OSIRIS Guidance. Important: All users must complete the CITI training using the Pitt CITI Access Portal available at

Transcription

1 OSIRIS Guidance 1 OSIRIS is the IRB web-based applicatin that was created t imprve human subject prtectins and enable the IRB t better serve the research cmmunity. This applicatin has a questin and answer frmat using smart frms. Based n yur respnse, the system may branch t additinal questins related t main questin. OSIRIS presents the investigatr the unique pprtunity t submit ne applicatin fr the entire review prcess. All required Pre-IRB reviews will be initiated based n yur respnse t specific questins. Once the Pre-IRB reviews are apprved, OSIRIS will frward yur applicatin fr IRB review. Based n yur respnses t the questins, ther departments r cmmittees will be granted access t yur applicatin and autmated ntificatins are generated (e.g., UPMC Fiscal, Investigatinal Drug Service). Therefre it is imprtant t take the time t ensure yu have answered the questins crrectly. The ntificatins are nly sent during the initial submissin prcess r if the prject was withdrawn and resubmitted. Only the names f thse individuals wh have cmpleted the required CITI training curses will be selectable in OSIRIS. This applies t all users f OSIRIS (e.g., investigatrs, crdinatrs, scientific apprvers, cmmittee members, nn-pitt investigatrs). Imprtant: All users must cmplete the CITI training using the Pitt CITI Access Prtal available at This dcument is designed t prvide yu with the basic tls t build and submit yur prjects fr review. Additinal infrmatin is available frm the IRB website ( us at irb@pitt.edu if yu need OSIRIS assistance at any time and be sure t include yur IRB number in the message. Cntact Patty Orndff, IRB Educatin Crdinatr, t schedule training r if yu need assistance building yur applicatin. The entire IRB staff is available t assist yu as needed and please d nt hesitate t cntact us. All cntact infrmatin is available frm the IRB website r just yur questins t askirb@pitt.edu.

2 2 Table f Cntents Required Research Training... 3 Lgin... 3 Create a New Study... 4 Basic Tips... 5 Selecting Study Team Members... 6 Selecting the Department fr Scientific Review... 6 Uplad a dcument... 7 Managing yur dcuments... 7 Scan a dcument... 7 Uplad cnsent frm... 8 Return t Yur Study Submit yur study Respnd t cmments frm review entities ther than the IRB Respnd t cmments frm IRB reviewer Current State Ntificatins Create a Mdificatin Create a Renewal Reprt Pint t Cnsider When Preparing yur Renewal Reprt Create a Reprtable Event Create an Exceptin Request Create a Final Reprt Create an Exempt Applicatin Seek a N human subjects r Nt research Determinatin... 26

3 Required Research Training 3 All students, faculty and staff must cmplete specific training that may vary depending n yur discipline and research activities. University f Pittsburgh training draws n resurces prvided by the Cllabrative Institutinal Training Institute (CITI), as well as by University f Pittsburgh Internet-based Studies in Educatin & Research (ISER). General training requirements: Always access CITI using the Pitt CITI Access Prtal: User will nt be able t access OSIRIS until the required training has been cmpleted. It will take apprximately hurs after cmpletin f the curses befre access t OSIRIS is pssible. This applies t University f Pittsburgh faculty, staff, r students and external investigatrs It is highly recmmended that all new users review the instructin sheet psted n the Pitt CITI Access Prtal befre initiating the prcess. There is a prcedure fr linking existing CITI accunts but it nly available the first time ne enters the Pitt CITI Access Prtal. Lgin G t Click n lcated in tp right crner f the page Enter Username (entire address) and Passwrd as registered with HSCnnect If yu have Frgtten yur passwrd Click n link available frm the lgin page and HSCnnect will yur username and passwrd directly t yur address G back t and click again

