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eIRB User Manual - eIRB-Information

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1. 2 02 2 2022 22222222 2 2 222 37 GLOSSARY UNDERSTANDING CURRENT 5 5 41 HELP SS asiq 43 dai e nth eda 43 STUDY IRB RELATED SUPPORT tee 43 GENERAL COMPUTER HELP DES REP EEUU 43 BROWSER REQUIREMENTS 43 S1 STEN REQUIREMENT tnt EE Riu exe iM beg 43 PART LL COMPLIANCE s ioa Cu buba 43 EXAMPLES OF COMMON ERROR MESSAGES 44 WHAT 15 NOT FOUND IN THE 44 INTRODUCTION The Electronic Institutional Review Board el RB is a web based application that provides tools for submitting and managing requests to the KPNW Institutional Review Board IRB for approval of human subjects research The el RB streamlines the process of submitting research studies to the IRB by eliminating the need for paper and by providing an easy way to process all study related documentation electronica
2. ane TRE Risen Deana Pages recu rye Container mcm enhy Enti COD 5574838 LSE MEIT 54D A SFEFE72FD x comet ill certet g seo nae perad Your cae curtrocen E dm Page e Tode e thwest KPNW gt Y L Laforge My Home Clipboard Projects Logoff Institutional Review Board inquiries sludies Ke searcher Pr Reports IRG Issees Site Administration Srudogs CKD elderly The impact of IRQ Qumber rrooooonso8 Approved Study Title F3 Edit Sbe y The impact of hypertension management in elderty Study Status Approwed n ia Principal Investigator Yremstemn Expiration 4 7 2011 Date KPAW Mentor A mentor was not listed required for this study Sponsor Investigator Reviewing IRE Kaiger Permanente Stody Martha est Modification Hew Reportable Frant PrimaryContacts Barbara Bachman Center for Health Research Pru Amanda Patrik Center for Health Research NY Approval Letter Click to View Study Madihcabons Aevis Reportable Events Documents Noles Change Log EJ Actrcity Date Canina Rewsevw Deadline Femindler Acdmirastraber System V
3. Figure 33 33 Reportable Event form will open prompt you to enter short name for your submission The name of the submission should be a short description of the event s being reported for example Participant hospitalization Do not exceed 50 characters with spaces see Figure 34 Edit View Microsoft Internet Explorer 1 x File Edit View Favorites Tools ay Q tack 4 E A 2 Search 5 0 Favorites A rel rs Address http kaiser dev webridge com KaiserIRB ResourceAdministration Project ProjectEditor Project com webridge entity Entity OID DFDSD3604ECE9D4494BDB2BBEB4D3F05 aMode smartform amp WizardPageOID com webridge er w EJ lt Links 3 E Kaiser Permanente Northwest KPNW LI Edit Reportable Event Adv00000035 x R Institutional Review Board eIRB LIUM lt lt Back Save Exit Hide Show Errors Print Jump To Unanticipated or Anticipated Continue gt gt Unanticipated or Anticipated 1 0 Provide a short name for your submission that briefly describes the event s being reported For example Participant hospitalization Do not exceed 50 characters with spaces Do not include any personal health information i e do not include a patient s name medical record number etc p 2 0 Isthe incident experience event and or outcome unexpected in nature severity or frequency given
4. LJ d Address http kaiser dev webridge com KaiserIRB ResourceAdministration Project ProjectEditor Mode smartform amp Project com webridge entity Entity OID 4697850C3DD7834C847ED2F4548C0D20 J amp WizardPageOID com webridge er Y ET Go Links 7 f AE Kaiser Perme nente Northwest KPNW Last Edit IRQ Pro00000599 Institutional Review Board eIRB lt lt Back Save Exit Hide Show Errors Print Jump To Study Summary Continue gt gt Study Summary Section Study Summary Study Summary 1 0 Study s expected start date Study Funding Section BR 11 24 08 Study Funding 2 0 Study s expected end date The duration between your start date and end date should encompass all Study Funding Information a analysis If applicable indicate unknown dure Fundi Industry Funding f Nonprofit Funding 3 0 Comrnents about study duration optional Study Funding Section Completed Categories of Research Activities Section Categories of Research Activities zl Study Locations Multisite Section 4 0 Provide a clear statement of the hypotheses to be tested or the question problem being addressed Study Locations Multisite List the measurable and specific scientific objectives of this research m 5 0 Briefly summarize existing knowledge pertinent to this study State what this study will contribute to existing knowledge 4
5. Revise Consent Form or Change PI and revise consent and recruitment docs The name of the submission should not exceed 50 characters with spaces see Figure 30 The RSPO will use this description will be included in the approval letter for the modification Therefore the description should contain no abbreviations and should be grammatically correct 29 Edit View Microsoft Internet Explorer x File Edit View Favorites Tools X 4 M ix E PN 22 search 50 Favorites O Y al T 4 e Address http kaiser dev webridge com KaiserIRB ResourceAdministration Project ProjectEditor Project com webridge entity Entity OID E7D63F60ED6C6F428524DA0C1FD5546A amp Mode smartForm amp WizardPageOID com webridge er w 2 Go Links Permanente Northwest KPNW 2t Institutional Review Board eIRB lt lt Back Save Exit Hide Show Errors Print Jump To Modification Request Continue gt gt Edit Study Modification MR2 Pro00000337 Modification Request 10 Provide a short name for your submission that briefly describes the modification s being requested The name of your submission should be for example Change PI Revise clinic visit process or Change PI and revise consent form Do not exceed 50 characters with spaces Changing survey document 2 0 Modification Request Check all that apply Madification T
6. the research procedures that are described in the study related documents such as the IRB approved research protocol informed consent document and or investigator brochure and b the characteristics of the subject population being studied including the expected natural progression of any underlying disease disorder or condition of the subject s and or the subject s predisposing risk factor profile for the adverse event yes No Clear example of when to answer yes Subjects with coronary artery disease presenting with unstable angina are enrolled a multicenter clinical trial evaluating the safety and efficacy of an investigational vascular stent Based on prior studies in animals and humans the investigators anticipate that up to 5 of subjects receiving the investigational stent will require emergency coronary artery bypass graft CABG surgery because of acute blockage of the stent that is unresponsive to non surgical interventions The risk of needing emergency CABG surgery is described in the IRB approved protocol and informed consent document After the first 20 subjects are enrolled in the study a DSMB conducts an interim analysis as required by the IRB approved protocol and notes that 10 subjects have needed to undergo emergency CABG surgery soon after placement of the investigational stent The DSMB monitoring the clinical trial concludes that the rate at which subjects have needed to undergo CABG greatly excee
7. Study s expected start date 11 24 08 ERR 2 0 Study s expected end date The duration between your start date and end date should encompass all study activities such as enrollment long term follow up and data analysis If applicable indicate unknown 11 24 09 3 0 Comments about study duration optional 4 0 Provide a clear statement of the hypotheses to be tested or the que Pttp jikaiser dev webridg Internet List the measurable and specific scientific objectives of this research 5 0 Briefly summarize existing knowledge pertinent to this study State what this study will contribute to existing knowledge 4 bibliography must be uploaded with this application either via the upload area directly below or in the next section as part of the uploaded study protocol 6 0 Upload bibliography Add El amp http kaiser dev webridge com KaiserIRB ResourceAdministration Project IE ET Internet start m C i 5l ie w 13 Q GO 2 5 Inbox Microsoft P SMART FORMSI W 2 Microsoft Office amp Modification 1 For L amp 3 Edit View Micro 2 5 QO M 2 51 PM Figure 15 Uploading documents In various places in the elRB forms you be asked to upload documents For example if you are doing primary data collection collecting information or samples directly from participants you will be asked to upload any recruitment materials to
8. converted hardcopy studies Because you were allowed to enter an abbreviated form to convert your hardcopy study to make modifications to these converted studies you may need to use the Other Study Information page at the end of the IRQ which presents the following text box labeled as follows Optional If you feel there is important relevant information about this research that was not solicited previously provide this information below You can use this text box to write in information describing the proposed modifications You CAN do modifications edits to documents including adding new documents on converted hardcopy studies since you were asked to upload documents with your conversion form The documents you loaded are at the end of your IRQ If you uploaded a protocol you can also 32 submit proposed modifications by tracking changes your protocol document submitting that for review An important note about modification requests You may only initiate one modification request at a time per study Only one modification request can be submitted i e yet to be reviewed by the IRB at a time If you have already submitted a modification request to the IRB and realize you wish to request another modification AND if the modification request has not already been sent to a reviewer or discussed at an IRB meeting You can contact the IRB see Send Email to RSPO activity on the workspace to ask If th
9. el 2B User Manual Research Subjects Protections Office Kaiser Permanente Northwest CONTACT INFORMATION el RB Technical Support 503 528 3945 tieline 60 3945 Email elRB kpchr org Mail Kaiser Permanente Center for Health Research Research Subjects Protections Office 3800 N Interstate Ave Portland OR 97227 RSPO Director David Holt JD CIP 503 335 6791 David Holt kpchr org RSPO Administrator Sandy Heintz CIP 503 335 6712 Sandy Heintz kpchr org IRB Technical Coordinator Lisa LaForge 503 335 6699 Lisa M LaForge kpchr org RSPO Technician David Matthews 503 335 6357 David M Matthews Qkpchr org RSPO Technician Suzi Jones 503 335 6357 Suzanne M J onjes kpchr org TABLE CONTENTS TABLE OF CONTENTS soka d o 3 INTRODUCTION rem 4 REGISTRATEION Q 4 LOGGING INTO THE RB EU P Fas uuu er DUELO Lr PM LEE 5 CREATING A NEW STUDY uuu stearate eae eee ee rcr Dum pa 8 ADDING INVESTIGATORS AND STAFF TO THE STUDY SUBMISSION 9 NAVIGATING THE INITIAL REVIEW QUESTIONNAIRE IRQ 13 UNDERSTANDING HELP TEX FAREA RP DRE DIERUM FERAT mei 13 SEARCHING UIS TS 13 USING THE FORM DROP DOWN LIST TO JUMP TO 13 SAVING THE INFORMATIO
10. 17 Edit iew Microsoft Internet Explorer x File Edit view Favorites Tools Help s Q x Search 52 Favorites LJ rel Address 4 amp http kaiser dev webridge com KaiserIRB ResourceAdministration Project ProjectEditor Mode smartform amp Project com webridge entity Entity OID A697850C3DD7234C8A7ED2F4548COD20 amp WizardPageOID com webridge er v ET Go Links Kaiser Permanente Northwest KPNW Institutional Review Board eIRB lt lt Back Save Exit Hide Show Errors Print Jump To Additional Research Study Information Continue gt gt Edit IRQ 00000599 Additional Research Study Information 1 0 Optional If you feel there is important relevant information about this research that was not solicited previously provide this information below or upload descriptive documentation 2 0 Upload Add Document s There are no items to display lt lt Back Save Exit Hide Show Errors Print Jump To Additional Research Study Information Continue gt gt 7 Done ep Internet start BOA 5 O Inbox Microsoft P Training SCREE W 3 Microsoft Offic 4 amp Modification 1 For I edit view micr ES QOM 3 16 PM Figure 17 The elRB will allow you to upload electronic documents of any type and format It is importa
11. 2 Microsoft o L P Training 44 OHSU eIRB User Ma W trainingStory doc Project Micr M 1 41 PM Exiting the Form Before exiting it is important to save your answers by clicking the link exit the IRQ please use the Exit link If applicable when you click on the Exit link Standard warning window will open asking you reminding you to save your answers If you have not saved your answers and wish to click OK and the system will save your changes and automatically exit you from the submission If you have not saved your answers and do NOT wish to save them click No and the system will not save your changes and automatically close your submission see Figure 15 15 Edit View Microsoft Internet Explorer x File Edit View Favorites Tools Rz sack M ix J Search 5 0 Favorites 2 L DR rel Address http Jkaiser dev webridge com KaiserIRB ResourceAdministration Project ProjectEditor Mode smartfForm amp Projeck com webridge entity Entity OID A697850C3DD7234C8A7ED2F4548COD20 amp WizardPageOID com webridge er Y Go Links Permanente Northwest KPNW MES Institutional Review Board eIRB lt lt Back S lt xit Hide Show Errors Print Jump To Study Summary Continue gt gt Edit IRQ 00000599 Study Summary 1 0
