Sheet Phone 111 222 333 Fax Email jdoe google com Date of Training 5 1 2005 Phone 966 3991 Fax 966 3887 Email bbb hotmail com Date of Training 4 1 2003 v 100 7 Fax Cover
7. Initial Application 120 Edit Fields Goto Last Study Research Procedures Web Form Initial Application 130 Edit Fields MEE EE Ricks and Discomfort Web Form Initial Application 140 Edit Fields TEE Other Reguirements Web Form Initial Application 150 Edit Fields EE Er Complete research proposal or project description Document Initial Application 200 TER Grant Application Document Initial Application 210 Abstract Summary of Research Document Initial Application 220 AAE Daddios Advertising Materials flyers newspaper ads etc Document Initial Application 230 Meeting Materials Interview script guestionnaire tests etc Document Initial Application 240 E Consent Form Document Initial Application 250 Create Letters Consent Form for Non English Speakers Document Initial Application 260 Mailing Labels Printable Single Project Approval Form Printable Form Initial Application 300 Reports Project Approval Sign off Sheet Fax Sheet Initial Application 310 Edit Fax Continuing Renewal Application Web Form Continuing Review 4000 Edit Fields Housekeeping Study Summary Document Continuing Review 4100 Adverse Event Flow Sheet Document Continuing Review 4105 Logout Consent Form with changes highlighted Document Continuing Review 4110 moi od Clean Consent Form Document Continuing Review 4120 References EE EE Summary of Protocol Deviations Document Continuing Review 4125 Personnel Listing for Continuing Review Document Continuing Review 4130 Printable Continuing Renewal
8. None E internet A 100 The screen contains the following sections e Planned Submissions Displays all submissions that need to be sent to the IRB office This includes submissions that have been returned by the IRB office for changes e IRB Action Pending Submissions that are awaiting review by the IRB office or by the IRB e Active Protocols Displays all Protocols that are active e Exempt Protocols Displays all Protocols that are exempt from IRB review e Closed Expired Protocols Displays all Protocols that have been closed or have expired Third Sky Page 5 of 35 RB IRB Online Submissions User Manual In the left menu you can select from a number of actions New Protocol Application Click this link to start a new online protocol application New Continuing Review Click this link to start a new continuing review application for one of your existing protocols New Amendment Change or Click this link to start a new amendment change or update Update application for one of your existing protocols New Adverse Event Click this link to start a new adverse event application for one of your existing protocols New Unanticipated Problem Click this link to start a new unanticipated problem application for one of your existing protocols Project Completion Click this link to start a new project completion application for one of your existing protocols 3 3 Managing Protocols amp Submissions This sectio
9. T httos www irbplus com eSubmissioninbox asp v 4 ty X Pir RY ve di met Mn v Page v Gf Tools gt 9 4 N eSubmission Inbox EED Op bag ato AT Initial Application Main Menu Find Study or Activity P Study Title Date Submitted Outstanding Documents eSubmission Inbox New Study Spitz Jonathan Tanning 4 12 2007 e Project Approval Sign off Sheet Goto Last Study Adverse Event My Selected Studies Study PJ Study Title Date Submitted Outstanding Documents Investigators Number Coordinat ea SBR 06 001 Whiteley George SBR Study 001 4 10 2007 e External AE Report Missed Deadlines Project Completion Meeting Materials Study Pd Study Title Date Submitted Outstanding Documents Create Letters Number ren SBR 06 001 Whiteley George SBR Study 001 4 10 2007 Housekeeping Logout References Need Help irbhelp thirdsky com Submissions remain in the eSubmission Inbox until you either return the submission to the PI to make changes or accept the submission Generally you should leave a submission in the inbox until all outstanding documents are received The outstanding documents are listed on the right side of the screen To return or accept a submission click on the protocol go to the submission and click the Accept Reject tab If the submission meets your approval click the Accept button to accept the submission The PI will
10. can be identified by the Form URL Custom forms will always have a Form URL while dynamic online forms will have no Form URL 4 3 1 Managing Online Forms amp Documents To create a new or edit an existing online form or document supply the following information Specify the name of the form in the Form Name text box This is the name that will appear on the Online Forms Documents or Printable Forms tab In the Form Type drop down select from Web Form Document Printable Form or Fax Sheet Web forms appear in the Online Forms tab Documents appear in the Document tab Printable Forms and Fax Sheets appear in the Printable Forms tab Documents can be uploaded to IRB in electronic format Printable Forms and Fax Sheets can be printed or filed in electronic format In the Submission Type drop down pick from Initial Application Continuing Review Amendment etc This will determine the type of submission the online form or document will be added to When IRB displays forms and documents it displays them in ascending order of the Form Order field Enter a number into this field A best practice is to count by 10 That way if you need to create a new form that will appear between two existing forms it is easy to pick an appropriate Form Order number The Form URL field lets you override the default behavior for the given form type You should not edit this field The Instructions field is useful for the forms that appear in the Online Form
11. changes are required Please submit the requested information or documents for re review You may not implement the proposed changes until your revised application is approved Contact Demo 800 123 4567 fax 800 987 6543 email demo if you have any questions or require further information When you chose to respond online the Online Response screen will be displayed In this screen you may enter response to the IRB questions and concerns and upload supporting documents Click the Submit button to submit your response to the IRB office Third Sky Page 23 of 35 RB IRB Online Submissions User Manual Study HSR 06 001 Protocol Tt gt Response Microsoft Internet Explorer provided by Verizon Online Principal In le https www irbplus com Response asp nActivityId 181310 Study Coor Status lew Continuing Review TT Click here to respond online w Unanticipated Project Completion Submit_ Cancer Third Sky Page 24 of 35 RB IRB Online Submissions User Manual 4 1RB Administrators 4 1 Logging onto IRB Members of the IRB office should logon to the WebKit with their email and IRB password 42 eSubmission Inbox The eSubmission Inbox shows recently submitted protocol applications continuing reviews amendments adverse events unanticipated problems and project closures that require review IRB Microsoft Internet Explorer provided by Verizon Online G by
