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Rowan University eIRB User Manual for Committee Members

1. 0 Research at Rowan Univers Page for Patricia Gessner Edit View x M v 3 d v Pagev Safety Toos jj A l 2 Cas Bhow Errors Print Jump To 1 Study identification D Reviewer Notes Add Delete Next Z 4 Study Identification Type va 1 Study Identification Dale There are no it 1 2 IRB Researcher Training Records 2 1 3 Conflict of Interest 1 4 Required Departmental Omsion Rewews 11 1 5 Review Help 1 0 Study Identification IRB Glassboro CMSRU This is the first step in your Research Application You will be automatically guided to the appropriate forms needed to complet 1 0 Select the type of submission for your study 3 Review Type Risk Determination Research Protocol Study 3 0 Review Type Risk Determination Facilitated Review Emergency Permission 4 Study Funding 4 0 Study Funding Humanitarian Use Device HUD Quality Assurance Quality Improvement Only Western IRB WIRB 4 1 Adding Sponsors 4 2 Other Funding Source 4A 7h cere 734 8 8 cd 20 Full Title of Research Middle school children and bullying 3 0 Short Title Study Name bullying among middle school 4 0 Principal Investigator PIGlassboro Test 5 0 Study Coordinator 6 0 Co Investigators Last Name First Name Department Division Institutional Status On Probation Done J Trusted
2. File Edit View Favorites Tools Help sly Favorites Rowan University S amp Page for Patricia G Internet Explorer ca amp TEST SITE eIRB Ho Glassboro CMS x RowanSOM Huma TEST SITEeIRBHome IRB Studies User Profiles Meetings gt Glassboro CMSRU Board 1 meeting on 5 9 2014 Current State dateCreated 4 14 2014 3 25 PM SCHEDULED Glassboro CMSRU Board 1 meeting on 5 9 2014 Oy View Meeting Agenda Committee E a Start Time IM Location 2 Meeting Agenda View Meeting Agenda E Meeting Agenda My Activities _ D Confirm Attendance Attendees ltemstoProcess History Log H Decline Attendance g Send Email to IRBA Minutes of Previous Meetings to be approved Meeting Glassboro CMSRU Board 1 meeting on 5 2 2014 Confirm Attendance Link to Meeting Mee00000244 S items submitted online Title Work Space b display Decline Attendance M ms miscellaneous or executive committee agenda items that have no electronic record Type Name Processed There are no items to display Reported Items Exempt Expedited items which have been approved Project PI Title Type Submission Type There are no items to display Expired Studies Type Title PI Work Space There are no items to display Confirmed Attendees 0 v v 3 E Page v Safety v Tools v 9 00 Glas
3. If you Acknowledge the continuing review a box will open allowing you to make comments or add documents Click OK to begin review process Auc kmowerledge Rewiew Comments Iwill do the review Add Documents Name There are no items to display Version 1 dated 6 2 2014 Description 20 Rowan Qg University When you view the Continuing Review in its smart form version you can use the Jump to menu and add review notes in the same way as a new study After you have added all your reviewer notes to the smart form exit the study and submit e Any additional notes e Add any documents e Select Review Motion e Check off Review Complete e Submit review by selecting OK T Back Exit Hide Show Errors Print Jump To 1 0 Study Status Continu 7 Reviewer Note Type Reviewer Date Created Date Modified There are no items to display Continuing Review Final Report Study ID Pro2014000054 Study Name sstest study Glassboro 1 0 Type of Report Continuing Report 2 0 Please indicate which of the following applies to your study Check all that apply Records Specimens Subject Interaction or Intervention IRB Researcher Training Records The following information is a read only view taken from your currently approved training records on your researcher profile e Verify that the information below is correct e Contact your local IRB offic
4. No Clear Version 1 dated 6 2 2014 23 Rowan Qg University Reviewing a Study Modification Study modifications are different from other workspace views within elRB since there are several steps that study staff must take to initiate the activity Each step in the process has its own workspace the Modification Request comes first followed by the changes applied to a Modified Study To view the Modification workspace click the name of the modification listed under My Inbox TEST SITEeIRB Home IRB Studies User Profiles Page for IRBCommitteeMemberSlassboro Test Current Role Page for IRBCommitteeMemberGlassboro Test COMMITTEE MEMBER Welcome to your Personal Folder the central resource for managing your Study applications Your Personal Folder provides all the tools you need in order to complete your role in the Study My Roles application process Use the following guidelines to process your Studies When you are using elRB you must tell the system which ROLE you Complete reviews for all items in your inbox by clicking on the study name want to work in Meetings for your committee are listed on the Upcoming Meetings tab Committee Member A listing of prior reviews is located in the All submissions tab My Committees 4 Name Glassbora CMSRU Board 1 Ndi 1010117 vl 100 Filter by ID Clear Advanced ID Name Date Modified Type State Campus Study 5 21 2014 2 52 PM
5. Changed Review Type Test RouterlRBAStratfordWIRBGlassboro 5 21 2014 2 51 PM EDT REVIEWER CHECKLIST FOR MODIFICATIONS When completing this form please note if the modification impacts any of the regulatory criteria for IRB approval 1 Is the modification being requested a minor change in the previously approved research i e Minor Revisions to approved research expedited procedure set forth in 45 CFR 46 110b2 and or 21 CFR 55 110 52 Yes Clear NOTE If NO modification is not eligible for expedited review 2 If the consent form has been revised is re consenting of previously enrolled subjects required Yes No NA Clear 3 Has the Risk Benefit ratio changed because of this change Yes No Clear 4 Do the proposed changes have any impact on vulnerable population requirements Yes No Clear Version 1 dated 6 2 2014 Rowan University _ E 2 http sttsomeirbstg01 rowan edu test Rooms DisplayPages Layoutlnitial Container com webridge entity Entity OID FF329A2CDBE4344E92D1A0ADAS866E12E File Edit View Favorites Tools Help ly Favorites 99 Rowan Uni 9 RowanSOM Huma Rowan University S Page for Patricia G Internet Explorer ca TEST SITE eIRB Ho Modification 2 f x TEST SITE elRB Home IRB Studies User Profiles IRB Studies gt sstest study Glassboro gt Modifi
6. Co Investigators Who Have Not Accepted Participation Left Navigation Bar Attachments Stamped Documents g Children Reviewer Checklist for Initial Review m Activity v Reviewer Checklist Consent IRBA Forwarded to Expedited Review Submit Review IRBA Assigned to Glassboro CMSRU Board 1 IRBA IRB Administrator Ownership Re assigned Filter by Activity Selected IRB Committee Assigned To Committee El Assigned to RouterlRBAStratfordWIRBGlassboro Test Dept Study Approved By Department PI Study Submitted for Review Created Study Study bullying among middle school Pro2014000057 Glassboro CMSRU m Department Review Circes D Pre Submission Cds IRB Review Post Review Complete 8 Display Reviewer Notes 7 Clarifications Clarifications Clarifications e Log Private Comment piena Required Department Approvals Reviewer Notes 30 children and their responses to questionnaire PiGlassboro Test Paid Faculty IRB Admin Glassboro CMSRU Board 1 Review Type Research Protocol Study Sponsor Co Investigators Who Have Declined Participation There are no items to display E Reviews ChangeLog 3 Advanced Author Test RouterlRBAStratfordWIRBGlassboro Test RouterlRBAStratfordWIRBGlassboro Test RouterlRBAStratfordWIRBGlassboro Test ApproverGlassboro Test PlGlassboro Test PlGlassboro RouterlRBA