12. Reminder The PI is the only person that can submit submissions Submit study If you are the PI for a study only you will have the option to submit equivalent to a signature on paper the study continuing review reportable event or modification request Once you have opened the submission draft and have reviewed it for accuracy you may click on the Submit activity located on the left section of the submission workspace page under My Activities Once the submit action has been completed the submission will enter the review process Suspend study ALLOWS the PI or IRB to suspend a study suspended studies must temporarily cease all study activities except those required to protect the health and welfare of study participants Terminate study ALLOWS the PI or IRB to terminate a study after which the study will no longer be in an IRB approved status 39 Withdraw ALLOWS the item to be withdrawn archived The Withdraw action allows the PI to effectively cancel the submission This action will be useful if during the review process events impact the plans for the study and it is decided that the study or particular submission will not proceed Withdrawing the study will not delete the study and its information but rather archive it You will still be able to retrieve the information you have entered into the IRQ should the need arise in the future See Figures 38 and 39 22 Doston Red Sox Microsoft Internet
13. Required LOK cancel Expiration Date 12 3 1 2500 Current Version 0 02 New Version 0 03 History amp Roll Back Max Versions to Keep Unlimited wawa Upload Icon Version Notes Required Figure 23 STUDY WORKSPACE OVERVIEW When you create a Study Continuing Review Reportable Event Modification or IRQ Inquiry a comprehensive area referred to as the project workspace is created which displays useful information about the submission see Figure 24 In a project workspace the submission s numbered number is displayed in bolded letters near the top When speaking with elRB technical support staff or with RSPO staff refer to the last digits of the ID number omitting the zeros In Figure 24 this would be number 593 22 yellow area indicates the Current State of the review process for the particular submission As the review progresses the state change See GLOSSARY Understanding Current States for more detail My Activities lists the activities available to you in the Current State of the review process for the particular submission As the review progresses available activities change See GLOSSARY Understanding Activities for more detail Note When a submission is in a pre submission state this is the area where the PI would find the Submit activity CCM elderhy The impact of hypertensisa managemen Windows Internet Explorer 2161 xil
14. 4 Reportable Events Completed Withdrawn Studies IRB Inquiries Continuing Reviews Inbox Study Protocols Modifications Displays Study Protocols ID gt Date Modified State 00000482 2 Hitchcock North by Northwest 9 23 2008 11 11 AM Suspended Pro0000n0607 Testing issue 697 9 18 2008 1 24 PM Pre Subme son 00000605 10 Fleming Wizard of Oz 9 16 2008 8 47 Pre Submission Pro00000599 10 Fleming The wizard of Oz 9 14 2008 3 33 PM Pre Submission Pro00000531 2 Ferrway Park The Red Sox 9 10 2008 6 27 PM Pre 00000494 2 Fenway park Red Sox 9 9 2008 11 34 Pre Submission Pro NWDBPT o4 2 North by Northwest 9 8 2008 11 46 AM Contingenaes Pending Pro00000384 test 8 18 2008 5 54 PM Pre Submission Study Modifications ID Name T Date Modified State MR1 NWw 08JOate 01 Modification 1 for IRB Study NW 08JOate 01 9 23 2008 11 54 M Changes Required By IRB Staff Continuing Reviews ID Date Modified State 00000 2009 Review for w07mcbv01 9 23 2008 11 57 Changes Required by IRB Reportable Events ID Name Date Modified State There are ne terns f cin ET FT M re BOS Jd 1 242 C cPoruments 30 OHSU ea use wenns Pta Folder for 1 J QO a 11 20 Figure 6 xj In t
15. Air Pollution Lo PASMART FORMSIREPO 4 O QO M 5 31 PM Figure 11 Updating study staff The Edit study staff activity located under My Activities in the study workspace see Figure 12 allows you to quickly change the study staff who either have been added to or have left a study to learn more about activities generally see Glossary Understanding Activities near the end of this manual Updating study staff is important to ensure appropriate staff are receiving notifications from the IRB regarding the study e g continuing review reminders This Edit study staff activity is available most states once a study has been submitted including pre and post approval states IRB approval is NOT required to change study staff on an approved Study Editing investigators on an approved study does require a modification request Submission 12 E 8 Nichols The Graduate Microsoft Internet Explorer l x Fie Edit view Favorites Tools Help Y ix B A J Search Favorites ed wj L4 ee 4 Address http kaiser dev webridge com KaiserIRB Rooms DisplayPages LayoutInitial Container com webridge entity Entity OID 7EA3C506DD72454B965704CE74E627FA Go Links 3j 4 L Permanente I rrhwesct K J n deas coc ed N west KPNW b 2i Lalala PI one My Home Logoff Institutional Review Board eIRB Si TB U BUOTHI
16. Board eIRB Welcome IRB Inquiries IRB Studies Help FAQ Folder for eirbPI Help PI Study Staff Folder for eirbPI Welcome to your Personal Folder the central resource for managing your Study applications CES B e My Inbox contains items that require your attention e My Roles allows you to switch between your user roles if you have multiple roles in the eIRB system e For active studies the tabs below filter by submission type Inactive Items are found in the Completed withdrawn tab Study Protocols Modifications Continuing Reviews Reportable Events Completed Withdrawn Studies IRB Inquiries Displays all items which require action by the study team Click on links for more information Study Protocols ID Name Date Modified z State Pro NWOSCHenn20 study title 9 3 2008 1 16 PM Changes Required by Expedited Reviewer 00000439 test4 9 12 2008 2 09 PM Changes Required by IRB Pro NWOSeirb70 6 On the Waterfront 9 3 2008 1 08 PM Changes Required By IRB Staff 00000253 Team 1 Carpathians 8 26 2008 10 15 Expired Pro NWOSeirb75 Protocol Fri Jul 11 14 40 15 PDT 2008 8 18 2008 11 24 AM Expired Pro NWOSeirb72 _Protocol Fri Jul 11 11 24 07 PDT 2008 8 18 2008 11 24 AM Expired 00000541 7 Wyler Ben Hur 9 11 2008 11 18 4M Pre Submission Pro NWOS8aeirb71 10Detroit Tigers 8 6 2008 10 36 Pre Submission 0000601 12 Huston Maltese Falcon 9 15 2008 10 54 Pre Su
17. Container com webridge entity Entity OID 733D6676C9E2 1 B4E9ACCF26834E0C7 AF amp Tab2 com webridge entity Entity OID 1C3F03E2B03D0B4468 Y Go Links NE Aud KPNW 2 Lalala PI one My Home Logoff Institutional Review Board eIRB LS IRB Studies RES Pig te IRB Studies 1 Pride and Prejudice IRQ Number proo0000337 Approved Study Title 3 War and Peace Study Status Approved Principal Investigator Lalala PI one Expiration Notification Date 8 17 2009 view Study KPNW Mentor mentor was not listed required for this study Review Category Sponsor Investigator Study No Reviewing IRB a PrimaryContacts IT New Modification Person Organization Rebecca Bogorad Center for Health Research NW D New Reportable Event eirbSS Other A New Continuing Review Suzanne Gillespie Center for Health Research NW Approval Letter Click to View Reportable Events Documents Reviewer Notes Change Log Continuing Reviews Study Modifications History ID Name State Last State Change MR2_Pro00000337 Modification 2 for IRB Study Pro00000337 Pre Subrnission 9 25 2008 9 50 MR1_Pro00000337 NW O0S8VvSsTEV 01 withdrawn 9 16 2008 4 12 Kaiser Permanente Northwest Research Subjects Protection Office 3800 N Interstate Ave Portland Oregon 97227 503 335 2400 For questions or comments on the eI
18. Figure 27 Initially the form will prompt you to indicate whether you are submitting a final or progress report and ask for a short name that briefly describes your continuing review see Figure 28 Use the Continue button located in the upper and in the lower right portion of the page to navigate through the form while answering all applicable questions page by page On the last page click finish to complete the questionnaire Once the continuing review is complete and error free the PI should submit it for review using the submit activity see submission section above vem free 7 V r NW ki i Institutional Review Board eIRB ET 1 A lt lt adi Study Status Status Ane you submitting Sudy Afina report for a completed study Note that for a study to be completed research related inberachons data collecbon and analysis as ceesonbeed in the IRB Bnnra ad rasaareh plan be Work nn manusenpts after data analysis ez campista in alread am camplated Aprograss raport or the study continuing rewiaw 24 7 Prowde zhort nina that briefly derribar your submeraon Start by ether Final Report ec Progress Baport and add che year in which tse will accur For example a submission for 2009 may be ether Final Report 2009 of Progress Report 20097 uu Save 1 P
19. IRB Studies 8197919 IRB Studies gt 8 Nichols The Graduate IRQ Number proo0000593 Approved Study Title 8 Nichols The Graduate Study Status Approved Principal Investigator Lalala PI one Expiration Notification Date 9 23 2009 view Study KPNW Mentor eirbMM eirbMM Review Category s sponsor Investigator Study Yes Reviewing IRB Kaiser Permanente Morthwest E Printer version Primary Contacts NEn MONIO Person Organization Suzanne Gillespie Center for Health Research NW 1 New Reportable Event Esl New Continuing Review Approval Letter Click to view Study Modifications Continuing Reviews Reportable Events Documents Reviewer Notes Change Log Activity Author Activity Date x 2 Project Snapshot Generated Joan Holup 9 23 2008 11 34 4M PDT 3 View Project Snapshot Correspondence Letter for Study Approved Joan Holup 9 23 2008 11 34 4M PDT E Project Snapshot Generated Joan Holup 9 23 2008 11 31 4M PDT View Project Snapshot firsa Scheduled for IRB Meeting Kaiser Permanente Northwest meeting on 9 24 2008 Joan Holup 9 23 2008 11 31 4M PDT PI Submitted Changes Joan Holup 9 23 2008 11 30 4M PDT E 2 Changes Logged Testing whether mentor gets 66 gree to Mentor eirbMM eirbMM 9 15 2008 4 08 PM PDT firsa Changes Requested by IRB Staff Joan Holup 9 15 2008 4 05 PM PDT zi 0 Reviewer Notes Logged Testing issues about mentor agreements firea Removed from amp genda Joan Holup 9 15 2008 4
20. The study will therefore be in an approved state Copy Study This activity will COPY this study The same Principal investigator will remain the Principal Investigator for the new Study Deny Cede from Other RB ALLOWS RSPO to indicate that the KPNW IRB does not accept review responsibility for another IRB Edit Consent Forms Allows RSPO staff to modify the contents of the set of draft consent forms prior to project approval and document watermarking Documents added to the draft consent form set via this activity will be available for watermarking using the Finalize Documents activity Edit Guest List ALLOWS any member of the study team to edit i e add delete the primary and secondary study staff contacts on the project Does NOT allow either PI or co investigator edits which must be made through a modification request Edit letter Allows RSPO staff to modify a letter that was previously sent to the study team in the instance of an error or other need to revise Expedite approval ALLOWS IRB Director to expedite approval of a submission Final Report Completed ALLOWS the RSPO staff to indicate that a ceded study is closed Finalize Documents ALLOWS RSPO staff to stamp and watermark multiple draft consent forms with the project approval and expiration dates Once finalized a copy of the corresponding document in the set of draft consent forms is converted to a read only PDF and is placed in the set of Approved Consen
21. Validation Failed The number entered for Newly Enrolled is greater than the Current Number of Participants Subjects in the Study at this site You must revise your number s WHAT IS NOT FOUND IN THE E IRB Single patient use submission forms Emergency use submission forms If you need to make one of these types of submission to the KPNW IRB please contact the RSPO for guidance V 1 02 1 2011 44
22. be used on the study see Figure 16 16 Edit View Microsoft Internet Explorer File Edit View Favorites Tools ix B 5 5 Favorites A l ey 4 Address http Jkaiser dev webridge com KaiserIRB ResourceAdministration Project ProjectEditor Mode smartForm amp ProjecE com webridge entity Entity OID A697850C3DD7234C8A7ED2F4548COD20 amp WizardPageOID com webridge er Y Go Links Kaiser rm gt North KPNW Reviews Board eIRB Y lt lt Back Save Exit Hide Show Errors Print Jump To Recruitment Continue gt gt Edit IRQ 00000599 Risk amp Benefit Assessment Recruitment 1 0 Description of Recruitment and Enrollment Describe in detail how study participants will be recruited and enrolled For example will you openly recruit through the use of advertisements websites or brochures Will you do targeted recruitment through the use of existing records or referral XCVXCVXCV 2 0 Study Materials Upload all recruitment materials including brochures advertisements mailings scripts website materials screen shots Note If your materials yet to be developed these must be submitted to the IRB as a modification request and approved prior to use with study participants Ada Delete Document s Edit View flyer 0 01 3 0 Optional Comments on recruitment mat
