IRB Module. Study Submission Guide

Transcription

1 IRB Mdule Study Submissin Guide May 2017

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3 2 Table f Cntents What is the Click Prtal?... 4 Getting a Click Accunt... 6 Lgging int the Click Prtal... 6 Basic Navigatin... 8 My Inbx... 8 The Wrkspace... 9 SmartFrms Creating a New Study Basic Infrmatin Funding Surces Study Team Members Adding Internal Team Members Adding External Team Members Study Scpe External Sites Drugs Devices Cnsent Frms and Recruitment Materials Cnsent Frms Recruitment Materials CITI Training Minimizing Delays Required CITI Curses Lgging int CITI Supprting Dcuments Assigning Additinal Staff t a Study Assign PI Prxy Assign Primary Cntact... 29

4 3 Manage Ancillary Reviews Manage Guest List Submitting a Study fr Review The Review Prcess Clarificatin Requests Creating a Mdificatin/CR Determining the Purpse f the Submissin Mdificatin/CR Prcess Cntinuing Review/Study Clsure Infrmatin Mdificatin Infrmatin/Amendments... 41

5 4 What is the Click Prtal? The SUNY Pre-Award and Cmpliance System (PACS) is a multi-year cllabratin created t supprt investigatrs and students alng with cmpliance and research administrative staff by giving them a new administrative tl - the Click Prtal. Click will autmate the submissin, review, and apprval prcesses while managing all majr administrative aspects f the research and cmpliance lifecycle frm prpsal develpment and submissin thrugh cmpliance checks, negtiatins, award setup and award management, t eventual prject clseut. This system integrates the fllwing aspects f grants management int a single system: IRB IACUC Grants Management Cnflicts f Interest (COI) Research Agreements Safety Under the stewardship f UB s Office f the Vice President fr Research and Ecnmic Develpment, this platfrm will allw the University at Buffal t achieve a new level f unifrmity and efficiency, while als prducing valuable data analytics that can guide future decisins. UB is helping lead this system-wide effrt and was the first SUNY campus t deply the IRB mdule in Fall 2015.

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7 6 Getting a Click Accunt Accunts have been created fr faculty and staff at the University at Buffal in preparatin fr campus-wide implementatin f the Click Prtal. Faculty and staff users will lg int the system using their UBIT Name and Passwrd. If yur lgin attempt is unsuccessful, r yu are a student participating n a research team, please fllw the instructins belw t request an accunt: 1. Navigate t the Click Prtal: IRB and Managing Cmpliance page at 2. Lcate the Click Prtal Lgin area at the tp-right f the page, and click n the registratin link. 3. Cmplete the Request Accunt frm at the bttm f the page, and then click the Register buttn. Be sure t select the University at Buffal as yur Campus Affiliatin. Yu will receive an ntificatin when yur accunt has been activated. Lgging int the Click Prtal 1. Navigate t the UB Research and Ecnmic Develpment page at 2. Lcate the Quick Links sectin in the center f the page.

8 7 3. Click n the Click Prtal Lgin link. 4. Enter yur UBIT Name and Passwrd in the fields, and then click the Lg In buttn.

9 8 Basic Navigatin My Inbx Each time yu lg int the Click Prtal, yu will be taken t the Inbx. This area f the prtal cntains studies (and/r ther submissins) that require yu t take actin. My Inbx is divided int tw tabbed pages: Cmpliance Tasks At present, this tab cntains a list f the IRB studies and Safety prtcls that require actin. SPO Tasks At present, this tab cntains a list f the Agreements that require actin. The listings within My Inbx can be srted by using the Filter by ptin. This ptin will allw yu t search by ID number, Name, Date Created, Date Mdified, r State. T determine what type f actin yu need t take n a submissin, lk at the State clumn; see the chart belw fr an explanatin f the actin required fr each State. Research team Yur rle Study team member r study's primary cntact Nte: Any team member can make changes t the study, but the PI must persnally submit the changes r respnse t the IRB. State Submissins in My Inbx Explanatin Pre-Submissin Cmplete the study frms. The PI must submit it t the IRB t let the review begin. Clarificatin Requested Mdificatins Required Change the study t clarify as needed, and prvide summary ntes t the IRB when submitting the changes. Nte: If the clarificatin was requested frm Cmmittee Review, yu can nly prvide ntes. Yu are nt allwed t change the study. Mdify the study t meet IRB requirements and submit it with changes. Nt in My Inbx Studies the IRB is reviewing Apprved studies Clsed studies

10 9 T pen a submissin, click n its Name. Yu can return t My Inbx at any time by clicking the My Inbx link in the Header at the tp right crner f the screen. The Wrkspace Once yu pen a study, yu will be taken t the Study Wrkspace. The Study Wrkspace allws yu t: View the study cntents and details, including all actins perfrmed n it Perfrm actins n the study

11 10 The key elements in the Wrkspace are: Header Links t yur prfile and My Inbx, and lets yu lg ff Tp navigatin menu Links t the different mdules within the Click Prtal Breadcrumb navigatin menu Lists the hierarchy f pages and enables yu t mve quickly t a previus lcatin Activities Actins that can be taken based n a submissin s current State Resurce tabs Cllected infrmatin regarding the submissin Histry Actins taken previusly n this submissin Shrtcuts Quick links t ther frequently used areas f the prtal, and t dcumentatin SmartFrms T pen a study frm the Wrkspace, click n the Edit Study buttn. NOTE: This buttn may als be labeled View Study, dependent upn the State f the study yu are pening. Studies are cmprised f several pages knwn as SmartFrms. They are referred t as smart because the prtal will branch t add additinal frms t yur study based n yur respnses t questins n the pages.

