Researcher s Guide to IRBManager

Transcription

1 Researcher s Guide t IRBManager This guide includes infrmatin abut hw t use IRBManager t submit an xfrm (IRB applicatin) fr bth new studies and thse requiring subsequent review (mdificatin, cntinuing review). It als describes hw the xfrm (IRB applicatin) mves frm submissin thrugh the IRB review prcess, and hw t access apprved prtcls and crrespnding materials. Table f Cntents IRB REVIEW PROCESS OVERVIEW... 3 Descriptin f Stages... 3 ACCESSING IRBMANAGER... 5 Lg In t IRBManager... 5 CITI Training Updates... 5 IRBMANAGER DASHBOARD... 6 COMPONENTS OF A STUDY... 8 Study, Study Site & Events... 8 IRB APPLICATION PROCESS... 9 xfrm Types... 9 Rles, Permissins, Requirements & Expectatins... 9 Adding Cllabratrs SUBMITTING AN APPLICATION FOR A NEW STUDY Entering Study Persnnel Uplading Dcuments Frm Navigatin and Saving Submitting the xfrm STUDY STATUS & EVENT STEPS/STAGES AMENDMENTS CONTINUING REVIEW, MODIFICATION, OR CLOSURE AMENDMENTS FOR A STUDY PREVIOUSLY REVIEWED IN IRBMANAGER AMENDMENTS FOR A STUDY SUBMITTED FOR REVIEW PRIOR TO IRBMANAGER LAUNCH LOCATING APPROVED INFORMATION & MATERIALS Lcating Apprved Infrmatin & Materials fr Studies Apprved in IRBManager Lcating Previusly Apprved Infrmatin & Materials fr studies Apprved Prir t IRBManager Launch SUBMISSION AND USE TIPS IRB/Researcher s Guide t IRBManager 1

2 Persnnel Table Tips Dcument Naming Cnventins Files fr Uplad PDF f IRB Applicatin Ntificatins Summary f Ntes Infrmatin Requested by the IRB Office IRB/Researcher s Guide t IRBManager 2

3 IRB REVIEW PROCESS OVERVIEW The review prcess hasn t changed, it is just handled electrnically. An xfrm (IRB applicatin) is entered by the researchers in IRBManager. The submissin prcess invlves the xfrm mving thrugh stages f data entry and PI, Supervising Investigatr, and Department Chair reviews where the invlved parties agree t the assurances and sign ff n the xfrm. Fllwing agreement, the xfrm is ruted t the IRB ffice where IRB staff screen the applicatin t determine the level f review and cnduct IRB staff pre-review, fllwed by frmal IRB review. Lastly, the PI (and Supervising Investigatr) is ntified f the final utcme. Descriptin f Stages 1. Applicatin Data Entry Infrmatin abut the study is entered int the xfrm (IRB applicatin). Questins in the xfrm are cnditined such that nly relevant questins will be visible and required fr submissin. In this stage, researchers wrking n the study tgether may cllabrate n xfrm cmpletin. 2. PI Signature, Supervising Investigatr Signature, and Department Chair Signature The xfrm will be ruted thrugh the signature stages electrnically. An will be sent t ntify the apprpriate individual(s) f any actin that shuld be taken n the frm. The PI, then Supervising Investigatr (when necessary), and Department Chair must review assurances and electrnically sign in agreement. A COI Check ccurs befre the xfrm is ruted fr Department Chair signature. This intermediary stage requires verificatin f any Significant Financial Interest related t the research. The PI and any ISU faculty r P&S staff listed as persnnel in the applicatin will receive an with instructins n cmpleting this step. 3. IRB Staff Screening (Receive Submissin) IRB applicatin is screened by IRB staff t determine if it cntains the necessary infrmatin fr review and whether it is eligible fr Exemptin, Expedited, r Full Cmmittee review. Once IRB staff make this determinatin, an IRB ID is assigned and the xfrm and all materials are recgnized by the system as a Study. Cncurrently, an Event (Initial Submissin, Mdificatin, Cntinuing Review) will be established fr the xfrm (applicatin). This prcess is IRB/Researcher s Guide t IRBManager 3