23. bibliography must be uploaded with this application either via the upload area directly below or in the next section as part of the uploaded study protocol 6 0 Upload bibliography zl Internet amp Edit View Mi 2 Microsoft Excel 9 M 12 52 PM Figure 13 Saving the information entered There are two ways to save information you have entered into the elRB forms You may use the Continue button to automatically save all data entered into a form thus far Or you may use the nex Save option The latter will save the information but will not automatically lead you to the t page screen It is important to save any work on a give page if you do not click the Continue button Using Hide Show Errors The of t Hide Show Errors link located in both the upper and the lower center of the blue menu bar he form allows you to check for any required questions that have been omitted The links 14 that display in the Errors Warning messages window allow you to jump directly to the required question and answer it Once you have answered the question click on the Save link and then click on the Refresh button located in the lower right section of the page Repeating this process will remove errors from the list as they are corrected until there are no errors left To turn off the error display entirely click on the Hide Show Errors one mor
24. co investigators may be listed in ite privileges to this submission in the eIRB system and if the study is approved to this study s eIRB Region an 4 Kaiser Permanente Northwest Gelmann Edward Region Haney Elizabeth Oregon Health amp Sciences University Johnson Eric Center for Health Research NW Organization Human Subjects Training Date LeBlanc Erin Center for Health Research NW 6 0 Reid Eric Oregon Health amp Sciences Univergfty t box below list the name degree s organizational information email and phone number for non INVV TIOTI CHIK CO IIIVESLIUdLOIS WHO IRB accounts mE WJ Local intranet 100 2 stat 2 3 5 Inbox Microsof 23 Calendar Micro amp amp Edit View wi 23 Z Help Desk 54 Microsoft Excel 89 User Manual v 1 My Computer gt My Computer gt QA J 97 10 48 am Figure 8 Adding Investigators and staff to the study submission There are two ways to add study personnel to the IRQ First type the first few letters of the last name the field the system will auto populate from the system s registered users You may also click the Select button to add study personnel see Figure 8 Once the Select page has opened in the Filter by drop down list box select Last name First name or Organization and enter the search criteria for example choose Last n
25. iterns to display Human Subjects Training Document s There are no items to display OCTRI Attestations Document s There are no items to display Bibliography Document s There are no items to display Study Protocol Document s There are no items to display Other Institution s Form Document s There are no items to display Deception Debriefing Statement Documents There are no items to display Interview or Focus Group Materials Document s There are no iterns to display Psychological Testing Quality of Life Materials Docurnent s View psych test 0 01 Surveys Questionnaires amp Psychometric Testing Materials Document s There are no items to display Investigator Brochure Document s There are no items to display Manufacturer Information Device Brochure Document s There are no items to display Clinical Trial Registration Document s There are no items to display u Document s Study Visits Sessions Schedule View evetn schedule 0 D1 Tissue Bank Operating Procedures Document s There are no items to display El Done fof Internet A start w 1 2 2 2 O Inbox Microsoft O 2 1 eIRB User Manual dr 23 5 5 11 User Manual draft d Nichols The e S M 10 08 Figure 24b Printing saving and documenting submissions There is a Printer Version feature within the system for printing hardcopies of the submi
26. kpchr org under Training Information and FAQ You may also contact Lisa M LaForge kpchr org or at 503 335 6699 to request a training session Study IRB Related Support For questions related to the wording and the meaning of the questions found within the elRB feel free to contact the Research Subjects Protections Office RSPO at 503 335 6699 or at elRB kpchr org TO can also view the list of RSPO personnel and their contact information at htt www kpchr org rspopublic public contactus aspx returnurl2 rspopublic public default as 1 Additionally RSPO maintains web site with useful information at http www kpchr org rspopublic public General Computer Help Desk The General Computer Help Desk provided to the Center for Health Research KPNW can be reached at 503 335 6671 tie line 60 6671 or at hotline kpchr org for questions that are not related to the el RB such as questions relating to your operating system network access and common software applications installed on your computer Browser Requirements Microsoft amp Windows 9x 2000 XP e Microsoft Internet Explorer 6 0 or higher available at http www microsoft com windows ie default mspx e Firefox 1 0 or higher on Windows platforms available at http www mozilla com en US products firefox System Requirements The elRB system will function on Microsoft Windows 95 and higher as long as the computer has Microsoft Internet Explorer 6 0 or higher
27. the questionnaire while answering all relevant questions On the last page of the reportable event form click finish to complete the questionnaire Once the form is complete and error free the should submit it for review using the submit activity You may discover that the event is NOT required to be reported to the IRB or that it should only be reported in summary at the time of continuing review The elRB system will ascertain through a series of questions whether the event must be reported You will be guided to submit to simply exit and not submit and withdraw Generally studies will use this Reportable Event form to report problematic unanticipated incidents experiences events and outcomes related to the study that have resulted in subjects or others experiencing physical psychological or other harms such as social or economic harm or that place subjects or others at increased risk of harm In addition to this general rule FDA regulated studies with a KPNW sponsor investigator only would also use this form to report any other additional incidents experiences events and outcomes as were specifically stipulated and required by the KPNW IRB for the study 34 CREATING IRB INQUIRIES There is a new optional submission type that was not available prior to the elRB system The form is designed for situations in which there is uncertainty about whether IRB review is necessary for a new project T
28. the additions and or the edits replacements navigate to the screen within the IRQ where such documents had been referred to uploaded IMPORTANT NOTE ABOUT DOCUMENTS It is important that you DO NOT DELETE any currently approved documents in the Modified Study unless specifically instructed to do so by the RSPO staff Use the Edit button to upload revised documents or add new documents Once you have navigated within the IRQ and made all the proposed changes click Save then Exit Once the Study modification is complete and error free the should submit it for review using the submit activity see submission section above 31 2 1 Pride and Prejudice Microsoft Internet Explorer E 81 x File Edit View Favorites Tools Back Q ix a FN search Se Favorites cx LJ d Address amp http Jkaiser dev webridge com KaiserIRB Rooms DisplayPages LayoutInitial Container com webridge entity Entity OID 9755642B2BFD3644839DAC58CC50506D m Go Links 3 Kaiser Permanente Northwest KPNW List Lalala PI one My Home Logoff Institutional Review Board eIRB IRB Studies MaG PAg te IRB Studies 1 Pride and Prejudice Modification 2 for IRB Study Pro00000337 1 Pride and Prejudice Modified Study 1 Pride and Prejudice MS2 Pro00000337 Description Modification Open Principal Lalala
29. with cipher strength of 128 bit installed 21 CFR Part 11 Compliance KPNW elRB is compliant with 21 CFR Part 11 including electronic signatures For more information see the KPNW 21 CFR Part 11 Electronc Signature Compliance statement 43 EXAMPLES OF COMMON ERROR MESSAGES You may experience the following error if the system is undergoing maintenance or service An internal server error occurred We apologize for the inconvenience and ask that you please try again later If you continue to experience problems please contact the el RB help desk at 503 528 3945 or elRB kpchr org You be presented with the following message if the elRB system is already in the process of uploading a file into your submission and you attempt to upload a file again You have already submitted the current form Please wait and the operation will be completed momentarily The following messages indicate that you have omitted to answer a required question a screen Could not update the IRQ due to one or more errors There were problems submitting this form This is a required field therefore you must provide a value Example of error message generated if there is incongruous information entered for example if the numbered entered for total study subjects is less than the numbered entered for study subjects specifically enrolled at the KPNW site Could not update the Continuing Review due to one or more errors
30. 04 PM PDT firsa Scheduled for IRB Meeting Kaiser Permanente Northwest meeting on 9 17 2008 Joan Holup 9 15 2008 4 04 PM PDT G 2 Project Snapshot Generated Joan Holup 9 15 2008 4 04 PM PDT f View Project Snapshot IR or2D Kaiser Permanente Northwest Internet start i s io iw 1 3 Q 2 7 O Inbox Microsoft o C9 PAATraining SCREE W7 2 Microsoft Office 9 Windows Media Pla 1 Nichols The 1101 12 31 Figure 12 NAVI GATING THE INITIAL REVIEW QUESTIONNAIRE IR Understanding Help Text Area Throughout the IRQ you can find the light gray Help Text Area located on the right section of each page see Figure 10 a few pages back The Help Text Area contains useful hints and explanations which will assist you in filling out the elRB forms Searching lists For some answers you will be asked to first try to select from a list rather than just typing in your answer For example in the funder sponsor questions you are asked to select from a list that is already within the elRB system In such areas it may be helpful for you to use the following example of a search technique If your funder is The Cancer Society but you are not sure The is really part of the funder s name you can try to use a percentage sign as follows enter cancer All funders and sponsors with the word cancer anywhere within their name will be filtered a
31. 2 D QOO 2 natans mt 1 study has Be Welcome 1 Mesa Figure 9a 10 Edit View Windows Internet Explorer http alpha kaiserIRB ResourceAdministration Project ProjectEditor ProjectT ype _Protocol amp ProjectCreator View com webridge entity Entity OID A 124DBFDE28B9749A468B357 x 18 x Ji File Edit View Favorites Tools oo w a Human Subjects Training If the Investigator s you indicated for this study has completed human research subjects compliance training at KPNW training information is taken from the currently approved training records on the researcher profile If certification of completion of human subjects training is not found in the researcher profile UPLOAD certification evidence here If the date of training is more than a year old investigator s must re certify before submitting this application Applications with training dates more than a year old will not be placed on an IRB agenda for review Read more at the RSPO website Add Document s There are no items to display CP E E Page Gods gt 9 0 Prime Awardee Who is the prime awardee of research support for this project Note Prime awardees from KPNW and or the Center for Health Research must H el p Text already eIRB account and be selected from the list that will appear below outside pr
32. 2008 Principal Investigator Lalala P1 ona Mentor mentor was not lished required for this study Review Category Reviewing IRB Study 5paonsar Investigabor Study Ho o Md ir ei eil Primary Contacts Person Organization lt a 7 Rebecca Center for Health Research NI eirbSs Other Center for Health Research suzannae Gillespie DEL Continulmg Review Approval Letter lick to Roportabie Events Documents Rovwrwer Notos Study Modificaoons Activity Date 7 17 2008 3 38 PM PDT 1 f 7 View Modification Workspace ject Snaps Suzanne Gillespie 7 17 2008 7 52 AM PDT 22 D nerate ann 7 ew ct Snapshot 15 ndence Letter Suzanne amp 7 17 2008 7 52 AM TA ew Correspondence Letter Study Submited for Review Lalala Pl one 7 17 2008 7 50 AM POT j Suzanne Gillesese 7 17 2008 7 48 AM POT anente hwe Rae i ubject ct 3800 Interstate A 2 50 240 For ts on the eIRB please contact elRB kpchr org 2 mos QUO 4 52 woke E G Windows Meds User Manu 4 B ubsrttamas 8 at Pride and QO 941 Figure 29 the first screen provide short for your submission of the submission should be a short description of the modification s being requested For example Change