7. Committee Glassboro CMSRU Board 1 Review Type Type of Submission Research Protocol Study Sponsor Co Investigators Who Have Not Accepted Participation Co Investigators Who Have Declined Participation RouterlRBAStratfordWIRBGlassboro Test Expedited There are no items to display View Differences E There are no items to display My Activities Display Reviewer Notes e Log Private Comment Reviewer Checklist for Expedited Review Categories Reviewer Checklist for Research Involving Children Clarifications Requested Attachments Stamped Documents Department Appro Reviewer Notes TN iews Reviewer Checklist for Initial Filter by Activity o Advanced Sa S MI Activity Author History Attachments Stamped Documents Department Approvals Reviewer Notes Reviews Change Log Filter by Type Clear Advanced Type O Committee Member Change Request Jump To 1 Study Identification Please add all co investigators that are listed on the Financial Disclosure Form Committee Member Change Request Jump To 7 0 Study Summary Protocol Section 1 The protocol and survey must contact a version date and pagination in a footer on each page of the document L Committee Member Change Request Jump To 5 01 Non RowanSOM Study Locations There are no items to display Activity Date Date 7 Date Created Modified IRBCommitteeMemberGlassboro 5 21 2014
8. Advanced CM Defer Review or a Activity Date IRBA E Print Frien d ly Stu dy RouterlRBAStratfordWIRBGlassboro 5 21 2014 2 51 PM EDT IRBA RouterlRBAStratfordWIRBGlass boro 5 21 2014 2 51 PM EDT View Changes RouterlRBAStratfordWIRBGlassboro 5 21 2014 2 51 PM EDT pdification Test PIGlassboro 5 21 2014 2 50 PM EDT Acknowledge Review ification Test PiGlassboro 5 21 2014 2 42 PM EDT Defer Review The Modification workspace contains the same Printer Version and header description as a new study You must Acknowledge or Defer the review to begin and click OK in new window that opens nttp sttsomeirbstqU1 rowan edu TActivityType comwebridgecntity Entiryo SBOIDSSSBCEDOFEASESDGA Windows Interner 8 Acknowledge Review Comments Attach Documents Mame Description There are no items to display C Cancel 25 Version 1 dated 6 2 2014 Rowan Qg University Viewing the Modification Click View Modification to open the Modification smart form The Modification will contain information about the proposed changes to a study The actual changes to the study are accessed through View Modified Study Exit Hide Show Errors Print Jump To Modification Request Exit Hide Show Errors Print Jump To Continue gt gt v Reviewer Note Maa Hon Sobitantie Change Juitblcatos Type Date Created Date Modifie
9. Display Reviewer fotes Filter by Activity Y Clear Advanced Activity Author 7 Activity Date Forwarded to Expedited Review Test RouterlRBAStratfordWIRBGlassboro 5 22 2014 3 28 PM EDT Acknowledge Review Changed Review Type Test RouterlRBAStratfordWIRBGlassboro 5 22 2014 3 28 PM EDT Defer Review Review Type Expedited Re assigned Owner Test RouterIRBAStratfordWIRBGlassboro 5 22 2014 3 27 PM EDT c Submitted Report Test PlGlassboro 5 22 2014 3 26 PM EDT Created Reportable Event Test PlGlassboro 5 22 2014 3 25 PM EDT Jo Trusted sites Protected Mode On fg v 910 The process for reviewing a Reportable Event is the same as the previous submission examples e Decide whether to Acknowledge or Defer the Reportable Event e View the Reportable Event by selecting View Reportable Event e Add Reviewer Notes in the same manner as before within the smart form application Version 1 dated 6 2 2014 37 Rowan Qg University Submit Reportable Event IRB Studies IRB Studies gt sstest study Glassboro gt SubjectID 130 Current State IN REVIEW Reportable Event Subject ID 130 REO0000177 Pro2014000054 Glassboro CMSRU id Principal Investigator DiClasshara D View Reportable Event Department E alas SUBMIT RE WE Study Title View Differences y This is your final step in the review process Related Modif
10. ED x _ uu http sttsomeirbstg01 rowan edu test ResourceAdministration Project ProjectEditor Mode smartform amp Project com webridge entity Entity OID 8112EC946401EB4AA71550A52 HA A b Bing P File Edit View Favorites Tools Help sly Favorites 38 Exit Hide Show Errors Print Jump FinalPage There are no items to display Help Final Page m Submission Type Research Protocol Study Review Type Requested Full IRB Review Submission ID MS2 Pro2014000054 Next Steps Submit study for IRB review Your application form will not be submitted for review until the Princi pal Investigator returns to the study workspace and clicks on Submit Study You can track the status of this study s submission by logging into the study workspace To submit the study Ensure that you have answered all questions in the application and all sections are error free e Click Finish to exit the application and return to the workspace e Navigate to the left of your screen and under My Activities click Submit Study to initiate IRB review Note All co investigators listed in this study must also agree to participate in the study priorto submission They will be required to log into this workspace and click on Agree to Participate Done of Trusted sites Protected Mode On 100 33 Version 1 dated
11. b submits clarifications or additional documents such that based on the assumption that the stipulations are satisfied the IRB is able to make a determination that the stipulation s are met 43 Version 1 dated 6 2 2014 Rowan Qg University Applicability Stipulations mandated by the IRB may prohibit the investigator s from conducting or initiating certain aspects of the study Stipulations may only be removed by submitting corresponding documents for review by the IRB Approval will only be granted if the IRB determines that the supporting documents satisfactorily address the stipulations Examples are Approval notices from other IRBs COCs letters of agreement Approval Denied The IRB determines that based on all applicable federal regulations the research cannot be approved Research activities may not be conducted at Rowan or by Rowan s employees or agents Tabled The IRB determines that there are major substantive issues that must be resolved or there is a lack of sufficient information about the research to proceed with its review The IRB review may not proceed and approval may not be granted until the convened IRB has approved a revised application incorporating all requested information or changes Applicability For this level of review the changes required are major and complex the protocol is judged to have serious problems or lack sufficient information for the committee to appropriately assess the ris
12. 6 2 2014 Rowan Qg University IRB Studies IRB Studies gt sstest study Glassboro gt Modification 2 for IRB Study 2014000054 Current State Modification Modification 2 for IRB Study Pro2014000054 Mod201400000002 Glassboro CMSRU IN REVIEW Description we would like to add additional questions to the questionnaire The protocol has been revised to reflect the changes Study Title Full title sstest study LIE Modification Principal Investigator PlGlassboro Test Study Coordinator E Print Friendly Modification Original Study ID 2014000054 Committee Glassboro CMSRU Board 1 Review Type Expedited Meeting E View Modified Study Co Investigators Who Have Not Accepted Participation Co Investigators Who Have Declined Participation E PrintFriendly study There no items to display There are no items to display View Changes Action Letter My Activities Log Private Comment Reviewer Checklist Filter by Activity Clear Advanced Modification Attachments Stamped Documents Continuing Reviews ReviewerNotes ChangeLog Activity Author Activity Date Forward to Expedited Review Test RouterlRBAStratfordWIRBGlassboro 5 21 2014 2 51 PM EDT IRBA Selected IRB Committee Test RouterlRBAStratfordWIRBGlassboro 5 21 2014 2 51 PM EDT i zi Assigned to Glassboro CMSRU Board 1 Complete Reviewer Checklist Modification
13. Created Study Test PlGlassboro 3 28 2014 11 03 AM EDT Version 1 dated 6 2 2014 Rowan Qg University Printer Version The printer version allows reviewers to preview all questions and answers presented to and answered by study staff Additionally any files uploaded into the form appear as clickable links within the printer view You may print or close the printer view by selecting the two buttons at the top of the page You may also save the page by selecting File then Save As in your internet browser Print Pro20140000 ing a Go 12 http sttsomeirbstg01 rowan edu test ResourceAdministration Project PrintSmartForms Project com webridge entity Entity 5BOID SBBEEC3AEDB2B8854 CB22FGEA9E74883A0 v ka p Xx b Bing Favorites 5 88 z o Home Rowan University Q9 RowanSOM Human Subje Research at Rowan Univers Page for Patricia Gessner Print Pro2014000057 m 3 d v Pagev Safetyv Tool gt Date Wednesday May 21 2014 12 02 48 PM iew 1 Study Identification Information 1 0 Study Identification IRB Glassboro CM SRU This is the first step in your Research Application You will be automatically guided to the appropriate forms needed to complete your submission 1 0 Select the type of submission for your study Research Protocol Study Facilitated Review Emergency Permission Humanitarian