4 similar t the IRB receiving a paper applicatin, assigning it an IRB ID, and placing it int a file. 4. IRB Staff Pre-Review r Full Cmmittee Pre-Review IRB staff cnduct a preliminary review f the xfrm (applicatin) t ensure it is cmplete and ready fr the final reviewer r the Full Cmmittee t cnduct the frmal review. 5. Exempt Review r Expedited Review The xfrm (applicatin) is directed t an assigned reviewer and underges frmal Exempt r Expedited review. 6. Assign t Full Bard Agenda fr Review The xfrm (applicatin) is assigned t a Full Cmmittee agenda. It is als assigned t a primary reviewer wh cnducts an in-depth review in preparatin fr final review by the cnvened IRB. 7. Ntify PI f Final Outcme The PI will be ntified f the final determinatin fr their study nce the review is cmplete. An ntificatin will be sent autmatically frm IRBManager infrming the PI and Supervising Investigatr that the determinatin letter and any apprved and stamped materials are available fr viewing and retrieval frm within IRBManager. Nte: The review prcess is fluid and an xfrm (applicatin) may be returned t the PI at any stage fr revisins r mre infrmatin. When this ccurs, an is sent t the Submitter, PI, Supervising Investigatr, and/r Department Chair t ntify them f any actin they need t take n an IRB applicatin. IRB/Researcher s Guide t IRBManager 4

5 ACCESSING IRBMANAGER All persnnel must lg int IRBManager using their ISU NetID and passwrd ne time t establish themselves as a cntact in the system befre they can be added t IRB applicatins. Individuals will be autmatically established as a cntact after lgging int the system nce there are n additinal frms t cmplete fr ISUaffiliated persns. We strngly advise having all study persnnel lg int IRBManager nce, if they have nt dne s already, befre yu cmplete an IRB applicatin. Lg In t IRBManager Username: ISU netid Passwrd: ISU passwrd CITI Training Updates Human Subjects Training thrugh CITI must be cmplete fr all persnnel in rder t submit the IRB Applicatin. If the CITI training shws as Missing within the applicatin, there are a cuple f reasns this may ccur. The individual has nt cmpleted all mdules fr the Scial/Behaviral Research Curse r Bimedical Research Curse t meet the human subjects training requirement in CITI. The individual signed in fr the first time the day f applicatin cmpletin. CITI training recrds are updated in IRBManager vernight. IRBManager recgnizes training in CITI that is taken by individuals wh dcumented their affiliatin with ISU and used their ISU t set up their CITI accunt. If the individual s cntact is created after the CITI update fr the day, training is cmplete, and their training is listed as Missing in the IRB applicatin, please wait until IRBManager is updated vernight befre submitting yur applicatin. If after the vernight update the training still shws as Missing, please cntact the IRB ffice. IRB/Researcher s Guide t IRBManager 5

6 IRBMANAGER DASHBOARD The dashbard is the hub f the xfrms (applicatins) and the landing page when lgging in t IRBManager. Studies and Events that individuals are assciated with can be lcated here. Areas f the Dashbard Find Study This field is used t lcate specific studies the main flder hlding all applicatins. Studies are cnsidered the verall prject and cntain Events (e.g., mdificatin, cntinuing review, etc.) and xfrms (applicatins). This field des nt lcate individual xfrms (applicatins) My Settings The settings within this link include Change My Passwrd, My Expiratins, amng ther persnal details fr yur IRBManager accunt. Actins The main actins that will ccur in IRBManager will be listed here. Submit an IRB Applicatin fr a New Study Shw Spnsr s Study ID (rarely will this be used as the majrity f studies the IRB reviews are nt funded). Recent Items This area lists the items that have been accessed mst recently. IRB/Researcher s Guide t IRBManager 6

7 Messages Used by IRB t relay key infrmatin. Useful Links "Hw T" guidance, infrmatin and/r tutrials My Dcuments & Frms User Attachments dcuments may be upladed here s they are easy t find. Examples may include: Cpy f a grant that cvers multiple studies Dcument templates that may be used n multiple studies xfrms the IRB applicatins that yu have initiated (as the submitter). Ntices Used by the IRB t relay frequently requested infrmatin r special ntificatins. Full Cmmittee meeting schedule Submit a New Study buttn My Studies Studies (Active Studies) The studies yu are assciated with The studies yu are listed as PI, C-I, Supervising Investigatr, r Investigative Staff Studies expiring in the next 90 days The next study that will expire xfrms (Active xfrms) The number f unsubmitted xfrms The number being prcessed at a later stage (after data entry) xfrms awaiting yur attentin Events (Open Events) The number f events yu have pen and the types Initial Submissin, etc. Nte: Pie Chart shws the types f Events that are pen IRB/Researcher s Guide t IRBManager 7