33. 224420 0046D08565 i 1 Lines i ei mma te N west KPN VU ki i Lalala Pl ane My Home Logoff Institutional Review Board eIRB Welcome IRP Inquiries IRB Studles Help FAQ oat W PII Hale PI Study Staff Folder for PI1 Welcome t your Personal Folder the contral resource for managing pour Study applications My Inbox contains hems that require your attention LE Study My Roles allows you to switch between your user rales if you have multiple roles in the elRE system For active studies the tabs below filter by submission type Inactive tems are found in the Completed f Withdrawn tab Study Protocols Maodilicabons Continuum Regportabie Events Comgleted Withdgaweri Studs TRE Inquiries Displays all items which require action by the study team Click on links for mare mtarmatian Study Protocols ID Nama z Date Modified State Pro00000485 az Hitchoock North by Northwest S 2a 2008 11 11 AM Suspended 000006057 Tesir dune 897 S 1B 2008 1 24 PM Pre Subia ian Pro00000605 10 Flaming The Wizard of Qz 9 16 2008 8 47 AM Pre Submission 310 Flequreg The Wizard ol O 14 2008 3 33 PH Pre Suberrms can 0000531 az Fenway Park The Red Sox s 10 2008 6 27 PM Pre Submission Pranaoon msdg4 2 Forveway park Thur Sox 9 2008 11 34 Erp Subseries can Pra NW BPI o4 2 North by Northwest J it 11 46
34. AM Contingencies Panding Pranaonm384 tst B 1B 200B 5 54 PM Pre Sube ID Marne E Date Stato MR NYe Od3Oabe 01 Modification 1 for IRD Study amp NwW O JOate 01 Sj23 2008 11 54 AM Changes Required By IP Staff Continuing Reviews ID Hama 12 Date Modified State CROD DCOOD 7 2004 Priore Tor rw D 7 mob 1 Bn 23 20DB 11 57 Charges by Hane Date State There items t display E Etat He Done doc Werner word m 6 odis C aa DAS 4 jJrbo Beet ouk EN Feke te P X 2000 Review for nam 28 aringarri Mao 12 21 29980 sa am Figure 7 CREATING A NEW STUDY From the My Home environment on the left hand side of the screen you have the option to create a New Study see above Figure 7 This button allows you to access the form through which you can 1 Submit a request to the IRB to have a new study approved 2 Convert an existing hardcopy study to the elRB or 3 Request that the KPNW IRB cede their review to another IRB for a new not yet submitted study When you click this New Study button the first page of the Initial Review Questionnaire IRQ appears see Figure 8 Answer the applicable questions on the page Required fields are indicted by a red asterisk Once you have completed entering information into this first screen click on the Continue button located in the upper and the lower right
35. Ceploner ATIE Teele Hale Q O A ose dre OG l LJ E L d HB hier litan pilla igs e er LESER ocn D pb PL g rasa PC ont vo n y Enti LORD EC D 1 CC ORG RTT Links M a rk REMY b 2 Lalala My Home Logat Institutional Review Board eIRB rSn Com Oo stem AA Studies IR P1 a13 In eviews Study Tithe 2 Boston Rod Sox Study Status In Exempt Aevi Principal Investigator Lalala PI ana Expiration Date EPNW Mentor 2 endure coon Kaiser Pll ReonrceAdministrabion Activity PP m inter et T xj Sponsor Invest B nethieest PrimaryCnnta Peran Perian Yictoria Gajin EEES To withdraw a study click gt withdraw i liga this activity to withdraw the item fram further review LL Reason For Withdrawal This weashows I Comments Aihdraeem By Spansor bi Study Subr Funding mu Is b Si Errar During Submission Other Kaiser Permanente Northwest Research Subsets Protection Office 2900 interstate Awe Portland Oregon 0727 503 336 241000 I This form will the pop up so that you canca can indicate a general reason for wit
36. N YOU HAVE ENTERED 202 222 2424 14 USING HIDE SHOVW ERRORS 14 FXI PING THE FORM uuu E E ues 15 UPLOADING DOCUMENTS Det d 16 DELETING DOCUMENTS stan 19 NG UPLOADED 5 0 0 220202 0 2022 220202022 22 4 21 STUDY WORKSPACE 22 PRINTING SAVING AND DOCUMENTING SUBMISSIONS 25 sJELINBSA Um 25 CONVERTI EXISTING HARDCOPY STUDIES INTO THE elRB 26 CREATING CONTINUING REVI 5 27 CREATING MODIFICATION REQUESTS 29 Investigator changes P RUPEE vor nett ee a w aphylla 32 TO MAKE MODIFICATIONS TO CONVERTED HARDCOPY STUDIES 32 AN IMPORTANT NOTE ABOUT MODIFICATION REQUESTS 2 4 33 CREATING REPORTABLE EVENT SUBMI 551 ONS 33 GLOSSARY UNDERSTANDING 5
37. PI one Study Coordinator None Investigator Expiration Date 8 17 2009 Modification MR2_Pro00000337 K etter of Approval View L Printer Version E View Differences Change Log The query produced no results H Done ly Internet Es 1 2 3 Inbox Microso windows Media 7 2 Microsoft Lg P User accoun Edit View Micr Pride leje ee 11 43 Figure 32 If you wish to see your requested changes to the compared to the approved version of the IRQ you may click on the View Differences button see Figure 32 Then to exit the View Differences area click on Back to Change Log Finally and importantly You MUST then come back to the page within the modification request form as shown in Figure 29 and click Continue to continue to navigate through this modification request Then click finish the final screen The PI will need to submit the modification request in the modification workspace Investigator changes Investigator changes including INTERIM changes need to happen via the Modification Request form If a PI needs to have a co investigator do submissions in their absence the PI needs to submit a Modification Request to switch the PI name and then another submission needs to be done later by the interim to switch it back To make modifications to
38. RB please contact eIRB kpchr org E Done I M nene Start Es i x ie iw F1 3 Q 2 OO 2 O Inbox Microsoft eIRB User Manual dr 2 PASMART FORMSIN Wi User Manual draft d Pride and Prej gt QO M 10 10 AM Figure 24a Important Note RSPO manages informed consents in the elRB Once a consent form is approved the RSPO staff will upload a clean version of the consent in the Draft Informed Consent Materials area of the Documents tab A PDF version of the consent with the IRB approval key will be uploaded the Approved Consent Forms area 24 8 Nichols The Graduate Microsoft Internet Explorer x File Edit View Favorites Tools Help Q sack ix E TN JO search Se Favorites w m LJ ey rel e Address 2 http kaiser dev webridge com KaiserIRB Rooms DisplayPages LayoutInitial Container com webridge entity Entity OID 7E43C506DD72454B965704CE74E627F4 amp T ab2 com webridge entity Entity OID 94471738DD7 148408 Y Go Links History Study Modifications Continuing Reviews Reportable Events Reviewer Notes Change Log This summary will list the current set of IRQ Documents for this study If there is no document listed in the Current Version column then the PI has not uploaded a document for this study Principal Investigator CV po jus Document s Co Investigator There no
39. Save Print New IRQ Continue gt gt Study Identification Information This is the first step in your Human Subject Research Application You will be guided to the appropriate forms needed to complete your submission 10 Study Title Include protocol number and acronym if applicable Study of the effects of air pollution on asthma in children 2 0 Abstract Short description of the study in lay language Ambient outdoor air pollution is now recognized as an important problem both nationally and worldwide Our scientific understanding of the spectrum of health effects of air pollution has increased and numerous studies are finding important health effects from air pollution at levels once considered safe Children and infants are among the most susceptible to many of the air pollutants In addition to associations between air pollution and respiratory symptoms asthma exacerbations and asthma hospitalizations recent studies have found links between air pollution and preterm birth infant mortality deficits in lung growth and possibly development of asthma This policy statement summarizes the recent literature linking ambient air pollution to adverse health outcomes in children and includes a perspective on the current regulatory process 3 0 Principal Investigator Indicate what researcher is overseeing research activities at the Kaiser Permanente Northwest site the Pri
40. Study Activity a Activity Date cca Log Comment To Study Team ala Pl one 9 24 2000 5 44 PM POT 1T 1d Solely as FYT T am letting the RSPO statt know that T will be traveling rough October 31st and therefore will not be able to 9 w swassssa resp ond to ha conti de cies Au 7 equ sii i as cant effort to address until after that time Fem Sent Correspondence Letter for ved Joan Holup 0 29 2000 5 49 PM POT 4 view Correspondence Letter iama Scheduled for IRB Meeting Kaiser Permanente Northwest meeting on 7 31 2000 Rob Anderson 7 25 2000 10 30 AM PDT o Project Snapshot Generated Rob Anderson 7 25 2000 10 30 AM PDT view Project Snapshot Study Submitted for Review Lalala 1 7 17 2008 10 45 AM PDT PI Created study Lalala 1 7 17 2008 9 01 AM POT er Permanente acus arch ibyects Pr in Office 360 ON Interstate Ave nd Oregon 97227 SU3 33 400 For questions or comments on the please contact EJ lig Done dep Interne ipse mos 5 5 gt 2 Q 2 32 212 Offe C Desktop 22 OHSU User 2 trainingStory doc internet txol a 4 8 Qe cen 5 45 PM Other IRB accepts reliance and documents complete ALLOWS the RSPO to indicate in the system that the other IRB has accepted review responsibility for the KPNW IRB The study will be considered ceded upon execution of this activi
41. Submitted for Review L3lala Bbc SS 12 31 PM PDT fo r YO to rev i if fey created Study Laaa Plone 8 6 2008 7 22 AM PDT needed then i A k r Permanente Northwest Research Subjects Protection Office submit again for 503 335 2400 ew For Questions Gr commans on the please waianawan temp ABRC AR TECE TTA TA IR DRACO DEA yp erus activity at Talon m ne SSIES OES 2 ijmesetem gyosensotii tar Figure 39 40 GLOSSARY UNDERSTANDING CURRENT STATES See Figure 24 There are many different submission states The following definitions sorted in alphabetical order provide a comprehensive explanation Acknowledged The Reportable Event submission has been acknowledged Approved The study or submission has been approved Assigned to IRB Meeting The submission has been assigned to KPNW IRB meeting Awaiting Correspondence The submission has been reviewed The RSPO is preparing related correspondence that will be sent to the study team Awaiting Other IRB Acceptance of Review The ceding reliance request submitted by the study team has been reviewed by the KPNW IRB The KPNW IRB has contingently approved the request and is waiting for communication from the other IRB about whether they agree to accept the review responsibility Cede
42. T 2011 2 41 AM Cantnumg Resort Comaleted Halt 4 5 2010 3 55 PDT Heil Continuing Rewew Deadine Reminder Admirustrator System 4 5 2010 2 41 AM D Continuing Review Deadline Reminder Admiristrater System 3 5 2010 2 41 PST Report Opened Bachman Barbara Irene 2 24 2010 3 34 PM 3 Waw Continuing Review workspace SBSSDEBEZGSGHHBH Cennnumg Review Deadline Reminder Admirastrater Syatem 2 4 2010 2141 AM PST ay Modification Completed Halt David 1 40 PH I FT Log Comment Ta Study Tear Matthews Brad M 8 2009 1 36 P PDT 3 Attached ane documents EM te request submitted wih study mod ProDOODGOSOB that RB accept and OHSU RB cede rewew and responsi bility for this study c 9 U Meme dated 8 20 08 T l ee x t q 8812 L 2 3 offe Tu The LA Desk T E User Karuai v 2 020 My Computer 19 My Computer A T EEE Figure 24 Study Workspace Details Refer to Figure 24 Study Title displays the first 50 characters of the title entered into the first field on the IRQ Your Old IRB e g NW 08MHorn 04 will be displayed as the IRQ Number only if you have converted an existing study from paper Once the study has been approved and given an IRB approval expiration date that date will display on the workspace If the study h
43. a Flore Expiration Motilication Date 17 2009 KPA Mentor mentor was nat listed required far this study Rewew Category Sponsor Investigator Study H Reviewing eee I Hee Reportable Puni PrimaryContlact Person Organization Rebecca Bagorad Center for Health Research HWY prts Other Suzanne Center for Health Research Hw lt Approval Letter Click P View Poportable Events Documents Notes Change Log Caontinumg Reviews Study o Artivity Author Artivity Date n Madihication Opened Latala 7 17 2008 3 38 PH PDT f View Modification Warkspare ri J Progect Generated uzanne Gilles T i7 2008 7 52 PDT View Project Snapshot Correspgandence Letter far Study Suzanna Gillegpia 7 502 PDT T view Correspondence Letter ir study Subenitted for esias Lalala B lt ore Ti 7 2008 7 50 reaued study 5uzanne F 17 2008 7 498 PDT Kaiser ante Marthe Research Prote r Interstate amp B r 335 2 4L For quesborrs e comments on e PB please contact elPBbkpehr org ry ap Interset of staat iac s mM ie E 3 i inbox 2 Wadows L r windows Baral d 1 Pride ana M
44. aintains a history of all subsequently uploaded documents and allows you to rollback to a previous version This function can be accomplished by clicking the Edit link in front of the document and then by clicking the Show Advanced Option button Once the advanced options are displayed click on the History amp Roll Back link Figure 23 You may now click on a previous version of a document to view it or select the document you wish to rollback to followed by clicking the button 21 http eirbdev kpchr org kaiserIRB ResourceAdministration VersionedResource ROME ac o x http eirbdev kpchr org formID 0 amp postback 1 amp valueField Protocol Submit a Document Help Roll Back To Previous Version Help Title peanut_application DOC dpa potas the name of the Title Peanut_application DOC will be File Peanut application DOC File Browse VIEW Owner a eirbPI Author a eirbPI Hide Advanced Options Content Type Document Version 0 02 Description Document History ID DOC00009958 Description tc Version Person Action Notes Uploaded File Owner 45595456 1 12 27 10 0 02 File Uploaded Peanut_application DOC 11 03 AM eirbPI amp Edited Author eirbPI 2 12 27 10 0 01 a Created STUDY_SUMMARY_ACW DOC eirbPI Document Categories Rernove Activation Date 1 1 1800
