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User Manual v 2.0 - eIRB-Information

1. Figure 13 12 NAVIGATING THE INITIAL REVIEW QUESTIONNAIRE IR Understanding Help Text Throughout the IRQ you can find the light gray Help Text Area located on the right section of each page see Figure 11 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 el RB 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 and listed Then you can select your funder if it is found on the filtered list If the funder sponsor is not on the list in the system enter the name in the text box provided Using the J ump To drop down list The form drop down list box see Figure 14 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 that you would like to modify You must click on the down arrow next to t
2. Siudy Tithe Regular zumas HI amp CHR irnestigator Study Satus Epp ied Principal Investigatar a eirbP Expiration Notification Date WT KPHW Mentor mentor was mot listed required far this study Sponsor Invesligaior Study Reviewing IRB Karser Permanente Have an Ft ee tees TES gt Person Organization Bebecca Bogorad Center lar Health Research NY Approval Letter Click to wiew History D ws BRA Aeta E Reportable Events D acuments Reviewer hates Change Log Ek Actraty Date rer 1 Copied Study arbre 9 23 2011 2 31 PM POT D Cony States Fi temortable Ewent Opened ewbPl 8 15 2011 4 11 PM PDT vw Reportable Event workspace e Cantinumg Report Opened girbP1 9 16 2011 3 04 PM POT I ven Conbmumg Review workspace Copied Study LaForge Lisa 5 23 2011 8 43 AM PDT irs New ID is PraQ0001143 Tithe EXP HI COPY 5 23 11 1 Modhfhcati n Opened erbPl 3 21 2011 11 48 AM POT View Modification Workspace TE Project Snapshot Generated CIRESAHI H 4 21 2011 11 43 AM PDT Df view Project Snapshat ac Project Snapshot Generated e RB AdHI H a 21 2011 11 43 AM PDT I view Project Snapshot len Sent Comespondence Letter for Study Approved eIRBAGHI H 4 21 2011 11 43 AM PDT Beg 2 YY T T Y oe C P ER P Bf mamas RES Figure 43 37 f Regukur subarirysiza ix investigato
3. E Googie cae x Oe v apphcable indicate unkno wn 72 nown 3 0 Comenents _about study duration optional 4 0 a dear stat ent of the bet ses to b ted dd d L u abl 9 speohc scient bjectrve ru dear statement of the x hypoth s to be tested or th problem b ddres the measurable d speot tf ctives of this research Windows Internet Oplorer h 2 Are you sure you want to delete the selected 5 0 Briefly summarize existing knowledge pertinent to this study St doe A biblography must be h thus appt tt via the upload area directly below or m the next section as part of summanze exisbng knowledge CK Cancel ipertinent to this study State what this study will contribute to aisting knowledge bibhography must be uploaded with thes either via the upload area direct below or in the next section as ipart of th uploaded Study protocol 6 0 Upload aphy ada Documerk s There are no items to amp eplay 7 0 I avadable upload the study protocol Aso Document s Uslued Revisien view Protocol 1 Delete Back Sf Local intranet WR e start LG d ail 2 3 Weosoft Office JI e tan mew L Zi tip Deck E user Manual v 1020 My Computer My Computer JS ini Editing replacing uploaded documents If you wish to upload an edited or newer version of the document click the
4. xr bet chr e ko oos E noms are Grp on tainen een webridge ensiry nteyTOTDTF 792 208720 A HLH 20853001 De mr e ps bo Bess de ES Bone turnover amor S571 users Hi ceding bo KPNE 5 DE m ren SI Kaiser Permanente Institutional Review Board 1 AT The eIRBPIGA Home Lagedf B Georgia Hawaii Northwest GIRB Information TRG Lequiries Studies IRA Studies turmever among SSRI users reng ra KPNI IRQ Number uw arghhhh 1 Pre Sehmbechon Title Done turnover among SSA users HI Cer to KPNC Siudy Status Pre Principal Investigator a eirbPl Fxplraiion Notification Date T KPAW Beno l mentor was mat ted required for tha smudy E Printer vergine Sponsor Investigator Study Mo Reviewing IRD Kaser Permanente Northwest View SmaerFonm Progress PrimaryContacts gt Person Or Rebecca Bogarad Critter for Keath Eresearch NW Lisa LaForge Center fer Health Research NW History Documents Reviewer Notes Change Log Thus acea shows mstruchons and questionis and mportant mobhcatons regardeng thes Study Actraty Author DI Date WO Created Study bP 3 22 2011 10 57 AM PDT Kaeser Permanente Georgia Hawan Northwest For technical questions contact 503 528 3945 xj Done
5. 1 for IRB Study Prag 1031 NAX DIIg 53 Pre Sunes mem Q Trusted ses i 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 KP IRB cede their review to another IRB for a new not yet submitted study e 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 8 e Once you have completed entering information into this first screen click on the Continue button located in the upper and the lower right 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 Ip kiip awe IRE sue Aino Pratar ect pea Prisar Lea ie arbi enbi 12408FDE SRT eA Sey l Bo Edt wew Tool
6. Name Version There are no items to display i Done Trusted sites 100 Figure 40 CREATING INTERREGIONAL SUBMISSIONS The elRB is used in the KP Georgia Hawaii and Northwest regions New studies may be Submitted to one of the three regions However each region s IRB operates independently and studies submitted to one IRB cannot be viewed by another IRB Therefore study staff must copy a study and submit the new copy to one of the other regions In the IRQ workspace click the Copy Study activity Figure 41 A new window will open Figure 42 giving you the opportunity to name the new study You can use the same title for multiple studies but you will not be able to tell to which region it is submitted unless you go to the study workspace When you have named the study click OK 35 7 Deupsksr zbsp san m Wimmie Imirt Explorer B Go E htro Uerbdev chr pr klong few Rooms Display apes Container ecnm webridge entity 164 596 SP ei 5 10685 280 31 Ue DA ger aede Den del Mer ae 1 x Ki Regler suiesissicn HI is CHR fo E m Pee Sh toe Kaiser Permanente Institutional Review Board y 5 SS a Heme Lego Georgia Hawaii Northwest lt W RIRE Inlormation TRE Inquiries Studies IRA 7 Regular subrmessin is CHE inves
7. Submit studies on which you are the PI this will be your role set e 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 elRB Information to see a general non tailored elRB page containing useful contact information for support personnel and materials related to the elRB system see below Figure 7 l x 4 zm Che pr ko ura Die La youtini aal mcom sebridge entity Entity s 5DE 760 2052810305904 344 7 140717247 14 548 50 8 5D Do Kew Took WF Comet fl Select WT rar fe the eiis E f ip C mie U Kaiser Permanente Institutional Review Board R VR teow e 1 THE Sab Hab ry Pre Uu Georgia Hawaii Northwest LES 4 IRB Doa viries IRB Studies tiny Stoll Page for The eIRBPIGA Welcome bo your Personal Folder the central resource for managing your Study E week My Inbox contains items that require your attenti y
8. Wes e x Wel to the Kai P t IRB inl ahd sd ai ma Ink gi Welcome to the Kaiser Permanente i E t sich Get A0 i i Iran gt Contact Us d The eIRB site is des igned to enable researchers and IRB reviewers to manage all aspects of e aire a Bitter ZE the Institutional Review Board IRE administration process for KP Georgia KP Hawaii and KP Northwest gistratien kal POF F EF wr Prane e eH Home I D Kaiser Permanente Institutional Review Board m Georgia Hawaii Northwest 5 B eIkERE Inhormatian eTRB Infonmaticn internet Protected Mode Off ns Rie 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 KP policies regarding the use of electronic resources These policies can be found at the following links http npl kp org pl do public record subcatid 25001 amp VI EWzM amp rid 276142601 amp rgid 900 Disciplinary action up to and including termination may be taken agains
9. elRB User Manual Kaiser Permanente Institutional Review Boards Georgia Hawaii Northwest CONTACTINFORMATION el RB Technical Support 503 528 3945 M F 9 00 AM 4 00 PM PST Email elRB kpchr org Georgia Kaiser Permanente Center for Clinical and Outcomes Research 3495 Piedmont Road NE Nine Piedmont Center Atlanta GA 30305 IRB Administrator Natalie Thurman 404 504 5543 Natalie Thurman kp org Hawaii Kaiser Permanente Corporate Compliance 711 Kapiolani Blvd Low Rise 2nd Floor Compliance Honolulu HI 96813 IRB Administrator Cate Alexander 808 432 5411 Catherine X Alexander kp org Northwest Kaiser Permanente Center for Health Research Research Subjects Protection Office 3800 N Interstate Ave Portland OR 97227 IRB Manager Sandy Heintz 503 335 6712 Sandy Heintz kpchr org IRB Coordinator Melinda Allie CIP 503 335 6753 Melinda Allie kpchr org IRB Coordinator David Matthews 503 335 6357 David M Matthews kpchr org TABLE OF CONTENTS TABLE OF EHNEN 3 INTRODUCTION 24i bb o EE 4 PFEGISIRATIEONXu EE 4 LOGGING INTO THE 222055055 EAS PA RER QUE EIN de ebd d ERAS 5 8 ADDING INVESTIGATORS AND STAFF TO THE STUDY 50 5510 9 NAVIGATING THE INITIAL REVIEW QUESTIONNAIRE 13 UNDERSTANDING BEP TIENI EE
10. The submission is now with the IRB staff to administratively handle Meeting Complete Awaiting Correspondence The submission has been reviewed at an IRB meeting The IRB staff is preparing related correspondence that will be sent to the study team Not Engaged in Human Subjects Research The IRB has determined that the submitted study does not require KP IRB 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 45 GETTING HELP el RB Technical Support You may receive technical assistance for the elRB system by contacting elRB technical Support at 503 528 3945 or at elRB kpchr org during the following hours Monday s ele EE 9AM 4 00PM PST Training is strongly encouraged for new elRB users Information regarding training can be found on the elRB home page at http el RB 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 I RB Related Support For questions related to the wording and the meaning of the questions found within the el RB feel free to contact the regional IRB where your study is
11. 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 44 In Exempt Review The study has been forwarded to reviewer who will determine if the study is exempt from IRB review 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 is now with the IRB IRB Correspondence Review The submission has been reviewed The IRB is preparing related correspondence that will be sent to the study team IRB Qualification Review inquiry The 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 IRB staff IRB Staff Review