14. Modification In Review Glassbora CMSRU sstest study Glassboro 20195 Review for ProzU 14000054 Sima etl Eh 5 21 2014 12 41 PM E Pro2014000057 bullying among middle school 1 505 10 24 Version 1 dated 6 2 2014 Rowan Qg University Viewing the Modification Workspace The Modification workspace is where study staff initiates the form that describes the proposed changes the modification or Amendment Modification Modification 1 for IRB Study Pro2014000063 Glassboro T IRB Studies User Profiles IRB Studies gt sstest study 1 5 cues zurrent State Modification Modification 2 for IRB Study 2014000054 Mod201400000002 Glassboro CMSRU IN REVIEW Description we would like to add additional questions to the questionnaire The protocol has been revised to reflect the changes Study Title Full title sstest study Principal Investigator PlGlassboro Test Study Coordinator Print Friendly Modification Original Study ID Pro2014000054 Committee Glassboro CMSRU Board 1 Meeting Co Investigators Who Have Declined Participation ino items to display There are no items to display E view Modified Study E Print Friendly Study YE View Modification El Print Friendly Modification ES View Modified Study EJ view Changes Reviewer Notes Change Log Acknowledge Review CM
15. Workspace The Modified Study workspace looks similar to the original study workspace however you ll notice the title says Modified Study T Modified Study sstest study ur IRB Studies User Profiles IRB Studies gt sstest study Glassboro gt Modificatiog Or IRB Study 2014000054 gt sstest study Glassboro Modified Study sstest study Glassboro MS2 Pro2014000054 Glassboro CMSRU Current State Description est study summary MODIFICATION OPEN Principal Investigator PiGlassooro Test Study Coordinator Expiration Date 4 13 2015 Edit Study E Printer version Modification Mod201400000002 Letter View n My Activities Change Log 8 Display Reviewer Notes fee Revised Study Activity Author Activity Date tevised Study 9 Change Log Page 7 0 Study Summary Protocol Section 1 Test PlGlassboro 5 21 2014 2 49 PM EDT 4 On Page 7 0 Study Summary Protocol Section 1 To see the changes to a study Click on the View Differences button located on the left navigation pane 28 Version 1 dated 6 2 2014 Rowan Qg University View Differences The View Differences page enables reviewers to easily compare changes made to a study Currently Approved Pro2014000054 Proposed Modifications Number of modification s on this page Back to Change Log Aevious Next Number of modified page s urrently A
16. for IRBCommitteeMemberGlassboro Test COMMITTEE MEMBER Welcome to your Personal Folder the central resource for managing your Study applications Your Personal Folder provides all the tools you need in order to complete My Roles your role in the Study application process Use the following guidelines to process your Studies When you are using elRB you must tell the system which ROLE you Complete reviews for all items in your inbox by clicking on the study name want to work in Meetings for your committee are listed on the Upcoming Meetings tab Committee Member A listing of prior reviews is located in the All submissions tab My Committees i Name Upcoming Meetings Glassboro CMSRU Board 1 4010110 100 Filter by Name Clear Advanced Name Owner State Last State Change e Glassboro CMSRU Board 1 meeting on 8 14 2014 Administrator System Scheduled 5112 2014 2 38 PM Glassboro CMSRU Board 1 meeting on 7 16 2014 Administrator System scheduled 5 12 2014 2 38 PM Glassboro CMSRU Board 1 meeting on 6 12 2014 Administrator System Scheduled 5112 2014 2 37 PM 030137 Glassboro CMSRU Board 1 meeting on 6 12 2014 Administrator System Scheduled 5 12 2014 2 37 PM 39 Version 1 dated 6 2 2014 Rowan Qg University Viewing Meeting Agenda uw E http sttsomeirbstg 1 rowan edu test Rooms DisplayPages Layoutlnitial Containerz com webridge entity Entity
17. the Rowan elRB log in page from laptop or home computers as this may compromise the security of confidential information Do not share your Rowan elRB password Do not leave your computer unattended while working in the Rowan elRB e If possible do not print the Investigators Brochure the protocol or other study materials If you do print from the Rowan elRB take precautions to destroy the paper upon completion of your review Getting Help If you have problems need help or have questions about the Rowan elRB please contact the Rowan University IRB office Version 1 dated 6 2 2014 Rowan Qg University Designated Reviewer Workflow The Rowan elRB enables IRB members to conduct review of new studies progress reports study modifications and reportable events in an electronic environment that improves record keeping and reduces environmental impact There are three ways that reviewers may access submissions to the IRB 1 Login to the Rowan elRB and view the Inbox 2 Click on the link in email notifications 3 Go to the meeting agenda in the Rowan elRB This manual demonstrates the recommended process for designated reviewers e Login to the Rowan elRB e Select the submission you wish to review e Preview the study e Enter reviewer notes e Submit your review and upload the reviewer worksheet Email Notifications When a study has been assigned for you to review you will receive an email from http eirb
18. 2 Version 1 dated 6 2 2014 Rowan Qg University IRB Determinations Guide Approved The IRB determines that based upon all applicable federal regulations and a review of all submitted documents the research may proceed without any conditions An Approval notice will be issued at which time the research may be initiated or continued Approved with Conditions At the time the IRB reviews and approves a research study or proposed changes to a previously approved research study the IRB requires that before research begins as a condition of approval that the investigator a make specified changes to the research protocol or submitted document s or b submit clarifications or additional documents such that based on the assumption that the conditions are satisfied the IRB is able to make all of the determinations required for approval Applicability For this level of re review the clarifications changes required are minor for example revised language to be incorporated into consent documents clarification of information provided in the application or submission of training certificates for study personnel Approved with Stipulations The IRB is able to make all of the determinations required for approval of proposed research or changes as submitted with stipulations Research activities may be initiated or continued if the investigator either a adheres to the stipulation s as required by the IRB or
19. 43 APPROVE RR R 43 APPROVED WITH CONDITIONS cccsesecssessecscessecscessecescevscsceevacscavacsceavacsceavacseeavacauavavsceesecacaevacesvavsceueees 43 APPROVED WITH STIPULATIONS 43 APPROVAL DENIED eerte trente trente trente tenete 44 44 44 ADMINISTRATIVELY CLOSED cescssccesesssceseesececeevevsccevscecesvscesevscesavacessavavaceesavaceesacaesueavaceeetaseavaenevavacen 45 SUSPENDED D 45 REQUEST CHANGES CLARIFICATIONS 45 NO FURTHER ACTION REQUIRED ccccecesessscesessecesesssceseevevsceevavsceevavacsevavacsevavaceavavacesevacaeeavavacessaseevacaeeess 45 ACTION REQUIRED c cccsccesessesecesesvsceceevsvceevececcevscscavacescevavaesavavsesavacsevavacsesavacsesavacausavacacessavacessaeestacaeen 45 ACKNOWLEDGED 45 ESE O e E E EE 46 Version 1 dated 6 2 2014 Rowan Qg University elRB Access The website is available via any Internet connection anytime with a supported browser https eirb rowan edu Confidentiality While PHI is typically not included in the Rowan eirb studies there are study designs ideas methodology and other proprietary information for which IRB members are responsible for safeguarding Precautions should be taken to protect Rowan University information in the Rowan elRB Please protect this information in the following ways select the Remember Me feature of