12 11 The key elements in the SmartFrms are: The Cntinue and Back buttns will mve yu frward r back ne page in the study; the Cntinue buttn als saves yur wrk. The navigatin bar at the tp and bttm f each page will allw yu t perfrm the fllwing actins: Save Saves yur wrk fr the current page Exit Exits the study and returns yu t the Study Wrkspace Hide/Shw Errrs Perfrms a check n every page within the study t ensure that all required fields have been cmpleted Jump t: - Allws yu t see and navigate t all pages within the study Any item n a SmartFrm that has a red asterisk (*) next t it is a required field. Clicking n the blue icns ( ) next t items will pen a windw that will ffer assistance with cmpleting the field.

13 12 Creating a New Study T begin the prcess f creating a New Study, please cmplete the fllwing steps: 1. Lg int the Click Prtal. 2. Click the IRB tab in the tp navigatin menu. 3. Click the Create New Study buttn. The sectins belw will prvide infrmatin n the general SmartFrms yu will be asked t cmplete as part f a new study. Basic Infrmatin 1. Enter a Title fr the study. 2. Enter a Shrt Title fr the study. NOTE: The Shrt Title becmes the Name f the study; be sure t make this unique acrss yur prjects. 3. Enter a Brief descriptin f the study.

14 13 4. By default, yu will be listed as the Principal Investigatr (PI). If yu are entering a study fr anther individual wh will be serving as the Principal Investigatr, please d nt change this field t that persn s name until yu have cmpleted all f the SmartFrms and are ready t have the PI submit the study fr review. 5. Indicate whether r nt the PI has a financial interest in the prject. Financial interests in a research prject usually ccur where there will be a tangible prduct related t the research, as ppsed t merely generating knwledge t be published. It als ccurs when there is crprate spnsrship f a study. Fr additinal infrmatin: HRP-211 Initial Review Frm available at UB's Cnflict f Interest page available at 6. Indicate whether r nt an IRB external t the University will act as the IRB f recrd fr the study. In all but the rarest f cases at UB and affiliated hspitals, an external IRB will nt be acting as the IRB f recrd. Fr an external IRB t act as the IRB f recrd, the institutinal fficials at bth institutins must enter int a written agreement t d s. NOTE: Indicating that an external IRB will act as the IRB f recrd will lead t a much shrter set f SmartFrms and an abbreviated wrkflw ruting. 7. Attach a digital cpy f the prtcl. NOTE: Please use the HRP-503 Template Prtcl r HRP-508 Template Site Supplement t Spnsr which can bth be lcated in the Library n the Templates tab. Click the Add buttn. Click the Chse File (r Brwse) buttn t lcate the file. Enter a Name fr the dcument. Click the OK buttn. NOTE: If changes t the prtcl are requested by the IRB, use the Update buttn t replace the current versin f the dcument with an updated ne. Click the Cntinue buttn t save yur wrk and mve t the next page within the SmartFrms.

15 14 Funding Surces 1. If yu anticipate funding fr the study, click the Add buttn. NOTE: If yur study is unfunded, please click the Cntinue buttn t mve t the next page. Click the Select buttn. Enter the Name f the rganizatin. Please d nt use abbreviatins (e.g., NIH); type the Name using cmplete wrds. Click the G buttn. Select the Name f the apprpriate rganizatin. Click the OK buttn. NOTE: If yu cannt lcate the Name f the rganizatin using the search tl, please click the Cancel buttn. Then enter the Name f the rganizatin in the Name field, and indicate its Type. Enter the Spnsr s funding ID number, if knwn. Enter the Grants ffice ID number, if knwn. The grant applicatin shuld be included as an attached file; click the Add buttn t attach it. Click the OK buttn nce mre t clse the windw. 2. If there are additinal funding surces, please repeat the prcess abve t add them. Click the Cntinue buttn t save yur wrk and mve t the next page within the SmartFrms.

16 15 Study Team Members The Study Team Members page is the lcatin fr identifying each persn invlved in the design, cnduct, r reprting f the research. There is n need t add the Principal Investigatr wh was listed n the Basic Infrmatin page. Adding Internal Team Members 1. T add internal team members, click the Add buttn. Begin typing the individual s last name in the Study team member field. If the last name is very cmmn, yu may have t type a cmma fllwed by the first name. Yu can als srt thrugh an alphabetical list by clicking the Select buttn. NOTE: Mst peple with active UBIT accunts wh have been emplyed in any capacity at UB (including graduate students n RA/GA/TA lines) will be accessible as internal persnnel. Select the individual s Rle in the research. If a specific Rle is nt in the list, please select the clsest match. Indicate whether r nt the team member is invlved in the cnsent prcess. Indicate whether r nt the team member has a financial interest in the research. Click the OK buttn. If yu have additinal team members t add, yu may click OK and Add Anther t repeat the prcess. Adding External Team Members 1. T add external team members, click the Add buttn. Click the Chse File (r Brwse) buttn t lcate the file.