4 Create a New Study 4 The fllwing infrmatin will guide yu thrugh the prcess f submitting a new study. If yu need assistance at anytime, use the Help link available n each page r us at irb@pitt.edu. Belw is an verview f the submissin prcess: 1. Pathway fr creating a study by answering a series f branching questins 2. Instructins fr uplading dcuments 3. Preparatin f paper items fr scanning 4. Special preparatin f the cnsent frms 5. Respnding t reviewer cmments Frm yur hmepage which displays Flder fr (yur name) Click n New Study which is displayed n the left hand side f page There are three main sectins in the New Study applicatin Triage Type in a shrt title fr display purpses as yu will enter the lng title later Select the prject review type and anticipated risk Cver Sheet Demgraphic infrmatin, selectin f Pre-IRB review, and study site details Prtcl Includes aims/bjectives, study ppulatin, detailed infrmatin n all research activities, supprt and ptential cnflict f interest issues HELP Text Gray area n the right side f the page may display a buttn (Plicy, Resurce, Guidance) Click n the buttn t btain additinal infrmatin t assist yu in answering the questin If yu change a respnse t a questin that branches, remember t clear all f yur respnses t the branched questins befre cntinuing (may include remving infrmatin typed int text bxes). OSIRIS hlds all the respnses s it is very imprtant t clear thse which are n lnger valid.

5 Basic Tips 5 Cntinue buttn Saves yur respnse as yu prceed thrugh the applicatin Lcated at the tp and bttm sectin f every page Red asterisk * Indicates a required respnse If yu fail t cmplete a questin that was required, the fllwing message will appear: Culd nt update the study due t ne r mre errrs: there were prblems submitting this frm Optins available at the tp f each page Save Click the Save buttn befre existing the applicatin r leaving yur cmputer area Exit Will take yu back t the summary page Exit withut clicking the Save buttn, a cnfirmatin bx will appear and warn yu t save yur wrk befre exiting Hide/Shw Errrs Identifies utstanding issues that must be addressed Hyperlink t the sectin is displayed at the bttm f the page Click Refresh and the system will remve the cmpleted items Print Allws yu t print the current page displayed Jump T: Click the dwn arrw t access the main questin fr each sectin (des nt display all the questins due t the branching prcess) Allws yu t jump t specific sectins/questins in the applicatin Use the buttn when first filling ut the applicatin

6 Selecting Study Team Members 6 Select Members fr yur research team Principal Investigatr (PI) Whever creates a New Study is listed as the PI If yu are nt the PI, be sure t give yurself a rle in the study (e.g., Cinvestigatr, Study Crdinatr) befre selecting the name f the PI If yu remve yur name frm the applicatin, yu will n lnger have access t the study Only the names f thse individuals wh have cmpleted the required training will be selectable If yu are including nn- Pitt faculty, staff, r student, click n their name and make sure their affiliatin is listed crrectly (Pitt schl r department shuld nt be listed) Selecting the Department fr Scientific Review Scientific Review If Department Review is requested, select the apprpriate entity frm the list Each department has assigned individuals wh are respnsible fr managing the scientific review prcess. Yu cannt designate an individual t cnduct the review. The names are already prgrammed in OSIRIS and ntificatins are sent t these specific individuals. Use the % sign (wild card) in the Filter by field t limit typing the entire name If yu selected the incrrect scientific reviewer ptin and have already submitted the applicatin [d the fllwing]: Withdraw yur study (yu will nt lse any f yur wrk) PI can then g t the Withdrawn study wrkspace and click n the Resubmit buttn fund under My Activities. The study is placed back int the Pre Submissin state and can be edited. G t questin CS8.0 r 8.1 and select the crrect department An ntificatin will then be send t the scientific reviewer Imprtant: Failure t Withdraw and Resubmit the study will result in delays as the new scientific reviewer will nt receive an ntificatin frm OSIRIS - It becmes yur respnsibility Dn t frget t click the OK buttn lcated in the bttm right crner f the textbx. It is smetimes hidden and yu need t mve the brwser bar dwn t display the buttn.