12. the Outstanding Documents column in the ESubmission Inbox screen If you do not want this document to appear in the Outstanding Document column e g the protocol can be reviewed without this document leave the checkbox unchecked 4 3 2 System Form The System form is a special online form that stores special fields used by IRB i e text of emails to be sent out This form must not be edited or deleted Third Sky Page 29 of 35 RB IRB Online Submissions User Manual 4 4 Edit Fields Screen To change the questions on a online form click the Edit Fields link to the right of the online form on the Manage Forms amp Documents screen When you click the button you will see the Edit Fields screen as shown below IRB Microsoft Internet Explorer provided by Verizon Online Tales ek AD EE Ed Edit Fields for Protocol Summary New Field Back to Edit Forms Field Name Field Text Field Type Field Order Sa Review Type What type of review are you applying for Radio 10 Main Menu B Find Study or Activity uttons nipped Department Department Drop Down 20 eSubmission Inbox List New Study College College School Graduate School of Drop Down 30 List Goto Last Study f 3 ee a as cee Begin Date Date Research is scheduled to begin Date 40 ya es Funding Agency Are you applying for funding through the Office of Research Administration and or what is Text 60 de ad your expected source of fun
13. Application Printable Form Continuing Review 4200 Registry and Database Renewal Form Web Form Continuing Review 5000 Edit Fields Data Collection Form Document Continuing Review 5100 Sub Investigator Statement of Assurance Document Continuing Review 5110 Questionnaires or Surveys Document Continuing Review 5120 Consent Form with changes highlighted Document Continuing Review 5130 M Mana l mal ca Tetarnat To edit a form or document click on the name of the form or to create a new form click the New Form button When you edit or create a form you will see the following screen Edit Form Screen Dynamic Online Form Edit Form Microsoft Internet Explorer provided by Verizon 0 m DK le https www irbplus com FormEdit esp2nFormId 122 Protocol Summary Web Form w Initial Application prr Sae Jess The above screen shot is of an dynamic online form This is an online form whose fields and instructions can be changed by the IRB office Third Sky Page 27 of 35 RB IRB Online Submissions User Manual Edit Form Screen Custom Online Form Edit Form Microsoft Internet Explorer provided by Verizon 0 Saks https jwww irbplus com FormEdit asp nFormId 121 arm Name Principa Web Fom 9 Delt The above screen shot is of an custom online form This is an online form whose fields and instructions cannot be changed by the IRB office and may only be change by Third Sky Custom forms
14. Ges ee ER Gr ee Ge GE ee de ee ee Gee ee ed RE ee Ge ee GE de er eed 25 4l LOGGINGONTO id AE EE AE EE EE N 25 Ae MSU OE STON TINO EE EE EE EE OE N OR RE 25 AS EDIT FORMS amp DOCUMENTS SCREEN uses Sessie ei ees oie os ee Res ei ee eed ee See es be ek Ge eo bie 26 4 3 1 Managing Online Forms amp DOCUMENIS ccccccccccccce cece cece eee EE Ee ee ee ee ee ee ee ee RR RE ee ee ee ee ee 28 Add YE AU OE N EE EE errr 29 EN io EE ei N TR EE N EE RE EE OE NE 30 4 5 EDIT ESUBMISSION SETTINGS SCREEN vssisssinusssnsennswsnsenssisndenpsdnosiendaondavesdnedenssdeedecesseeavendiasderesveedeaindas 34 Third Sky Page 2 of 35 RB IRB Online Submissions User Manual 2 Introduction This document describes how to use the Online Submissions Module of IRB The Online Submissions Module allows investigators to e Submit initial applications continuing reviews amendments adverse events unanticipated problems and project completion applications online e Upload supporting documents like the consent form full protocol description advertising material etc e View their activity letters online and respond online e Check which IRB meeting their studies are scheduled for The Online Submissions Module integrates seamlessly with the IRB Administrator Module of IRB allowing IRB Administrator to e Accept submissions online or return submissions to the PI for changes e View all information entered by the PI online and download the supporting do
15. Sheet Microsoft Internet Explorer provided by Verizon Online tl SAZA e https www irbplus com FaxSheet asp nSubmiss v 4 ty X co gle 7 Q sr abe Ee Fax Cover Sheet m gt Bl ah r Ee Gtoos Fax Signature Sheet 0 Fax Phone Re Signature Page for Study From John Doe Pages Date CC It is understood that will keep on file for at least three years from the project completion date and make available on request by the IRB copies of signed Informed Consent Forms of all subjects participating in this research it is understood that any medical procedures or medical treatments of human subjects for the purposes of the present research will be performed by or under the supervision of a person who is licensed or certified to perform hat particular procedure It is understood that students at should be initially recruited as research subjects by public announcement and not by personal solicitation It is understood that if there are any changes modifications or revisions either in the research protocol title or names of Researchers the IRB must be immediately notified and prior permission must be received before proceeding Done 3 3 6 Security Tab CE internet Q 100 You can give personnel on this protocol permission to see and edit the protocol in IRB To grant access to a protocol go to the Security tab select the person f