8 COMPONENTS OF A STUDY The IRBManager system acts as a filing system cntaining study infrmatin, xfrms (IRB applicatins), cmmunicatin dcuments, study status infrmatin, etc. Study, Study Site & Events These are the cmpnents that make up an entire prject within IRBManager. xfrm Pages Event Study Site Study IRB Applicatin Frm Sectins within the xfrm (applicatin) Type f Submissin (e.g., Cnversin histrical event infrmatin, Initial Submissin, Mdificatin, Cntinuing Review, Adverse Event, etc.) Detailed Study Infrmatin (e.g., apprval dates, expiratins, enrllment status, etc.) General Study Infrmatin (e.g., title, IRB ID, exempt r expedited determinatin, spnsrs, etc.) Acts as a flder that cntains all infrmatin abut the prject. IRB/Researcher s Guide t IRBManager 8

9 IRB APPLICATION PROCESS xfrm Types IRB Applicatin A new study requiring IRB review may be submitted by cmpleting the IRB Applicatin xfrm. This frm may be started by lcating the Submit an IRB Applicatin fr a NEW Study link r the Submit a New Study buttn n the dashbard. The IRB Applicatin xfrm is used fr Initial Submissin as well as any Cntinuing Review r Mdificatins t the Study. Other types f xfrms are in develpment (e.g., Adverse Event reprts, Preliminary Determinatin, etc.) and will be available in the near future. Rles, Permissins, Requirements & Expectatins Submitting User - individual wh initiates the frm. It may r may nt be the PI n the prject. Cllabratr - individuals with access t the stage that the frm is in - they can be added using the cllabratr link and prvided with ptins fr access (edit, manage, submit, etc.) and an will autmatically be sent t them infrming them that they have access t the xfrm. PI - Principal Investigatr Supervising Investigatr - individual wh is supervising the prject fr student prjects, r wh will be the C-investigatr fr individuals nt eligible t serve as PI alne (per the VPR PI Eligibility guidelines) ISU Faculty r P&S Staff Investigatrs individuals including ISU Faculty r P&S Staff wh may be C- Investigatrs respnsible fr the study, r ther persnnel that are cnsidered ISU P&S Staff r Faculty wrking n the study. Other Individuals - individuals wrking n the study, but are nt ISU P&S Staff r Faculty. This includes research assistants, student persnnel, hurly staff, transcribers, cders, etc. Nn-ISU/Unaffiliated Investigatrs/Researchers - individuals wh are nt affiliated with ISU wh are wrking n the study, r wh may be respnsible fr study prcedures at their wn institutin. IRB/Researcher s Guide t IRBManager 9

10 Adding Cllabratrs The submitter f an xfrm will need t add the PI and Supervising Investigatr as cllabratrs n the study with edit, manage, submit capabilities at the beginning f the data entry stage t allw them t access the xfrm and cntribute t the applicatin s cmpletin. Cllabratr permissin is nt autmatically given t thers besides the submitter during data entry. Since they are als respnsible fr the Study, they shuld have this access. Yu will need t grant them this access manually. The cllabratrs that are added at any stage are nt retained nce ut f that stage in this instance, the data entry stage. Nte: When a frm is returned t the submitter frm a later stage - such as when the IRB ffice returns the frm fr mre infrmatin the system is set up t include the PI and Supervising Investigatr as cllabratrs. As a reminder, this des nt happen befre the frm is submitted t the IRB the first time, s the submitter will need t add thse peple and any additinal cllabratrs they wish t include. IRB/Researcher s Guide t IRBManager 10

11 SUBMITTING AN APPLICATION FOR A NEW STUDY Frm the Dashbard click n Submit an IRB Applicatin fr a New Study. A blank xfrm will be available fr cmpletin. The frm is cnditined t shw and hide questins based n infrmatin entered. A drp-dwn menu at the tp f the frm allws users t quickly mve between sectins. Hwever, we recmmend cmpleting the frm in rder as additinal questins appear thrughut the frm based n respnses t questins n prir pages. Entering Study Persnnel Study persnnel (including the PI and Supervising Investigatr) are listed by entering their ISU address int relevant fields in the frm. The Key Persnnel sectin includes prmpts fr infrmatin abut each individual s rle in the study. Click Add (n the right side f the table) t save each entry. IMPORTANT: If an ISU affiliated individual is nt recgnized when their address is entered, they must lg in t IRBManager using their ISU credentials ne time. Lgging in t IRBManager ne time establishes individuals as an ISU cntact in the system. Fr persns wh d nt have an ISU address, the frm includes the ptin t Add Nn-ISU Cntact in the Key Persnnel sectin. IRBManager autmatically verifies human subjects training fr all study persnnel. Training thrugh the CITI mdules must be cmplete fr all study persnnel befre the xfrm may be submitted. IMPORTANT: If CITI training is Missing, please see the guidance n CITI Training Updates. Uplading Dcuments Dcuments, such as infrmed cnsent dcuments, data cllectin materials, recruitment materials, grant prpsals, etc., are upladed in relevant sectins f the xfrm. Infrmed cnsent frms and recruitment materials must be a Wrd dcument r PDF. See the Submissin Tips at the end f this guide fr imprtant infrmatin regarding uplading dcuments. IRB/Researcher s Guide t IRBManager 11