7 Uplad a dcument 7 All attachments will need t be submitted electrnically fr review. If the dcument is available in an electrnic frmat the fllwing instructins will guide yu thrugh the prcess. If nly a paper cpy f the required dcumentatin is available, yu will need t scan the dcument and then fllw the instructins fr uplading a dcument. We will start with an verview fr uplading dcuments and then a sectin n scanning dcuments: Click n the Add buttn and anther windw will pp-up knwn as a brwser windw Name the dcument and click brwse t identify the current surce f dcument Click OK and the dcument will autmatically be placed in the specified sectin Click n the Add buttn as shwn belw A new Brwser windw will pen Title: add the title f the dcument (suggest including a date r versin# in the title) File: click n and select the dcument n yur cmputer Click OK t add the dcument t yur OSIRIS submissin Nte the buttn in the n the right side f page (link t UPMC frms)-this is an example f the HELP guidance. Nte: Always click n the upladed dcument t ensure it pens prperly befre prceeding. If the reviewer is unable t view the dcument, it may result in a needless delay as changes will be requested t uplad the dcument prperly. Managing yur dcuments It is imprtant that all dcuments are upladed int the apprpriate sectins. They may nt be reviewed if they are dumped int the last sectin f the applicatin, Supprting Dcumentatin. D nt Add dcuments when yu are uplading a revisin f an existing OSIRIS dcument. It becmes difficult fr the reviewers and members f yur research team t determine which versin is current. Use the Add buttn fr new dcuments nt currently displayed in OSIRIS - Use the Uplad Revisin fr newer versins f existing dcuments - Scan a dcument Paper cpies f required dcumentatin such as spnsr prtcls, investigatr brchures, and crrespndence must be scanned r cnverted t electrnic cpies. It is preferred that the dcuments be scanned using an Adbe Acrbat PDF frmat but OSIRIS will accept MS Wrd r HTML frmat. Please scan in a reslutin n greater than 300dpi t cmply with the OSIRIS file size limits. Scanning at a greater reslutin will result in unnecessary disk space usage.

8 Uplad cnsent frm 8 It is imprtant that yu always start with a clean dcument and d nt edit an existing frm. There are ften hidden frmatting prblems which will prevent the IRB frm apprving in a timely manner. All cnsent frms in a WORD frmat require the IRB fter s the dcument can be watermarked (insert the dates and IRB #). Template is available n questin 4.9 Yu can use the template r cpy and paste the fter t yur frm It is very imprtant that yu manage yur cnsent versins apprpriately. D nt display multiple versins f the same cnsent frm. If yu are using nly ne cnsent frm fr yur study, then nly ne shuld be displayed. It is recmmended that yu use highlighting t dcument yur changes but it is als pssible t use track changes. fr a brand new cnsent frm t revise an existing cnsent frm Once yu uplad a cnsent frm int OSIRIS, always g t OSIRIS t edit the dcument. D nt use frms saved n yur cmputer as this may result in the wrng versin being changed. This applies t all dcuments upladed int OSIRIS. In rder t pen a dcument in OSIRIS and edit, yu must first save the dcument t yur cmputer. Then pen the saved dcument t edit. If yu wish t edit an apprved cnsent frm already displayed in OSIRIS, yu must dwnlad the Draft Cnsent Frm frm questin 4.9. When a study is apprved, OSIRIS makes a cpy f that dcument which is displayed as a Draft Cnsent Frm Apprved cnsent frms are lcked and nt editable If yu are being creative and using a new cnsent prcess r frmat (e.g., PDF brchure, electrnic prcess), please cntact us at irb@pitt.edu and we will be happy t assist yu. G t Sectin 4, questin 4.9 Add a new cnsent frm A new Brwser windw will pen Title: add the title f the dcument File: click n and select the dcument n yur cmputer Click OK t add the dcument t yur OSIRIS submissin

9 9 Revise an existing cnsent frm Draft Cnsent Frms fr editing: click n the Name and save t yur cmputer Open the cnsent frm saved t yur cmputer, make the edits, and save Click n A new Brwser windw will pen Title: Revise the existing title File: click n and select the revised cnsent frm frm yur cmputer Click OK t add the dcument t yur OSIRIS submissin Nte: Yu cannt pen a dcument frm OSIRIS and edit. Yu must first save the dcument t yur cmputer and then edit the saved item. Preparatin f the cnsent frms Use the cnsent frm template r insert the required fter t yur frm 9 Fnt fr shaded sectin f the fter If the IRB # r dates are displayed, then yu did nt use the required Draft Cnsent Frm fr editing