17 16 Yu will need t cmplete an External Team Member Infrmatin Template fr each external team member wh will be participating in the study. This frm is available in the Library n the Templates tab. Cllabratrs wh will be cvered under their wn institutin s IRB d nt need t be added as external team members. Enter a Title fr the dcument use the persn s last name, first name as the naming cnventin (e.g., De, Jhn). Click the OK buttn. If yu have additinal team members t add, click OK and Add Anther t repeat the prcess. NOTE: External team members will need t btain a UBIT accunt if they need t access the prtcl and cnsent frms. These individuals will need a vlunteer appintment frm yur department. Please cntact supprt@research.buffal.edu fr mre infrmatin. After yu have finished adding team members, click the Cntinue buttn t save yur wrk and mve t the next page within the SmartFrms.

18 17 Study Scpe Answering yes t any f the questins psed n the Study Scpe page will trigger the additin f additinal SmartFrm pages t the study. 1. Indicate whether r nt the investigatr will cnduct r versee research at any external sites. Kaleida hspitals and clinics, and the Erie Cunty Medical Center (ECMC) are cnsidered t be internal sites. External sites generally means ther institutins that are engaged in the research as a part f the functin f the institutin. They ccur mst typically when there is a grant funded study that is being dne in cllabratin with anther institutin wh is als receiving a prtin f the funding. Fr example: Businesses perfrming cmmercial services related t the research (e.g., the Buffal News running yur advertisement, a lab that is cntracted t d standard bld analysis, a transcriptin service) are nt engaged in the research itself and d nt need t be listed as external sites. Cnducting interviews at a lcal cffee shp wuld nt be cnsidered an external site.

19 18 Cnducting research at a lcal schl wuld nt usually be cnsidered an external site unless the schl persnnel were members f the research team assisting n the prject as a cnditin f their jb. Fr questins regarding internal and external sites, cntact the: Clinical Research Office, available at Scial and Behaviral Research Office, available at Answering yes t this questin will trigger the additin f the External Sites page. 2. Indicate if the study will invlve any f the listed cnditins: Specify the use f an apprved drug r bilgic Use an unapprved drug r bilgic Use a fd r dietary supplement t diagnse, cure, treat, r mitigate a disease Answering yes t this questin will trigger the additin f the Drugs page. 3. Indicate if the study will d any f the fllwing: Evaluate the safety r effectiveness f a device Use a humanitarian use device (HUD) Answering yes t this questin will trigger the additin f the Devices page. After yu have finished defining the scpe, click the Cntinue buttn t save yur wrk and mve t the next page within the SmartFrms.

20 19 External Sites NOTE: This page will nly appear in the study if yu answered yes t questin 1 n the Study Scpe page. 1. T add external sites, click the Add buttn. Enter a Site name. Enter a Cntact name; please name the individual wh is heading up the effrt at the site (e.g., the c-pi r crdinatr fr the site). Enter a phne number fr the Cntact. Enter an address fr the Cntact. Indicate whether r nt the external site s IRB will be used t review the research. Indicate whether r nt UB s IRB will be used t review the research. The questins regarding the IRB have institutinal ramificatins as well as ramificatins fr the prtcl and assciated materials t be reviewed by the UBIRB. Usually ne f these tw items must be a yes respnse. When an external site will rely n UB s IRB: An agreement between the institutinal fficials at bth institutins must have/enter int a written agreement t d s. The prtcl reviewed by UB s IRB must cmpletely cver the research activities t be carried ut at bth UB and the ther site(s). Persnnel frm the ther institutin(s) will need t be specified in this applicatin and may have t meet UB s requirements fr things like CITI Training and/r Cnflict f Interest.

21 20 When an external site will NOT rely n UB s IRB: Each site's IRB may review and apprve the research activities t be perfrmed at its wn site. The prtcl reviewed by UB s IRB usually will nt need t cver the research activities t be carried ut at the ther site(s). Persnnel frm the ther institutin(s) shuld nt be specified in this study prtcl unless therwise directed t d s by UB s IRB. After yu have finished adding external sites, click the Cntinue buttn t save yur wrk and mve t the next page within the SmartFrms.