16. bmissionId 105 va pe Ladi B ey se Te ed E Study HSR 06 001 Expedited se de Ve dar Protocol Title SWOG 9999 A Double Blind Randomized Study of XYZ in Patients with AML Principal Inv Dakhil Shaker Phone 123 123 1234 Email dshaker swog org Study Coord Marge Good WCCOP Phone Email Status ACTIVE Expires 4 17 2008 New Continuing Review Init Application Amendments AEs Unanticipated Problems Project Completion Security New Amendment Date Activity Change or Go to My Studies Update 4 17 2007 Revision as communicated View Letter As described in 03 01 06 ee New Adverse Event Revisions to protocol amp consent oet Full board review of revision reguest New Unanticipated Response required oie 4 17 2007 New study as communicated ey oe E Protocol version through 03 01 06 C Initial full board review Approved Example Activity Letter View Letter Microsoft Internet Explorer provided by Verizon Online L https www irbplus com eSubmissionViewLetter asp nActivityid 181310 April 17 2007 RE Your application dated regarding study number HSR 06 001 SWOG 9999 A Double Blind Randomized Study of XYZ in Patients with AML Southwest Oncology Group Dear Dakhil our request for revision of the study listed above was reviewed at the 4 17 2007 meeting of the Thirdsky IRB he requested revision involves changes to the protocol and consent form The following information and or
17. cuments for the submission This document is divided into two sections Investigators This section explains how the researcher community should use the Online Submissions Module in IRB IRB Administrators This section explains how the IRB Administrators should use the Online Submissions Module in IRB All screen shots and examples in this user manual are of test information only and utilize the demo system The actual online forms supporting documents and printable forms in your Online Submissions Module will be customized for you organization Third Sky Page 3 of 35 RB IRB Online Submissions User Manual 3 Investigators 3 1 Login Screen IRB is located at the following website hitp www irbplus com To use IRB you must have Internet Explorer 6 or 7 Click the Customer Login button and enter your email address and password in the following login page gt IRB Microsoft Internet Explorer provided by Verizon Online MEI GOS v https www irbplus com Login asp v gq 4 X Pl w dar EIE ma irs x Es 7 e H mn b ssp Page 7 GP Tools Terms of Use Welcome to IRB Click here if you have forgotton your password Email Address Password E internet 100 If you have forgotten your password click the Click here if you have forgotten your password link You will be asked to enter your email address IRB will e
18. d Third Sky Page 14 of 35 RB IRB Online Submissions User Manual Upload Document screen Upload Microsoft Internet Explorer provided by Yeri ig https nnn irbplus com FileUpload asp ninstanceld 937 Click the Browse button to select the file to upload You can upload any file on your computer Click the Upload button to save this document to your submission IRB New Test Study Microsoft Internet Explorer provided by Verizon Online GOS x https www ircbplus com eSubmission asp nStudylid 371968 amp nSubmissionids 152 v 3 tr X orade forms 6 pre block e x Ta ai w dir TR8 New Test Study fp X mn sp Page x iG Tools 7 1 re med A ma Protocol Title New Test Study Save Principal Inv Email Go to My Studies Study Coord Emak Document Status Instructions Complete research proposal or project Click here to upload the document description Abstract Summary of Research Uploaded Click here to remove the document or click here to upload a new document and replace the existing document Advertising Materials flyers newspaper Click here to upload the document ads etc Consent Form Click here to upload the document Consent Form for Non English Speakers Click here to upload the document Once the file is uploaded the name of the document becomes a link and the status changes to Uploaded To see what you uploaded cl
19. d and will be reviewed AE Date lt AE Date gt AE Description lt AE Description gt In a few days you can check the status of your AE submission an the web lf you have any questions please contact the IRB Office Third Sky Page 35 of 35
20. d for an initial application the following new window will be displayed Project Summary Online Form Initial Application Protocol Summary Microsoft Internet Explorer provided by Verizon Online E fx https www irbplus com WebForm asp nInstanceId 936 vla What type of review are you applying for Exempt Review O Expedited Review O Full Review Department College School Graduate School of v Date Research is scheduled to begin Are you applying for funding through the Office of Research Administration and or what is your expected source of funds if any po Date proposal must be submitted to funding agency if applicable Abstract or summarize your proposed research Third Sky Page 9 of 35 RB IRB Online Submissions User Manual Entering data e Inthe online forms the required fields are marked with a red and must be entered before saving Some fields become required depending on the answers given to prior questions e Dates should be entered in the format mm dd yyyy e Numeric fields should only contain numbers commas and decimal points ls this study related to ecoli OYes ON ls this a pet food study OYes ONo 5 Done F a Internet 100 Saving the Form At the end of each online form you will see a Save button a Save as In Process button and a Cancel button If you click the Save button a
21. ds if any ooi Funding Agency Deadline Date proposal must be submitted to funding agency if applicable Date 70 Coordinators gt care oi nee Abstract Abstract or summarize your proposed research Multi Line 80 vie JES Text Missed Deadlines Appended copy of an abstract Would you like to upload or mail in a document to respond to this question Yes No 90 a yd or summary eed ae Bioterrorism Is this study associated with Homeland Security Yes No 100 a ERE Party What political party do you belong to Radio 110 Create Letters Mailing Labels Buttons Re tthe nig Food study Is this study related to ecoli Yes No 120 Ee Poisonous pet food Is this a pet food study Yes No 130 Housekeeping Logout References Third Sky Page 30 of 35 RB IRB Online Submissions User Manual To change an existing field click on the field name or to create a new field click on the New Field link in the left navigation bar When you edit or create a field you will see the following screen Edit Field Microsoft Internet Explorer provided by Verizon 0 E Are there any alternative ways to acquire your research information from human subjects that may avoid the risks identified above Update ltem Delete Item If the value of this field is Yes the field Explain why not using alternatives becomes mandatory Enter the name of the field in the Name box This is the name that will be shown if the field is required