20. 5 21 2014 Test 12 41PM 12 41PM Reviewer IRBCommitteeMemberGlassboro 5 21 2014 5 21 2014 Test 11 05AM 11 05 AM IRBCommitteeMemberGlassboro 5 21 2014 5 21 2014 Test 11 04AM 11 04 AM A summary of reviewer notes can be viewed from the Study Workspace under the Reviewer Notes tab Again these notes will only be visible for IRB staff and other reviewers Version 1 dated 6 2 2014 15 Rowan Qg University Complete Checklists When you have completed adding your reviewer notes you will also have to complete the reviewer checklists under My Activites n order to fill out the Reviewer s Checklist forms simply click on checklist on the left hand side My Activities Display Reviewer Notes D Ei Log Private Comment Reviewer Checklist for Expedited Review 2 Categories Reviewer Checklist for 3 Research Involving Children Reviewer Checklist for Initial Review Pew Reviewer Checklist Consent 4 CM Submit Review T L Complete the Reviewer checklist for Initial Review Complete the Reviewer Checklist for Expedited Review Categories Complete the Reviewer Checklist for Research Involving Children po pe pu Complete the Checklist for Consent if applicable Additional Checklists when applicable to the study are 1 Complete the Reviewer Checklist for Research involving Pregnant Women if a
21. 53BOID S5BBEECSTAEDBZBSBE e O Add Reviewer Notes Type Committee Member Change Request Note Lal Required 13 Version 1 dated 6 2 2014 Rowan Qg University Note Please restrict these notes to the item you would like changed or clarified on a given smart form page General comments about the study should be reserved for when you submit your review de Show Errors Print Jump 1 Study identification Advanced Reviewer IRBCommittee Test Committee Member Change Request Your reviewer note will become visible on the page it is related to by selecting the small black arrow on the left side of the yellow panel You may delete the note or add an additional note To edit the existing note click on the link Committee Member Change Request Once you have completed all reviewer notes for each appropriate smart form page select Exit at the top of the page to return to the Study Workspace 14 Version 1 dated 6 2 2014 Rowan Qg University Viewing Reviewer Notes T TEST SITE elRB Home IRB Studies User Profiles IRB Studies gt bullying among middle school Current State IN REVIEW E view Study Printer version Study bullying among middle school Pro2014000057 Glassboro CMSRU Description middle school age children and their responses to questionnaire Pl PIGlassboro Test Paid Faculty IRB Admin
22. IRB Admin RouterlRBAStratfordWIRBGlassboro Test 177 view Study Committee Glassboro CMSRU Board 1 Review Type Expedited Type of Submission Research Protocol Study Sponsor There are no items to display Co Investigators Who Have Not Accepted Participation Co Investigators Who Have Declined Participation View Differences There are items to display There are no items to display My Activities Display Reviewer Notes Log Private Comment Reviewer Checklist for Expedited Review Categories Reviewer Checklist for Research Involving Children Pre Submission Printer Version Attachments Stamped Documents Department Approvals Reviewer Notes Reviews ChangeLog Reviewer Checklist for Initial Filter by Activity lear Advanced Review Activity Author 7 Activity Date Reviewer Checklist Consent firsa Forwarded to Expedited Review Test RouterlRBAStratfordWIRBGlassboro 5 21 2014 10 57 AM EDT Submit Review IRBA Selected IRB Committee Test RouterlRBAStratfordWIRBGlassboro 5 21 2014 10 57 AM EDT Assigned To Committee 9 Assigned to Glassboro CMSRU Board 1 IRB Administrator Ownership Re assigned Test RouterlRBAStratfordWIRBGlassboro 5 21 2014 10 57 AM EDT 9 Assigned to RouterlRBAStratfordWIRBGlassboro Test Dept Study Approved By Department Test ApproverGlassboro 4 16 2014 9 02 AM EDT PI Study Submitted for Review Test PlGlassboro 4 16 2014 8 59 AM EDT K 8
23. Rowan Ga University Rowan University elRB User Manual for Committee Members Version 1 dated 6 2 2014 Rowan University Table of Contents Rowan University elRB 5 3 DESIGNATED REVIEWER WORKFLOW cccecscesescscesescecescscececeevaceseevavecsevaceusevacsesevacestevasaeeavavseeavavaeeseeseass 4 PERSONAL WORKSPACE MY 6 STUDY WORKSPACE c escssecesesseccesvscsceevscsccevscscevavsesavavscevavacesavscaevavacausevavausavavaesevavscesvavacsacauesvacuesvacseeess 7 REVIEWING A NEW STUDY 8 ADDING REVIEWER NOTES cccsecesceccesescscescscsceccecsceesevsceeevscessevacasssvscaevavacacessavacessavaceavavaceesaecavacsevavaces 13 REVIEWING A CONTINUING REVIEW cccccccccccssessecscescscesesvscecsevecsscevacecsevacessevacessevacessavacaesavacaeeavavsesacaeenss 18 REVIEWING A STUDY MODIFICATION c ccsceccssececescecescecscsceevscsceesacscessacsceevacacessacsceavacessavacessavacasavaceneeas 24 MODIFIED STUDY WORKSPACE ccesceseceseesecsscsvsceccevscccevscsecavscsucavacseseacaesavacaesavacauesvavacauvavacnusaceatacaaeess 27 REVIEWING A REPORTABLE EVENT renes entrer treten serene entere seen stent 36 REVIEWING AND IRB MEETING AGENDA eccecessesecescececescevsceecevscescevscecsevscesvavscessacsestevaseutavaceutavaenesaees 39 41 IRB DETERMINATIONS
24. StratfordWIRBGlassboro Test Expedited There are no items to display There are no items to display 7 Activity Date 5 21 2014 10 57 AM EDT 5 21 2014 10 57 AM EDT 5 21 2014 10 57 AM EDT 4 16 2014 9 02 AM EDT 4 16 2014 8 59 AM EDT 3 28 2014 11 03 AM EDT There are several items that appear in all workspace types e The left navigation bar is the white area that appears on the left side of each workspace page e Activities are available to reviewers in the navigation pane e Ahistory of all the project s activities appears under the History tab Other tabs include documents submitted in the project and reviewer notes Version 1 dated 6 2 2014 Rowan Qg University Reviewing a New Study To conduct a review in the Rowan elRB you will e Preview the study e Acknowledge or Defer Review e View the study e Enter reviewer notes e Upload the completed worksheet e Submit the review Preview the study Aconvenient way to preview a study is to click on the Printer Version button 4 Printer version sly Favorites 95 bullying among middle school m 7 dA v Pagev Safetyv Took v T Maye IRB Studies User Profiles IRB Studies gt bullying among middle school Current State Study bullying among middle school Pro2014000057 Glassboro CMSRU IN REVIEW Description middle school age children and their responses to questionnaire PlGlassboro Test Paid Faculty
25. Use Device HUD Quality Assurance Quality Improvement Only Western IRB WIRB 2 0 Full Title of Research Middle school children and bullying 3 0 Short Title Study Name bullying among middle school 4 0 Principal Investigator PIGlassboro Test 5 0 Study Coordinator 6 0 Co Investigators LastName First Name Department Division Institutional Status Probation There are no items to display 7 0 Other Study Staff Interaction or access to Institutional On Name Department Role Status There no items to display NOTE m Done Jv Trusted sites Protected Mode On fg vy Q10 Version 1 dated 6 2 2014 Rowan Qg University Acknowledge Review After previewing the printer version of the study you will decide whether to Acknowledge Review or Defer Review located under My Activities Once you Acknowledge Review you can begin your review and you will want to view the study so that you can enter comments and questions about the study If you Defer Review you may send a comment to the IRB Office noting the reasons for the deferral My Activities Log Private Comment cw Acknowledge Review Defer Review 10 Version 1 dated 6 2 2014 Rowan Qg University Viewing a New Study To access the study select the View Study button Once you have selected View Study a window will open containing the smart form pages completed by the
26. a Minimal Risk Greater than Minimal Risk NotApplicable Clear No Should review occur more frequently than once a year NA If YES please specify how often Have you completed all Reviewer Checklists Yes No Clear If No please add reviewer checklist comments In the Modification Workspace submit your review by clicking on the Submit Review button then e Upload any documents e Record any comments Select Review Motion e Check off Review Complete e Select OK to submit 35 Version 1 dated 6 2 2014 Rowan Qg University Reviewing a Reportable Event To review a reportable event select the title of the study listed under My Inbox bd nd w ad i sttsomeirbstg01 rowan edu test Rooms DisplayPages Layoutlnitial Container com webridge entity Entity OID ED4DD70F3D3E114192F7 COACFBE9F183 File Edit View Favorites Tools iy Favorites 5 RowanSOM Huma Rowan University S Page for Patricia G Internet Explorer ca TEST SITE elRB Ho PageforIRBCo X i v d v Pagev Safetyv Toolsy TEST SITE elRB Home IRB Studies User Profiles Page for IRBCommitteeMemberGlassboro Test Current Role Page for IRBCommitteeMemberGlassboro Test COMMITTEE MEMBER Welcome to your Personal Folder the central resource for managing your Study applications Your P