12. xl IT T T IT gast ans Figure 41 Study This activity will this study You will remain the Principal Investigator for the new Study it will be placed in your Inbox All attachments will be copied This activity takes time but can save you work We thank you for your patience Figure 42 36 The amount of time it takes for a study to copy depends on the size of the original study Larger studies with more documents take longer The history log of the originating study will show the Copied Study and a status if the copy is still running Figure 43 Refresh the page in your internet browser every few minutes to get an updated status When the copy is completed the new study ID will appear in the originating studies history log Figure 44 F7 Beamer sukama aman HT Exgplkarrr 4 sier o vx hcl erben hor on Dev Deci Peces bal Con tuner coe eebnidae entty Entity ORO DEC 1 Soli JP PRO 10615 ae EI KEE z F d s m m Roe oe Ph epo Sonet ime V di tubmason CHR p El Pm RU Kaiser Permanente Institutional Review Board t I airbPI My Heme Loge Georgia Hawaii Northwest eIRG Information IRB UI ep Studies Shoes Regular subisson HT va CHR vest IRQ Number pronnanaass
13. Documents Reviewer Notes Change Log Activity Author z Activity Date Log Comment Study Team eirbPI a 9 23 2011 4 03 PM PDT f The Co investigator has updated her training 2 Project Snapshot Generated LaForge Lisa 8 8 2011 10 29 AM PDT View Project Snapshot Project Snapshot Generated LaForge Lisa 8 8 2011 10 28 AM PDT View Project Snapshot Sent Correspondence Letter for Study Approve LaForge Lisa 8 8 2011 10 28 AM PDT Project Snapshot Generated LaForge Lisa 8 8 2011 9 07 AM PDT View Project Snapshot Study Submitted for Review LaForge Lisa 8 8 2011 9 07 AM PDT 0 Created Study LaForge Lisa 5 23 2011 9 59 AM PDT IN 4 1 7of7 gt M El Done Trusted sites 100 7 Figure 47 Other I RB accepts reliance and documents complete ALLOWS the IRB to indicate in the system that the other IRB has accepted review responsibility for the KP IRB The study will be considered ceded upon execution of this activity Other I RB denies request ALLOWS the IRB to indicate in the system that the other IRB does not accept review responsibility for the KP IRB The submission reverts to pre 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 IRB to indicate that a study previously verified as exempt from IRB review now requires R
14. 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 23 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 19 http eirbdev kpchr org formID 0 amp postback 1 amp valueField Protoco Submit a Document http eirbdev kpchr org formID 1 amp valueFie File Z Training Sample studies for training PEANUT Browse VIEH Show Advanced Options Required Figure 23 OK OK and Add Another STUDY WORKSPACE OVERVIEW If not provided the name of the file will be used Cancel Z 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 ID number is displayed in bold letters near the top When speaking with elRB technical support staff or with IRB staff refer to the last digits of the ID number omitting the zeros In Figure 24 this would be number 593 The ye
15. IRBs listed above You will need to select one IRB per application Once the first appScation is created you can copy it select the other KP regional IRB above and any req onaully required pages will then appear in the appropnate sections For assistance with copying please refer to the User Manual on the eIRB Information page of the eIRE or contact the elRB Help Desk at eIRDOkpchr org lt lt beck eve Ex ride vt Print mp To Reg al IRG e Contnve gt gt d Trusted stes 00 Figure 46 39 GLOSSARY UNDERSTANDING ACTIVITIES Accept Cede from other IRB ALLOWS the IRB to indicate that the regional KP IRB accepts review responsibility for another IRB Acknowledge ALLOWS the IRB to acknowledge receipt of reportable event submission Agree to mentor ALLOWS the Mentor to attest to mentoring responsibilities on the study if a mentor is needed on the study Ceding revoked ALLOWS the IRB staff to revoke ceded status on an active study indicating that the regional KP IRB will assume review of the study Changes requested by contingency reviewer ALLOWS the IRB to forward a request for changes to the PI Changes Required by Expedited Reviewer ALLOWS the IRB to forward a request for changes to the PI Changes Required by I RB Staff ALLOWS the IRB to submit a change request to the PI the Principal Investigator will be notified that changes are required to the protocol Continuing review completed ALLOWS th
16. Study Actnaty Author Actraty Date Item Withdrawn girbPT 97 23 2011 4 08 PDT 3 we made a m Create Study erbe a 5 23 2011 2 53 PS PDT Ad Tzo2 s 5 Kaiser Permanente Georgia Hawaii Horthwest For technecal questions contact 503 S28 3946 pr eikag ikpechr org PT T T T T RP trate es Kee Figure 49 43 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 a KP IRB meeting Awaiting Correspondence The submission has been reviewed The IRB 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 regional KP IRB which has contingently approved the request and is waiting for communication from the other IRB about whether they agree to accept the review responsibility Ceded to Other IRB The ceding reliance request submitted by the study team has been reviewed by the regional KP IRB which approved the request and the other IRB agreed to accept the review responsibility The regional KP IRB is now relying on an
17. on ML ner my a My Roles stows you bo switch beteeen pour user roles f you have mulbiple robes m the 2 sysbem For active studies the tabs below filter by submission type Inactree Items are found in the Completed Withdrawn tab Study Continuing Reviews Reportable Events Completed Withdrawn IRE niques dema whech regure action by the study beam Cek on ka for more mihormat Stuy Protocols ID Name i Dat rate Pre 1031 EXP GA alRHPIGA TEST WORKSPACE REVIEWING 4 19 2011 Si24 2011 2 51 AM Expired ProDDDD 1 138 EXP GA COPY S 5 22 11 Sla2 2011 11 08 PM Pre Submission G 11LLafo 02 G 11LLaloa 02 G Conversion eJREPE 4 11 2011 5 6 2011 4 41 PM Suspended Fro 1044 test to copy GA 11llalo 02 4 21 2011 12 57 Pre Submission Prot 1035 Wee Test of Copy for CAE f20 2011 9 21 AM Pra Submissia n Protea Expansion GA Ragular cubmiccion 4 18 2011 10 54 Pre Submission N w olghhhh 01 Bone turn ver SSRI users ceding t KI 3 22 2011 2 41 PM Pre Submissian ER playing 3 17 2011 9 52 Pre Submission Prove New Study Mar 14 2011 3 14 2011 8 38 AM Pre Submissian Study Bodilficalions Modded State brongt 1 31 Acaton 1 for amp PraOOn01130 523 2011 9 27 AM Pr MET T1406 Modern 1 for IRB Study sPradog1126 523 2011 9 18 AM Pre cubmisti n MET Prob tos
18. placed in the set of Approved Consent 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 47 40 gt EXP COPY 3 NW 5 23 11 Windows Internet Explorer Gc j http eirbdev chr or kp org Dev Rooms Displa File Edit View Favorites Tools Help Convert select we dv copy 3NW 5 23 11 0 dm Page Ch Toos Kaiser Permanente Institutional Review Board mI Georgia Hawaii Northwest k i a eirbPI My Home Logoff lt IRB Studies IRB Studies EXP COPY 3 NW 5 23 11 yPages Layoutinitial Container 2com webridge entity Entity OID 3C 78F04A 297B 1344AE8DEF 7 10DDE7C7D IRQ Number proo0001172 Approved Study Title EXP COPY 3 NW 5 23 11 Study Status Approved Principal Investigator a eirbPI Expiration Notification Date 7 8 2014 KPNW Mentor A mentor was not listed required for this study Sponsor Investigator No Reviewing IRB Kaiser Permanente Northwest KPNW IRB Study PrimaryContacts D New Reportable Event Person Organization Lisa LaForge Center for Health Research NW A New Continuing Review Approval Letter Click to View Study Modifications Continuing Reviews Reportable Events
19. view Project Snapshot To Propect Snapshot Generated 4 7 view Project Snanshat amp eIRBAdHI H fH Sent Comespordence Letter for Study Anoroved wt Pun um gek gan a El Actiaty Date 9 23 2011 2 51 PM PDT 3 16 2011 4 11 PM PDT 9 16 2011 3 04 PM PDT 23 2011 8 43 AM PDT 4 21 7011 11 48 AM PDT 4 21 2011 11 33 AM PDT a 21 2011 11 33 AM PDT 4 21 2011 11 43 AM PDT T AMOR e A Navigate to your home page to find the new copied study in Pre Submission Figure 45 kee bar rirbfFT W RB Faker ter eil gIRB Inlormation Folder for erbpi PI Tudy Stall KJ few ery l Figure 45 wulerara binirat z karar pr kp ong Der Rooms Dipa ages La vcutinitial Container econ webridge entity t 380600 A 508735124605 E 239066741 57 ZE34 334 35 8 SCHO lei 5 e u Tol ee ths 2 38 E Kaiser Permanente Institutional Review Board 5 a erbPl MyHeme Lego Georgia Hawaii Northwest TRE Inquiries IRE Studies Help Folder for eirbPI Welcome to your Personal Folder the central resource for manager your Study applications a My Inbox contams tens that regure your atbention My Roles you to switch between your user roles if you have multiple roles m the system For active studies
20. 011 9 40 AM Changes by 188 RI ProDODODS77 Maodidhicabon 1 lor IRB Study ProDDIMRIOT7 5 23 2011 8 31 Pre i I T fadus awa Edit the new study and select the new committee for the submission figure 46 Selecting a different region may require different questions to be answered in the IRQ Be sure to answer any relevant branching that may be required for that region Also check the application carefully to ensure that the answers are indeed appropriate for the region s IRB to which this copy will be submitted When the PI submits the copied study it will be routed to the new region s IRB and will not be able to be viewed by the original study s IRB Any correspondence generated by the el RB will reference the reviewing IRB s region ITT nT 191 dor Protectecom webndge entity 8 79 3040 140067 A 37 538 5006 21896 semati y Aix Edt Gen eck Convert lt FPO Select Beaver 1 Kaiser Permanente Institutional Review Board Georgia Hawaii Northwest lt lt Rack e Ext Mido She Edit IRQ Pro00001106 Regional IRB Kaiser Permanente Georgia KPGA IRB C Karner Permanente Haw an KPHI IRB aiser Permanente Northwest IRR For users who wish to submit to more than one of the
21. 1 23 2011 9 53 AM Pre Submission 000008 Study to Train Mentors 10 1 2009 9 35 AM Pre Submission Study Modifications ID Name 3 Date Modified State MR2_Pro00000005 Modhcabon 2 for IRB Study sPro00000005 6 8 2011 10 20 AM Pre Submusseor Continuing Reviews ID Name 2 Date Modified State CROO000002 Progress report 2012 6 8 2011 10 34 AM Pre Submission Reportable Events ID Name Date Modified State Ad 00000001 Protocol De viabon 10 9 2009 10 55 AM Pre Submission IRB Inquiries ID Name Date Modified State There are no items to desplay zi Dore T T T T Z wen 4 Figure 5 F Fokher tor eirbPl Widows Internet Explorer 3 2191 v9 nes feeb ocr org traning Rooms ages Layoulintal Contane ecom webridge Entity 01D B353246924C 23408684 15C 7694 39435 sl a x pp mem Pm pm 8 S E th Ese we Kaiser Permanente Institutional Review Board Georgia Hawaii Northwest a eirbPi My Home Logoff ein KPNW IRD Inquiries IRD Studies Help FAQ Folder for eirbPT Study Staff Folder for eirbPI Welcome to your Personal Folder the central resource for managing your Study applications New me Inquiry pU CONNU p e My Inbox contams items that require your attenbon e My Roles allows you to switch between your user roles if you have multiple roles in the eIRB system e Fo