10 Return t Yur Study 10 OSIRIS allws yu t edit yur study at anytime prir t the PI clicking n the submit buttn. Once the study is submitted fr review, changes can ccur nly if requests are made by the reviewers. The system permits any listed member f the research team t edit the study. This sectin will demnstrate hw t identify the study yu wish t edit, identify which sectins are nt cmpleted (View Smart Frm Prgress) and submit the study fr review. Lgin Opens t yur persnal flder als knwn as My Hme Always g t My Hme if yu get lst in the system Link t My Hme is lcated in tp right-hand crner f the page My Tasks All prjects will stay in Pre Submissin state until the PI clicks n the submit buttn Studies tab displays all studies yu are assciated with in any state Click n the name f the study which will take yu t that prject wrkspace Same prcess fr Renewals, Mdificatins, Reprtable Events, Exceptins Edit Study Use this view t make changes t the IRB applicatin Reviewer Versin Prvides a display f all the questins and respnses withut the Help links View Smart frm Prgress Identifies which sectins are incmplete

11 11 Submit yur study Click n Finish The buttn is replaced with a finish buttn when yu reach the end f the questins Yu can click Finish nce yu reach the end f the smart frms Any member f the research team may click n Finish This des nt submit the prject fr review Click n Submit Applicatin Only the Principal Investigatr has access t the Submit Applicatin buttn Lcated nly in the PI s flder as an ptin n the study under My Activities When the PI clicks Submit Applicatin, the system will autmatically check t make sure all the required questins have been addressed If the system identifies incmplete sectins within the smart frms, a windw will pp up listing all the incmplete areas. The tp f the page is labeled Errrs. Click n the 1 st errr and prceed thru the list f required questins t be addressed. Yu can click either Cntinue t save any changes t the page r click Save befre prceeding t the next page. As yu cmplete each page, click Refresh n the ERROR page t have the system recheck and remve the cmpleted items frm the list. Submit and n errrs reprted Click OK Once the study is submitted fr review, it is nw lcked dwn and n further changes are permitted unless changes are requested by a reviewer.

12 Respnd t cmments frm nn-irb reviewer 12 Yu have submitted yur study fr review and have received an ntificatin that changes are requested. As stated previusly, nce yu submit the study fr review it is lcked dwn and n further changes are permitted. The reviewer must request changes within the applicatin t unlck it fr editing. If they send yu an t make the changes but fail t request changes in OSIRIS, the applicatin will be lcked and yu cannt edit the applicatin. When a reviewer requests changes, OSIRIS unlcks the study and editing is permitted. OSIRIS will track every change made in the applicatin(persn, date, and time will be recrded) The first step is t lgin t OSIRIS and g t My Tasks. This sectin cntains all the requests fr changes r clarificatins frm Pre-IRB reviewers t IRB review. This is yur t-d list which requires yur attentin. Remember t make the requested changes within the IRB applicatin r any upladed dcuments if required. Respnses t the reviewer cmments are nt archived s remember t always edit the IRB applicatin first befre respnding t the actual cmment. There is a difference in the prcess fr cmments frm the IRB versus ther review entities within OSIRIS (e.g., scientific review, radiatin safety). Lgin Click n Search fr the study which requires a respnse t cmments Click n the Name f the study yu wish t review PI and Primary Research Crdinatr are ntified by that cmments need addressed The ntificatins display a hyperlink which will redirect t the study wrkspace Click n Once cmpleted, the PI can click n and revise the applicatin t send it back t the reviewer

13 Respnd t cmments frm IRB reviewer 13 The IRB may request a clarificatin respnse and/r direct edits t the applicatin. If n changes are required within the applicatin: Yu can respnd by ging t the Reviewer s Ntes and use the Click here t respnd link. If changes are required within the applicatin, it is a tw-step prcess t respnd: Step 1: G t the page and edit the applicatin Be sure t click Save befre exiting the page Step 2: Let the reviewer knw yu made the requested change Click t dcument the change was made Imprtant: This dcumentatin des nt stay with the applicatin s make sure yu edit yur applicatin if yu wish t dcument yur respnse There are tw ways t view the IRB reviewer cmments: 1 st way: G t the study wrkspace, click n t view the cmments 2 nd way: G t the study wrkspace, click n and then use the buttn t mve thrugh the cmments All prjects requiring yur respnse will be displayed in Click n the name f the prject that is underlined in yur persnal flder Click Click t view all the cmments t g the page t edit the applicatin and dn t frget t save Click t select yur respnse and click n t save