22. e g Review Process is a required field Enter the text of the question in the Text box You can use the standard HTML tags to format the text of the question For example lt B gt indicates that bold should begin and lt B gt indicates that bold should end Other HTML tags worth noting include lt U gt and lt U gt for underline and lt I gt and lt I gt for italics HTML is case insensitive so you can use either upper or lower case letters However make sure you correctly end all tags or the generated online form may look different than expected You can use the lt br gt to enter a line break Select one of the following from the Type drop down to indicate how the investigator will enter select the answer Text The investigator will tyoe the answer into a single line text box Yes No The investigator will pick from either a Yes or No radio button Yes No NA The investigator will pick from either a Yes No or N A radio button Check Boxes The investigator will pick from one or more check boxes Check Boxes The investigator will pick from one or more check boxes An checkbox labeled Other will automatically be added to the end of the list Third Sky Page 31 of 35 RB IRB Online Submissions User Manual with an textfield next to the checkbox If the user checks Other they will be required to enter a description in the textfield Multi Line The investigator will type the answer into a multi line te
23. eeting Materials 2 Adverse Event Dear lt PI Full Name Create Letters Rejected Mailing Labels Your online lt Submission Type gt submission for the above references protocol can not be processed for the following reason s Reports Event Date lt AE Date gt Housekeeping Event Description lt AE Description gt lt Reason gt Logout The system has unlocked your submission so you can address these issues and re submit If re submission is not required References this event may be deleted from the pending submissions area If you have any questions please contact the IRB Office Need Help ma EEN Amendment Dear lt PI Full Name Accepted Your online lt Submission Type submission for the above references protocol was accepted for IRB review Upon review you will receive and e mail notification of the IRB action lt Third Sky Page 34 of 35 RB IRB Online Submissions User Manual Click on the setting name to edit the setting and you will see the Edit Setting screen Any text within angle brackets e g lt PI Full Name gt is dynamic information and will replace automatically replaced with the appropriate information for that submission Edit Setting Microsoft Internet Explorer provided by Verizon Online https www irbplus com SettingEdit asp nSettingld 2 Dear PI Full Name The following online adverse event submission for the above references protocol has been receive
24. ents and Printable Forms tabs Each form will have a submission type e g initial application amendment continuing review and a form type which may be e Web Form This form appears on the Online Forms tab for the submission type e Document This document appears on the Documents tab for the submission type The document can be uploaded to IRB in an electronic format e Printable Form This document appears on the Printable Forms tab for the submission type This is a printable version of all online forms on the submission e Fax Sheet This document appears on the Printable Forms tab for the submission type This is a printable fax sheet often used as sign off sheets for the submission Third Sky Page 26 of 35 IRB IRB Microsoft Internet Explorer provided by Verizon Online Go LAAF Edit eSubmission Forms and Documents GIE IRB Online Submissions User Manual EIE Ba RE di ip Page G Tools em Ja gt Main Menu Form Name Form Type Submission Type Form Order Eier ar AT ES TA System Web Form Edit Fields eSubmission Inbox Principal Investigator and Co Researchers Web Form Initial Application 100 Edit Fields New Study Protocol Summary Web Form Initial Application 110 Edit Fields Subjects and Recruitment Methods Web Form
25. ick on the name of the document At any time before you electronically submit the application to the IRB office you can re upload the document if the document changes by clicking the Click here to upload a new document link To delete the document click the Click here to remove the document link If you do not submit the appropriate documents either electronically or by mail your protocol may not be reviewed and you will not be able to perform your study 3 3 5 Printable Forms A printable version of each submission may be found under the Printable Forms tab e g Printable Single Project Approval Form Clicking on this link will open a new window containing Third Sky Page 15 of 35 RB IRB Online Submissions User Manual a printable version of all the online forms for this submission This document may be printed for your files by clicking the Print button at the bottom of the window The Printable Forms tab also contains fax sheets such as the Project Approval Sign off Sheet that may be printed and faxed for sign off IRB New Test Study Microsoft Internet Explorer provided by Verizon Online Go a E https www irbplus com eSubmission asp nStudyId 37 1968 amp nSubmissionId 152 RE E Erger Tos vla 44 X oracle forms 6 pre block e J gt Ww di ERA New Test Study Ce Protocol Title New Test Study Principal Inv Doe John Phone 111 222 333
26. le com Go to My Studies Study Coord Pickerel Margaret Phone 301 295 0819 Email mpickerel usuhs mil uDbmit he following items have not been completed and are required for submission e Risks and Discomfort e Research Procedures he following documents if applicable must be mailed to the IRB e Complete research proposal or project description 2 copies for exempt 3 copies for expedited 11 copies for full review e Advertising Materials flyers newspaper ads etc 2 copies for exempt 3 copies for expedited 11 copies for full review e Consent Form 2 copies for exempt 3 copies for expedited 11 copies for full review e Consent Form for Non English Speakers 2 copies for exempt 3 copies for expedited 11 copies for full review our submission cannot be reviewed until all applicable documents are received by the IRB Once you have completed each of the items listed on the Submit tab a Submit button will be displayed Click on the Submit button to electronically submit the protocol application to the IRB office Please note this is analogous to handing a paper copy of your protocol to the IRB office Hence once you have submitted your protocol you will not be able to make any changes to the protocol If you need to make a change after submission contact the IRB office and they can return your submission Your returned submission will appear in the Planned Submissions section of the My St