22. 13 SEARCHING LIS DS stt anusaassnuaqsasssnsamapunsasanakhasamaaananamassnunanwaupaqaakuhusaqwaqasaqmasnpumamusupaanaa 13 USING THE JUMP TO DROP DOWN LIS TEE 13 SAVING THE INFORMATION YOU HAVE ENTERED s 14 BB IER RTE e L EE LA EXITING THE AER EE 15 UPLOADING DOCUMEN TS QER uuu perdus Nisus Er dure Parm dde Maas cH a aaa iota eis 16 PELETING DOCUMEN RE 19 EDITING REPLACING 5 5 19 STUDY WORKSPACE OVERVIEW stet C dice Pe EX LEHRER 20 PRINTING SAVING AND DOCUMENTING SUBMISSIONS 22 SUDBIMIE TT Ku LEE ER CONVERTING EXISTING HARDCOPY STUDIES INTO THE es 23 CREATING CONTINUING REVIEW 25 CREATING MODIFICATION REQUESTS 26 INVESTIGATOR GHANGE Sic EE 31 MODIFICATIONS TO CONVERTED HARDCOPY 5 31 CREATING REPORTABLE EVENT 5 551 0 5 32 CREATING INTERREGIONAL SUBMI 551 5 35 GLOSSARY UNDERSTANDING 5 7 40 GLOSSARY UNDERSTANDING CURRENT STATES 44 GETTING HELP u haytan 46 EXAMPLES OF COMMO
23. 4250565 LEE T eb d ncm elena a sl per Os Di Ven Favorites Covert FO Select ae s m TESCA Ml Fiegular buten i amp Et G Teo a A Kaiser Permanente Institutional Review Board A Georgia Hawaii Northwest gt KH IRE Studies Studies Regular submeton Hl re CHR me ccpgater IR Number rronoo009096 Siudy Title Regular submession HT rs CHR ireestigator Study Status Approved Principal Investigator Expiration Motilicatiom Date 4 21 2012 ENW Mentor A mentor was mot listed required For this study v Soon Investigator Study Mi Reviewing IRR Kare Permanente Haw am IRB PrimaryConl acts Por sr Organization Rebecca Bogerad Canter Tar Health Research NV Approval Letter Clics fo View History Study Medihieations Reviews Reportable Events Documents Reviewer Notes Change Leg Authar iz Date w Copied study LaFerge Lisa 5 23 2011 FAI AM POT Copy ID is Pr0 4001133 Title EXP HI COPY 5 23 11 81 rm Opened 3 21 2011 11 48 AM POT 3 view Modification Workspace 1 J Project Snapshot Generated alRRAdH H 4 21 2011 11 43 SOT view Propect 5napshot SL Project Snapshot Generated a amp IRBAGHI H 4 20 2011 11143 AM POT T view Project Snapshot cont Comespondence Letter for Study Anavi eIRBAd
24. B review Schedule for I RB Meeting ALLOWS the IRB 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 IRB Staff ALLOWS the study team to email the IRB staff within the el RB environment Send email to Study Staff ALLOWS the study team to email the study staff listed on the study within the el RB 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 I RB 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 41 Submit Continuing Review Once the submission draft is finished ALLOWS the PI to submit the form for IRB review 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 accurac
25. Board Georgia Hawaii Northwest 44 Back Save Dot Hide Show Errors Print Jump To Regional IRD Continue gt Edit IRQ Pro00001102 Regional IRB 1 0 Please indicate to which regional IRS you are submitting this application name C Kaiser Permanente Georgia KPGA IRB Kais HD IRB 6 Kaiser Permanente Northwest KPNW IRB Clear For users who wish to submit to more than one of the IRBs listed above You will need to select IRB per apphcabon Once the first apphcation 15 created you can copy select the other KP regional IRB above and any regsonally required pages will then appear in the appropriate sections For assistance with copying please refer to the User Manual on the eIRB Information page of the e RE or contact the eIRB Help Desk at eIRB S kpchr org lt lt Back Save Hide Show Errors Print dump To Regional IRS gt Centinwe gt gt V FF TF ass ws Figure 28 Foi weer Winrar Explorer go zi ht chro kn ong hey Mirad ne I webridce Entity ts BOTAS S AGAS TA San ROSSA IC 533 Kaiser Permanente Institutional Review Board Georgia Hawaii Northwest Edit IRQ 0001182 Save Ext HideEhaw Erreri Prin Jump Tus Type of Centinos Ty
26. HI H 3 21 2011 11 33 AM P T 1 2 Project Snapshot Generated erbPl a 4 21 2011 11133 AM PDT p Vu Project Snapshot Le Suhmitted Changes erbPl A 3 21 2011 11 33 amp M POT Changes Logged 79 Project Snapshot Generate alRBAdHI H I 121 A 3 hat G d Aj2lj23011 11 31 AM PDT E Propect hem jerbdev ar kp ebe roms Teenie Faces ban dree scan Vert EE SORTE Temm Figure 30 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 31 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 will need to submit it for review using the submit activity see submission section above 25 Ea ayu pis Explarcr sl l xi ejm f bie bebe e e kn arm ey anon XOrpjectType m regen m h Dgn ew Presse ne B inne anm enpry Ente TOID SEER S el ee x fesse 7 fats Men Fuerte Toon me Comet FP Select ww FE Kaiser Permanente Institutional Review Board 3 Georgia Hawaii Northwest Study IDPro00DDDHHS Stu
27. Information expired Figure 19 2 http eirbdev chr or kp org postback 1 amp formID O amp valueField ProtocoLcustomAttributes E Submit a Document Title f not provided the name of the file will be used File BE Show Advanced Options Required Figure 20 Once you have located the document on a network drive select the document click the Open button see Figure 21 and then click the OK button on the document upload window or click and Add Another if you wish to upload multiple documents Choose file Look in Sy elRB Consent Form doc rou Mu Computer i File name Network P Files of type Figure 21 18 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 22 WARNING ONLY DELETE DOCUMENTS THAT HAVE NOT BEEN REVIEWED BY THE IRB DO NOT DELETE ANY IRB APPROVED DOCUMENTS IN THE SYSTEM 48559544 20 3BF ASOROC AMode esmartferm Aira Q Convert P O Sect E 4 w we Centertiet Det xseo Res amat Your
28. LA S m 2 q di d lt lec toe Back Reportable Event Summary Kaiser Permanente Institutional Review Board en r Edit Reg ve 8 Event Wapenmasig Zmmm rg FF Provide a shert for your Mg era in that briefly desonbes the event being reported tr example Participant hospitalization De not exceed 50 characters with spaces Da net indude any personal health infarmatian i at not indude patient s name medic al record number et If this is a follow up of a previously submitted reportable event please reference the ID number eg Follow up to Axly00000001 Privacy Breach Please refer to the table below for types of reportable events and reporting timelines 1f you are unsure of when bo report contact the IRB administrator where thes study is approved Type of Reportable Event Timeline to Report bo IRE Unanticpated and Related Death inex eecht death that is determined by the to be at least possibly related to the study Within one business day folowing discover god at ome of continuing Favre un X Geh Problem mcudeasg thes ony incident experience or outcome that meets all of thee follewimg reporimg citer Within 10 business days at Grieg GEES or discovery at tima of copnbmum i deeg in the elinicnl Unexpected in terms Eeer er frequency
29. N ERROR MESSAGES nnns 47 WHAT IS NOT FOUND IN THEE IRR nh 47 INTRODUCTION The Electronic Institutional Review Board el RB is a web based application that provides tools for submitting and managing requests to the KP Georgia Hawaii and Northwest Institutional Review Boards IRB for approval of human subjects research The elRB 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 electronically REGISTRATION 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 Lefz C kuu xj ht ache orig er airing Lapin Con tsinier can webnidge en ty at SE CO JC 424 30 120 w X j b ME eae S Esse d i ers ew Ap E ss 3 mee Kaiser Permanente Institutional Review Board e Georgia Hawaii Northwest Yo u Wi PIRR KPN W IRB KPNI register CIRE Updates Attention O n ce e Welcome to the Kaiser Permanente Northwest eIRB valid user account is t us Zys5bem H you FAQ net GENEE Our eIRB site is designed to enable researchers and IRB reviewers to manage all aspects of CAR Mean IDE RES DET the In
30. RB Inquiry button located in the left portion of the screen see Figure 39 This will bring up a short one page form see Figure 40 O Fok er bar ewbP1 Windows Internet Explorer e che Moons Dapa Contae ecom webridoe Entity 5801056588 SSI2ASE SMC 2340848 4 1 SCIESA A35 5 80540 x a Besch Te H oem INS mcm Fle Edt Yew favores Teo 5 WS Broce tz Pe ED M Be O Tess gt Kaiser Permanente Institutional Review Board ty tenet Georgia Hawaii Northwest eIRB Information IRB Inquiries IRB Studies Folder for PI Study Stali Folder for eirbPI Welcome to your Personal Folder the central resource for managing your Study appbicatione e My Inbox contains items that require your attention My Roles allows you to switch between your user roles f you have m ie roles in the eIRB system For active studies the tabs below filter by submission type E E gew IRB Inquiny S Inactive Items are found in the Completed withdrawn tab Study Protocols Modifications Continuing Reviews Reportable Events Completed Withdrawn IRB Inquiries Displays stems whech require action by the study team Check on links for more mformation Study Protocols ID Name 2 Date Modifiad State 00001182 New study dated 9 16 2011 9 20 2013 3 17 PM Pre Submis
31. age Study Poapulabon Behavor al amp Data Collection d d s L Figure 35 If you wish to see your requested changes to the IRQ compared to the approved version of the IRQ you may click on the View Differences button see Figure 36 To exit the View Differences area and click on Back to Change Log Finally you MUST then come back to the page within the modification request form as shown in Figure 34 and click Continue to continue to navigate through this modification request Then click finish on the final screen The PI will need to submit the modification request in the modification workspace 30 Wo Winda riese Fephorer A 18 x Ka he ve ke O g Die Enkel acts Sane D Berenice Fg en nile En EES HE SS s eech dengen trage em S AS DD Edt Favorites Toos Hep Fu Select w 5 a ira mite x Om Te I P Kaiser Permanente Institutional Review Board eg i T aquo Georgia Hawaii Northwest E eIKH Information IMA Inquiries Studies Number of madification s on this page 3 Number of mocihed page s 3 Currently Approved Pro000009096 Proposed Modifications Study Population Children Study Population Children You indicated that your research may include children 18 years old You andscabed th
32. at your research may include children lt 18 years oki 1 0 Check one box below that re most applicable to your research 1 0 your research ome Des below Pat ig meet aggiircable xs We The research invalves n more than maumal nk 2 0 Classification Ralionale Prowde your rabonale for the dassicabion you chase above d r1 1 La your ou BIV COOL A Wel s H Wi SLL4 DE Ee eg mere 2 0 Classification Ratlonale Provide your rationale for the classification you chose above potentially involve children who are wards of the state or any s Trusted gites Figure 36 Investigator changes Investigator changes including INTERIM changes must be submitted to the IRB using 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 Modifications to 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 to write in information describing the proposed modifications You CAN upload revised documents and add new docume