45. ame and then enter the first letter of the individual s last name Click the Go button and the name should appear in the results field Then select the checkbox next to the person you wish to add and click OK see Figure 9 You must add yourself as a Primary Contact or the system will not allow you to proceed to the next page diste o bese dry mnn Sele nen Morr Perenn Ma pref E Dn erret Explorer Filter by Last b Go advanced i 1 019 1 b A L Organ bites Tor Hear Nw Dil b Cancel MB 12 OA emus G Windows B pde l http kanar E9 GO M 12 06 P Figure 9 personnel listed as or study staff will receive notifications about submissions as the review process progresses These notifications contain working links to the submission workspace Read the notifications carefully as some are merely informative and do NOT require any action from the study see Figure 9a Bl fee study hat bron scheduled for an esses HME j mh Chuspi to Chromed 4 Kee vB Dh ER W pem Fase od ge pel org Help kama L Sublet hour been scheduled or s FB esting wed Ern wW lE1 210 fon CF s
46. as a Mentor assigned the mentor s name will appear in the workspace If the study has KPNW sponsor investigator yes will display This is for IRB administrative interest related to FDA regulated studies only The primary contacts listed on the IRQ are displayed If there is an Approval letter for the study a link will be available to view The tabs on the study workspace contain and if clicked will display History Events associated with the IRB review of the study see History tab figure 24 Note that new studies and other types of submissions Study Modifications Continuing Reviews and Reportable Events also have their own history tabs that display events in their review process Submissions subsequent to the initial submission Study Modifications Continuing Reviews and Reportable Events tabs see figure 24a 23 Documents When new study documents approved once documents subsequently approved through a Modification Request this tab will automatically update to display current versions Documents tab see figure 24b and If applicable reviewer notes and a change log for the study 1 Pride and Prejudice Microsoft Internet Explorer E la xj File Edit View Favorites Tools Help aw B TN JO search Se Favorites wil L4 4 Address http kaiser dev webridge com KaiserIRB Rooms DisplayPages LayoutInitial
47. brnission 00000561 11 Capra It s a wonderful Life 9 11 2008 5 16 PM Pre Submission K Q 1 10 0f32 D D ID Name z Date Modified State MR2_Pro NWOSRSimm38 Modification 2 for IRB Study amp Pro NWOS8RSimm38 9 16 2008 4 22 PM In Expedited Review MR1I_NW 04Shein 04 Modification 1 for IRB Study N VV 04Shein 04 9 15 2008 6 05 PM Assigned To IRB Meeting MR2_NW 01SHein 06 Modification 2 for IRB Study N VV 01SHein 06 9 12 2008 4 37 PM Pre Submission MR1 NW O01SHein D6 Modification 1 for IRB Study N W 01SHein 06 9 12 2008 12 52 PM Pre Submission MR1_Proo0000319 Modification 1 for IRB Study Pro00000319 9 2 2008 5 15 PM Designated Reviewer Contingency Review MRi Pro NWOS8RSimm38 Modification 1 for IRB Study Pro NWOSRSImm38 8 26 2008 12 23 PM Approved Done Internet A start Em i 19 x le jw 1 Q 2 7 O Inbox Microsoft Folder for eirbPI amp Folder for Joan Hol W 2 Microsoft Office L9 P User accounts 2 5 QUO M 4 47 PM Figure 25 The Initial Review Questionnaire IRQ will open Enter information on the first page and click Continue On the next screen for the type of submission choose the option A conversion of existing already IRB approved paper study into the elRB see Figure 26 This will branch you through an abbreviated version of the IRQ Use the Continue button to navigate through the rest of the questionnai
48. cess Folder for to pair P ervuanal alder the cantra For pour Sto By xem that your actenbon ky Roiri in pei bete pour aiar roh huk Fer actis sbadiei tha Lata baize ler E submission iat Duci i I EL LICET Figure 5 Thang aem Fans Bri 0 2 and of re ot eee Fada older for P11 Microsoft Internet Lxplorer alj xj Fie Yew Favortes Took e Ou O xz sa oem O La RO lt Address hip webricge com Kaser DRB Dipin Pages econ entity Eni y 55BOTD5B839F C 4837622442900 6DC6B65170F4 3 5D 48D t KPNW Lalala Pl one My Home Institutional Review Board eIRB Welcome IRB Inquiries IRB Studies Help FAQ Folder for PI1 PI Study Staff Folder for PI1 Welcome to your Personal Folder the central resource for managing your Study applicati E Mew IRB inquiry My Inbox contains items that require your attention My Roles allows you to switch between your user roles if you have multiple roles in the eIRB system For active studies the tabs below filter by submission type Inactive tems ane found in the Completed Withdrawn tab
49. conduct review 1 a ceding request Clear lt lt Back Save Exit Hide Show Errors Print Jump To Type of Submission Continue gt gt E Done aD Internet start w 1 2 2 74 5 Inbox Microso L 5 view mi W trainingStory d Wh 55 4 doc 24 Microsoft o QO M 12 43 PM Figure 26 CREATI NG CONTI NUI NG REVI EWS Before you can create a continuing review you must have an active approved study in the el RB If you already have an active paper study you may convert it in the elRB For details on converting an existing study read the section of this user manual Converting Existing Hardcopy Studies into the el RB In order to create a continuing review open your active study the left section of the page click on the New Continuing Review button see Figure 27 You may only initiate and be drafting one continuing review at a time on a given study and you may only have one continuing review submitted at a time for any given study 27 51 Pride and Prejudice faerasaft Internet E Vew Favorbes Took Hep i d t PNW Lalala PI aru My Home Lagaff Institutional Review Board eIRB IF Studies Studies 1 Pride and Prejudice IRQ Number prooo000337 Approved Stud
50. d to Other IRB The ceding reliance request submitted by the study team has been reviewed by the KPNW IRB The KPNW IRB approved the request and the other IRB agreed to accept the review responsibility KPNW IRB is now relying on another IRB to conduct review of the study it is ceded Changes Required by Exempt Reviewer The submission has been forwarded to an exempt reviewer The exempt reviewer has requested changes clarifications from the Changes Required by Expedited Reviewer The submission has been forwarded to an expedited reviewer The expedited reviewer has requested changes clarifications from the Changes Required by IRB The IRB has reviewed the submission and has requested changes clarifications from the Changes Required by IRB Staff The IRB RSPO staff have requested changes clarifications from the Committee Member Review The submission has been forwarded to a reviewer Changes Required by Committee Member Review RE The Reportable Event submission has been forwarded to a reviewer The reviewer has requested changes clarifications from the Complete study is complete closed longer active Contingencies Pending The IRB has reviewed the submission and has approved the submission with contingencies response is now required from the in order for the submission to be formally approved Correspondence Review The submission has been reviewed T
51. ds the expected rate and communicates this information to the investigators This is an example of an unanticipated problem because the frequency at which subjects have needed to undergo emergency CABG surgery was significantly higher than the expected frequency An example of when to answer no An investigator is conducting a psychology study evaluating the factors that affect reaction times in response to auditory stimuli In order to perform the reaction time measurements subjects are placed in a small windowless soundproof booth and asked to wear headphones The IRB approved protocol and informed consent document describe claustrophobic reactions as one of the risks of the research The twentieth subject enrolled in the research experiences significant claustrophobia resulting in the subject withdrawing from the research This example is not an unanticipated problem because the occurrence of the claustrophobic reactions in terms of nature severity and frequency was expected lt lt Back Save Exit Hide Show Errors Print Jump To Unanticipated or Anticipated Continue gt gt Ej e Done interne A start B ao e w 2 o Inbox Microsoft o Windows Media Player iil User Manual draft d Ly P User accounts an IE Edit Yiew Micros BDE Q M 12 18 PM Figure 34 Answer the next question and click on the Continue button in order to navigate through
52. e IRB Inquiry has been forwarded to a reviewer who will determine if the project will require IRB review IRB Staff Contingency Review The submission was reviewed and approved with contingencies The submission is now with the RSPO IRB Staff Review The submission is now with the RSPO to administratively handle Meeting Complete Awaiting Correspondence The submission has been reviewed at an IRB meeting The RSPO is preparing related correspondence that will be sent to the study team Not Engaged in Human Subjects Research IRB has determined that the submitted study does not require KPNWIRB review Pre Submission The submission is being prepared by the study team Qualification Review Complete inquiry The IRB Inquiry was reviewed and is complete Suspended The study s IRB approval is suspended Terminated The study s IRB approval has been terminated Withdrawn The submission was withdrawn from the review process It is no longer active within the review process 42 GETTING HELP el RB Technical Support You may receive technical assistance for the Kaiser Permanente Northwest KPNW el RB system by contacting elRB technical support at 503 528 3945 tieline 60 3945 or at elRB kpchr org during the following hours Went PrIg y 4 00PM Training is strongly encouraged for new elRB users Information regarding training can be found on the elRB home page at http elRB
53. e already submitted modification request can be routed back to the investigator so that the investigator can insert append the additional modification request s within the submission or You may withdraw the original modification request submission This would then allow the PI to create and submit an entirely new modification request If the RSPO has determined that a modification must go to the full board but it is urgent that a minor modification be approved through an expedited review contact the RSPO staff who can provide guidance on how to accommodate these requests CREATING REPORTABLE EVENT SUBMISSIONS Reportable events are unanticipated events related to the research that involve increased risk to Subjects In order to submit a Reportable Event open your active study and click on the New Reportable Event button located in the left portion of the screen see Figure 33 You are able to submit and have more than one Reportable Event submission pending IRB review at a time Jat Pride anl rr juice Polis nisa Inber Explorer sll x File View Qua O A dre OOS 3 2 ved bula a KPNW b kil Lalala Pi ane My Hama Logoff Institutional Review Board eIR Studies MIDI LM Ua Sturbas 1 Ende and Prejudice IRQ Number rronongna337 Approved Study Tithe War and Pach Study Status Approved Principal Investigator Lalal
54. e time See Figure 14 Please note that the PI will not be able to submit the study if there are any required questions that remain unanswered Edit Project Microsoft Internet Explorer g 2 l File Edit Favorites Tools Help ae tA c ix A 79 Search 50 Favorites lt E WI v L4 rel Address http kaiser dev webridge com KaiserIRB ResourceAdministration Project ProjectEditor WithYalidation Project com webridge entity Entity 5BOID 5B4697850C3DD7234C847ED2F4548C0D20 5D 5DaMode smartform amp wWiz Y ET Links 3 7 Kaiser Permanente Northwest KPNW 5457 Institutional Review Board eIRB UR lt lt Back Save EX Hide Show Errors Bint Jump To Study Funding Continue gt gt Edit IRQ 00000599 Study Funding 1 0 Was funding sought or will funding be sought for this research Yes C No Clear lt lt Back Save Exit Hide Show Errors Print Jump To Study Funding Continue gt gt Error Warning Messages Field Name Jump To o This is a required field therefore you must provide a value IRQHypotheses Study Summaries This is a required field therefore you must provide a value IRQKnowledge Study Summary o This is a required field therefore you must provide a value IRQBioMedicalOther Other Medical Procedures start B C 8 e 0
55. elow the co investigator list must include any outside Principal Investigator Note Co Investigators from KPNW and or the Center for Health Research must already have an eIRB account and be selected from the list that will appear below outside co investigators may be listed in the text box below This individual will have read and edit write privileges to this submission in the eIRB system and if the study is approved to this study s eIRB workspace 3 0 Prin archer is overseeing research activities at the Kaiser Permanente Northwest site the Principal Investigator for KPNW of the research funding The Principal Investigator for KPNW must have an eIRB account and be selected from read and edit write privileges to this submission in the eIRB system and if the study is approved to this Last First Organization Eckhardt Cara Portland State University Eden Karen Oregon Health amp Sciences University 4 0 n veMrigator s curriculum vitae or biosketch eIRBPI 1 Center for Health Research NW 5 0 eIRBPIX A Harvard Pilgrim Health Care ib ingestigators If applicable if the prime awardee of research funding differs from the KPNW investigator Kaiser Permanente Northwest thelico investigator list must include any outside Principal Investigator Note Co Investigators from KPNW Elder Charles RB account and be selected from the list that will appear below outside