12 Frm Navigatin and Saving At the tp f the page is a drp-dwn menu that allws users t quickly mve between sectins f the frm. The system aut-saves cntent befre mving t anther sectin when this drp dwn menu is used. At the bttm f the page, several ptins are available. Clicking Next saves cntent and navigates t the next page in the xfrm. Users may als Save fr Later clicking this will save cntent and clse the xfrm. Submitting the xfrm When the frm is cmplete, be sure t click Submit. If yu clse the brwser r save withut submitting, the frm will nt rute t the next stage. IRB/Researcher s Guide t IRBManager 12

13 STUDY STATUS & EVENT STEPS/STAGES These are sme f the indicatrs shwing an xfrm s lcatin in the review prcess, and if the prcedures f a Study may cmmence. Study Status The status f the IRB s determinatin (details lcated under the study site) Cnversin Indicates the study was imprted int IRBManager. New frm PI (under IRB review) Study is underging the review prcess and a determinatin has NOT yet been made. Open t Enrllment - Apprval/Determinatin is granted and human subjects research prcedures including recruitment, data cllectin, etc. may cmmence. Data Analysis Only The remaining human subjects research prcedures nly invlve analysis f private and identifiable data. Withdrawn - PI Directed Study is Nt Apprved as the PI requested t withdraw the IRB applicatin. Withdrawn - PI Nn-Respnse IRB returned the applicatin t Applicatin Data Entry fr mre infrmatin and PI did nt respnd t the request in the requested timeframe. Clsed - Apprval Lapsed An IRB applicatin was nt submitted and reviewed prir t the cntinuing review date. The Study is cnsidered Administratively Clsed until apprval is reinstated. Clsed - PI Directed The PI requests the Study t be clsed. Apprval Suspended (rarely used) Apprval Terminated (rarely used) Disapprved by IRB Cmmittee (rarely used) Event Steps/Stages Where the xfrm is in the review prcess (details lcated under the event) Receive Submissin The IRB applicatin is in the hands f the IRB and cnsidered received. Staff Pre-Review The IRB applicatin is sent t the IRB staff t ensure applicatin is ready fr final review. IRB/Researcher s Guide t IRBManager 13

14 Exempt Review The IRB applicatin is sent t an Exempt reviewer fr review. Expedited/IRB Chair Review The IRB applicatin is sent t the IRB Chair fr expedited review. This step/stage refers t the determinatin categry, nt speed. Assign t Full Bard Agenda fr Review The IRB applicatin is added t a Full Bard agenda fr the Full Cmmittee review. Ntify PI f Final Outcme This is the step/stage that the PI will be ntified f the IRB determinatin. Ntify Full Bard f Apprval/Cmmittee Determinatin This step/stage is an infrmatinal ntice t the IRB Full Cmmittee nly t ntify the members f the final determinatin f the Study. IRB/Researcher s Guide t IRBManager 14