27. ary Protocol Section 1 Jo Trusted sites Protected Mode On gv 100 31 Version 1 dated 6 2 2014 Rowan Qg University T lt lt Back Save Exit Hide Show Errors Print Jump To 1 Study Identification Reviewer Notes Filter by Type zum Advanced Type RB Staff Change Reques Reviewer Date Created RouterlRBAStratfordWIRBGlassboro 6 2 2014 9 18 AM Bi Test Please add Dr Jones as a co investigator in the study Change Request Completed PlGlassboro Test 6 2 2014 9 22 AM Dr Jones has now been added as co investigator to this study 1 0 Study Identification IRB Glassboro CM SRU This is the first step in your Research Application You will be automatically quided to the appropriate forms needed to complete your submission 1 0 Select the type of submission for your study Research Protocol Study Facilitated Review 6 Emergency Permission 6 Humanitarian Use Device HUD The Modified Study is a copy of the originally approved study The reviewer notes work the same way in this view as the previous submission examples 32 Version 1 dated 6 2 2014 Rowan Qg University After you enter your reviewer notes and continue through the entire smart form application you will end at the Final Page of the Modified Study To return to the Modified Study Workspace select Finish at Ex nlorer provided by Rowan Un E
28. ate Comment Notice Ack Related Reportable Events Fen T View Continuing Review Name Link to Reportable Event State etg There no items to display qos Printer Friendly version k iiw Attachments Stamped Documents Modifications Reportable Events Reviewer Notes Change Log Filter by Activity Clear Advanced Activity Author 7 Activity Date IRBA Forward to Expedited Review Test RouterlRBAStratfordWIRBGlass boro 5 21 2014 1 46 PM EDT La Changed Review Type Test RouterlRBAStratfordWIRBGlassboro 5 21 2014 1 46 PM EDT New Review Type Expedited REA Re assign Owner Test RouterlRBAStratfordWIRBGlassboro 5 21 2014 1 46 PM EDT 7 Assigned to RouterlRBAStratfordWIRBGlassboro Test Selected IRB Committee Test RouterlRBAStratfordWIRBGlassboro 5 21 2014 1 46 PM EDT Assigned to Glassboro CMSRU Board 1 PI Submit Test PlGlassboro 5 21 2014 1 45 PM EDT 19 Version 1 dated 6 2 2014 Rowan University To being the review Acknowledge or Defer the Continuing Review by clicking the appropriate buttons under My Activities T TEST SITE elRB Home IRB Studies User Profiles IRB Studies gt sstest study Glassboro gt 2015 Review for Pro2014000054 Current State IN REVIEW Current study status Study Title View Continuing Review iti zeci Initial study submission type di Printer Friendly Version Principal Investig
29. ate Modification Modification 2 for IRB Study Pro2014000054 Mod201400000002 Glassboro CMSRU IN REVIEW Description we would like ta add additional questions to the questionnaire The protocol has been revised to reflect the changes Study Title Full title sstest study TE View Modification Principal Investigator PiGlassboro Test Study Coordinator E Print Friendly Modification Original Study ID Pro2014000054 Committee Glassboro CMSRU Board 1 T view modifed Sway Review Type Expedited Meeting _ Co nvestigators Who Have Not Accepted Participation Co Investigators Who Have Declined Participation E Print Friendly Study There are no items to display There are no items to display Action Letter View Changes View Changes Ei Log Private Comment Acknowledge Review Fitter by Acity Clear Defer Review Activity Author E Activity Date 8 Display Reviewer Notes Forward to Expedited Review Test RouterlRBAStratfordWIRBGlassboro 5 21 2014 2 51 PM EDT Selected IRB Committee Test RouterlRBASiratfordWIRBGlassboro 5 21 2014 2 51 PM EDT Assigned to GlassborolCMSRU Board 1 Changed Review Type Test RouterlRBAStratfordWIRBGlassboro 5 21 2014 2 51 PM EDT New Review Type Expedited Submitted Modification Test PlGlassboro 5 21 2014 2 50 PM EDT 8 Created Modification Test PiGlassboro 5 21 2014 2 42 PM EDT 27 Version 1 dated 6 2 2014 Rowan Qg University Modified Study
30. ator Study Status My Activities Number subjects enrolled to date E54 Log Private Comment Related Modifications Name Linkto Modification State There are no Acknowledge Review Defer Review Display Reviewer Notes History Acknowledge Review Defer Review Continuing Review 2015 Review for Pro2014000054 CR00000553 Pro2014000054 Glassboro CMSRU Approved Full title sstest study Research Protocol Study P Glassboro Test College of Engineering Glassboro CMSRU Active Open to Enrollment No enrollment to date 25 eviewer Notes Review Type Study Coordinator Type of report Continuing Report Are any changes to the research being proposed at this time no Expedited Notice Related Reportable Events Name Link to Reportable Event State There are no items to display Change Log Author Activity Date IRA Forward to Expedited Review Test RouterlIRBAStratfordWIRBGlassboro 5 21 2014 1 46 PM EDT Changed Review Test RouterlIRBAStratfordWIRBGlassboro 5 21 2014 1 46 PM EDT 31 New Review Type Expedited Re assign Owner Test RouterlRBAStratfordWIRBGlassboro Assigned to RouterlRBAStratfordWIRBGlassboro Test Selected IRB Committee Test RouterlRBAStratfordWIRBGlassboro Assigned to Glassboro CMSRU Board 1 PI Submit Test PlGlassboro 5 21 2014 1 46 PM EDT 5 21 2014 1 46 PM EDT 5 21 2014 1 45 PM EDT
31. cation 2 for IRB Study 2014000054 Current State Modification Modification 2 for IRB Study 2014000054 Mod201400000002 Glassboro CMSRU IN REVIEW Description we would like to add additional questions to the questionnaire The protocol has been revised to reflect the changes Study Title Full title sstest study view modification Principal Investigator PiGlassboro Test Study Coordinator E Print Friendly Modification Original Study ID Pro2014000054 Committee Glassboro CMSRU Board 1 view modified Study Review Type Expedited Meeting Co Investigators Who Have Not Accepted Participation Co Investigators Who Have Declined Participation Print Friendly Study There no items to display There are no items to display View Changes Action Letter My Activities Please Note History Attac e Log Private Comment e Please make sure that all Reviewer Checklists have been completed prior to selecting the OK option below In order to complete the checklists click on the Cancel button below e PUBLIC comments are visible by the PI and Study team PRIVATE comments are visible by IRB personell only Reviewer Checklist Filter by 7 a Submit Review OD T Display Reviewer fiote LS IRBA Assigned Review Documents IRBA Name Description There are no items to display New Revi Review Type Full IRB Review M Review Motion Submit Review Revisions to be reviewed by
32. d There are no items to displ Modification Request Indicate the type of change and or addition Check all that appl Changes in Questionnaires Changes to Protocol Document s 1 0 Degree of change Minor Non Substantive Change 2 0 Indicate the type of change and or addition Check all that apply Changes in Questionnaires Changes to Protocol Document s 3 0 Description of Changes briefly summarize the change we would like to add additional questions to the questionnaire The protocol has been revised to reflect the changes 40 Current Subjects are any subjects currently enrolled in the study Yes 5 Description of Changes briefly summarize the change we would like to add additional questions to the questionnaire Exit Hide Show Errors Print Jump Modification Request Continue gt gt Click Exit to return to Modification Workspace 26 Version 1 dated 6 2 2014 Rowan Qg University Modified Study Workspace In the Modification workspace Click on View Changes button to open the Modified Study workspace uy Favorites i 5 EB Home Rowan University RowanSOM Human Subje Research at Rowan Univers Modification 2for IRB S X Wr 3 m Pager Took IRB Studies IRB Studies gt sstest study Glassboro gt Modification 2 for IRB Study amp Pro2014000054 Current St