56. enerated with a trusted certificate but has UU NU Figure 21 You may also be presented with the following message if the elRB system is already in the process of uploading a file into your submission and you attempt to upload the file again You have already submitted the current form Please wait and the operation will be completed momentarily 20 Editing replacing uploaded documents If you wish to upload an edited or newer version of the document click the Edit link in front of the document and repeat the upload procedure Click the OK button in order to close the window The document version will be automatically incremented Version 0 01 to Version 0 02 etc Note that the Title field of the navigation window will not update the title of the document Figure 22 You may either rename the title of the document or clear the field if you want the document title to be retained from your files the file path will not be included in the title gt http eirbdev kpchr org formID 0 amp postback 1 amp valueHeld _ProtocolcustomAl trib 8 x Submit a Document http eirbdev kpchr org formID 20 amp postback 1 amp valueFie Tit STUDY_SUMMARY_ACW DO If not provided the name of the file will be used File Training Sample studies for training PEANUT Browse VIEH Show Advanced Options Required Add Another Cancel zi Figure 22 The elRB m
57. er dleas r TFE Site 15 designe edt nable researchers and IF ewers bo manage all aspects of register liik Baliw Engestratin F edd the Institutional Review oard ad min stratio ani prox t n the elBE please contact eiBapiachr arg 4E Done ym x GR C CD cl s d erret Welcome Miera C Hl eran BORER irany 2 ER DA Figure 3 After clicking log in enter your username and password see Figure 4 below If this is your first time logging in the el RB will prompt you to change your password This is necessary for security reasons The new password is case sensitive and will need to be at least 8 characters and contain at least 1 number Please safeguard your password You should be the only person who has access to your el RB account Please note that willingly providing your username and password to anyone will constitute a violation of KPNW and CHR policies regarding the use of electronic resources These policies can be found at the following links http centernet centernet LeadershipPolicies policies COMP ACC html http npl kp org pl do public record subcatid25001 amp VI EW M amp rid 76142601 amp rgid 900 Disciplinary action up to and including termination may be taken against those who fail to adhere to this policy per KPNW Principles of Responsibility http kpne
58. erials 4 0 Recruiter Describe by position title who will be recruiting and enrolling participants providing the particular name of each research team member is not qwe 5 0 Optional Investigators sometimes plan to re contact and re recruit participants for future follow up studies That is investigators may anticipate that participants for currently proposed study will be logical participants in a future study if there are any such expectations or plans for the participants in the currently proposed to be re contacted for follow Done Internet E CO 5l x e w 1 Q 2 2 O Inbox Microsoft 2 P Training SCREE Microsoft Office 4 amp Modification 1 For I le Edit View Micro 21269 QO M 3 14 PM Figure 16 In addition to the standard documents that are requested throughout the IRQ form such as consent forms or a protocol there is a place for other documents to be uploaded at the end of the submission Use this option if you have progressed through the submission process to the end and have not had a logical designated place to upload a certain document see Figure 17 You are strongly encouraged to use this general area only when there has been no other logical place to upload the material Following this rule will help your study team and the IRB later when you need to make modification requests related to documents
59. evising a copy of the currently approved IRQ see Figure 31 Consent materials DSMB reports and or new or revised Investigator Brochure s Investigator s New waiver or alteration of informed consent New waiver or alteration of the privacy rule authorization New or revised Risk Assessment and Mitigation Process RAMP Recruitment flyers advertisements Study forms questionnaires surveys abstraction tools communications or other materials Study Protocol Other answers provided on the online Initial Review Questionnaire 30 Edit View Microsoft Internet Explorer File Edit View Favorites Tools Help ae 2 ix E Search Favorites E LJ Address In ws com webridge entity Entity OID E7D63F60ED6C6F428524DAO0C1FD5546A J amp Mode smartForm amp WizardPageOID com webridge er Y EJ Go Links Kaiser Permanente Northwest KPNW Pu y Institutional Review Board eIRB lt lt Back Save Exit Hide Show Errors Print Jump To Online Initial Review Questionnaire Continue gt gt Edit Study Modification MR2_Pro00000337 Instructions for Changes You indicated that you wish to modify at least one of the following on the study Consent materials DSMB reports and or new or revised Investigator Brochure s Investigator s New waiver or alteration of informed consent e New waiver or alteration of the privacy
60. hdrawing and include any comments Por questions Or on the pease car p meret DG gri OS 4 RI eoe al neto 23 internet Empl 2 2 Figure 38 0 7 foston Red Son nk eras Fxplorer TS gt seien iorri Earner orm Dee C or wn om ade ni E ega CODE COs eee E L58C CAT di te Northwest KPNW as Institutional Review Board eIRB study will then A __ withdrawn a aiioa state If you wish to Withdrawn NL Study Status With aem Principal Investigator Lalala Flore Explratlan Motlfication Date S u b m It It r O u flvessu Mentor A mentor was rent reped hee bhea sud Review Cabegary y Spiir Investigator Study H Reviewing Pormaenene Northeast 4 Printer versie PrimaryCantacts Reactivate the mm 5 05 Self submission which will put it in a Pre PewiewerMotez Change Log Tht area sheners erences amus arit rustic aano regarden thus Srusdy le Bathor acini Dane 3 Withdrawn Lalala PE one 92 4 2608 5 50 S u b m 6 6 sta te m Need to remise some Josumpoons Study
61. he RSPO is preparing related correspondence that will be sent to the study team Designated Reviewer Contingency Review The submission was reviewed and approved with contingencies The PI submitted a response and this response is under review The PI response must be reviewed in order for the submission to be formally approved Disapproved The study or submission was disapproved by the IRB Exempt Verified The study was determined to be exempt from IRB review Expired The study s IRB approval has expired In Exempt Review The study has been forwarded to reviewer who will determine if the study is exempt from IRB review 41 In Expedited Review The submission has been forwarded to a reviewer who will determine if the submission qualifies for expedited review In Expedited Review Contingencies Review The submission was forwarded to a reviewer to determine if the submission qualifies for expedited review The reviewer has requested changes clarifications from the A response is now required from the PI in order for the Submission to be formally approved In Expedited Review Staff Review The submission was forwarded to a reviewer to determine if the submission qualifies for expedited review The submission 15 now with the RSPO IRB Correspondence Review The submission has been reviewed RSPO 15 preparing related correspondence that will be sent to the study team IRB Qualification Review inquiry Th
62. he left hand section of the My Home area you will find My roles see above Figure 6 which indicates your role s within the el RB system Most users will have one of the following Study staff If you draft prepare submissions for an investigator but do not act as an investigator this will be your role Study staff and Principal Investigator PI If you draft prepare submissions and act as an investigator Submit studies on which you are the PI this will be your role set Study staff Principal Investigator and Mentor If you draft prepare submissions act as an investigator Submit studies on which you are the PI and have the ability to act as a mentor to less experienced researchers this will be your role set If you have multiple roles click on use the role appropriate to your current purpose The display for your inbox for example may differ depending on the role you are using Note From your My Home page you may click el RB Information to see a general non tailored el RB page containing useful contact information for support personnel and materials related to the el RB system see below Figure 7 folder for Microsoft internet Explorer Fie Yew Favores Took e Om O x 2 A J sa 1 15 oj Er ey kasar webrichge com Kaiser DB TP noms Dipin Pages t nbis E nnt inier anam webridge OTD EGER CABR 6
63. his optional inquiry form would be submitted prior to a new study Submission if you are unsure whether IRB review is required When this form is submitted it will be sent to a reviewer who will then indicate whether the new project will require IRB review In order to submit an inquiry form from your home page click on the New IRB Inquiry button located in the left portion of the screen see Figure 35 This will bring up a short one page form see Figure 36 Z Folder for PI1 Microsoft Internet Explorer File Edit View Favorites Tools Help ix A Search 52 Favorites jw LJ Address http f kaiser dev webridge com KaiserIRB Rooms DisplayPages LayoutInitial Container com webridge entity Entity 5BOID 5B835FC4B8376224429D046DDBB65 1 7DF4 5D 5D er Permanente Northwest KPNW L Institutional Review Board eIRB p Welcome IRB Inquiries IRB Studies Help FAQ Folder for 1 Lalala PI one My Home Logoff Help PI Study Staff Folder for PI1 Welcome to your Personal Folder the central resource for managing your Study applications 8 New IRB Inquiry e My Inbox contains items that require your attention X e My Roles allows you to switch between your user roles if you have multiple roles in the eIRB system e For active studies the tabs below filter by submission type Inactive Items are found
64. ime awardees may be listed in the text box below a Is in this Last Name First Name Degree s Organization There are no items to display g ra y a rea 10 0 Prime Awardee with eIRB Account In the text box below list name degree and organizational information for a non KPNW non CHR prime awardee who does O n t h e not have an eIRB account 11 0 Primary Contact s Primary Contact s for this research project e g Project Manager or Research Coordinator Note Primary Contact s for research projects must already have an eIRB account and be selected from the list that will appear below This individual will have read and edit write privileges to this submission in the eIRB system and if the study is approved to this study s eIRB workspace Add Last Name First Name Organization Human Subjects Training Date winn Kevin Kaiser Permanente Northwest Region Remove 12 0 Other Other study staff who will have access to this study the e IRB system Note Study staff who wish to have access to this study in the e IRB system must I er already have eIRB account and be selected from the list that will appear below Individuals selected from the list below will have read and edit write privileges to TE t this submission in the eIRB system and if the study is approved to this study s eIRB workspace i ide 09 Add selected yourself in one Last Name First Name Organization H
65. in the Completed withdrawn tab Study Protocols Modifications Continuing Reviews Reportable Events Completed Withdrawn Studies IRB Inquiries Displays all items which require action by the study team Click on links for more information Study Protocols ID Name Date Modified State Pro NWOSPI o4 amp 2 North by Northwest 9 29 2008 2 11 AM Contingencies Pending N 08JHolu 14 Example for Jan 9 25 2008 10 40 AM Pre Submission 00000599 10 Fleming wizard of Oz 9 24 2008 2 57 Pre Submission Pro00000485 2 Hitchcock North by Northwest 9 23 2008 11 11 Suspended 00000607 Testing issue 697 9 18 2008 1 24 PM Pre Submission 00000605 10 Fleming Wizard of Oz 9 16 2008 8 47 4M Pre Submission 00000531 2 Fenway Park Red Sox 9 10 2008 6 27 PM Pre Submission 00000494 2 Fenway park Red Sox 9 9 2008 11 34 4M Pre Submission 00000384 test 8 18 2008 5 54 Pre Subrnission ID Name 1 Date Modified State MR2_Pro00000337 Modification 2 for IRB Study Pro00000337 9 25 2008 11 37 Pre Submission MR1 N W 08JOate 01 Modification 1 for IRB Study 0810 01 9 24 2008 2 39 PM Changes Required By IRB Staff Continuing Reviews ID Name Date Modified State CRODO00077 2009 Review for nwO7mcbvO1 9 23 2008 11 57 AM Changes Required by IRB Reportable Events M m A start ie iw 1 Q 2 7 O Inbox Micro