15 AMENDMENTS CONTINUING REVIEW, MODIFICATION, OR CLOSURE IRBManager allws researchers easy access t current and cmplete study infrmatin. The mst recent xfrm (IRB applicatin) prvides a clear picture f cmplete apprved prtcl at any given time. Additinally, having a fully cmplete xfrm will make prcessing subsequent amendments simpler. Amendments t a Study include: cntinuing review, cntinuing review with mdificatin, mdificatin, r clsure. The first xfrm IRB Applicatin submitted fr the study is called the Initial Submissin. T seek apprval f mdificatins r submit a request fr cntinuing review r clsure, the mst recent apprved xfrm (IRB Applicatin) must be cpied fr amendment and changes made within that cpied frm. The cpied frm is a cmplete cpy f the previusly apprved xfrm; thus, the entire xfrm des nt need t be cmpleted again. Hwever, sme new questins may appear depending n the type f amendment (cntinuing review, mdificatin, clsure), r if changes are made t answers within the frm. The questins in the xfrm are prgrammed t skip unnecessary questins, yet shw new questins when needed. This sectin f the guide prvides instructins fr the Amendment prcess. AMENDMENTS FOR A STUDY PREVIOUSLY REVIEWED IN IRBMANAGER Tip: Check the Study Status befre cnsidering an amendment. A study status f Open t Enrllment indicates that an Apprval/Determinatin is granted and human subjects research prcedures including recruitment, data cllectin, etc. may cmmence. Any changes must be submitted t the IRB fr review and an apprval/determinatin granted prir t implementatin. A study status f New frm PI (under IRB review) indicates the study is underging the review prcess and a determinatin has NOT yet been made. T request changes befre the review is cmplete, please cntact the IRB ffice t have the xfrm returned t yu. A study still under IRB review cannt be amended. Step 1: Lcate the Study t be clsed, mdified r submitted fr a cntinuing review. Step 2: Click n the IRB ID t pen the Study details. Step 3: Lcate the mst recent reviewed Event fr the Study (Initial Submissin, Mdificatin, Cntinuing Review, r Cntinuing Review with Mdificatin). Step 4: Click n the Event t pen the Event details. Step 5: Click n the xfrms n the left menu (within the Event details screen). The screen shuld shw the xfrm that was reviewed with the Stage/Status marked as cmplete. Step 6: In rder t have an updated prtcl that includes all research plans at any pint in time, mdificatins and cntinuing review frms will be prcessed using a "Cpy fr Amendment" functin in the system. This IRB/Researcher s Guide t IRBManager 15

16 allws a cpy f the previusly apprved frm t be revised and include all current research prcedures. Click n the flder icn t the left f the xfrm name. This will create a Cpy fr Amendment that can be edited. Nte: Tw xfrms will nw be listed under the event. The cpied xfrm (nt cmplete and withut the flder icn next t it) is the ne t wrk with. It will remain under that Event until it is sent t the IRB fr review and determined that it is ready fr review as a New Event (Cntinuing Review, Cntinuing Review with Mdificatin, Mdificatin, r Clsure). It may mre easily be lcated under the xfrms link under My Dcuments & Frms, r within the unsubmitted xfrms ttal under My Studies xfrms n the dashbard. Step 7: Within the xfrm, select the type f applicatin. The first page f the xfrm will indicate it is a nninitial submissin and the applicatin type shuld be selected (cntinuing review, mdificatin, clsure bth cntinuing review and mdificatin may be selected when mdifying a study in cnjunctin with renewing apprval). Step 8: As with an Initial Submissin, add cllabratrs (PI, Supervising Investigatr) t the xfrm s that the apprpriate individuals have access t the frm in this stage. Step 9: Finish cmpleting the frm. IRB/Researcher s Guide t IRBManager 16

17 AMENDMENTS FOR A STUDY SUBMITTED FOR REVIEW PRIOR TO IRBMANAGER LAUNCH Tip: Basic prtcl infrmatin abut studies submitted utside f IRBManager will be available in IRBManager. Studies can be lcated by searching using the IRB ID number assigned t it at the time f review. These studies will have a study status f Cnversin indicating that basic prtcl infrmatin was imprted. Step 1: Lcate the Study t be clsed, mdified r submitted fr a cntinuing review. Step 2: Click n the IRB ID t pen the Study details. Step 3: In the Actins menu n the left, click n Start xfrms t access the Pre-IRBManager Amendment Frm. Step 4: The Pre-IRBManager Amendment frm includes a link t a blank IRB Applicatin yu will need t cmplete. Step 5: Within the xfrm, select the type f applicatin. The first page f the xfrm will indicate it is a nninitial submissin and the applicatin type shuld be selected (cntinuing review, mdificatin, clsure bth cntinuing review and mdificatin may be selected when mdifying a study in cnjunctin with renewing apprval). Step 6: As with an Initial Submissin, add cllabratrs (PI, Supervising Investigatr) t the xfrm s that the apprpriate individuals have access t the frm in this stage. Step 7: Finish cmpleting the frm. IRB/Researcher s Guide t IRBManager 17