22 21 Drugs NOTE: This page will nly appear in the study if yu answered yes t questin 2 n the Study Scpe page. 1. T list a drug, click the Add buttn. Yu must include all drugs that are a part f the prtcl, whether r nt they are investigatinal. Select a Drug Type. Begin typing the drug s name in the Select the drug field. Yu can als srt thrugh an alphabetical list by clicking the Select buttn. If yu cannt lcate the drug, please enter the Generic Name and Brand Name in the fields prvided. Enter the IND Number, r indicate that the drug is IND exempt. Indicate wh hlds the IND. Click the Add buttn t attach any files related t the drug (e.g., package insert, investigatr brchure, prduct labeling, r verificatin f IND Number). All materials related t the drugs utilized in the study prtcl shuld be upladed using the prcess utlined abve. Fr each IND, ne f the fllwing must be prvided: Spnsr prtcl with the IND Number Cmmunicatin frm the FDA r spnsr with the IND Number Click the OK buttn. If yu have additinal drugs t add, click OK and Add Anther t repeat the prcess. After yu have finished adding drug infrmatin, click the Cntinue buttn t save yur wrk and mve t the next page within the SmartFrms.

23 22 Devices NOTE: This page will nly appear in the study if yu answered yes t questin 3 n the Study Scpe page. 1. T select a device, click the Add buttn. Only thse devices that are used as an HUD r evaluated fr safety and effectiveness n human subjects as part f the study need t be listed. Begin typing the device s name in the Select the device field. Yu can als srt thrugh an alphabetical list by clicking the Select buttn. If yu cannt lcate the device, please enter the infrmatin in the field prvided. Select the Device exemptins that are applicable t the study. Click the Add buttn t identify IDE and HDE numbers, if applicable. Investigatinal Device Exemptin (IDE) number - identifies a device apprved by the FDA fr use in a clinical study t cllect safety and effectiveness data needed t supprt further applicatins t the FDA. Apprved IDEs are exempt frm several regulatins. Abbreviated IDE - The device is cnsidered t pse a nn-significant risk f harm. If the IRB apprves the study including the device as nt psing a significant risk n FDA apprval is needed t prceed with the study. Humanitarian Device Exemptin (HDE) number - identifies a device apprved by the FDA as a humanitarian use device (HUD) with limited

24 23 ptential patients, withut meeting the effectiveness requirements f premarket apprval. The FDA agrees that the device des nt pse an unreasnable r significant risk f illness r injury, and the prbable benefit t health utweighs the risk f injury r illness frm its use. Click the Add buttn t attach any files related t the device. Fr each IDE/HDE number, ne f the fllwing must be prvided: Spnsr prtcl with the IDE/HDE number Cmmunicatin frm the FDA r spnsr with the IDE/HDE number After yu have finished adding device infrmatin, click the Cntinue buttn t save yur wrk and mve t the next page within the SmartFrms.

25 24 Cnsent Frms and Recruitment Materials Cnsent Frms 1. T add a cnsent frm, click the Add buttn. Click the Chse File (r Brwse) buttn t lcate the file. Cnsent Materials t be upladed include: Signed Cnsent Dcuments Assent Dcuments fr Children Parental Permissin Dcuments Verbal Cnsent Scripts Cnsent Infrmatin Pages (e.g. cnsent dcuments fr mailed r internet interactins) Enter a Name fr the dcument. Click the OK buttn. If yu have additinal frms t add, click OK and Add Anther t repeat the prcess. Recruitment Materials 2. T add a recruitment dcument, click the Add buttn. Click the Chse File (r Brwse) buttn t lcate the file.

26 25 Recruitment Materials t be upladed include: Verbal Scripts Flyers Mailings Text fr Newspaper advertisements Web pages (links are nt acceptable- print the page t a pdf) Radi r TV ads (r scripts fr them if the final frm is nt yet available). Keep in mind that the final frm f any advertisement must be apprved by the IRB befre it is used s if yu nly prvide the text, yu will need t prvide the final frm via an amendment at a later date. Enter a Name fr the dcument. Click the OK buttn. If yu have additinal materials t add, click OK and Add Anther t repeat the prcess. After yu have finished adding cnsent and recruitment materials, click the Cntinue buttn t save yur wrk and mve t the next page within the SmartFrms.

27 26 CITI Training There are n fields t update n this page; a cnnectin between the Click Prtal and CITI will autmatically add curse infrmatin fr yur study team members. At present there are sme issues with integratin between the tw systems. These issues have caused the IRB t manually verify CITI cmpletin fr all study persnnel. Minimizing Delays In rder t ensure that yur prtcl is nt delayed, yu shuld verify that all study persnnel have cmpleted the apprpriate CITI Training. 1. Ask any persn wh has a curse within 60 days f expiratin t lg int their CITI accunt and cmplete the basic r refresher curse as required. 2. Ask any persn wh has nt taken the required curses fr the type f study being perfrmed t cmplete them. 3. Obtain verificatin f cmpletin fr any recrds that d nt appear belw a persn s name and save electrnically just in case there is a situatin fr which the IRB cannt lcate the recrds. A screensht f the Main Menu page in CITI can serve as verificatin. Required CITI Curses All curses must be the University at Buffal prescribed CITI curses. Similar CITI curses frm ther institutins will nt be accepted. Hwever, sme f the mdules in thse curses may be applied autmatically by CITI t yur UB CITI curses. Fr Scial/Behaviral/Educatin Research the fllwing are required: Human Research Curriculum, Scial & Behaviral Research Investigatrs Basic r Refresher Curse cmpleted within the past 3 years.