66. iple documents Choose file Look in eIRB Consent Form doc File name Files of type All Files Cancel Figure 19 Deleting documents If you mistakenly upload a document and need to remove it place a checkmark next to the document and then hit Delete A message will appear asking if you are sure you want to delete the document Indicate OK to delete the document Be aware that deleted documents may not be retrieved within the elRB You would need to upload them again from your file service See Figure 20 19 Edit View Windows Internet Explorer MM i d g CenterNet 2 Activity Det Notification 5 Res eIRB Infor M Gmail Your Google Cale OurGroceri Edit View x Fp E dm gt Gp Tools applicable indicate unknown us Unknown 3 0 Comments about study duration optional 4 0 Provide a clear statement of the hypotheses to be tested or the question problem being addressed List the measurable and specific scientific objectives of this research Provide a clear statement of the gt hypotheses to be tested or the question problem being addressed List the measurable and specific scientific objectives of this research Windows Internet Explorer gm J Are you suri ant to delete the selected item 5 0 Briefly summarize existing
67. ission The must submit the form regardless of who drafted the form Once the PI has ensured that the submission is accurate and ready for IRB review the PI will click on the Submit activity 25 located the left section of the submission workspace page under Activities If it is new study submission the PI will be presented with and will need to check a number of attestations as part of the submit activity Once the submit action has been completed the submission will move to a state of Staff Review and will have entered the review process CONVERTING EXISTING HARDCOPY STUDIES INTO THE el RB If your active study is currently on paper and you are planning to do any IRB submission including continuing review soon you MUST first convert your active hardcopy study to the elRB by selecting New Study located in the upper left section of the My Home page see Figure 25 4 Folder for eirbPI Microsoft Internet Explorer File Edit View Favorites Tools sax x ix al TN 0 search S Favorites ed El LJ x rel Address 2 http Jkaiser dev webridge com KaiserIRB Rooms DisplayPages LayoutInitial Container com webridge entity Entity 9 5BOID955B83532A6E924C234086B415C7E9A39A359 55D 55D g Go Links A 7 r m y 4 Kaiser Permanente Northwest KPNW b 2 eirbPI My Logoff Institutional Review
68. knowledge pertinent to this study St 22 i via the upload area directly below or in the next section as part of Briefly summarize existing knowledge Cancel pertinent to this study State what this study will contribute to existing knowledge A bibliography must be uploaded with this application either via the upload area directly below or in the next section as part of the uploaded study protocol edge A bibliography must be uploaded with this application either 6 0 Upload bibliography Add Document s There are no items to display 7 0 If available upload the study protocol Add Document s Upload Revision View Protocol 0 01 lt lt Save Exit Hide Show Errors Print Jump Study Summary Continue gt gt 100 start 3 5 gt S 3 Microsoft Office Edit view windo 23 Z Help Desk 4 Microsoft Excel 89 User Manual v 1 020 My Computer gt My Computer gt 2 OMO 11 16 AM Figure 20 You may get the following Figure 21 the first time you attempt to upload a document into the IRQ Check the Always trust and click on Run Warning Security x The application s digital signature has an error Do you want to run the application Name _ClusterLIploadApplet _ Publisher CLICK wEBRIDGE INCORPORATED Run Cancel W Mises signature was g
69. lly REGI STRATI ON To register in the system open your Internet browser Go to https eirb kpchr org Click the Registration link located in the upper right section of the page see Figure 1 we Le id 68 eem Serene e JEU EL TITI s T Institutional Review Board eIRB xc You will register once 9 Welcome to the Kaiser Permanente Northwest eIRB ae eet vga 4 the Ir coches a Pen avian n ard ood ORB ator e reper z o _ Register by clicking here mimi EE fen 224 xum Que do je emet Pes a eem Lemno SO Figure 1 Next fill out and submit the e form see Figure 2 2 Hia Arein reb 0m 0 u 2 rmm d Jat ad B Twana des com Eo Dacia P gs pai Ina nar eco sabre yp ii DOP Te PR Registration same Farst Mang ett Middle Name Degreed Credential tis ada acid LE E Therg are no came to dala L i Organiration Nene Othe rg ar n hieni mail Addrrises Primary Adres Secondary E mail Address Comiact Infecmation Primer Phone Member Secondary Phone aro LI m a
70. ncipal Investigator for KPN Note that this may not always be the prime awardee of the research funding The Principal Investigator for KPNW must have an eIRB account and be selected from the list that will appear below This individual will have read and edit write privileges to this submission in the eIRB system and if the study is approved to this study s eIRB workspace eirbPI Select Principal Investigator IRB Certification Date 7 31 2008 4 0 de 7 Principal Investigator s curriculum vitae 0 01 Edit Reset 5 0 Co Investigator s List co Investigators includes sub investigators If applicable if the prime awardee of research funding differs from the KPN investigator you indicated that prime awardee should be listed below the co investigator list must include any outside Principal Investigator Note Co Investigators from KPNW and or the Center for Health Research must already have an eIRB account and be selected from the list that will appear below outside co investigators may be listed in the text box below This individual will have read and edit write privileges to this submission in the eIRB system and if the study is approved to this study s eIRB workspace Add m 2 E Done Internet E start x e iw 1 Q 2 72 O Inbox Microsoft Outlook 1 Edit View Microsoft Ambient
71. nd listed Then you can select your funder if it is found on the filtered list If the funder sponsor is not on the list the system enter the name the text box provided Using the form drop down list to J ump To pages The form drop down list box see Figure 13 is a convenient way to navigate through the IRQ if you do not wish to use the Continue button and if you already know the name of the section 13 that you would like to modify You must click on the down arrow next to the jump to menu do not click the text that says Jump to Menu The Jump To menu will highlight your current page screen in red font It is very important to note that the form drop down list box will dis play only the list sections that currently apply to your study As you move through the form the list may expand asnew required sections of the forms are completed However it is highly recommended that you use the Continue button to progress through the application as the system will then be smart enough to walk you through the proper branching and the submission will seem most logical in terms of the progression of questions start wW 1 9 4 E 2 Microsoft P Training W 2 Microsoft 4 5 windows Media Edit View Microsoft Internet Explorer l File Edit View Favorites Tools Help ae sek 4 B TN pO Search y Favorites
72. neurology case report HealthConnect and Emergency Care QI etc Inquiry Description Attached Documents Add Name Version There are no items to display lt lt Back Save Print Continue gt gt El EL Es ie w 1 Q 2 72 O Inbox Microsoft Outlook L3 PASMART FORMSINEED i4 User Manual draft doc IE Edit View Microsoft DE Q M 9 34 am Figure 36 36 GLOSSARY UNDERSTANDING ACTIVITIES See Figure 24 Accept Cede from other I RB ALLOWS RSPO to indicate that the KPNW IRB accepts review responsibility for another I RB Acknowledge ALLOWS RSPO to acknowledge receipt of reportable event submission Agree to mentor ALLOWS the Mentor to attest to their mentoring responsibilities on the study if a mentor is needed on the study Ceding revoked ALLOWS the RSPO staff to revoke ceded status on an active study indicating that the KPNW IRB will assume review of the study Changes requested by contingency reviewer ALLOWS the RSPO to forward a request for changes to the PI Changes Required by Expedited Reviewer ALLOWS the RSPO to forward a request for changes to the PI Changes Required by I RB Staff ALLOWS RSPO to submit a change request to the the Principal Investigator will be notified that changes are required to the protocol Continuing review completed ALLOWS RSPO to indicate that a continuing review is now complete
73. nt to keep mind that the reviewer of these documents such RSPO employee or IRB reviewers must have the same software application as you to be able to open and read the uploaded document When possible use standard software applications available on KPNW workstations such as Microsoft Word Excel PowerPoint and Adobe Acrobat Reader Most document upload areas allow you to upload multiple documents if that is needed on your study Click on the Browse button in order to locate the document you would like to upload You may provide a title for the document s you upload If you do not title the document s the file name s will be used as a default See Figure 18 18 l devoeerhridige Tillie Ibert Explarer Help zm cuni Tithe Af rest riy hii to rare GF fie wil b a File 2 Browne Shaw Advanced Cptiang Eegquired OK and Add Anather i started OO SOF j ap QC CD En eroe o C Plin E PowerPoint 2 0 Qd a Scat em Figure 18 you have located the document network drive select the document click the Open button see Figure 19 and then click the button on the document upload window or click OK and Add Another if you wish to upload mult
74. page within the modification request form and click Continue to continue to navigate through this modification request process link D gt MS2_Pro00000337 lt lt Back Save Exit Hide Show Errors Print Jump Online Initial Review Questionnaire Continue gt gt Done Internet start 8 ao ie jv P1 3 CO 7 9 5 nbox micros 9 Windows Medi 441 User Manual d i4 trainingStory P User accou Uu M QO M 11 37 Figure 31 The link shown Figure 29 should appear after you hit refresh as described in the instructions on screen if the link does not appear please wait a few minutes and then refresh as the system may need a bit more time The more documents in the IRQ the longer it will take for the link to appear Click on the link shown in Figure 31 This will take you to an area where you can click on the View Study button see Figure 32 This will navigate you in a new window or tab to a copy of the approved IRQ i e the online form that was filled out and submitted to the IRB to request approval for the study called the Modified Study You will be able to make your modifications directly onto this copy of the IRQ A link to the Modified Study will also be available from the Modification workspace Use this same process to request to add documents and or to edit replace previously approved documents To make
75. portion of the page Alternatively if you wish to exit and not move beyond the first screen click on the Save link first which is located in the upper middle portion of the page and the elRB system will automatically save your IRQ and create a new IRB number for your study Once you click Save you may click Exit to exit the form Edit View Windows Internet Explorer 81 x G j http alpha kaiserIRB ResourceAdministration Project ProjectEditor ProjectType Protocol amp ProjectCreatorView com webridge entity Entity OID A 124DBFDE 28B9749A 468B35 7 X File Edit View Favorites Tools Help j Convert P select ww 97 55 centernet B Golder for Lisa RsPO Resea Z e1RB Informat M Inbox Google Calendar OurGroceries GEdit View EJ dm Q Tools Study Identification Information This is the first step your Human Subject Research Application You will be guided to the appropriate forms needed to complete your submission 10 Study Title Include protocol number and acronym if applicable Test study for the updated user manua 2 0 Abstract Short description of the study in lay language Co Investigator s List co Investigators includes sub investigators If applicable if the prime awardee of research funding differs from the KPNW investigator you indicated that prime awardee should be listed b
76. r sum tha nm COTAS pana i 2 E a a ac Pebe weh aui r e Of Pol dew Buc gabe anche pour robes Geekery T unb Porn ell De bor poor Ey Requested User Role s h iue m m 8 iix p OU S 3 4 ete eet p egra a dx toes 1T art die 2598 ram Figure 2 LOGGING INTO THE el RB You will receive an e mail containing your username and temporary password usually within two business days after submitting the registration form You can use this username and temporary password to log into the elRB Go to http eirb kpchr org click on Login located the upper right section of the page and enter your username and temporary password see Figure 3 welcome Microsoft Internet nl xi Edt Taos Hep Qs D e g Z Sp Fees 0 7 LIE a Hel haglar dene dee 20 vno eise erue oth nous Endesa PC ong M ea se S E E Can repa st KPNW Inetitudonal e eIRB Rd jue ntin AIRRA Updates I h j i hw aidu Training Information and Welcome to the Kaiser Permanente Mort est eIRE ih im EE mies pe FAQ BORS ore first T s