18 LOCATING APPROVED INFORMATION & MATERIALS IRBManager will stre all study infrmatin and materials. Basic study infrmatin is visible when selecting the study t view. Upladed materials, final apprved materials, determinatin letters, etc. are stred under the Actins menu within each event (i.e., Initial Submissin, Cntinuing Review, Histrical Attachments, etc.) fr the study. Lcating Apprved Infrmatin & Materials fr Studies Apprved in IRBManager Apprved materials are lcated within each Event under the Actins menu. Apprved Dcuments are lcated under Attachments. Apprved IRB Applicatins are lcated under xfrms Clean cpies f materials are lcated as links within the apprved xfrm Lcating Previusly Apprved Infrmatin & Materials fr Studies Apprved Prir t IRBManager Launch An event called Histrical Attachments will be available under the Study. At the time f cntinuing review r mdificatin, if access t the previusly apprved materials is needed, cntact the IRB Office. IRB apprved prtcls, determinatin letters, r related dcuments fr these studies are lcated under Attachments. IRB/Researcher s Guide t IRBManager 18

19 SUBMISSION AND USE TIPS Persnnel Table Tips Cmplete the Persnnel Tables apprpriately and use the Add Cntact frm fr nn-isu persnnel when necessary. When adding a nn-isu cntact, a cnfirmatin will be sent t the submitter. Once the is received, the cntact may be added t the frm. Human Subjects Training must be cmplete befre the applicatin may be submitted. Dcument Naming Cnventins Use cnsistent naming cnventins fr dcuments. Using the same filename fr a dcument when replacing the previus versin is helpful t the reviewer s that it is clear what was replaced. The dcument name may include versin number r dates, but maintaining the descriptive part f the name (e.g., child_assent_letter.dc, parental_cnsent_letter.dc, etc.) is requested. Files fr Uplad Files fr uplad shuld nly cntain ne dcument type. The file that will be upladed shuld nly cntain what is requested in the particular questin. Fr instance, when uplading data cllectin materials, d nt include r attach cnsent r recruitment dcuments within the file. If mre than ne type f data cllectin materials will be used (e.g., survey questins, interview questins, etc.), uplad them separately. Apprval stamps are applied t materials based n the file type. If cnsent materials are included within data cllectin materials files, they will nt be stamped. The IRB expects that stamped versins f the dcuments will be used in the recruitment and cnsent prcess. Infrmed cnsent dcuments and recruitment materials are nt nrmally required fr initial review f exempt research. PDF f IRB Applicatin PDF f the xfrm is available fr dwnlad at the bttm f the pened xfrm. The cmpleted xfrm may be saved as a PDF fr ease f cllabratin and recrd-keeping. IRB/Researcher s Guide t IRBManager 19

20 Ntificatins IRBManager sends autmated ntificatins t thse that shuld take the next actin n an IRB applicatin. A link t the IRB applicatin is prvided within the fr ease f accessing the frm. Sme examples include: Ntifying the Supervising Investigatr t review an applicatin fr which the PI is nt eligible t serve as PI alne. Ntifying persnnel t cnfirm any Significant Financial Interests related t the research. Ntifying Department Chairs when an applicatin is ready fr departmental review. Ntifying investigatrs when the IRB is requesting additinal infrmatin r actin n their IRB applicatin. The will be sent t the Submitter, PI, and Supervising Investigatr. Ntifying investigatrs f upcming Study expiratins that require cntinuing review. The will be sent t the Submitter, PI, Supervising Investigatr, and C-Investigatrs. Ntifying investigatrs when apprval has lapsed and the study is clsed. The will be sent t the Submitter, PI, Supervising Investigatr, and C-Investigatrs. Summary f Ntes Ntes may be added in the xfrm. Ntes are essentially electrnic sticky-ntes; using this feature allws easy cmmunicatin between researchers and IRB Staff (r any thers wrking n the xfrm). Ntes can be added and remved as needed; ntes remved by the research team prir t submissin will nt be available t IRB Staff. An ptin t view a summary f the ntes n the frm is available, which is helpful when cllabrating n the Applicatin Data Entry stage f the frm, r when the IRB returns the xfrm t the submitter fr additinal infrmatin. Infrmatin Requested by the IRB Office The xfrm may be returned t the Applicatin Data Entry stage during the review prcess fr additinal infrmatin requested by the IRB ffice An will be sent t the submitter, PI, and Supervising Investigatr infrming them that the IRB requests mre infrmatin. Ntes will be prvided within the xfrm alngside the questin(s) they pertain t with detailed infrmatin abut the requests. In additin t updating the questins as necessary, ntes may be added by the submitter, PI, r Supervising Investigatr fr clarificatin in respnse t the IRB s requests. IRB/Researcher s Guide t IRBManager 20