14 14 Alternate prcess: Click and then click t reach the reviewer ntes. Many find this a much easier prcess but it is still a 2-step respnse: edit the applicatin and then select an ptin as nted abve Belw is an example f a page view where the investigatr upladed the flyer as requested and dcumented the respnse. Any study team member can respnd and make changes, but nly the PI can submit the changes.

15 Current State 15 Yu can easily identify the current state f yur study. Current State - displayed n the tp left crner f each prject summary page Once a study has been Renewed, the field als displays the current status f enrllment Histry tab prvides a running list f all activities perfrmed Can easily identify the persn requesting changes r clarificatins Prvides the name, link fr cntact infrmatin, date/time activity perfrmed Examples f Current Study States: Example f Histry display: Nte: Click n the Authr s name t btain cntact infrmatin

16 Ntificatins 16 OSIRIS sends ntificatins t specific persns/ffices based n yur respnse t questins. Apprvals may be needed frm the fllwing befre IRB review will cmmence: Scientific review Radiactive Drug Research Cmmittee (RDRC) Cnflict f Interest Cmmittee (COI) Institutinal Bisafety Cmmittee (IBC) Office fr Investigatr-Spnsred IND and IDE Supprt (O3IS) Offices ntified but apprval nt required befre IRB apprval can be granted: Investigatinal Drug Service (IDS) UPMC Office f Spnsred Prgrams and Research Supprt (OSPARS) UPMC Mercy Religius Directives Oversight Office Human Stem Cell Research Oversight (hscro) ntificatins are always sent t the Principal Investigatr and Primary Research Crdinatr. All members f the research team will receive an ntificatin if the study is suspended, expired r cmpleted. Examples f ntificatins sent t the PI and Primary Research Crdinatr: Submitted fr mentr review In IRB review Assigned fr cmmittee review Changes requested by reviewer Final reprt accepted Send cmments t study team Imprtant Reminder: The IRB utilizes the infrmatin prvided thrugh HSCnnect in rder t cmmunicate with research teams. It is imprtant t remember t update yur prfile if it changes r at a minimum, annually. All changes must be made n the HSCnnect site ( N changes can be made within the OSIRIS system.

17 Create a Mdificatin 17 If yu wish t make any changes nce yur study is apprved, yu will need t create a New Mdificatin. The mdificatin prcess prduces a cpy f the currently apprved study. There are (2) types f mdificatins available. Please chse carefully. 1. Create a Md Lite if the reasn fr the mdificatin is change a member f the study team (except fr the PI). This prcess des nt cpy the entire study but nly specific questins related t changing study team members. Yu are nt permitted t make any additinal changes. The IRB review time is hurs. 2. Create a Full Mdificatin fr all ther changes. In this prcess, OSIRIS cpies all sectins f the currently apprved study including attachments (upladed dcuments). Yu can edit any f yur respnses, edit upladed dcuments, r add new dcuments. All edits t the applicatin require a justificatin/ratinale fr each requested change. The IRB is unable t review/apprve a mdificatin withut perfrming a risk/benefit assessment based n the justificatin/ratinale fr the changes. T cmplete yur Mdificatin Request, yu will need t make the necessary changes t yur IRB prtcl, cnsent, r ther dcuments. If any new questins were added t the OSIRIS applicatin, yu will be required t respnd during this mdificatin prcess. If yu wish t revise an existing dcument, be sure t save the existing dcument t yur cmputer, edit, and then click n the Uplad Revisin buttn. D nt use the ADD buttn and display several versins f the same dcument. The ADD buttn is reserved nly fr additin f new dcuments. Step 1: G the Apprved Study wrkspace and click the buttn t create a New Mdificatin Step 2: Click n the View Mdificatin Cver Sheet and answer the questins M1 - M13. Yur respnses determine if any Pre-IRB reviews are required.