28 27 Scial and Behaviral Respnsible Cnduct f Research Curse Basic r Refresher Curse cmpleted within the past 3 years. * *Currently the in-persn GRP training fr nn-clinical researchers cnducted by UB can be substituted fr the abve indicated RCR curse. The IRB has infrmatin n the in-persn curses n recrd and will verify this upn prtcl submittal. Fr Bimedical/Clinical Research the fllwing are required: Human Research Curriculum, Bimedical Research Investigatrs Basic r Refresher Curse cmpleted within the past 3 years. CITI Gd Clinical Practice Curse Basic r Refresher Curse cmpleted within the past 3 years. ** **Currently the in-persn GRP/GCP training fr clinical researchers (parts I and II) cnducted by UB can be substituted fr the abve indicated RCR and GCP curses. The IRB has infrmatin n the in-persn curses n recrd and will verify this upn prtcl submittal. NOTE: It is nt required that yu pay fr CME credit fr the purpse f meeting UB s human subjects requirement. If yu wish t btain CME credit, yu may d s at yur wn expense. Lgging int CITI 1. Navigate t 2. Enter yur Username and Passwrd. If yu have never had a CITI accunt, create ne by clicking the Register buttn. When creating a new accunt, be sure t indicate SUNY-Buffal (University at Buffal) as yur institutin and use yur UBIT address fr any addresses requested. If yu have a CITI accunt with anther institutin, yu can lg int that accunt and then add an affiliatin with SUNY-Buffal (University at Buffal) by clicking n the Click here t affiliate with anther institutin link tward the bttm f the CITI Main Menu page. Be certain t enter yur UBIT address fr any addresses requested. After yu have verified that study persnnel have met the training requirements, click the Cntinue buttn t mve t the next page within the SmartFrms.

29 28 Supprting Dcuments 1. T add a supprting dcument, click the Add buttn. Click the Chse File (r Brwse) buttn t lcate the file. Supprting Dcuments that are upladed n ther pages d nt need t be added here. All ther Supprting Dcuments (e.g., study instruments, HRP-504 (Schls), HIPAA dcuments, additinal frms) shuld be added here. Name the dcument as yu want it t appear in the apprval letter. If yu dn t, and fr sme reasn need t have the dcument name changed in yur apprval letter, yu will have t wait fr an amendment t the study t be apprved. D nt uplad IRB Wrksheets r Checklists unless requested by the IRB. Enter a Name fr the dcument. Select a Categry frm the drp-dwn menu. Click the OK buttn. If yu have additinal frms t add, click OK and Add Anther t repeat the prcess. After yu have finished adding supprting dcuments, click the Cntinue buttn t save yur wrk and mve t the next page within the SmartFrms. On the Final Page, click the Finish buttn t return t the Study Wrkspace.

30 29 Assigning Additinal Staff t a Study Once the study has been created, additinal staff and reviewers can be added at the discretin f the PI and IRB staff. Assign PI Prxy A PI Prxy can perfrm all f a Principal Investigatr s duties, with the exceptin f assigning additinal PI Prxies. The PI Prxy must be a member f the study team. 1. Frm the Study Wrkspace, click Assign PI Prxy. 2. Place a checkmark next t the Name f the persn yu wish t be PI Prxy. 3. Click the OK buttn. Assign Primary Cntact A persn identified as a Primary Cntact will receive all the system-generated ntificatins that a Principal Investigatr des. By default, the system will assign the Primary Cntact rle t whever created the study in the system. Fllw these steps t change the default t anther persn. 1. Frm the Study Wrkspace, click Assign Primary Cntact. 2. Click the Select buttn, and select an individual t serve as the Primary Cntact. 3. Click OK, and then click OK nce mre. Manage Ancillary Reviews The assignment f an Ancillary Review allws fr the study t be reviewed by individuals, departments, etc., as determined by the PI and/r IRB staff. Ancillary Reviews happen in parallel with the wrkflw, are ptinal, and can happen at any pint between the states f Pre-Submissin and IRB Review. 1. Frm the Study Wrkspace, click Manage Ancillary Reviews, 2. Click the Select buttn, and select an individual t serve as an Ancillary Reviewer. NOTE: The individual must pssess the rle f Ancillary Reviewer; an abbreviated list f individuals will appear. 3. Select a Review Type frm the drp-dwn menu.

31 30 4. Indicate whether r nt a respnse is required. NOTE: If a respnse is required, the study cannt be apprved until the Ancillary Review has taken place. 5. Click the OK buttn. An ntificatin will be sent t the Ancillary Reviewer ntifying them f their respnsibility. Manage Guest List Thse n the Guest List can read the study and any ther submissins, but cannt edit them. 1. Frm the Study Wrkspace, click Manage Guest List. 2. Click the Add buttn, and select an individual t include n the Guest List. 3. Click OK, and then click OK nce mre.