33. ate these requests CREATING REPORTABLE EVENT SUBMISSIONS Reportable events are unanticipated events related to the research that involve increased risk or the potential of increased risk such as a breach 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 37 You are able to submit and have more than one Reportable Event submission pending IRB review at a time in CHR Widen Imbormed Explorer g ve de ce ko ong Ae Roms Den elaun Container sm webridge entity E 01D TOC 168 596 Ha 16858 31 K E De Sen Fyverites Tools convert Po select a ay E Regular bnsa HI is Ze EJ m i Pepe 2 Ce E 1 Kaiser Permanente Institutional Review Board Logs Georgia Hawaii Northwest i TRG Inquiries IRB Studies Srur Regular submission HL 15 CHE investigator IRQ Number erannonnaaas Study Tithe Regular HE is CHR mvestigater Study Status Approved Principal Imeestigator a eirbPt Explration Notiflcation Date 3 21 2012 KHN Mentor merde was mor bied required for this study ma Printer version Sponsor Investigator Study Reviewing IRE Kaiser Permanente Hawai KPHI IRB PrimaryContacts Person Organza EI Rebecca Bogoor ag Center for Heath Re
34. catson ether the upload area directhy below or in the next as part of the uploaded study protocol There is knowledge on this research xj upload biography E Documenti s Upload Ravozinm Vae 0111 J 1 avaiable upiead the study protocol ED Documents There are no d m bo display Save Est Print Some T6 lt Study Summary Cneminum zx Bac an Figure 17 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 18 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 Echt View 5 J Tp B Kaiser Permanente Institutional Review Board Georgia Hawaii Northwest Sve we FH 7 ES h w tudy Int e Additional Research Study Information 1 0 Optional tf you feel there is important relevant information about this research that was not solicited pr
35. chr org e You may be presented with the following message if the eI RB 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 e The following messages indicate that you have omitted to answer a required question on 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 e 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 KP site Could not update the Continuing Review due to one or more errors 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 15 NOT FOUND IN THE E IRB e Single patient use submission forms e Emergency use submission forms If you need to make one of these types of submission please contact the IRB for guidance V 2 01 4 2015 47
36. ctan NW Approval Letter Click to vire Contnumg Reviews Reportable Everts Documents Reviewer Motes Change Log Actnity Author Iz Activity Date Continuing Report Opened airbPl a sr 15 2011 3 04 PM PDT 3 view Cont o Review k Copied 5tud Lateroe Lisa S 23 2011 8 43 AM PDT 7 New Copy ID is PraoQ0001143 Title EXP COPY 5 23 11 21 Opened a 4 21 2011 11 48 AM PDT D view Workspace d Propect 5riapshol Generated eIRBEAdHT H 4 21 2011 11 43 AM PDT 7 view Project Snapshot 1 Project napshot Generated CIEBAOHI H grz 2011 11 33 AM PDT view Project Snapshot Sent Correspondence Letter far Study Anaad eIRBEAdH I H amp r21 2011 11 43 AM PDT KC Propect Snapahot Generated eirbPI 4 21 2011 11 33 AM PDT D view Propect m Submitted Changes 4 21 2011 11 33 AM PDT Changes Logged Jerbdev dr ze ba egen Roma y sees obt acon webretos entity Entity OLD HASS Ee f ferdeg 00 lt Figure 37 The Reportable Event form will open and prompt you to enter a 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 38 32 G w dr o ip ogbe Bernus roe rpe E dio jetem 2626 Ea 22 32 98 34990
37. dest A bar Propel Prope Eten dv Bars een erie Erb Ls 1 ee w R Hep SC Eesen PO Select a v i i D E ge Page 73 Tools A Edit IR ProCHIEROHOB 20 ee ach Continua wx Study Identification Information This i5 th first step in your Human Subject Research Applicaton You will b guided t thet appropnate forms needed ba complete your submisssan 10 7 Study Title Indude pratocal rsumber and acronym d apgpicable Examination of d olds 20 Absiract Shit description of the study m lay ng Examination of dental caries in 2 3 year olds 2 13 Me 1 Thi 1 J w Trusted gres Figure 15 Exiting the form Before exiting it is important to save your answers by clicking Save To exit the IRQ please use the Exit link If applicable when you click on the Exit link a standard warning window may 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 16 15 Wide Id 0 1 15 Wa e rime I phaea chr te len ee p Drs B sipas tr ame
38. dy Title Eegular submission HE is CHR Study Status 10 Status Are you submitting rm Alert for a completed study Note for study t be completed all research related interventmrns mberactians data oo approved research plan must be Mashed Work en after data analysis is complete is allowed on completed studies m A progress report for the study continuing review Clear lection and analyses as described m the IRB 2 0 Provide a short name that briefly describes your submission Start by indicating either Final Report of Progress Report and add the year in which the submission will occur For example a submissian for 2009 may be either Fanal Report 2009 or Progress Report 2009 Trusted stes me Figure 31 CREATING MODIFICATI ON REQUESTS Your study must be active and approved in the elRB before you submit a modification request on the study 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 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 32 26 g hope ferbdev chron p aa Dev eos Doria Pigeon NC rier cpm e ey Ena 39FB 4 7980995 LOGS S NSDIC 1 Be dt gew r m Ioh
39. e aerbPi Select Clear 7 31 2008 4 0 Curriculum Vitae Please upload the Prinopal Investigator s cumculum vitae or beosketch For KP Georgia upload the PI s research qualifications if applicable Document s Upload Revision View PI Bi sketech 0 01 Delete Upload Revision View PI Cv 0 01 Delete 5 0 Co Investigator s List co Investigators includes sub investigators If applicable d the prime awardee of research funding differs from the Principal Investigator you mdicated that prime awardee should be listed below the co anmvestigator list must indude any outside Prinapal Investigator Note Co Investigators from KPNW KPHI KPGA 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 eak write privileges to this submission in the e RB system and if the study is approved to this study s eIRB workspace Last Name First Name Degree s Organization Human Subjects Training Date elRGP IGA The Kaiser Permanente Georgia Remove J 6 0 Co Investigator s with No eIRO Account in the text box below list the name degree s organizational information email and phone number for co tors who do not have eIRB accounts boe l RW masus mw lt KR bo Wien niemei
40. e IRB to indicate that a continuing review is now complete 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 I RB ALLOWS the IRB to indicate that the KP IRB does not accept review responsibility for another I RB Edit Consent Forms Allows IRB 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 IRB 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 the IRB to expedite approval of a submission Final Report Completed ALLOWS the IRB staff to indicate that a ceded study is closed Finalize Documents ALLOWS the IRB staff to stamp and watermark multiple draft consent forms with the project approval date Once finalized a copy of the corresponding document in the set of draft consent forms is converted to a read only PDF and is
41. e 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 or to exit and withdraw If you are uncertain if your event is reportable to the IRB contact the IRB staff 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 KP 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 KP IRB for the study CREATINGIRB INQUIRIES There is an optional submission type that was not available prior to the elRB system The IRB Inquiry form is designed for situations in which there is uncertainty about whether IRB review is necessary for a new project This 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 33 In order to submit an inquiry form from your home page click on the New I
42. e upload ares diredi below of in the next secti n 3s part of the uplogded study protocol There is lite knowledge on thes research 5 i Upload biblia graph isse cv oc arg Dev Raasaaqspusqatsapiqas CES T T I rs Kee 44 15 Eirean mee JA Ta 3 memet Caiweecex My computer My Computer Figure 16 Uploading documents You may be asked to upload documents in the elRB forms For example you may be asked to upload your study protocol see Figure 17 F Elit Viru wulcrecs Peper 2181 zj Go lesbdev E escuronmikchrurstratony rorect erukectedhtrri ocde sraskforriProsect scosm_ webridge entty EC DEE aoa SE lt F A E BM fe Inh me Vq Fp E 20 Shadys expected end date The duration between your start date and en applicable unknown urikriciwri Comments about study duration antional 21 Provide A clear statement of the hypotheses to tested for the questions problem bimg ad ressed List the measurable and specific scenic objectives of this research We wall be testing sugar miake and affect on dental caries zl Grafh existing knowledge pertinent bo the study State what this study contribute to existing knowledge 4 bibhography must be uploaded with thes apph
43. eviously provide this information below or upload descriptive documentation E lt lt Back TN TM 1 vd eren na Continue gt gt Figure 18 The elRB will allow you to upload electronic documents of any type and format It is important to keep in mind that the reviewer of these documents such as an or IRB reviewer 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 most 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 the Add button in the form to upload a file Figure 18 above You may get the following message Figure 19 the first time you attempt to upload a document into the IRQ Check the Always trust and click on Run 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 20 17 Warning Security 3 X The application s digital signature has an error Do you want to run the application Name ClusterUlploadApplet Publisher CLICK WEBRIDGE INCORPORATED QU The digital signature was generated with a trusted certificate but has More