18 Step 3: Click n View Mdifiable Study buttn t access a cpy f the currently apprved applicatin. This link is als available n the last page f the mdificatin cversheet. DO NOT RE-ANSWER all the questins. Use the Jump T: link lcated at the tp f each page t g t the sectin yu wish t edit. 18 Step 4: Add a Justificatin n every page edited. Use the Reviewer Nte lcated in the yellw header n the tp left crner f each page t add yur justificatin and include a summary f changes requested. Click n the 'Add' buttn t add the required scientific, clinical, r administrative ratinale. Dn t frget t click the OK buttn lcated in the bttm right crner f the textbx. It is smetimes hidden and yu need t mve the brwser bar dwn t display the buttn. Tip: Click n the Hide/Shw Errrs link nted lcated in the blue sectin at the tp f each page t check fr any errrs (unanswered sectins)and if fund will be displayed at the bttm f the page. It is strngly recmmended that yu click n this link befre sending t the PI fr review. Step 5: The PI must review and submit fr IRB review

19 Create a Renewal Reprt 19 All expedited and full bard studies are required t be reviewed and apprved at least annually. The IRB cmmittees have the latitude t require mre frequent reviews based n the risk f the study. Yu will need t g t the Apprved Study wrkspace and click n the buttn New Renewal. Yu will answer a series f questins and cmplete a summary table f subject enrllment. If this study was previusly renewed, be sure and review last year s Renewal Reprt. The IRB ften finds discrepancies in the summary f subject enrllment. G t the Apprved Study wrkspace and click n the Renewal tab that displays all f the Renewal reprts. Use the textbx t address any discrepancies r issues that yu feel the IRB may questin. It is imprtant that yu submit yur Renewal at least 5 weeks prir t the expiratin date. The federal regulatins require that the IRB apprve the Renewal befre the expiratin date (submitting the applicatin des nt cnstitute apprval). Step 1: G the Apprved Study wrkspace and click the buttn New Renewal Step 2: Click n the View Renewal t answer the series f questins Step 3: Answer the Study Status questin carefully. If yu select permanently clsed t additinal enrllment and decide yu wish t enrll additinal subjects, yu will be required t submit a new study. Step 4: The PI must review and submit fr IRB review

20 Pint t Cnsider When Preparing yur Renewal Reprt 20 Data and Safety Mnitring reprting Lcal plan is the research team meeting Answer the series f questins Actual cnvened Data and Safety Mnitring Bard (DSMB) Answer the series f questins Uplad the mst recent meeting minutes frm the last cnvened meeting Sme are lcal while thers are ff-site at ther institutins Sme studies require mre elabrate mnitring independent bards r special requirements (Department f Defense Studies (DD) requires medical mnitrs) N r lw enrllment Prvide a plan fr increasing recruitment if yu wish t cntinue the study The IRB may assess whether it is acceptable t let the study cntinue if is likely the study will result in n generalizable utcmes Reprtable Events Remember yu can submit a Reprtable Event at anytime If any issues are identified during the preparatin f this reprt If prblems are identified during a DSMB meeting Created a Related Mdificatin Yu are permitted t submit a related mdificatin nly if it is safety related issues If it is nt fr a safety related issues, yu are required t wait until the Renewal is apprved and then submit a Mdificatin

21 Create a Reprtable Event 21 If yu need t submit a Reprtable Event, g t the Apprved Study wrkspace and click n the New Reprtable Event buttn. Yu will answer a series f questins and prvide a detailed descriptin f the event. Yu will select the type f reprt t be submitted: adverse event, ther unanticipated prblem invlving risk t subjects r thers, r deviatin r nn-cmpliance. Review the HELP text definitins t determine the type f reprt t submit Reprtable Events can be submitted at any time nce the prject is apprved This applies even if a Renewal, Mdificatin r any ther prject is in prcess If yu are unsure whether the event meets ur reprting guidelines r have any ther questins, please cntact the IRB Adverse Event Crdinatr befre prceeding. Cntact Jamie Zelazny via at zelaznyjh@upmc.edu Step 1: G the Apprved Study wrkspace and click New Reprtable Event Step 2: Click n Edit Reprtable Event and answer a series f questins. Step 3: Answer a series f questins Step 4: The PI must review and submit the reprt fr IRB review. If needed, a Related Mdificatin can be created and submitted with this Reprtable Event.