33. e for any discrepancies Principal Investigator PIGlassboro Test Date Completed Renewal Deadline Study Coordinator Date Completed Renewal Deadline e besse mbm mh mee Hee ravan adii Triictad citer Draterted Made Mn 1n 21 Version 1 dated 6 2 2014 Rowan Qg University Completing the Reviewer Checklists T IRB Studies User Profiles IRB Studies gt ssteststudy Glassboro gt 2015 Review for Pro2014000054 Current State Continuing Review 2015 Review for Pro2014000054 CR00000553 Pro2014000054 Glassboro CMSRU IN REVIEW Current study status Approved Study Title Full title sstest study view continuing Review Initial study submission type Research Protocol Study Review Type Expedited E Printer Friendly version Principal Investigator P Glassboro Test College of Engineering Glassboro CMSRU Study Coordinator Study Status Active Open to Enrollment No enrollment to date Type of report Continuing Report My Activities Number subjects enrolled to date 25 Are any changes to the research being proposed at this time no e Log Private Comment Notice Display Reviewer Notes Related Modifications Related Reportable Events Name Linkto Modification State Name Linkto Reportable Event State Reviewer Checklist for There are no items to display There are no items to display Expedited Review Categories Reviewer Checklist Co
34. ersonal Folder provides all the tools you need in order to complete your role in the Study My Roles application process Use the following guidelines to process your Studies When you are using elRB you must tell the system which ROLE you Complete reviews for all items in your inbox by clicking on the study name wantto work in Meetings for your committee are listed the Upcoming Meetings tab Committee Member e A listing of prior reviews is located in the All submissions tab My Committees E Name Upcoming Meetings Glassboro CMSRU Board 1 K 41 mto1oft1 Vi 100 Filter by 10 Clear ID Name 7 Date Modified Type State Campus Study n RE00000176 subject ID 2 5 22 2014 3 28 Reportable Event Review Glassboro CMSRU sstest study Glas Mod201400000002 Modification 2 for IRB Study Pro2014000054 5 22 2014 3 16 Modification In Review Glassboro CMSRU sstest study Glassboro oF CRO000 2015 Review for Pro2014000054 5 21 2014 2 11 Continuing Review Review Glassboro CMSRU sstest study Glassboro oF Pro2014000057 ing among middle school 5 21 2014 12 41 PM Study In Review Glassboro CMSRU oF Pro2014000058 school age chi 5 21 2014 10 57 AM Study In Review Glassboro CMSRU Pro2014000056 test 5 21 2014 10 54 AM Study In Review Glassboro CMSRU I q 1 to6of6 VI 10 REUO0000176 subject 5 22 2014 Tesi In sstest Test College of Glassboro CMSRU Glassboro CMSRLU Expedited Unanticipate
35. ete select then select Submit Review under My Activities 17 Version 1 dated 6 2 2014 Rowan Qg University Reviewing a Continuing Review To view a study s continuing review workspace return to My Home select the name of the continuing review listed under My Inbox TEST SITE elRB Home IRB Studies User Profiles Page for IRBCommitteeMemberGlassboro Test Current Role Page for IRBCommitteeMemberGlassboro Test COMMITTEE MEMBER Welcome to your Personal Folder the central resource for managing your Study applications Your Personal Folder provides all the tools you need in order to complete your role in the Study My Roles application process Use the following guidelines to process your Studies Nhen you are using elRB you must ell the system which ROLE you e Complete reviews for all items in your inbox by clicking on the study name vantto work in e Meetings for your committee are listed on the Upcoming Meetings tab Committee Member A listing of prior reviews is located in the All submissions tab Committees Name Upcoming Meetings Glassboro CMSRU Board 1 IN qd 1 to1of1 100 Filter by ID Clear Advanced CRO0000553 2015 Review for Pro2014000054 5 21 2014 1 46 PM Continuing Review In Review Glassboro CMSRU sstest study Glassboro 2 2014000057 bullying among middle school 5 21 2014 12 41 PM Study In Review Glassboro CMSRU oF Pro2014000058 schoo
36. fications to specific questions Or b submit requested changes to revised documents such that based on the assumption that these changes or clarifications are satisfactory the IRB is able to make all of the determinations required for approval No further action required The IRB Committee determines that no further changes revisions or corrections are required on the part of the investigator or the IRB committee Action required The IRB Executive committee determines that further changes revisions or corrections are required on the part of the investigator or the IRB committee Acknowledged Upon receipt of a reportable event the IRB reviews and issues confirmation of the submission 45 Version 1 dated 6 2 2014 Rowan University RowanSOM Office of the Institutional Review Board 4O East Laurel Road UEC 1106 Stratford NJ 08084 Office 856 566 2712 FAX 856 566 7195 Website http www rowan edu som hsp index html Rowan University Office of Sponsored Programs James Hall 3 Floor Rm 3121 Glassboro NJ 08028 Office 856 256 4058 Website http www rowan edu open provost grants index cfm Version 1 dated 6 2 2014 46
37. ications Name Linkto Modification Once you Bune comgpleled mig form and pele tre opliion bow My Activities There are no items to display Tog reda wil be complete Aw submission will routed back ta Tyre assigned IRE Administrator Togwilnmn be able bo change or modify your resiea comments Too wil fo add commerntis regarding Tie study ei Log Private Comment E Attachments Re Fen submit Review Filter by wy Activity Activity IRBA Forwarded to Expe IRBA Changed Review E Ada New Review Type Exped Hama arg ders io display Review Expected Re assigned Own Submitted Report Review Motion Revisions n be by edReportabll yeu completed Reviewer FAD aine Checks comments Select Submit Review Complete the form and select OK 38 Version 1 dated 6 2 2014 Rowan Qg University Reviewing and IRB Meeting Agenda Each month you will receive an email from Rowan University elRB indicating that the meeting agenda is ready to view To view projects assigned to other reviewers select the Upcoming Meetings tab in the grey menu bar at the top of your My Home page view Select the name of the upcoming meeting you wish to view TEST SITEeIRBHome IRB Studies User Profiles Page for IRBCommitteeMemberGlass Test Current Role Page
38. ick Edit Study to enter reviewer notes Note Edit Study does not actually allow you to edit the study because the Modified Study workspace is a copy of the original study it appears identical Qe WENNS http sttsomeirbstg01 rowan edu test Rooms DisplayPages Layoutlnitial Containerz com webridge entity Entity OID 8AD086CDF9129049A03235563D70E0F9 E aaa File Edit View Favorites Tools Help iy Favorites 35 88 o Home Rowan University RowanSOM Human Su Rowan University Scho e Page for Patricia Gessner New Tab sstest study Glassboro m hi v dh v Safetyv Tools v e n T IRB Studies User Profiles IRB Studies gt sstest study Glassboro gt Modification 2 for IRB Study 2014000054 gt sstest study Glassboro Modified Study sstest study Glassboro MS2 Pro2014000054 Glassboro CMSRU Current State Description Test study summary MODIFICATION OPEN Principal Investigator P Glassboro Test Study Coordinator Expiration Date 4 13 2015 Modification Mod201400000002 Letter View ib Printer Version View Differences My Activities Edit Study 8 Display Revie Revised Study Activity Author Activity Date 9 Change Log Page 7 0 Study Summary Protocol Section 1 Test PlGlassboro 5 21 2014 2 49 PM EDT On Page 7 0 Study Summ
39. ing Children Reviewer Checklist for Initial Filter by V Activity M leaf Advanced Review Activity Author 7 Activity Date Reviewer Checklist Consent IRBA Forwarded to Expedited Review Test RouterlRBAStratfordWIRBGlassboro 5 21 2014 10 57 AM EDT Submit Review IRBA Selected IRB Committee Test RouterlRBAStratfordWIRBGlass boro 5 21 2014 10 57 AM EDT Assigned To Committee Assigned to Glassboro CMSRU Board 1 IRB Administrator Ownership Re assigned Test RouterlRBAStratfordWIRBGlassboro 5 21 2014 10 57 AM EDT E 9 Assigned to RouterlRBAStratfordWIRBGlassboro Test Dept Study Approved By Department Test ApproverGlassboro 4 16 2014 9 02 AM EDT PI Study Submitted for Review Test PiGlassboro 4 16 2014 8 59 AM EDT 78 Created Study Test PiGlasshoro 3 28 2014 11 03 FDT i J Trusted sites Protected Mode On g v 100 Open files uploaded to the project from links with the smart form view Attachments can also be found in the Attachments tab in the Study Workspace Version 1 dated 6 2 2014 11 Rowan Qg University Study Smart form view Windows Rae by Rowan Unies WW http sttsomeirbstg0l rowan edu test ResourceAdministration Project ProjectEditor WizardPageOID com webridge entity Entity 5BOID 5B578 C6B3AEE875B44AD0294FBE7FO File Edit View Favorites Tools Help Favorites 95 Home Rowan University RowanSOM Human Subje