27. mail the current password on your account to this email address If you do not have a login contact your IRB office They will add you as an investigator to IRB and give you a temporary password 3 1 1 Terms of Use It is important that you read and agree with the Terms of Use before using IRB The Terms of Use are located in the left menu of the Login screen Third Sky Page 4 of 35 IRB 3 2 My Studies Screen IRB Online Submissions User Manual After logging in you will see the My Studies screen that will be similar to the following screen shot gt IRB Microsoft Internet Explorer provided by Verizon Online me Ge av Nee https www irbplus com MyStudies asp vla el we di gg saad va rr gt me De E New Protocol Application New Continuing Review RB Action Pending gt ma Rs x Es RE ah E Page g Toos i Planned Submissions Study Number Submission Type P I Protocol Title Delete not assigned Continuing Review Lo Reg test 2 x New Amendment Study Number Pd Study Title Online Date Submitted IRB Meeting Last Correspondence Change or Update not assigned Lo Reg test New Adverse Event New Unanticipated Active Protocols Problem ee Study P I Study Title Status aon EE EEN Number Date Lo Reg test 2 ACTIVE 4 9 2008 Exempt Protocols None Closed Expired Protocols
28. metratad da nannla aat in lane airline muonoc x a l l l lao eem M acc Select the protocol for which you wish to create the Continuing Review and click the OK button The drop down list will be populated with protocols in a valid status for continuing reviews IRB HSR 06 001 SWOG 9999 A Double Blind Randomized Study of XYZ in Patients with AML Microsoft Internet Explorer provided b MEE vale ree ee Study HSR 06 001 Expedited A Protocol Title SWOG 9999 A Double Blind Randomized Study of XYZ in Patients with AML Principal Inv Dakhil Shaker Phone 123 123 1234 Email dshaker swog org Study Coord Marge Good WCCOP Phone Email Status ACTIVE Expires 4 17 2008 Go to My Studies ew Continuing Review ew Amendment Change or Update Expiration Date Associated with Continuing Review 4 17 2008 New Adverse Event Web Form Registry and Database Renewal Form Incomplete Please complete this form Status Instructions New Unanticipated Problem Project Completion Third Sky Page 21 of 35 RB IRB Online Submissions User Manual The new continuing review submission will be displayed in the Protocol Edit screen You must complete the online forms upload the documents and submit as per an initial application process 3 3 9 Meetings tab The Meetings tab display all meeting this study is scheduled for IRB HSR 06 001 SWOG 9999 A Double Blind Randomized S
29. nator s email address in the Protocol Header Each of the tabs in the Protocol Edit screen will be described in more detail in the sections below e Online Forms tab All online forms that must be completed for this submission e Documents tab Supporting documents associated with the submission e Printable Forms tab A printable version of the submission and other printable documents e g fax sheets Pl s Assurance Sign off Sheet e Submit tab Allows you to electronically submit the submission to the IRB office for review e Security tab Allows you to grant and remove access to personnel on the protocol The following tabs will be displayed once the initial submission has been submitted to the IRB office e Meetings tab All IRB Meetings this study has been scheduled for e Correspondence tab View activity letters for this study and respond online e Init Application Initial application online forms supporting documents and printable forms for this study e Cont Reviews Continuing review submissions and associated online forms supporting documents and printable forms for this study e Amendments Amendment submissions and associated online forms supporting documents and printable forms for this study e AEs Adverse event submissions and associated online forms supporting documents and printable forms for this study e Unanticipated Problems Unanticipated problem submissions and associated online forms supporting docume
30. nd a required field is unanswered IRB will remind you to specify an answer If you would like to save the online form without completing all the required fields click the Save as In Process button Note the status of the online form then remains at In Process until you go back and complete the form Click the Cancel button if you do not wish to save any of your changes Optionally Required Fields Some fields in the online forms are optionally required depending on the value of other fields in the form For example in the Risks amp Discomfort form for initial applications if you answer Yes to the question When you have completed your contact with the research participant will there be a debriefing session then you will be required to explain the procedures for the debriefing session Risks and Discomfort Microsoft Internet Explorer provided by Verizon Online EIER https www irbplus com WebForm aspeninstanceld 939 When you have completed your contact with the research participant will there be a debriefing session OvYes ONS lf your answer is YES please describe the procedure that you will utilize Optionally Required Forms amp Supporting Documents In the online forms specifying certain information will require you to fill out additional forms or attach additional supporting documents For example in the Description of Change online form in the amendment submission
31. ns describes all activities related to creating and submitting submissions e g completing online forms uploading documents granting access to protocols 3 3 1 Submitting a new protocol application To create a new protocol application click the New Protocol Application link on the top left of your screen You will see the following screen New Protocol Application Screen New Protocol Application Microsoft Internet Explorer provided aB What is the title for this new study New Test Study Dane L Internet 100 Enter the protocol title and click the OK button to continue and you will then see the Protocol Edit screen Note You new protocol will appear in the Planned Submissions section of the My Studies screen until you submit it to the IRB office Third Sky Page 6 of 35 RB IRB Online Submissions User Manual 3 3 2 Protocol Edit Screen The Protocol Edit screen allows you to manage all submissions for a protocol The Protocol Header which is above the tabbed panel displays general information about the protocol such as the study title and PI If you need to change the title of the protocol you can enter the new title at the top of the screen and click the Save button All other fields in the Protocol Header are read only You can quickly email the PI by clicking the PI s email address in the Protocol Header Similarly you can email the Study Coordinator by click the Study Coordi