44. for Duplicate withdrawing and s include any comments Reason For Withdrawal Comments The study will then be in a withdrawn state If you wish to submit it later you Reactivate the submission which will put it in a Pre submission state for you to revise if needed and then submit again for Figure 48 review OK 42 f Wem ECKE 0 275 2401 Windows labera Httip ierbdev de pr Rooms orane pes enbtiy Entity ODD 17428 3436 136 00408 38847 6C EBEN 451 al er U X z pm yew pertes Dh dep Zeen gt e E d y Doe gt me Kaiser Permanente Institutional Review Board Georgia Hawaii Northwest Home pp Studies IRE Studies New copied study name 9 23 2011 IRQ Number rronono1 186 Wer anon study Title copied study name 8 73 2011 Study Status withdrawn Principal investigator 3 Expiration mnotificatiam Date KPNW Mentor mentor was not Ested remused for this study Sponsor Investigator o Reviewing IRB Kaiser Permanente Northwest IRB a ss Porson Organization Rebecca Bogorad Center for Health Research NW Reviewer Roter Documenta Change Log This area shows instructions and quesmans and important nanficabians regarding thus
45. g 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 see Figure 12 Note If there is a pending modification on your study the Edit study staff activity should be used not only in the main study workspace but also in the modified study refer to the Creating Modification Requests section of this manual for more information on the modified study 11 View Windows Internet Explorer go kp org DevResourceAdmmnistr son Project Er gece Project ecom webridge enisty Entity 010 2860 77800 7253 1942946008 50355 LA C 3 Mode esmert v y xe P De En yew Feste To teb convert d Sp 0 eh pe 2 0 Abstract Short description of the study in lay language language Principal Investigator indicate w searcher 16 Overseeing research activities at the Kaiser Permanente site the Pnnopal Investigator for the reviewing region Note that thes may not always be he prime awardee of the research funding The Prnapal Invesbgator must have an CIRB account and be selected from the list that wil appear below This individu will have read and edit write privileges to this submission in the elR system and if the study is approved to this study s eIRB workspac
46. ge Log Fray n ime vi You MUS iT the na back to THIS page Ser modi Jn reques it form t cic ck Con ats oats Bi Sat m S us ugh this madian i request process Link zc Rari delnhew E ZCanbnug gt gt X Trusted sies M e A Figure 34 The link shown in Figure 34 above 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 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 34 This will take you to a new project called the Modified Study where you can click on the Edit Study button see Figure 35 The Modified Study is an exact copy of your approved IRQ that you can edit with your updated answers and documents 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 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 IRB Use the Edit button to u
47. given the research icone that ana 9 are descnbed m the protocol relabed documer ni such ug IRH Sek EN ed re ch probecol informed consent SE umant and b tha characteristic shject populatio bala green of possibly related to Paraiba hor the research where related means there is a podsiiebky that Gee incident experience or outcome may have been caused by the prouedutes or interventions involved the research and that the research places subjects or others A 3 dee mn nek of harm muda physical psychological economic socal harm than was Fe kretewri or The unaurhonzed acquacmon access use or Gecdosure of PHI that compromises ite prreacy or Eet Motte KP Privacy Officer ang Ik immediately follower ng Seu at b Protec vrolatron and non compharnce departure fron the IRB appra gch that may or does put the safety nahla or welfare Withi wn 110 business days fallig bras or mere isk o or l elle the ir integrity of the study discovery and at time oc akin Nea safety information Updated investigators brochure contami ngr new Salat information i which tha is na yat aware Aithin t business days fo that suggests an increased mak or change m or A undoocumented ri dis Cover and at tr mie od contmunn PEN Note J A Bkupdy det ma al amp a be required Emergent revisi n ta E en approved
48. he 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 display only the list sections that currently apply to your study AS you move through the form the list may expand as new 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 13 Te n x r kee _ G 3 chr or An ge Des E escurceAcmnietrabonFrodectProectedame Project cpm webnidge entry 10400 200 6 7 127 9 ole exmart Ix Dis Fgarniee Took comet lt E siet we RB editores E de Boge Kaiser Permanente Institutional Review Board w Georgia Hawaii Northwest d carve Hide Show Ernsrs Pra jumo Te Study Identeliesthen Costin x Study Section Study Identification Information Study Ederntificatior Typa of Submission This the hrst step in your Human Subject Research Tou will be guided to the appropnabe Forms study Summary Section 1 0 Study Title
49. ications 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 25 Documents When new study documents are approved or once documents are subsequently approved through a Modification Request this tab will automatically update to display current versions Documents tab see figure 26 ELE G w chr or An ogbe Euspis aces Lavyoutinital Container acom ee Eni 29 a 77 L Tebi ma Zei 2 View Took Comet Fr Select P Te z M d di ga ea Kanaren Er lt El Ch Tuh II B Kaiser Permanente Institutional Review Board s E ae E Georgia Hawaii Northwest XA Y eirbPE My Home Logo EGLI EEN IRE Inquiries Studies Studies Klean Kanteen IRQ Number rroononon2n Study Tithe Klean Kanteen Study Sabine Jpn Principal Investigator A eirbPl Expiration cation Date 7 1 2012 KPNW Mentor mentor was not listed required fer this study 5yponsor Investigator Study Revlewing IRE Kaiser Permanente Northwest ontact Person Organiza tian Rebecca Bogorad Cenber for Health Research NY Approval Leller Chek to Vie
50. is study Document Name Current Version Praga Investsgabor CV Document s There are items to display l Documents There are no ens bo display Daeum There are rip items to display Documents There are no ema bo display Documents There App nb its Fo display Documents 2 There no items to display There are nn items fo display are pp items fo display There are no items to display Documents There are no lems bo display Document s view evetn 01 Doeumen ie There are pp ema bo display 1 zl ot ss Lei V L i geet s s D a Q Microsoft sth user gege lemer reen draft a EI gp feck The GO M 10 00 n Printing saving and documenting submissions There is a Printer Version feature within the system for printing hardcopies of the submissions 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 25 You are encouraged to rely on the elRB system itself for documentation since the system is designed to provide a sufficient project history record of submissions and record of IRB approvals KP s adoption of an elRB system can result in cost savings and significant environmental benefits if fewer hardco
51. it Study Modification 1 ProDD0D00996 Instructions for Changes reu indicated that vou wish to med y at laast one of tha following en the study a Co nt mater ps i He a ons s andjeo er new cr revised investigator Brochures ln New vw Ly or of anform consent e Mew wawer or altera of the Sp rule authorization e Recrumment Thees e Study forms qupestunguyaires s d ys abstraction tools communications of other materials Study Protocol a Offer answers provided on the orile Please use the link below P make ma de dific 4 from the t above by revising the oppe Wiel Go EN A nk will Fake vi u to af the applic o n foem the onhne form that was Mied eut and nte dr p ee ph eque 5 approwal the study Once changes a de a oy the een bo ie al dh pr his r ei ators NUT To make y ied trii rini Ges sse wait for a dn chte nute and then chek on the refresh on your Foobar ink should appear below the link does not appear please wat a bit and reir av e Ke ka the a ia d on eg Edit Study button and you will be presented with the ut reveew quesbtonname ERO that was eeaeed for this study You wit be ani sto make y our modificato neto the iR 2 1 ba de ate ed a in all Ou Md an Aan s ass and then click X ssh to ou che n the w Dille t from the diei P SS Chan
52. jects are currently enrolled in the study If this study R 4 4 ting FACE SOUIces DO NOT USE COMMAS Provide any clarification or details on enrciment numbers apntanali si of Trasted ses e ox Figure 33 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 revising a copy of the currently approved IRQ see Figure 33 e Consent materials e DSMB reports and or new or revised Investigator Brochure s e Investigator s e New waiver or alteration of informed consent e New waiver or alteration of the privacy rule authorization e New or revised Risk Assessment and Mitigation Process RAMP e 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 28 f x r P _ G Je Chr e bo ur g Dee TProgect com sebridae Entry Op BO EOSDE GA 34 324 73 bode warmth m m Uo D Hep select WoW rotes elRB Kaiser Permanente Institutional Review Board Georgia Hawaii Northwest Ed
53. llow 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 will change See GLOSSARY Understanding X Activities for more detail i gt Exaremation of yew Tools teo d tuemnaten of zeng canes n 2 3 year olds eIRG Information IR8 Inquiries IRE Studies canes in 2 3 year olds Windows Internet Explorer ntn lertbdev CY w m og Dev Rooms spia Pages Layout rial ptn ecom webnedoe entity En covet Kaiser Permanente Institutional Review Board f Georgia Hawaii Northwest 55 of dental cares in 2 3 year Figure 24 olds IRQ Kfumber rrooon00820 Study Title ination of dental canes m 2 3 year olds Principal Investigator a eirbPil KPNW Mentor Sponsor Investigator Study No PrimaryContacts Person Organization s ewb55 Other Approval Letter Chok to View Reviewer Notes Change Log This ares shows instructions and questions and important notifications regarding thes Study Activity 7 Too long Project Snapshot Generated 7 View Project Snapshot Sen
54. n Request This study is approved by the IER 1 0 Provide short mame for your submission that bnefly disons the modihtaton s being requested The nama of your submession should be for example Change PI Barse cheg vert process or Change and newer consent Tomm Da not exceed 50 characters with spaces Revised phone script Check pph 2 0 Check all that apply Basse noter I Cedngreguest Another IRB Ge institution rely on the reviaw of KP IRR vou check Ceding request KP rely on the review of another IRB Do NOT check this with any other option This type of Ceding mocddhicabon request must be submitted mdependent af any ether request ee eke KP FRG a Consent materials D the preview of DSM reports new or resised Investigator Brochure 5 IRB ier D NOT check r investigators this wibh New or revised warmer or albaration af informed consent a 3 LF New pr revised warmer or alteration af the privacy rule authorization mogification must p Other answers provided on the org nisal Review Questionnaires stulti Recruitment materials irdezuendent of any other p Risk Assessment and Mitigation Process RAMP 1 Study forms questionnaires surveys abstraction tools communications or other materials Study pretocal D Demie the proposed medications and the purpose of the modifications D scnpte E zl 4 0 How mary sub