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33 32 Submitting a Study fr Review When yu have cmpleted all f the SmartFrms fr yur study, yu will be returned t the Study Wrkspace. In rder t send the submissin fr review, the Principal Investigatr (r PI Prxy) must cmplete the fllwing actins: 1. T submit yur study fr review, click Submit under My Current Actins. The Click Prtal will run a brief check t ensure that all f the required fields have been cmpleted within the SmartFrms. If an errr appears, click the link(s) and update any required fields that were missed. Save yur changes, Exit the SmartFrms, and then click the Submit buttn again. If there are n errrs, a statement will appear in the windw. 2. Read the statement and then click OK t submit the study fr review. 3. Check t ensure that the fllwing things have ccurred: The Status Bar in the upper-left crner f the Wrkspace will change frm Pre-Submissin t Pre-Review. The highlighted state in the wrkflw image at the tp f the page will nw be Pre-Review. On the Histry tab, the mst recent actin will be Submitted. The Review Prcess Submitting infrmatin t the IRB initiates a series f activities that may include: Review within yur department Pre-review by an IRB staff member Review by the IRB Cmmittee and/r a Designated Reviewer Cmmunicatin f the IRB decisin t the Principal Investigatr Any f these may lead t a request fr the study team t take further actin, such as prviding clarificatins r mdifying the study. Whenever the study team needs t act, the PI receives an ntificatin, and the study appears in My Inbx fr all study team members when they lg in t the Click Prtal.

34 33 Clarificatin Requests At several pints during the review prcess, the IRB may request clarificatins frm the study team. Whenever a Request fr Clarificatin is made, an ntificatin will be sent t all study team members, and the study will appear in their Inbx with a status f Clarificatin Requested. The PI (r PI Prxy) is respnsible fr making any changes necessary, and fr respnding t the request. 1. T respnd t a request, either click n the link embedded in the ntificatin r navigate t My Inbx and lcate the study with the status f Clarificatin Requested. Click n the study s Name t pen it. 2. On the Histry tab, find the Clarificatin Requested activity and read the cmments. 3. Click the Edit Study buttn. 4. If necessary, click the Jump T: link t g right t the SmartFrm that requires edits. Nte: If n changes were needed t the study, the PI wuld simply respnd t the request. 5. Make and Save the requested change(s). 6. Click Exit n the navigatin bar t clse the study. 7. Under My Current Actins, click Submit Respnse. 8. In the windw, enter any Ntes and then click OK. 9. Check t ensure that the fllwing things have ccurred: The Status Bar in the upper-left crner f the Wrkspace will change frm Clarificatin Requested t Pre-Review r IRB Review (dependent upn which state the request was made in). The highlighted state in the wrkflw image at the tp f the page will nw be Pre-Review r IRB Review. On the Histry tab, the mst recent actin will be Respnse Submitted.

35 34 Creating a Mdificatin/CR Determining the Purpse f the Submissin Upn clicking the Create Mdificatin/CR buttn, yu will be taken t a page where yu will need t specify the purpse and scpe f yur submissin. Click the apprpriate radi buttns and checkbxes t indicate yur chices. NOTE: These selectins cannt be undne nce yu click the Cntinue buttn. The fllwing chart can be used t determine the purpse f the submissin which will guide yu t which type(s) f submissin yu shuld select. In cases where the scpe includes changes t bth study team members and ther parts f the study, bth checkbxes shuld be selected. D yu need t make any mdificatins t the Study s infrmatin, persnnel, prtcl, cnsent dcuments, recruitment materials, instruments, r any ther dcumentatin? Yes Are yu clsing r renewing the Study at this time? N Are yu clsing the Study and/r the first 4 bxes under Research Milestnes n the Cntinuing Review/Study Clsure Infrmatin page will be checked? N Yes N Yes Submit Mdificatin & CR Submit Mdificatin & CR Was the Study was previusly apprved in IRBNet and this is the 1 st Mdificatin/CR in the Click Prtal? Submit Mdificatin & CR Yes Submit Mdificatin & CR N Submit Mdificatin & CR

36 35 NOTE: In mst cases nly ne Mdificatin/CR can be submitted at ne time. There is n way fr this system functinality t be verridden by the IRB, s please plan accrdingly. Mdificatin/CR Prcess T begin the prcess f creating a Mdificatin/CR, please cmplete the fllwing steps: 1. Lg int the Click Prtal. 2. Click the IRB tab in the tp navigatin menu. 3. Lcate the Active tab, and click the Name f the Study yu wish t make changes t. 4. Yu will be taken t the Study Wrkspace; click the Create Mdificatin/CR buttn under My Current Actins. NOTE: If the Create Mdificatin/CR buttn is nt available, it may mean that yu have already submitted a Mdificatin/CR fr this Study. Yu cannt create an additinal Mdificatin/CR until the previus ne is apprved. 5. Indicate the purpse and scpe fr yur submissin, and then click the Cntinue buttn.