32. nts and printable forms for this study e Project Completion Project completion submissions and associated online forms supporting documents and printable forms for this study Third Sky Page 7 of 35 RB IRB Online Submissions User Manual The screenshot below displays a newly created initial application IRB New Test Study Microsoft Internet Explorer provided by Verizon Online Ge gt Ji https www irbplus com eSubmission asp nStudyId 37 196 v Q ty X Jorade forms 6 pre block Pe w dir IRB New Test Study fo H dh Page v CF Tools e E itle a dm Ty Protocol Title New Test Study Principal Inv Phone Email Go to My Studies Study Coord Phone Email Online Forms Documents Printable Forms Submit Security Web Form Status Instructions Principal Investigator and Co Incomplete Researchers Protocol Summary Incomplete Subjects and Recruitment Methods Incomplete Research Procedures Incomplete Risks and Discomfort Incomplete Other Requirements Incomplete In the left menu you can select the following action Go to My Studies Click this to return to the My Studies screen to view all your protocols and submissions 3 3 3 Online Forms Tab The Online Forms tab lists all the online forms that you will need to complete before you can submit the protocol to the IRB office These forms should be familiar to you as they contain ques
33. ontain the name of the online field to be shown as the first column in the All Submissions tab to help differentiate different submissions of the same type e g in the All Adverse Events this field is the Date of Adverse Event e lt Submission Type Field 2 Settings with a name in this format e g Adverse Event Field 2 contain the name of the online field to be shown as the second column in the All Submissions tab to help differentiate different submissions of the same type e g in the All Adverse Events this field is the Description of AE IRB Microsoft Internet Explorer provided by Verizon Online x G by httos www irbplus com SettingList asp v 4 X Pp P d S n ma w dir Es fey D fm Page iG Tools 1 9 24 fF Edit eSubmission Settings a die er ED 71 Name Setting Main Menu Address Bie EA N Adverse Event Dear lt PI Full Name MIE ENT Accepted New Study The following online adverse event submission for the above references protocol has been received and will be reviewed AE Date lt AE Date Goto Last Study AE Description My Selected Studies AE Description In a few days you can check the status of your AE submission on the web Investigators Coordinators If you have any questions please contact the IRB Office Members Adverse Event Field Date of Adverse Event 1 Missed Deadlines Adverse Event Field Description of AE M
34. receive email notification that the study is approved If you wish to return the submission to the PI enter the reasons for return and the changes that should be made to the study in the text box When you click the Reject button the submission will be returned to the PI and they will be emailed the reasons for return Third Sky Page 25 of 35 RB IRB Online Submissions User Manual IRB SBR 06 040 Tanning Microsoft Internet Explorer provided by Verizon Online Go ba e https www irbplus com eSubmission asp nStudyId 37 1548 amp nSubmissionId 137 i 4 9 X Google x w di IRB SBR 06 040 Tanning Q dah E Page Tools ep sye SE Siudy SBR 06 040 Expedited de Vo dad Protocol Title Tanning Principal Inv Spitz Jonathan Phone 877 999 8887 Email jspitz cox com Study Coord Phone Email Status EXEMPT Expires Back to Study Info Date Submitted 4 12 2007 lick the Accept button to upload this Initial Application into IRB o reject this Initial Application enter a reason below and click the Reject button his Initial Application will be unlocked so the Principal Investigator and or Study Coordinator can continue to make changes 4 3 Edit Forms amp Documents Screen The Edit Forms amp Documents screen can be found under the Housekeeping menu The Edit Forms amp Documents screen lets you customize the Online Forms Docum
35. rom the drop down and click the Third Sky Page 17 of 35 RB IRB Online Submissions User Manual Grant Access button To disable access click the button next to the person s name under the Click button to disable access title IRB New Test Study Microsoft Internet Explorer provided by Verizon Online S v https www irbplus com eSubmission asp nStudyId 37 196 amp nSubmissionId 152 i Fy bed x Pl EE RE OE OR AE EE ei 5 Pe ww IRB New Test Study i fa dh i Page G Tools i lt salad Protocol Title New Test Study ow Principal Inv Doe John Phone 111 222 333 Email jdoe google com Go to My Studies Study Coord Phone Email Click button to disable access Dakhil Shaker o grant another user access to this protocol select the user from the list and click the Grant Access button Grant Access Third Sky Page 18 of 35 RB IRB Online Submissions User Manual 3 3 7 Submit Tab The Submit tab summarizes all items that must be completed before your protocol can be electronically submitted and reviewed IRB New Test Study Microsoft Internet Explorer provided by Yerizon Online BER G ay e https www irbplus com eSubmission asp nStudyId 37196 amp nSubmissionId 152 v Q ty X triple j Pe HE j gt Protocol Title New Test Study Save se Principal Inv Doe John Phone 111 222 333 Email jdoe goog