55. n rnnt Peer TE ri mr Pen amar riypa Aene rt eem vehngkge rity aji 32H00 2CO SSA ABATE DCA w ze LX zagr x fef we Ten nen Q Cent see El ti gt Page s H A ah P he nn iB id i BE 51 AR RAE ll i A A E R ra LI Kaiser Permanente Institutional Review Board j Georgia Hawaii Northwest KC A p AE lt Errors Print Mimp Siudy 5ummary Canbnug gt gt Edit IRQ 2 Study Summary LO Study s expected start data 1177 08 2 0 Study s expected end date The duration between your start date and end data sheuld encompass all study activities such as enrollment long term follow up and data analysis 17 angahlicable indicate unkown 3 0 Comments ataut study duration rapthanali 2 Ed uu Let s ax Save changes before exiting igi s esses E 4 0 Provide a chear statement of the hypotheses to be tested or the que List the measurable and speit scenic Ob pacts of thus research We will b testing intake and it affect on dental canes E 5 0 Briefly summarize acting knowledge pertinent te this study State what this study will contribute t existing knowledge bibbagraphy must be uploaded with this application ether via th
56. napshot Geer erbPl 4 21 2011 11 33 AM PDT view Project Snapshot Le Submitted Changes airbPi 4 21 2011 11 33 AM 7 0 Changes Logged T T f maeudss H Figure 32 the first screen of the modification request form provide short name for your submission The name of the submission should be a short description of the modification s being requested For example Change Revise Consent Form or Change and revise consent and recruitment docs The name of the submission should not exceed 50 characters with spaces see Figure 33 The IRB 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 The modification request form should be used to clearly describe any proposed changes you plan to make to your IRQ You will have an opportunity to make changes to the application at the end of the form 27 21815 BEES gt n o E hee ferbdey korg Des leto re Admnia tr son E E Ger Fans pes Hep Comet select a gedit view 2 4 Edit Study Modification MEI Protoss xx Back Save Exi Hide Show Errors Print wimp Tor Modificobon Request Continua x Kaiser Permanente Institutional Review Board m Georgia Hawaii Northwest Modificatio
57. ntinuing Reviews Reportable Events Completed Withdrawn IRB Inquiries Desplays adi items whath require action by the study team Chck on links for more evormation Study Protocols ID Name J Date Moddied State 00000820 Exammnation of dental canes m 2 3 year olds 9 16 2011 10 40 AM Pre Submission 00001180 Study of Arms and Legs 9 7 2011 9 28 AM Pre Submission 00001025 Study of Arms and Legs 9 7 2011 9 03 AM Pre Submission 00001120 EXP KPNW COPY 27 5 22 2011 9 2 2011 2 14 PM Expired ProO0000840 Test 2 for issue 831 8 29 2011 2 51 AM 00000858 RAMP Test 2 with one page for Q 3 and 4 6 22 2011 3 56 PM Expired Pr 00001178 Ohstu collaboration 6 1 2011 10 57 AM pre Submicsio n 00000947 new study 2 12 23 2010 3 23 2011 2 51 AM Expired 00001046 of pro1025 5 23 2011 1 24 Pre Submission Pro00001170 EXP NW COPY 2 5 23 11 5 23 2011 9 58 AM Pre Submission 1 10o0 48 Study Modifications ID Name z Date State 00000840 3 for IRE Study st 9 15 2011 3 01 AM Contngenaes Pending Pro00000843 Modfication 3 for IRB Study f B 15 2011 9 40 AM Changes Required by IRB MR Pro00000977 Modification 1 for IRR Study sProo00000977 5 23 2011 8 41 AM Pre Submecei n MR1 Pro00001 101 Modfication 1 for IRR Study amp Pro00001101 5 22 2011 10 20 PM Pre Submession MR1 00000998 Modfication 1 for IRB Study 00000998 5 22 2011 9 08 PM Pre Submession J v Tr
58. nts 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 in the review process F Fokher for eirbPl Windows Internet Explorer 2181 xj t 2 pr erieep oc org tareq Rooms spia pages aN n Contan ecom webridoe EnttyiOiD BIS32AGE924C 23408584157 7594 39A 351 X 229 D Kaiser Permanente Institutional Review Board Al e Georgia Hawaii Northwest amp eIRD KPNW IRB Inquiries IRD Studies Help FAQ Folder for eirbPT Help Study Staff Folder for eirbPI Welcome to your Personal Folder the central resource for managing your Study appkcations New WS inquiry e My Inbox contams tems that require your atteron 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 cubmession type Inactive Items are found m the Completed Withdrawn tab Inbox dy Protocols Modifications Continumg Reviews Reportable Events Completed Withdrawn IRB Inquines ems which require action by the study team Click on for more information Study Protocols ID Name J Date Modified State Pro00000010 New training study 12 29 2010
59. nts 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 Any proposed modifications to IRB approved documents Should be uploaded in tracked changes 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 ie 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 e You can contact the IRB see Send Email to IRB activity on the workspace to ask if the 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 31 e You may withdraw the original modification request submission This would then allow the PI to create and submit an entirely new modification request However once a modification is withdrawn it cannot be reopened and a new modification will need to pe initiated e Ifthe IRB 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 IRB staff who can provide guidance on how to accommod
60. oard Georgia Hawaii Northwest New IRB Inquiry 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 e Quality Assurance or Quality Improvement projects where there is no plan to publish or share the results outside of Kaiser Permanente e Publishable case reports or small series reports When KP 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 will advise you Please provide a short title that summarizes your inquiry eg recruitment poster in OB GYN clinics neurology case report HealthConnect and Emergency Care QI etc To which KP region are you submitting this inquiry Note that if you wish to submit an inquiry to more than one region you will need to create a separate inquiry for each Kaiser Permanente Georgia KPGA IRB Kaiser Permanente Hawaii KPHI IRB Kaiser Permanente Northwest KPNW IRB Clear Inquiry Description Attached Documents Add
61. onum am ADD seesiimk anda he mn Em mini ienas He Eu POOR R bes REENEN Heic tes 100 e Figure 14 Saving the information you have entered There are two ways to save information you have entered into the el RB forms You may use the Continue button to automatically save all data entered into a form thus far Or you may use the Save option The latter will save the information but will not automatically lead you to the next 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 Hide Show Errors link located in both the upper and the lower center of the blue menu bar of the form allows you to check for any required questions that have been omitted The links 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 more time See Figure 15 Please note that the PI will not be able to submit the study if there are any required questions that remain unanswered 14 FK Flit Propet Winders Explorer G hbi jera de ze a g ie Bio
62. other 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 PI Changes Required by IRB The IRB has reviewed the submission and has requested changes clarifications from the PI Changes Required by IRB Staff The IRB staff has requested changes clarifications from the PI 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 PI Complete The study is complete closed no longer active Contingencies Pending The IRB has reviewed the submission and has approved the submission with contingencies A response is now required from the PI in order for the submission to be formally approved Correspondence Review The submission has been reviewed The IRB 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
63. pe of Submission for New study dated 9 16 7011 This submissa ic for tha KPA IRB 1 0 Te this submission Select ONLY one o ACpeguiar new study submission Acanwersen of an existing already IRB approved pager study into the Aremuest that the indicated above rely an anather s RE to conduct review Ig a ceding request Clear Bari Save Exit Hid ihaw Errerz Print Var Tyee of Submission _fontinon gt gt E Done T ee j masus x Figure 29 24 CREATING CONTINUING REVIEWS Before you can create a continuing review you must have an active approved study in the elRB 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 In the left section of the page click on the New Continuing Review button see Figure 30 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 ZC Rirrpalar sulanirssigzn HEL Ps CHR Winders rier o all xj 9 E chr Ggs Pens manani enppe Entry ODD Dod 16A 596 3088
64. pies 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 The drafted submission should display in the Pl s inbox in a state of pre submission The PI 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 located on the left section of the submission workspace page under My Activities If it is a 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 22 submission will move to a state of IRB Staff Review and will have entered the review process Any changes requi
65. pload revised documents or add new documents Once you have navigated within the IRQ and made all the proposed changes click Save and 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 29 E bs chr ze ka pe n Der Bora Dipl Pages ayeutinital arom sebriige entity Entry ODD DCP 43 0580 BLOF 3080 35836526 347 Q Comet Py Select fp El d Pee Ads Regular Hi i Kaiser Permanente Institutional Review Board m Georgia Hawaii Northwest Regular 15 CHE I Wir pn Studies HI SCHER Modified Study Regular submission HI is CHR Investigator 51 00000996 Description Revieed Study Coordinator hone e amp IRB Informathon Macaon 1 for ER Study sPregngogoos fon fe Studies Principa Investigator 472112012 Modification n Date 00996 a Change Log Reviewer Notes Author Ki Activity Date Activity dll Lio PM qf Change Log Page Informed Consent Children a On Page Enfarmed Consent Children exb l 4 21 2011 11 59 AM PDT 3 On Page Children este 4 21 2011 11 56 AM POT Change Leg Page Study Population Social Behavioral BiaMedica amp Dara Calle m Dn P