37 36 Cntinuing Review/Study Clsure Infrmatin When there are n Mdificatins, this page is the nly ne that needs t be cmpleted fr a Cntinuing Review r Study Clsure. If yu have als requested Mdificatins, yu will be taken t an additinal page t indicate yur changes. 1. Specify Enrllment Ttals Yu must enter ttals fr all 3 fields: When there are multiple grups f participants (e.g., participants wh receive interventins and cntrl participants) sum up all participants. When participants partake in research prcedures at mre than ne pint (e.g., pretest and psttest situatins), cunt each persn nly nce. In cases where an exact cunt cannt be btained, yu shuld make yur best estimate f the participant number. Fr example, if participatin was annymus and yu cllected 45 pretests and 52 psttests estimate that the participant cunt was 52.

38 37 T btain the number Since Last Apprval, subtract last year s figures frm yur ttal. Yu can check in IRBNet n the Cntinuing Review frm fr this infrmatin. Of curse, if last year was yur initial study apprval, last year s cunt will equal 0. Studies that have nt happened at multiple sites arund the cuntry (e.g., multi-center drug r medical device trials, cllabratin with anther university) will typically prvide the same number fr At this investigatr s sites and Study-wide. 2. Research Milestnes The Research Milestnes are very imprtant; the answers yu prvide here can have a significant impact n the IRB Review prcess, including requests fr yu t prvide further materials r infrmatin. NOTE: If the first fur Research Milestnes are checked the Study will be clsed t discntinue IRB versight because the human subjects prtin f the research is dne. Statements like r n subjects were enrlled are included in many f these Milestnes s that a Study that has been cmpletely called ff withut any subject participatin can be clsed by the IRB. Check Study is permanently clsed t enrllment OR was never pen fr enrllment when any f the fllwing are true: N further participants will be added; yu are dne recruiting and starting peple n any interventins r interactins. NOTE: OHRP Definitins Interventin includes bth physical prcedures by which data are gathered (fr example, venipuncture) and manipulatins f the Subject r the Subject's envirnment that are perfrmed fr research purpses. Interactin includes cmmunicatin r interpersnal cntact between the Investigatr and Subject. Yu decide t call ff the entire Study; pssible reasns fr this wuld include nt receiving the grant r cntract that was t pay fr the

39 38 prject, r simply that yu decided t cmpletely change yur research fcus. All subjects have cmpleted all study-related interventins OR nt applicable Many studies d nt use any interventins. Fr example, studies that include nly recrds reviews r interview prcedures wuld nt usually cntain interventins. Cllectin f private identifiable infrmatin is cmplete OR nt applicable (n subjects were enrlled) Keep in mind that while yu may still be cllecting infrmatin frm peple, as lng as the data is never identifiable, yu culd check ff this bx. This might mean that fr sme studies this bx culd be checked right at the utset. NOTE: OHRP Definitins: Private infrmatin includes infrmatin abut behavir that ccurs in a cntext in which an individual can reasnably expect that n bservatin r recrding is taking place, and infrmatin which has been prvided fr specific purpses by an individual and which the individual can reasnably expect will nt be made public (fr example, a medical recrd). Private infrmatin must be individually identifiable (i.e., the identity f the Subject is r may readily be ascertained by the investigatr r assciated with the infrmatin) in rder fr btaining the infrmatin t cnstitute research invlving human subjects. Analysis f private identifiable infrmatin is cmplete OR nt applicable (n subjects were enrlled) First, see the abve tw bullets. If yu have cmpletely de-identified all data, even thugh it was at ne time identifiable, yu culd nw check this bx. If yu retain a master list that cnnects identities t the data thrugh a cde number, it is nt cmpletely de-identified until yu get rid f all cpies f the master list. Names are nt the nly identifiers. It is especially true that fr small participant pls, smetimes a persn can be readily identified by cmbinatins f infrmatin in the data. Fr example, cnsider the pl f Presidents f the United States. If tw f the data fields are the State they were brn in and their plitical party, while we might nt be able t distinguish between Martin Van Buren and Franklin Rsevelt (bth

40 39 brn in NY and Demcrats) based n nly this data it des nt take much effrt t figure ut that Thedre Rsevelt is the nly Republican frm NY and Millard Fillmre was in the Whig Party (Grver Cleveland and Chester Arthur weren t brn in NY). Yu can smetimes retain identities and still check this bx as lng as they are cmpletely separate frm yur data. Fr example, a signed cnsent frm wuld prbably have a persn s identity in the frm f their name but as lng as there was n link between the cnsent frm and the private data cllected (like a cde number in the upper left hand crner f the page) the data is still nt readily identifiable. Smetimes the identifiability f data t the researcher depends upn their ability t easily access ther infrmatin. Fr instance, mst peple culdn t identify an individual based n a list f curses taken as an undergraduate in cllege even thugh they might knw the name f the schl. Hwever, if yu happened t wrk in the registrar s ffice f that cllege, they wuld be easily identifiable t yu. Remaining study activities are limited t data analysis Writing and publicatin are als cnsidered a part f data analysis. Even thugh yur study may be clsed with the IRB because the human subjects prtin is dne, yu can still analyze data and write it up. Study remains active nly fr lng-term fllw-up f subjects This usually nly applies in clinical studies where tracking factrs like recurrence f the disease/cnditin ver time may be an imprtant in analysis f the effectiveness f the new treatment. 3. Financial Interest Questin Financial interests in a research prject usually ccur where there will be a tangible prduct related t the research, as ppsed t merely generating knwledge t be published. It als ccurs when there is crprate spnsrship f a study. Fr additinal infrmatin: HRP-211 Initial Review Frm available at