36. s tab as you can tell the researchers any important instructions for filling out the online form These instructions will appear next to the form name in the Online Forms tab For Documents these instructions will Third Sky Page 28 of 35 RB IRB Online Submissions User Manual appear on the Submit tab next to the document name For Printable Forms and Fax Sheets these instructions will appear on the Printable Forms tab next to the form name The Document Instructions field contains any instructions for filling out this document These instructions appear on the Documents tab next to the document name If the Auto Create checkbox is checked this form will automatically be created when the investigator starts the corresponding submission For example in the screen shot above the Principal Investigator amp Co Researchers online form is automatically created for each initial application If you do not check the Auto Create check box make sure one of your online forms has a rule that adds this form to the protocol Otherwise the investigators will never be able to access the form refer to the Edit Rules section below for instructions on how to create rules The Track Date Received checkbox only applies to Documents If you want to track the date that the document was received check this checkbox If this checkbox is checked the PI will be reminder to upload these documents to the WebKit These documents will also appear in
37. s you create a hierarchy of questions Entering 1 in this box gives the question a small indent entering 2 in this box gives the question a double indent and so on The Order field lets you specify the order that the questions will appear on the online form The questions will appear in ascending order A best practice is to count by 10 when initially establishing the order Later wnen a new question must be inserted between two existing questions you can then pick the appropriate order number Third Sky Page 33 of 35 RB IRB Online Submissions User Manual 4 5 EditeSubmission Settings Screen The Edit eSubmission Settings screen can be found under the Housekeeping menu The Edit eSubmission Settings screen lets you customize the emails sent out upon acceptance or rejection of a submission and the values show All Submissions tab e g All Continuing Reviews All Amendments etc Types of settings e lt Submission Type gt Accepted Settings with a name in this format e g Adverse Event Accepted contain the format of the emails to be sent to the PI upon acceptance of the submission by the IRB office e lt Submission Type gt Rejected Settings with a name in this format e g Adverse Event Rejected contain the format of the emails to be sent to the PI upon rejection of the submission by the IRB office e lt Submission Type Field 1 Settings with a name in this format e g Adverse Event Field 1 c
38. ternet 100 Click the Add Co Investigator or Add Study Coordinator button to add personnel to the Study Staff form with the specified role The Find Person screen will be displayed Enter the first few letters of the person s first name or last name and click the Find button All matching people in the system will be displayed Click the person s name to add the person to the Study Staff form If you cannot find the person you are looking for check the spelling of the person s name or contact the IRB office and ask them to create this person s record 3 3 3 3 Demographic Information Online Form The Demographics Information online form is used to record the breakdown of participants by ethnicity and gender The total fields are ready only and will be automatically calculated as you enter the participant figures Third Sky Page 13 of 35 RB IRB Online Submissions User Manual Demographic Information Microsoft Internet Explorer provided by Verizon Online https www irbplus com eSubmissionDemographicInfo asp ninstanceld 877 4 DEMOGRAPHIC INFORMATION Black not White not n P Hawaiian American of g of i i Hispanic s A or Other or Indian or Hispanic p Hispanic a x American Pacific Unknown Alaskan American American Islander a 7 wal Ld NOTE Total must equal Item D in the Web Form 3 Enrollment Information Save Save as In Process Cancel
39. tions similar to the paper based forms you have used previously As you complete each form the status of the form will change from Incomplete to Complete Partially completed forms may be saved as In Process All incomplete forms will have a status in red and all in process forms will have a status in beige to indicate that they require further action Instructions may be displayed next to each form to give further information on what the form contains and how it must be completed Third Sky Page 8 of 35 RB IRB Online Submissions User Manual IRB New Test Study Microsoft Internet Explorer provided by Verizon Online DM https www irbplus com eSubmission asp nStudyId 37196 amp nSubmissionId 152 X oracle forms 6 pre block D f 4 pA gt ww RB New Test Study MR dah Page G Tools dd ie eed Protocol Title New Test Study Save Principal Inv Phone Email Go to My Studies Study Coord Phone Gia Status Instructions Principal Investigator and Co Incomplete Researchers Protocol Summary In Process Subjects and Recruitment Methods Complete Research Procedures Incomplete Risks and Discomfort Incomplete Other Requirements Incomplete 3 3 3 1 Completing Online Forms To open a online form click on the name of the form and it will be displayed in a new window For example when the Protocol Summary online form is clicke
40. ton Co investigators and study coordinators may be added to the study by clicking the Add Co Investigator and Add Study Coordinator buttons If you need to edit the contact details of an existing person click the Edit Person button Remember to click the Save button after you have finished editing the research personnel Editing a Person 2 Study Staff Microsoft Internet Explorer provided by Verizon Online https www irbplus com eSubmissionStaff asp salutation First Name Last Name Degrees ddress 1 222 Main Street Phone 111 222 333 State Zip 12345 Date of Training 5 1 2005 Once you click the Edit Person button the person s contact and other details will be editable as shown above Most fields in the Edit Person view are self explanatory The more complex fields are explained in more detail below The Email address is used by that person to logon on to IRB so it is important to enter this correctly The Date of Training of IRB training All personnel are required to have up to date training Third Sky Page 12 of 35 RB IRB Online Submissions User Manual Find Person Screen gt Find Person Microsoft Internet Explorer provided by Verizon Kof le htips www irbplus comjfPersonFind asp Fra Wiliams Dennis 641 4492 immed sitwin com Villiams Dennis Williams Margaret 004 555 1212 mwilliams stmaryscross_org Miliams Thomas 569 5227 CB in