22 Create an Exceptin Request Investigatrs must fllw the IRB apprved prtcl and are nt permitted t deviate frm the plan unless there is an immediate risk t a research subject r IRB apprval is btained. It is pssible t request an exceptin t deviate frm the currently apprved prtcl but apprpriate justificatin is required befre the IRB will cnsider the request. In additin, apprval may als be required frm the spnsr and pssibly the FDA. 22 The Exceptin Request is t be used fr deviatins that have nt yet ccurred. If yu have already deviated frm yur prtcl, yu must submit a Reprtable Event. If the need fr requested exceptin is likely t be repeated in the future, the investigatr will be instructed t submit a mdificatin as nly ne exceptin may be apprved by the IRB. Step 1: G the Apprved Study wrkspace and click the buttn New Exceptin Step 2: Yu will answer a series f questins and prvide a justificatin fr the request. Step 3: The PI must review and submit fr IRB review Step 4: The Exceptin Request will be reviewed by the IRB Chair r designee. Yu will receive an ntificatin infrming yu f the decisin. Yu may nt prceed until yu receive the IRB Chair s determinatin. Nte: Even if the spnsr apprves the exceptin, it cannt be implemented with the University f Pittsburgh IRB apprval.

23 Create a Final Reprt 23 It is imprtant that yu clse ut yur study and dn t just let it expire. Just like the ther submissins, yu will be asked t respnd t a series f questins. Tw ptins: Final Reprt-Study Cmpleted Early Terminatin If yu are leaving the institutin, it is yur respnsibility as the PI t either clse the study r mdify the study t add a new investigatr t assume the rle as PI. One f these ptins must be submitted and apprved by the IRB befre yu leave. Step 1: G the Apprved Study wrkspace and select the apprpriate activity: Study Cmplete-Final Reprt r Early Terminate Study Step 2: A frm will be displayed and yu will be asked t respnd t a series f questins.

24 Step 3: It is imprtant t nte that if the PI answers the questins, he/she can just use the buttn at the tp f the frm t submit. If anther member f the research team creates the dcument, the PI must review and submit the reprt. 24 Step 4: The reprt is reviewed by the IRB Chair and if acceptable, the current state n the Apprved Study wrkspace will be display cmpleted.

25 Create an Exempt Applicatin 25 The IRB des nt actually apprve an exempt study but instead makes a determinatin that the prject meets at least ne f the federal exempt categries criteria. Annual review is nt required and n expiratin date will be listed n yur apprval letter It is very imprtant that yu clse-ut yur prject when cmpleted r if yu leave the university. Faculty mentrs are respnsible fr versight f student prjects and shuld ensure exempt studies are cmpleted and clsed-ut in OSIRIS befre the student leaves the university. The Exempt Review prcess is als used fr prjects designated as Nt Research r Des Nt Invlve Human Subjects Students are strngly encuraged t meet with an IRB staff member befre initiating the IRB applicatin. This is especially imprtant if the study is being cnducting utside the U.S. r if children will be research subjects. Imprtant: Exempt applicatins have a special pathway in OSIRIS with limited questins d nt use the jump t menu t bypass questins until yu have answered all the questins up t E1.0 t set the exempt pathway. Fllw the steps t Create a New Study n page 4 f this dcument Use the cntinue buttn n the right side f the page t build yur applicatin When yu get t questin T4.0, answer Yes Click n lcated t the right f T4.0 fr detailed infrmatin befre prceeding Yu are nw in the Exempt Review pathway

26 26 Seek a N human subjects r Nt research Determinatin Fllw the same steps as are described abve fr an exempt determinatin It is nrmally best t use an exempt frm that is specific t the type f prject yu plan t cnduct. Yu can specify which determinatin yu are requesting in the upladed exempt frm. The frm Nt Research r Des Nt Invlve Human Subjects is rarely used. Cntact askirb@pitt.edu with any questins prir t cmpleting the frm.