40. ks to subjects Deferred 1 The IRB is not able to make all the determinations due to a lack of sufficient time for discussion b because it feels it lacks the required expertise or c an Expedited Reviewer does not feel it meets the criteria for Expedited Review At that time the study must be a reviewed at a later convened meeting providing sufficient discussion time Or b reviewed by the campus Executive IRB committee for sufficient expertise Or c reviewed by a fully convened IRB committee 44 Version 1 dated 6 2 2014 Rowan Qg University Full Board Committee Actions or Requests Administratively Closed O This is an administrative process by which a previously approved study has expired and the principal investigator has not submitted a Continuing Review application or a Final Closure indicating study completion Suspended The IRB determines that in the best interest of human subjects some or all aspects of the research must cease temporarily This may occur when a study is under investigation due to compliance issue s following a protocol deviation adverse event or unanticipated event involving risks to human subjects or others Request Changes Clarifications At the time when the IRB reviews and approves a research study or proposed changes to a previously approved research study the IRB requests modification of the application at which time the investigator must either a provide clari
41. l age children 5 21 2014 10 57 Study In Review Glassboro CMSRU oF Pro2014000056 test 5 21 2014 10 34 AM Study In Review Glassboro CMSRU K lt 1 to40f4 Vil 10 CROO00053 2015 Review for PRO2014000054 5 21 2014 Continuing Review In Review Glassboro CMSRU 1 46pm The Continuing Review Workspace is similar to that of a New Submission Review except that the header information will include a continuing review ID and a description of the continuing review 18 Version 1 dated 6 2 2014 Rowan Qg University You may open the Printer Version or view the continuing review the same way you view the smart form pages with a new submission by selecting View Continuing Review T IRB Studies IRB Studies gt sstest study Glassboro gt 2015 Review Current State Continuing Review 2015 Review for Pro2014000054 C900000553 Pro2014000054 Glassboro CMSRU IN REVIEW Study Title Full title sstest study View Continuing Review al study submission type Research Protocol Study Review Type Expedited E Printer Friendly version Ppficipal Investigator PiGlassboro Test College of Engineering Glassboro CMSRU Study Coordinator Study Status Active Open to Enrollment No enrollment to date Type of report Continuing Report My Activities Number subjects enrolled to date 25 Are any changes to the research being proposed at this time no Log Priv
42. nating email account is not monitored Additional help and quidance is available at the following http www rawan edu sam hsp som eirb CONFIDENTIALITY NOTICE This email communication may contain private confidential or legally privileged information intended for the sole use ofthe designated and or duly authorized recipients s If you are nat the permanently delete all copies ofthis email including all attachments without reading them If you are the intended rerinient secure the contents in manner that conforms to all annlicrahle state andlor federal ranuiraments related Version 1 dated 6 2 2014 Rowan Qg University Personal Workspace My Home When you log in to the Rowan elRB you can see all submissions assigned to you by selecting your My Home age view l pag Your name will appear here TEST SITE eiRB Home IRB Studies User Profiles Page for IRBCommitteeMemberGlassboro Test My Home urrent Role Page for IRBCommitteeMemberGlassboro Test Welcome to your Personal Folder the central resource for managing your Study applications Your Personal Folder provides all the tools you need in order to complete your role in the Study application process Use the following guidelines to process your Studies When you are using elRB you must tell the system which ROLE you e Complete reviews for all items in your inbox by clicking on the study name want to work in Meetings for your committee are li
43. ntinuing Review Attachments Stamped Documents Modifications Reportable Events Reviewer Notes ChangeLog Submit Review Filter by Activity M Clear Advanced Activity Author 7 Activity Date Forward to Expedited Review Test RouterlIRBAStratfordWIRBGlassboro 5 21 2014 1 46 PM EDT Changed Review Test RouterlIRBAStratfordWIRBGlassboro 5 21 2014 1 46 PM EDT ff New Review Type Expedited IRBA Re assign Owner Test RouterlIRBAStratfordWIRBGlassboro 5 21 2014 1 46 PM EDT 9 Assigned to RouterlRBAStratfordWIRBGlassboro Test Selected IRB Committee Test RouterlIRBAStratfordWIRBGlassboro 5 21 2014 1 46 PM EDT 9 Assigned to Glassboro CMSRU Board 1 Submit Test PlGlassboro 5 21 2014 1 45 PM EDT m BER a Aa S FON anna Complete the Checklists Version 1 dated 6 2 2014 eq Reviewer Checklist for Expedited Review Categories Reviewer Checklist Continuing Review 22 Rowan Qg University Submit Review TEST SITE elRB Home IRB Studies User Profiles IRB Studies gt sstest2 Glassboro gt 2015 Review for Pro2014000063 Current State Continuing Review 2015 Review for 2014000063 CR00000554 Pro2014000063 Glassboro CM SRU Study Title sstest2 Glassboro full title view Continuing Review Initial study submission type Research Protocol Study Review Type Exempt E Printer Friendly Version Principal Investigator P Glassboro Te
44. pplicable 2 Complete the Reviewer Checklist for Research involving Neonates if applicable 3 Checklist for Prisoner if applicable 16 Version 1 dated 6 2 2014 Rowan Qg University Submitting Your Review Once you are satisfied with your reviewer notes you will want to click on Submit Review and complete the form SUBMIT REVIEW THIS IS YOUR FINAL STEP IN THE REVIEW PROCESS Once you have completed this form and selected the OK option below Your review will be complete The submission will be routed back to the assigned IRB Administrator You will not be able to change or modify your review comments You will be able to add PRIVATE comments regarding the study Please Note e Please make sure that all Reviewer Checklists have been completed prior to selecting the OK option below In order to complete the checklists click on the Cancel button below e PUBLIC comments are visible by the Pl and Study team PRIVATE comments are visible by IRB personell only Review Comments Review Documents Name Description There are no items to display Review Type Full IRB Review Review Motion Revisions to be reviewed by Minimal Risk Greater than Minimal Risk Risk Level Not Applicable Should review occur more frequently than once a year If YES please specify how often Have you completed all Reviewer Checklists 5 Yes No Clear If No please add reviewer checklist comments Once compl
45. pproved Pro2014000054 Proposed Modifications 1 0 Study Identification IRB Glassboro CM SRU 1 0 Study Identification IRB Glassboro CMSRU 2 This is the first step in your Research Application You will be automatically guided to the appropriate forms needed to This is the first step in your Research Applicatio Num ber of modification s on this page 1 complete your Submission complete your Submission 10 Select the type of submission for your study 10 Select the type of submission for yc Number of modified pages 1 Research Protocol Study Research Protocol Study Facilitated Review Facilitated Review Emergency Permission Emergency Permission Humanitarian Use Device HUD Humanitarian Use Device HUD Quality Assurance Quality Improvement Only Quality Assurance Quality Improvement Only Western IRB WIRB Western IRB WIRB 2 0 Full Title of Research 2 0 Full Title of Research Full title sstest study Full title sstest study 3 0 Short Title Study Name 30 Short Title Study Name sstest study Glassboro sstest study Glassboro 40 Principal Investigator 40 Principal Investigator PlGlassboro Test PiGlassboro Test 5 0 Study Coordinator 5 0 Study Coordinator 6 0 Co Investigators 6 0 Co nvestigators LastName First Name Department Division Institutional Status Probation LastName First Name DepartmentDivision Institutional Status Probation Test ColnvestigatorGlassboro College of Engineering Paid Faculty no Test Coln