41. tudy of XYZ in Patients with AML Microsoft Internet Explorer provided b lt gt 6 https www irbplus com eSubmission asp nStudyId 247268 amp nSubmissionId 105 a 4 4 X triple j Pi ae eN Study HSR 06 001 Expedited ar de Vo aid Protocol Title SWOG 9999 A Double Blind Randomized Study of XYZ in Patients with AML Principal Inv Dakhil Shaker Phone 123 123 1234 Email dshaker swog org Study Coord Marge Good WCCOP Phone Email Status ACTIVE Expires 4 17 2008 Tec Meeti Init Application _ AEs Unanticipated Problems Project Completion Security Go to My Studies New Amendment Date Reason Change or 3 31 2006 Update 4 14 2007 Continuing Reviews New Protocols New Adverse Event New Unanticipated Problem Project Completion 3 3 10 Correspondence tab The Correspondence tab displays all correspondence activity letters from the IRB office You may view these activity letters by clicking the View Letter button Some activity letters may require a response and for these activity letters you may respond online by clicking the Click here to respond online link Third Sky Page 22 of 35 RB IRB Online Submissions User Manual IRB HSR 06 001 SWOG 9999 A Double Blind Randomized Study of XYZ in Patients with AML Microsoft Internet Explorer provided b Go https www irbplus com eSubmission asp nStudyld 247268nSu
42. udies screen Third Sky Page 19 of 35 RB IRB Online Submissions User Manual gt IRB New Test Study Microsoft Internet Explorer provided by Verizon Online Ge J v https www irbplus com eSubmission asp nStudyld 37 1968 amp nSubmissionId 152 v Q X triple j Pe _ s n EE Protocol Title New Test Study Principal Inv Doe John Phone 111 222 333 Email jdoe google com Go to My Studies Study Coord Pickerel Margaret Phone 301 295 0819 Email mpickerel usuhs mil Online Forms Documents Printable Forms Submit Security Click the Submit button to send this Initial Application to the IRB Office You should also print this page as a reminder to mail fax the required documents listed below to the IRB he following documents if applicable must be mailed to the IRB e Complete research proposal or project description 2 copies for exempt 3 copies for expedited 11 copies for full review e Advertising Materials flyers newspaper ads etc 2 copies for exempt 3 copies for expedited 11 copies for full review e Consent Form 2 copies for exempt 3 copies for expedited 11 copies for full review e Consent Form for Non English Speakers 2 copies for exempt 3 copies for expedited 11 copies for full review our submission cannot be reviewed until all applicable documents are received by the IRB Once you submit your submission will appear in the
43. udy of XYZ in Patients with AML Principal Inv Dakhil Shaker Phone 123 123 1234 Email dshaker swog org Study Coord Marge Good WCCOP Phone Email Status ACTIVE Expires 4 17 2008 EES Meetings Correspondence Init Application _ AEs Unanticipated Problems Project Completion Security _ New Amendment Change or Update Go to My Studies Version Date of Amendment Description of Change New Adverse Event Status Instructions Document New Unanticipated Problem Clean Consent Form Click here to upload the document Consent Form with Changes Highlighted Click here to upload the document Project Completion Most of the online forms are self explanatory However the following more complex online forms are described in the sections below Third Sky Page 11 of 35 RB IRB Online Submissions User Manual 3 3 3 2 Study Staff Online Form 2 Study Staff Microsoft Internet Explorer provided by Verizon Online https www irbplus com eSubmissionStaft aspeniInstanceld 935 Principal Investigator Address 1 Phone Address 2 Fax Email Date of Training City State ip Add Co Investigator Add Study Coordinator The Study Staff online form contains all research personnel associated with this study and will be required for all initial applications You can replace a person or lookup a person by clicking the Lookup Person but
44. xt box Number The investigator must enter a number Date The investigator must enter a valid date Drop Down List The investigator will pick an item from a drop down list Radio Buttons The investigator will pick one item from a series of radio buttons Instructions This field actually provides instructional text and no answer is expected The List Items section lets you specify the items for check boxes drop down lists and radio buttons To add a new item to the list enter it into the top box and click the Add Item button To change an existing item select it from the list change it in the top box and click the Update Item button To remove an item from the list select it from the list and click the Delete Item button List items will be displayed in the online form in the order they have been entered Do not use commas or HTML tags in the list items as this will cause the page to function incorrectly The Length field lets you specify the maximum number of characters for a Text field If the investigator must answer this question before they can submit the application check the Required checkbox Required fields will have a red asterisk next to them in the online form You must save the field before the Rules section only becomes available When you return to the field you will see a New Rule button Clicking this button will display the following screen gt Edit Rule Microsoft Internet Explorer provid A Ed https
45. y new study x Application not assigned Initial Application asdf x E not assigned Initial Application humans x Review 7 not assigned Initial Application Test Study x not assigned Initial Application Test Study x New Amendment not assigned Initial Application survey x ig Change or Update not assigned Initial Application Karri x oe New Continuing Review Microsoft Internet Explorer provided by Verizon Online x New Unanticipated le https aww irbplus com ANewOther asp sSubmissionType Continuing Review x Problem AML x Project Completion m e AML x aa AMM X AML x AML x AML x Done N E GEM 100 ham X HSR 06 001 Unanticipated Problem Dakhil Shaker SWOG 9999 A Double Blind Randomized Study of XYZ in Patients with AML x SBR 06 001 Adverse Event Whiteley George SBR Study 001 x SBR 06 001 Adverse Event Whiteley George SBR Study 001 x SBR 06 001 Amendment Whiteley George SBR Study 001 x SBR 06 001 Continuing Review Whiteley George SBR Study 001 x SBR 06 001 Continuing Review Whiteley George SBR Study 001 x SBR 06 001 Project Completion Whiteley George SBR Study 001 x SBR 06 001 Project Completion Whiteley George SBR Study 001 x SBR 06 001 Project Completion Whiteley George SBR Study 001 x SBR 06 001 Project Completion Whiteley George SBR Study 001 x SBR 06 001 Unanticipated Problem Whiteley George SBR Study 001 x SBR 06 001 Unanticipated Problem Whiteley George SBR Study 001 x SRB NENNG Adverce Fuant Sanfard Theraca How fr
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