77. re and answer all applicable questions On the last page click finish to complete the questionnaire Once the IRQ for the converted study has been drafted the study PI will submit it The RSPO office will expedite the Approval of the study the system order to create the study within the elRB Once the status changes to Approved you will then have the option to create other Submission types for the study such as a continuing review modification request etc View Microsoft Internet Explorer a File Edit Favorites Tools Help di gt Tad ix J Search 52 Favorites lt s LJ Address http f kaiser dev webridge com KaiserIRB ResourceAdministration Project ProjectEditor Mode smartform amp Project com webridge entity Entity OID 64C65F498805784D8874396BFC32CCB5 J amp WizardPageOID com webridge en Y Go Links l Kaiser Permanente Northwest KPNW gt Institutional Review Board eIRB 94 lt lt Back Save Exit Hide Show Errors Print Jump To Type of Submission Continue gt gt Edit IRQ NW O8JHolu 14 Type of Submission for Example for Jan 1 0 Is this submission Select ONLY one A regular new study submission conversion of an existing already IRB approved paper study into the eIRB Arequest that the KPNW IRB rely on another institution s IRB to
78. rr Contry 18 5 El ixl PIOS C 2 mem Eminem lt Cy vermes Media Maver i uses Prada nta nem Micron 5 M enn Figure 28 28 CREATING MODIFICATION REQUESTS Your study must be active and approved the elRB before you submit a modification request on the study If you already have an active paper study you may convert the elRB For details on converting an existing study read the section of this user manual Converting Existing Hardcopy Studies into the elRB Once you have opened your active study click on the New Modification button located in the left section of the study workspace See Figure 29 LI Pride and Internet E u B 218 xj Edt View Favorkes Took ir 7 FE x Qm 12 0 2 vere Ge Swe webridge com E aizer nem Dispo ages Tira C com webridge eriy Enkin OTD 7 35065 705 2 APOC AP TAF T x Go Links a h are west D Lalala My Logaff Institutional Review Board eIRB IRE Studies Studies 1 Pride Prejudice IRQ Approved Study Tithe War and Pc Status Approved Expiration Notification Date 8 17
79. rule authorization Recruitment flyers advertisements e Study forms questionnaires surveys abstraction tools communications or other materials e Study Protocol e Other answers provided on the online Initial Review Questionnaire Please use the link below to make the desired modification s from the list above by revising the online Initial Review Questionnaire This link will take you to a copy of the application form the online form that was filled out and submitted to the IRB to request approval for the study Once changes are made follow the on screen instructions to submit the proposed modifications NOTE To make your modifications please wait for at least a minute and then click on the refresh icon on your toolbar A link should appear below if the link does not appear please wait a bit and refresh again as the system may need a bit more time When the link appears click on the link Then click on the View Study button and you will be presented with the initial review questionnaire that was created for this study You will be able to make your modifications to the IRQ Once you have navigated within the IRQ and made all the proposed changes click Save and then click Exit If you wish to see your changes you may click on the View Differences button To exit from within the View Differences area click on Back to Change Lo Finally and importantly You MUST then come back to THIS
80. soft 23 PASMART FORMSIN 9 User Manual IRB REVIEW INQUI i Folder for PIL Mi O QO M 9 31 Figure 35 Z Edit View Microsoft Internet Explorer File Edit View Favorites Tools Help Back M ix E A 2 Search y f Favorites GU Uke ente Northwest Institutional Review Board eIRB lt lt Back New IRB Inquiry Save Print Continue gt gt IRB Review Inquiry Form for New Projects If you are unsure whether IRB review is necessary for a new project submit this query Here are some situations where people often have questions and IRB review may sometimes not be needed other types of institutional review may still be necessary Clinical care of individuals patients e g using drugs off label Quality Assurance or Quality Improvement projects where there is no plan to publish or share the results outside of Kaiser Permanente Publishable case reports or small series reports When KPNW s involvement is limited to placing posters and or brochures about research opportunities in patient care areas If you think your project may fall ito one of these categories or if you are unsure if it needs IRB review please describe in about one paragraph and the IRB Chair or Director will advise you Blease provide a short title that summarizes your inquiry 2 recruitment poster in OB GYW clinics
81. ssions and saving a copy of the submission as an electronic file See the Printer Version button in the left area of the submission workspace see Figure 24 You are encouraged to primarily rely on the elRB system itself for documentation since the system 15 designed to provide a sufficient project history record of submissions and record of IRB approvals KPNW s adoption of an el RB system can result cost savings and significant environmental benefits if fewer hardcopies are associated with the IRB process The Project Snapshot that runs at designated points in the review process and is found in the History tab is another method used to freeze and capture a Snapshot in time of a study submission Submitting Only the PI on a study has the option to submit the new study continuing review reportable event or modification request equivalent to a signature on paper If you are not the investigator and you have drafted a submission form Once you have drafted filled out the initial review questionnaire IRQ continuing review reportable event or modification request you must then notify the PI that the draft is ready for him or her to review and submit You may provide the PI with the IRQ number and or the study title for reference If She or he 15 listed as the PI within the study submission see question 3 on figure 11 earlier in this manual the drafted submission should display in the Pl s inbox a state of pre Subm
82. t Forms for this project I ssue Mentor Approval ALLOWS the Mentor to approve a modification request submission Log Public Comment ALLOWS any member of the study team or the IRB staff to log a comment in the project history log that is visible to everyone that has read access to the project See Figure 37 37 4181 xl 3 2 North by Northwest Microsoft Internet Lioplorer File Edt View Favorkes Tools Help Qe 2 27 5 6 00 02 4 J A lt Address ttp haiser dev webnidge com KaiserIRE Roore DeplayPages Layoutintial tC w enbty Lrtty OIDI061r 76060 9CT 165 l t KPNV N P Lalala Pl one Home Logoff Institutional Board eIRB IRD Studies SETARI 2 North by Northwest IRB Studies IRQ Number rro nwospi o4 Study Title 2 North by Northwest Study Status Contingencies Pending Principal Investigator Lalala Pl one Expiration Notification Date KPNW Mentor A mentor was not listed required for thes sbudy Review Category New Studios Contingencies Pending Sponsor Investigator Study No Reviewing IRB Kaiser Permanente Northwest db Printer Version z PrimaryContacts View SmartForm Progress Person Organszabon Terresa Fair Self Registration History Documents Reviewer Notes Change Log d area shows instructiorss and quectionz and important nobhicabonz regarding Wus
83. t kp org national compliance principles introduction disciplinary html rf gines Wi io j q u Q 3 3 NL IMM I fem imma sj mam Figure 4 Overview The My Home area of the elRB is considered the starting point of the elRB system If you lose track of where you are in the elRB you can click on the link My Home located in the upper right section of the elRB system to return to this page See Figure 5 In the main area of the My Home screen you will find a tab labeled Inbox see Figure 5 which contains the following submission header types Study Protocols I ROs studies Modifications Continuing Reviews and Reportable Events If an item is listed below one of these headers when the inbox tab is selected some type of action is required from the investigator such as revising the submission as instructed by IRB staff member responding to contingencies etc Next to the My Inbox tab you will find tabs for the following submission types Study Protocols IRQs studies Modifications Continuing Reviews Reportable Events Completed withdrawn Studies and IRB inquiries see Figure 6 Each tab contains the same type of submissions as described by its name However unlike those filtered under the My Inbox tab these tabs contain items that do not generally require your action to move them to the next state the review pro
84. ty Other I RB denies request ALLOWS the RSPO to indicate in the system that the other IRB does not accept review responsibility for the KPNW IRB The submission reverts to Submission status Reactivate ALLOWS PI SS to reactive the submission which was previously withdrawn so it can then be worked with submitted Revoke Verification ALLOWS the RSPO to indicate that a study previously verified as exempt from IRB review now requires IRB review Schedule for IRB Meeting ALLOWS RSPO to place the submission on a Board agenda and to assign a primary reviewer Send Correspondence to Study Team ALLOWS correspondence manager to send IRB Correspondence to the study team Send email to IRBA ALLOWS the study team to email the RSPO within the elRB environment Study Completed ALLOWS the study team to indicate that an exempt study is closed Submit Once the submission draft is finished Submit ALLOWS the form to be submitted for IRB review Reminder The PI is the only person that can submit Submit Changes ALLOWS the Principal Investigator to respond to a request for changes or clarifications from the IRB staff Submit changes or contingency response ALLOWS the PI to submit the requested changes or response to contingencies Reminder The PI is the only person that can submit 38 Submit Continuing Review Once the submission draft is finished ALLOWS the PI to submit the form for IRB review
85. uman Subjects Training Date of the There are no items to display investigator or study staff areas you will not have future access to this submission or to the study workspace Select yourself now to ensure your access zl M Locaintranet start gt 3 Inbox Microsof 23 Calendar Micro Edit View Wi 2 Z Help Desk Ps Microsoft Excel 89 User Manual v E My Computer gt My Computer gt QA O W 10 55 AM Figure 10 Human subjects training The date of completion of KPNW human subjects training will be stored in user profiles Information will be imported from the training system s database into the el RB system periodically If you or someone on the study submission has just completed human subjects training and if the submission must go in right away contact the el RB Help Desk to request an unscheduled immediate system update see Figure 11 11 Edit View Microsoft Internet Explorer la xi E File Edit view Favorites Tools Q ix B A Search Sp Favorites J A LJ lee rel rs Address http t kaiser dey webridge com KaiserIRB ResourceAdministration Project ProjectEditor ProjectType _Protocol amp ProjectCreatorview com webridge entity Entity OID 84D734388B46EE49BBD445B56C464F97 J amp ThisContainer c Y Go Links Kaiser Permanente Northwest KPNW D M Institutional Review Board eIRB lt lt Back
86. y Tithe War and Pac Status Principal Investigator Lalala 1 Expiration Notification Date g 17 2008 Mentor mentor was not listed required for this study Review Category Sponsor Investigator Study No Reviewing IRB Study PrimaryCuntarls Person Organization Rebecca Bogorad Center for Health Research NW Reportable Ever eirhss Other GE New Continuing Review _ Suzanne Gillespie Center for Health Research NW Approval Letter Click to View Smudy Modifications Cnt Foires Evarts Docuir Pantas Change Log Activity Author Activity Date x Modificaien Opened Lalala cree 7 7 2008 3 38 BOT View Modification Workspace 79 Project Snapshot Generated Suzanne alllesaia 3 17 2008 7 52 AM PDT E View Project Snapshot Sant Carrespondance Letter for Study Approved Suzanne QGill sgse J iTf20U0B 7 52 AM PDT 3 View Correspondence Letter Study Submited for Review Lalala Pl oree 7 17 2008 7 50 AM POT Created Study Suzanne Gillezese T 17 200B 7 48 AM PDT Kaiser Permanente Northwest Farsireh Subjects Probecton Offic 1900 M Interstate Ave Portland Oregon 97227 503 335 2400 Questions or comments an the contact eLRBapkprehr ang EI meu pma OO Am jrbocMeosoa Ciz wake E G windows TM SALAM
87. ype Ceding request Another IRB rely on the review of KPNW IRB Ceding request KPN W IRB rely on the review of another IRB Consent materials DSMB reports new or revised Investigator Brochure s Investigator s New waiver or alteration of informed consent New waiver or alteration of the privacy rule authorization Other answers provided on the online Initial Review Questionnaire Recruitment fliers advertisements SD DmDmg nmjnmgogg og minm Study forms questionnaires surveys abstraction tools communications or other materials Study protocol 4 3 0 Description Describe the proposed modification s and the purpose of the modification s We are changing the survey to include a section on caregiver burden 4 0 Enrolled Subjects How many subjects currently enrolled the study If this study ol involves only existing or secondary Sources enter 0 DO NOT USE COMMAS El Done Internet A start Em ao ie iw 1 2 Q 3 o box Micros 5 Windows Medi 1 User Manual d trainingStory C P User accou amp dit view M Eee M 11 36 am Figure 30 Once the first screen has been filled out click on the Continue button in order to answer all applicable questions If your modification includes changes to any of the following you will use a link to make the desired modification s by directly editing r

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