66. protocol number and acronym applicable Examination of dental canes in 2 3 year alds Summary xj Study Funding Section Shady Funding 2 0 Abstract Short descnpoon of the study in lay language ques Shady Funding Section Completed Examenatian of dental caries m 2 3 year olds Categorles of Research Activities section Categones of Research Actitis Study Locations Multisite Section Bo E b 4 0 Sai Inyestigata pne wha r the tbe l ator for the ben Nate that tes s may not the iech aw rar raes s of the res ear ch nang Prnopal Im sth gator must h av ean St x count and be ie le ei a Iram kt that wil appea below This xal will has and edit ge aubm the sys nd if the study it approved to this di study w ge aer f Clase Principal Investigator IRB Certification Date a1 2008 4 0 Curriculum Vitae Please upload the Principal Inzestigater s curnoulum virae Gr biasketch For KP Georgia upload the PT e research qualihicatiamg applicable Docume de Bagues anHe deco 01 Dalate 5 0 ger gt n invastigat hade investigators If applicable if the prime awardee of re ch si ech di del om rud Pr m Stigator yon nica 0 Th 4 one sw Se i ie db de Es c imestsgarar kat must acude any Ine N ie es gt na ial toe sieves b
67. r eIRE Informatlon 188 Studies Approved P ones study mew Modification Kepornable Event D ew Continuing Figure 44 Kaiser Permanente Institutional Review Board Georgia Hawaii Northwest Wem RE Studies Regular r amp CHE Wbcrez Fplacer IRQ Number rropoo00996 Sclmby Tithe Principal Investigator abe KPNY Hentar ment r was not listed required for this study sts Investigator Study No PrimaryContacts Person Rebecca Boporad Regular submission H1 15 CHR Stody Salus Reviewing TRB Organzaman Center tor Health Research NV Approval Letter Click to view Expiration MNotiticalion Date F El rusqa w nh Al a ewBPI MyHome Laget Annraved arzl 2012 Kader Permanente Hay an KFHT IRR Change Log Study Medhcationg Conunuing Reviews Reportante Events Documents Reviewer Notes Auth r 3 E Copy ID is Pra000011F Title Mew copied study mame 9 23 2011 9 Reportable Event Opened ewbPl 3 view SSES LN Report Opened r i View Aeee workspace Copied Study LaForge Lisa 3 New Copy ID ma ProDo001143 Title EXP HI COPY 5 23 11 1 an Madifhcanan Gianag erbPl e View Workspace Ic Prajpect Snapshot Generabed eIRBAdHI H
68. r active studies the tabs below filter by cubmessian type Inactive Items are found m the Completed Withdrawn tab Study Protocols Modifications Continumg Reviews Reportable Events Completed Withdrawn IRB Inquit Displays all items which require action by the study team Click on inks for more information Study Protocols ID Name Date Modified State Pro00000010 New training study 12 29 2010 1 23 2011 9 53 Pre Submission Pro00000008 Study to Train Mentors 10 1 2009 9 35 AM Pre Submission Study Modifications ID Ham 9 Date Modifred State MR2_Pro00000005 Modhcabon 2 for IRB Study Pro00000005 6 8 2011 10 20 AM Pre Subrussson Continuing Reviews ID Name Date Modihed State CROO000003 Progress report 2012 6 8 2011 10 34 AM Pre Submission Reportable Events ID Name Date State Ad 00000001 Protocol Deviabon 10 9 2009 10 55 AM Pre Submission IRD Inquiries ID Name Date Modified State There are no items to desplay Dore Z wen 4 Figure 6 In the left hand section of the My Home area you will find My roles see above Figure 6 which indicates your role s within the elRB system Most users will have one of the following e Study staff If you draft prepare submissions for an investigator but do not act as an Investigator this will be your role e Study staff and Principal Investigator If you draft prepare submissions and act as an investigator
69. red by the IRB to a study submission must also be submitted by the PI 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 27 F Fokker tor eirbPT Wissdows Internet Explorer g JP hhtp erb rcv cdr o oag Dew Mocs aa yPages Layouttesbal NX ontmmer ecom wetrkige entity S BOD 5 81532 8 92472340888415 777 344 35 4 5D 4 5D Xx Edt Vem fgavontes Took F Comert Select r ie fo crt Zp d k ng gt G tech gt Kaiser Permanente Institutional Review Board Let neri mum Georgia Hawaii Northwest T My Mo eIRD Information IRB Inquiries IRB Studies f older for eirbP1 Help Study Staff Folder for eirbPI Welcome to your Personal Folder the central resource for managing your Study applications 4 My Inbox contains iteme that requ OS Mew Study d My Roles allows y f you have muluple roles m the system ire your attention ou to Switch between your user roles f yo For active studies the tabs below hiter by submissson type inactive Items are found in the Completed Withdrawn tab Study Protocols Modfications Co
70. s see vg Be m for Lise Dozen 48 etruninformas 71 Gad inbes calendar ourcrocanes x G s EJ Pe Study Identification Information This is the first step in your Human Subject Research Application You will be guided te the appropriate forms needed to complete your submission 1 0 Study Title protocal number and acranym i aggplicable Test study for the undated user manua 2 0 Abstract Short d esonpib on of the study im lay language Co Make Ge at e oe ub an eT 1 Uf cht dee of rese Oh io PNW vastigator y u indi cate ad ma prime s awardee should be i be low the ou stigat to e A KPNW per or tho aan ebe uh ain zady n Sp iem sount ebe Z S ri d da ms ist Fi dei ar below side E yb in the bext edi vi ha ead iis rae r v us O Ce eric ie SEN Gr Sr d the stu red t thes shud s eIRB eben 3 0 P Wei ME vibes the Karser Permanente Northwest site the Prinegsal Investigator lor M iii may SEI vay m be ha pi Ee ep rch fund ai ihe Princ ipa all im es for ye an elRB ac count and be sele Tus ed from Fe bert that will appear b 1 S nd v eges Fo teg submi F if the study a workspace j Last First Organization Eckhard
71. sson Pro00000820 Examnation of dental canes m 2 3 year olds 9 16 2011 10 40 AM Pre Submissson 0000 1180 Study of Arms and Legs 9 7 2011 9 28 AM Pre Submission 00001025 Study of Arme and 1 606 9 7 2011 9 03 4M Pre Submission Pro00001120 EXP KPNW COPY 7 5 22 2011 9 2 2011 2 14 PM Expwed Pro00000840 Test 2 for issue 021 8 29 2011 2 51 AM Expired 00000858 RAMP Test 2 with one page for 02 and 4 6 22 2011 3 56 PM Expred 00001178 Ohsu collaboration 6 1 2011 10 57 AM Pre Subrmssson ProQ0000947 new Study 2 12 23 2010 25 2011 2 51 AM Expered 00001046 copy of pro1025 5 23 2011 1 24 PM Pre Submission Yd 1100649 D Dl Study Modifications ID Name Date Modified State MR1 00000996 Modification 1 for IRB Study 00000996 9 16 2011 3 17 PM Pre Submission 01000000840 Mod ication 3 for IRB Study sProD0000B40 9 15 2011 3 01 AM Contbngenoaes Pending Pro000008543 Modification 3 for Study sProDD0005233 8 15 2011 9 40 AM Changes Redquered by IRB ProD0000977 Modification 1 for IRB Study Pro00000977 5 23 2011 8 41 AM Pre Subeussion MSL 00001101 Modification 1 for IRS Study 00001101 5 22 2011 10 20 PM Pre Submission T TE FT f ida KG T Figure 39 34 Edit View Windows Internet Explorer File Edit View Favorites Tools Help d EditNiew elRB lt lt Back Q Convert P Select Kaiser Permanente Institutional Review B
72. st name in the field and 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 name 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 Emea Lak ig Dora S internet CN mos wgumeguo ss Heroic Crete pee ema us wander Media panas Mies Map Gem Figure 9 The personnel listed as PI 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 10 Kater Permanente Georgia new study has been submitted for Expedited Review Message HTML De yew Format ook Adobe ppt di Reply to 44 ap Forma d 4 E v gt Wi x Sen
73. stitutional Review Board IRB administration pracess Registratien am Register by clicking here Figure 1 Next fill out and submit the registration form see Figure 2 Je geet NITE e m e hips eet org X esed ELT ryPagevLeyout nnerz thenige t Enti t St 1510F AE 1564 8 5 x E p X Soda POF we m uar Favorites Fequstratson n 8 5 Pee Tooke Q d Name First Name Last Name Middle Name Degrees Creditials Organization Information Degrees Credentials 44 add 0 oon There are no items to display Organization Select Note 8 b to fi ur org In th pros seleri Sell Regist abe pa on an y m or organization in the Other Oryenseativn area belor E mail Addresses Primary E mail Address Secondary E mail Address Done Internet Protected Mode Off q v 10 gt 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 in the upper right section of the page and enter your username and temporary password see Figure 3 Sue ae w Ep ef Sen 1 d i a E F Ef TES B ix D D Bae ec Teh
74. submitted You can also view the regional IRB websites as follows KPGA Research Department http kpnet kp org 81 ga sites research KPHI Research Compliance insidekp kp org national compliance regional hawaill research index html KPNW Research Subjects Protection Office RSPO http www kpchr org rspopublic public Browser Requirements Microsoft Windows all versions _ or later Microsoft Internet Explorer version 7 0 _ Firefox 3 0 or later _ Google Chrome Macintosh OS X 10 4x or later _ Safari 4 0 or later _ Firefox 3 0 or later f you install a theme in Google Chrome vertical scrollbars might disappear in pop up windows Limited testing has been done on the iPad 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 with cipher strength of 128 bit installed 21 CFR Part 11 Compliance The KP elRB is compliant with 21 CFR Part 11 including electronic signatures For more information see the 21 CFR Part 11 eI RB compliance statement pdf statement 46 EXAMPLES OF COMMON ERROR MESSAGES e 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 kp
75. t Thy 4 21 2011 12 24 PM Subject Kaiser Permanente Georgia KPGA IRB mew study has been submitted for Expediled Review Please do not reply to this message Use the link below to navigate to the project workspace and use the Send Emad activity in the eIRB system A new study requires your review Figure 10 Human subjects training For personnel who have completed the KPNW Human Subjects and Bioethics training the date of completion 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 10 In right away contact the elRB Help Desk to request an unscheduled immediate system update see Figure 11 Bis Pees Tech f seen i n zf Q 2228027 k fe Bent ictum Tomi caras 2 rm ST x ust Rage e Sate nt Porritt Human Subjects Training P the raigs onp rou for the viet ATL v orm m baken Irem He oureg wr promi UPLOAD certfs mon na with dates more than Document s Tharg me ro er Prime aru Kee Di MERC gg Or tes propcer kee Hirak har an eIRB account ard Ee seed from thee bat that wil appear Deko outside prae aw orden mae Eg in tha text E
76. t Cara Portland State University ef e 5 Universit 4 0 Eden Karen Oregon Health amp Sciences Unneraity Ebats cumulum vtae of biosketch eIRBPI 1 Canter for Haalth Research NW PIX A 1 a care r i gg esbigators If applicable if the prime aw ofr h funding differs from khe KPNW i Elder Charlie Kaeser Permanente Northwest fine Sie ves RE h ha Kieler derre any bet Lech nal m estigator Note a pata ri from r2 LLL Regen and 6 fed From the lis at tha t will ar below outsi ted in Kaiser Parmanente dall s M ae dei 5 bo sth Imes son Ip Ef Wet ar ei if the se che ig to this M 5 1 Y Elizabeth Oregon Health Saencesgfiversiti je enter far Health Arch Nu 51 Organization Human Subjects Trainin g Date LeBlanr Enn T Health Bezearch Mii pei Eric Oregon Health amp Sciences un sity tt box below t the name degrees organzabonal information email amd phone number for non APNE rant OSES VITIO UU at TE ind acce de x ied Loca ritranet mm Host GJ 395 Meronaf calendar Ree raa em zone De tacet Manual s L My Conger Computer 3 die UT Figure 8 Adding I nvestigators 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 la