41 40 UB's Cnflict f Interest page available at 4. Checklist f Items Mst f the time, all f the items in this list can be given a few minutes f thught and then checked ff. Just answer them hnestly and t the best f yur knwledge after checking with yur research team t see if they encuntered any issues that wuld nt allw a bx t be checked. It is expected that in mst cases there will be nne (r very few) f the items in this list left unchecked. 5. Supprting Dcuments Mst f the time, there will be n need t uplad any supprting dcuments. If ne r mre f the items in Step 4 abve remains unchecked, then there shuld be a supprting dcument(s) t cver each unchecked item. Fr instance, if bth N Subjects Withdrew frm the Study and N Data Safety and Mnitring Reprts are unchecked, yu shuld uplad tw supprting dcuments, ne giving a descriptin f the withdrawals that ccurred alng with yur evaluatin f why they ccurred, and a secnd dcument cntaining the Data Safety and Mnitring Reprts. D NOT uplad items that are a parts f the Study itself here (e.g. prtcl, cnsent frms, advertisements, edited study instruments, investigatr s brchure, etc.). These are upladed as a part f the riginal Study dcumentatin and nt as supprting dcuments fr renewal.

42 41 Mdificatin Infrmatin/Amendments When there are Mdificatins, either n their wn r as a part f a Cntinuing Review, this page will need t be cmpleted. After cmpleting this page, yu will be taken t the SmartFrm pages in rder t make the actual Mdificatins t the Study materials and uplad any updated dcuments (e.g., prtcl, cnsent frms, advertisements, edited study instruments, investigatr s brchure, etc.). 1. Study Enrllment Status The Enrllment Status is very imprtant because the answers prvided here can have a significant impact n the IRB Review prcess, including requests fr yu t prvide further materials r infrmatin. Nte: If yu als submitted a Cntinuing Review with this Mdificatin, make sure yur respnses are cnsistent with the Research Milestnes that yu indicated fr the Cntinuing Review. See the Research Milestnes sectin under Cntinuing Review/Study Clsure Infrmatin fr definitins and guidance relevant t cmpleting this sectin. 2. Ntificatin f Subjects

43 42 Nt all amendments require prcedures fr ntificatin f past, current, r even future Subjects as a part f the initial cnsent prcess. Participants shuld, hwever, be tld infrmatin that might be pertinent t their well-being and their chice t cntinue current r future participatin in the Study. While the circumstances f each situatin are unique, cnsider the examples f amendments belw when deciding n whether changes in the cnsent prcess r ntificatin f current/frmer participants shuld be undertaken. An amendment t add prtcl-related infrmatin abut the risk f increased ptential birth defects assciated with children f wmen wh have in the past used a study drug wuld certainly warrant changes t the prtcl risk sectin, the cnsent dcument fr future enrllees and frmal written ntificatin t all current and frmer wmen wh are/were subjects in the study. An amendment t add prtcl-related infrmatin abut a side effect f nausea while n the study drug wuld certainly warrant changes t the prtcl risk/discmfrt sectin, the cnsent dcument fr future enrllees and frmal ntificatin t all current Subjects wh have nt cmpleted the interventin. Participants wh have cmpleted the interventin and frmer Subjects wuld nt need t be ntified. An amendment t reduce the number f Study fllw-up visits frm 16 t 12 wuld require a change in the prtcl, cnsent dcument fr future enrllees, and ntificatin t current enrllees (prbably using a verbal prcess) at their next visit. There wuld be n reasn t ntify frmer Subjects wh had already cmpleted their 16 th visit. An amendment t delete a few questins in a questinnaire f apprximately 100 items that was t be filled ut by participants at initial and final Study visits wuld prbably require just a change in the Study instrument itself. A revised prtcl wuld prbably nt be needed, nr wuld there be need t update the cnsent dcument (as the time it will take t cmplete the items will still be abut the same). Current participants wh still need t cme fr their final Study visit and past participants wuld prbably nt need t be ntified f this change. 3. Summarize the Mdificatins

44 43 This is nt just fr the recrd; it als lets the IRB reviewers triage the level f review an amendment will require. Give a brief descriptin in simple language f what is changing and why. One cmmn situatin encuntered is when this is yur first transactin in the Click Prtal but yu really are nt making any changes at this time. The Cntinuing Review with Mdificatins is just the mechanism that allws yu t electrnically get the study int the system. Simply state this fact if it is the case.

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46 45 Office f Research Cmpliance (ORC) Clinical and Translatinal Research Center 875 Ellictt Street Buffal, NY ubirb@buffal.edu Electrnic Research Administratin (era) UB Cmmns, Suite 114 University at Buffal Nrth Campus Buffal, NY supprt@research.buffal.edu