77. t Correspondence Letter for Study Approved with Contingencies 7 0 Reviewer Notes Logged View Correspondence Letter J Project Snapshot Generated View Project Snapshot Scheduled for IRB Meeting KP Northwest IRB meeting on 4 20 2011 shot Generated Study Workspace Details Refer to Figure 24 e Study Title displays the title entered into the first field on the IRQ 20 A mentor was not ksted required for this study Study Status Notification Date Reviewing IRB ii E i gt Page 3 Tools Ge My M Logoff Pre Submission 15 2015 Permanente Northwest Cl Actraty Date 8 4 2011 3 01 PM PDT 8 4 2011 3 00 PM PDT 7 15 2011 3 21 PM POT 7 15 2011 3 21 PM POT 2 23 2011 5 10 PM PST 2 23 2011 5 10 PM PST 2 23 2011 2 44 PM PST 2 23 2011 2 44 PM PST 11 6 2008 5 26 PM PST Trusted sites Study ID 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 Expiration date If applicable the study s Mentor KP sponsor investigator if applicable this is for IRB administrative interest related to FDA regulated studies only The primary contacts listed in the IRQ Determination letter if available Tabs on the study workspace contain O History Events associated with the IRB review of the study Note that new studies and other types of submissions Study Modif
78. t those who fail to adhere to this policy per KP Principles of Responsibility http kpnet kp org national compliance principles introduction disciplinary html TE Leer Wee Internet Deag ER dp n t TE T e Se A Gog B X SodaPOE g E P Wr eege QS Login fp EI mi Page Safety Toph h gt I Kaiser Permanente Institutional Review Board Georgia Hawaii Northwest Internet Protected Mode Of g SIR Figure 4 My Home 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 the 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 IROs 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 or study team such as revising the submission as instructed by an 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 Eve
79. ta Ger t the safety mghts ar welfare of one or mare subjects WI Spe five business days of beginneng when mene i me t abrain 188 appe implemen study m also req Incarcerabon of research parbopant Arry research partiomant who rs mr volur mi andy confined of detamed m a penal ole b i two business days alte alternative crirninal aes ice facility and or sunk vg trial or se v aal i tudy Del ame Inspechon by extemal regulatory agency Contact by federal sLate or non UE regulatory that an mnspecben or irverbgalteon will Nibbun eun business days after dis Foy g Follow us to an reportable event Use m rare Crrrumrrst aneoes when the correctree and preventative CAP A was not at As jii as passable after the miral tima of initial reporting of the event enee Other example amy other reparte speofically stipulated and required by the KP for the Trusted stes 38 Navigate through the form 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 PI 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 tim
80. teb Zeen gt Essen wd 1 QE Regular submission HL i CHR wem ep e pe Tea Kaiser Permanente Institutional Review Board Georgia Hawaii Northwest a eirbPi My Home Logoff p Informe eee RE Studies RE Studies Regular submission is CHR investigator IRQ Number rropo000996 Study Title Regular submission is CHE investigator Study Status Approved Principal Investigator A Expiration Notification Date 3 21 2012 Futur was net heed regumed for thus study Sponsor Investigator Study No Reviewing IRB Kaiser Permanente Hawan KPH IRB 4 PrimaryContacts Person Orgarerabon Rebecca Bogorzd Center for Health Research Nu Approval Letter Click to view Study Moddscatiarra Reviews Reportable Events Activity Authar DI Activity Date OW Contmumg Report Opened erbPl 5 15 2011 3 04 PM PDT 7 view Continuing Review workspace Copied Study LaForge Lisa 5 23 2011 8 33 AM PDT New ID rs ProOUD01143 Tile EXP HT COPY 5 23 11 ei Madiheatian Opened eirbPl a 4 21 2011 11 48 AM POT 7 vie A Mod cation Warkepaca Is amp IRHAdHI 4 21 2011 11 33 AM PDT ei View Project Snap Hrot Ki Prajert Snapshot Generated eIREAdHI H 4 21 2011 11 43 AM PDIT View Project Snapshot Sent Correspondence Letter Far Study eIJRBAdHL H 4 71 7011 11 43 AM POT cU Progect S
81. the taba below filter by submission type Inactive tems are found in tha Completed Withdrawn tab Study Protocols Modhcatons Continuing Reviews Reportable Events Completed Withircawn Displays all items which require action by the study beam Chick on for mare infarmmatian Study Protocols Mani Dh Dato mid Str Now study mame 9 23 2011 0 23 2011 2 53 Pre Eulmmsson 1 5 23 2011 2 44 Pre Submin PragO0011B8Bn Study of Amos and Legs 5 23 2011 2 38 Pre 5ubmersaon 0001152 New study dated 9 16 2011 97 20 2011 3 17 PM Pre Submission 20 Examination of dental canes 2 3 year olds S I6 2011 16 40 Pra Submission 00001025 Study of and Legs amp 7 2011 9703 AM Pre Submission EXP KP COPY 5 2202U011 DA A011 7 14 Fxpered Pragoooob4o Test 2 far issue 831 B 29 2011 2 51 ProOOOODESR RAMP Test 2 wilh one page for C 3 and 4 B 22 2011 3 55 PH Expand 00001178 Chey collaboration B LZ011 10 57 AM Pre Subse H bide Sa D Pl in Name i Gate Modified State Pra ODDOB 51 Madificanian A for Study 59 23 2011 2 47 Pra Submuggian MEI Pra O000585s Madificaban 1 for IRB Study aPreob uda T5 2011 3 17 PM Pre Subimassi n MAS Praggoppsdqao Macicatnn 3 for IER Study ibroDDOXOOHAC 15 2017 3 01 Pining ProgoDOODRA3 Maddicamon 3 for IER Study 8 15 2
82. tigator IRQ Mumbear rroonongaos Approved Study Title Regular subtree HE 19 CHR Siudy Salus Approved Ch ven Steg Principal a airb l Explration Notification Date 34 21 2012 KHN Mentor merde was bied regquired for this study Sponsor Investigator Study Reviewing IRB Kaiser Permanente Hawan IRE E wen e Person org New Reportatie Event Rebecca Bagorad Center for Health Reseanch NY fies Continuing rrira Approval Letter Click to ve 4 F Study Modifications Continumg Reviews Reportable Events Documents Reviewer Nores Change Log Activity Date Reportable Event Opened 9 16 2011 4 11 2 view Reportable Event workspace qp Continuing Report Opened eirbPl a 9 16 2011 2 04 PM PDT 7 view Coming Review workspace Copied Study LaForge Lisa 5 23 2011 8 43 AM PDT 7 New Copy ED 15 Pradgon01143 Title EXP HI COPY 5 23 11 1 a Moddcabon Opened erbPl 4 21 2011 11 48 4M PDT 7 view Madification Workspace Project Snugehot Generated el8B ACHI H 4 21 2011 11 43 AM PDT view Project 5napshat Prajext Snapshot Generated IRBAdHI H 4 21 2011 11 43 AM POT 3 view Project Snapshot Sent Correspondence Latter for Study elRESdHI H 4 71 3011 11 43 AM POT iJ Project Snapshot Generated rbPl 3 21 2011 11 33 AM PDT 7 view Project Snapchat 4 ee BT KREE MS
83. usted eier 4 Figure 27 The Initial Review Questionnaire IRQ will open Enter information on the first page and click Continue On the next screen for the regional IRB select the IRB where the study is currently approved see Figure 28 If the study is approved at more than one of the three regions listed you will need to create a separate application for each region see CREATING INTERREGIONAL SUBMISSIONS On the following page when prompted to select which type of submission choose the option A conversion of an existing already IRB approved paper study into the elRB see Figure 29 This will branch you through an abbreviated version of the IRQ Enter the study as it is currently approved at the time of conversion Use the Continue button to navigate through the rest of the questionnaire 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 IRB will expedite the Approval of the study in the system in 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 23 Windows Interect Explorer En yem gentes Ioh teo convert Sen Kaiser Permanente Institutional Review
84. w Study Di E Coninuing Reviews Reportable Events Documents Reviewer Notes Change Log ID Name Stabe l Last State Change Gm MEZ _ 28 Modification 2 for RB Study zProe00000828 Pre Submission 51712011 11 13 AM 1 Pro nDODB2AR 1 for RE Study ProDo00828 Approved 3 7 2011 11 08 AM For bechrucal questions contact 503 528 3945 of Trusted stes 100 Figure 25 Important Note The IRB manages informed consents in the elRB Once a consent form is approved the IRB staff will upload a clean Word 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 in the Approved Consent Forms area 21 Pic The Graal Moor Inberncl Explorer Power Took n Qm 0 1 12 5 se voeem 07 2 4 JE a Address L I http ami scenes eor be com aar IHE Rooms Eiere sier Lay ou inis cont nr mcer viride Enter CHE FEXCIKCSOSDO Tran aba tom erede entity SEDO T LAUR Ee Links History Study Modifications ContwingRenews Feportablaivents Reviewer Habeas Change Log This summary will list the current set of IRQ Docugmgente far this study If there i na dacument listed in the Current Vercion calunin then the PI has not uploaded a document ur th
85. x Delos P s Last Fre Depe Dro dn e p ex There no tem to bb Prime Kwarder with No eIRB Account Ini fhe text box below kt rums depte and Grott miyon f r ka pakpi mon CHE prime aw arge who doas S n th S nob haer an rough gray area on the E right of pr rna tege Lt Ve wl soper bar Tike indi dusi wit have read and Uus MUMAN iN the p age Nama Fest COeganiration Human Subjects Tras Dara degen L Kuper Pemanen D i Regen EI GOthrr bo tas a fem must i D ID 47 a m thag ae piste deg r ase je LEI F start ui P ibu Caer erg E unra EI aris i usar pg w 1 ty Campur e Ce iB QU JO oe Figure 11 Updating study staff The Edit study staff activity located under My Activities in the study workspace see Figure 13 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 is receiving notifications from the IRB regarding the study e g continuing review reminders This Edit study staff activity is available in most states once a study has been submitted includin
86. y 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 Withdraw ALLOWS the item to be withdrawn and 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 48 and 49 To withdraw a study click withdraw in the study workspace F http eirbdev chr or kp org Dev ResourceAdministration Activity form ActivityType com webridge Windows Withdraw Instructions Use this activity to withdraw the item from further review This form will then pop up so that you can indicate a Withdrawn By Sponsor Funding Revoked general reason

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