46. rowan edu The ID will link you to the Rowan elRB Log In Page and after you log in the Project Workspace Version 1 dated 6 2 2014 Rowan Qg University ees NIU EM This is an auto generated email Please do not reply to this email message The originating e mail account is not monitored If you have questions please contact your local IRB office Full Board Review An elRB Submission Requires Your Review IRB Administrator RouterlRBAStratordVIRBGlassboro Test Board Glassboro CMSRU Board 1 Meeting 4 2 2014 ID Pro2014000054 Study number Title sstest study Glassboro An elRB submission is currently waiting for your review To navigate to the project workspace click on the above ID Steps to review IRB Submission 1 Click on study ID link located in this email notification 2 Click on the ACKNOWLEDGE REVIEW activity 3 Review the submission by clicking on the Printer Version or View Study activities 4 Add reviewer notes on the application by clicking on the View Study activity and navigating to the appropriate smart farm section Description 5 Complete ALL Reviewer Checklist activities 6 Finally click on Submit Review in order to send the submission back to the IRB office NOTE If you require additional help and or guidance with this review please contact RouterlRBAStrattordWIRBGlassboro Test simonsc rowan edu Please do not reply to this email notification The origi
47. sboro Campus m Date Minutes Document 5 2 2014 Project State Done V Trusted sites Protected Mode On j amp 100 e You can Confirm or Decline your meeting attendance by selecting the appropriate button located on the left navigation pane e Select View Meeting Agenda to open the smart form page of the agenda Version 1 dated 6 2 2014 40 Rowan Qg University Glossary Attachments Lists documents attachment to study Change Log Lists changes made to the initial application Conditions Status of contingencies for the approval of the study Current State Specifies where the study is in the IRB review process Three possible study states include In Review Meeting in Progress or In Review Revisions Department Approvals Lists the department that approved the study Rowan University elRB Home Brings your back to the elRb homepage History Lists of all actions performed on this study submission IRB Studies Lists the studies Jump To Menu A tool located at the top of a form in a project which enable users to navigate through the submission pages without having to land on pages unnecessarily Logoff Ends your elRB session Modification The form which study staff completes describing the proposed changes made to a Modified Study Modified Study The copy of an approved study where study staff make actual changes to the IRQ My Activities Displays the actions tha
48. sites Protected Mode On 910 v From this view you may 1 Navigate using the Back or Continue button 2 Add edit and delete reviewer notes 3 Use the Sump To menu to select the specific page you wish to see the name of the page is the link to the text Jump To 4 Exit to return to the study workspace 12 Version 1 dated 6 2 2014 Rowan Qg University Adding Reviewer Notes Reviewer notes are added to each page where the designated reviewer wishes to make comments These notes will only be viewable by IRB staff who will finalize them for study staff and other reviewers Exit Hide Show Errors Print Jump To 1 Study Identification Type mss Reviewer Date Created 1 0 Study Identification IRB Glassboro CMSRU This is the first step in your Research Application You will be automatically guided to the appropriate forms needed to complete your submission 1 0 Select the type of submission for your study Research Protocol Study Facilitated Review Emergency Permission Humanitarian Use Device HUD Quality Assurance Quality Improvement Only Western IRB WIRB To add Reviewer Notes select Add A new window will open where you will add your comments about the section in question Click OK after you write your note or Cancel to cancel the activity ec httpu sttsoreirbstg 1 rowan eduj lodgqedForOID cornr webriddqe entity Entity2
49. st College of Engineering Glassboro CMSRU Study Coordinator Study Status Active Open to Chart Specimen Record Collection No collectionto Type of report Continuing date Report ctivities Number subjects enrolled to Are any changes to the research being proposed atthis no e Log Private Comment date time g Display Reviewer Notes Notice R Reviewer Checklist LUTTER RE Ee Continuing Review CM Submit Review Crus Potes ip Moro hod duplicia Fo Di opio Tour Prd mill D Complete Tra dinh will Da Foxuledd le Pos ai ale Tou mill bp aca mods pour niei Commit it PRE Cee Te 10855 o t Su bmit Reyiew puri dl peer Cc Den Doped pi Br Lacechng fs NK opfeon beby in fo Tpi P charges Cor on Cea Dein D i PUELIC covrants ang veis bs aed Sede luam PRAJETE corns ang ias ba per boul ony Review Documents Name Description There are no items to display Review Type Exempt Review Motion Revisions to be reviewed by Minimal Risk Greater than Minimal Risk Risk Level Not Applicable Clear Yes No Should review occur more frequently than once a year 2 J N A Clear If YES please specify how often Have you completed all reviewer checklists Yes
50. sted on the Upcoming Meetings tab Committee Member A listing of prior reviews is located in the All submissions tab To review a submission click on the Current role study name Determines My Inbox Upcoming Meetings access level Filter by V 10 4 Advanced Multi p le roles ID Name Date Modified Type State Campus Study will be listed here 828 2014000057 5 21 2014 11 05 AM Study inRevew Glassboro CHSRU if applicable of Pro2014000058 5 21 2014 1057 AM Study InRedew GlassboroICHSRU a lack e Select current 05 Pro2014000056 test 5 21 2014 10 54 AM Study In Review Glassboro CHSRU role Each role has own inbox You can always return to this view by selecting My Home in the upper right hand corner Studies requiring your review will appear in My Inbox There are four types of submissions Study Initial Submissions Pro Continuing Reviews CR e Reportable Events RE e Modifications Mod Version 1 dated 6 2 2014 RowanQg University Study Workspace Each type of project new study continuing review study modification and reportable event will have its own Workspace Current State specifies where the study is in the IRB review process 4 IN REVIEW I AX El Printer Version View Differences User Profiles Descfiptre Committee Type of Submission
51. study staff w B http sttsomeirbstg01 rowan edu test Rooms DisplayPages Layoutlnitial Containerz com webridge entity Entity OID 4D974DD38B5FBE47 AE03401 309E96BE2 File Edit View Favorites Tools ve Favorites SIO IRB Studies IRB Studies gt bullying among middle school Home Rowan University RowanSOM Human Subje Research at Rowan Univers amp Page for Patricia Gessner bullying among middle x Current State Study bullying among middle school Pro2014000057 Glassboro CMSRU IN REVIEW Description middle school age children and their responses to questionnaire PIGlassboro Test Paid Faculty IRB Admin RouterlRBAStratfordWIRBGlassboro Test TD ommittee Glassboro CMSRU Board 1 Review Type Expedited Type of Submission Research Protocol Study Sponsor There are no items to display 3 Co Investigators Who Have Not Accepted Participation Co Investigators Who Have Declined Participation There are no items to display View Study IRB Review Clarifications Clarifications Log Private Comment Requested Required There are no items to display 6 fm v Pagev Safety v Took n Reviewer Checklist for Expedited Review Categories Attachments Stamped Documents Department Approvals Reviewer Notes Reviews ChangeLog Reviewer Checklist for Research Involv
52. t ID 2 3 28 PM RoutelRBAStatfordWiRBGlassboro Review study Engineering Problem Glassboro Note Reportable Events are easy to recognize because their icon is an exclamation point as compared to other study states 36 Version 1 dated 6 2 2014 Rowan Qg University Viewing the Reportable Event w http sttsomeirbstg0l rowan edu test Rooms DisplayPages Layoutlnitial Containerz com webridge entity Entity OID D5F05CEA7350ED4DA55F378EA7 A4FD7B Y File Edit View Favorites Tools jy Favorites 95 m Home Rowan Uni RowanSOM Huma 9 Rowan University S Page for Patricia G Internet Explorer ca amp TEST SITE eIRBHo subject ID 2 x n 3 d v Pagev Safetyv Tools v IRB Studies IRB Studies gt sstest study Glassboro gt subjectID 2 Current State IN REVIEW Reportable Event subject ID 2 RE00000176 Pro2014000054 Glassboro CMSRU Prin bboro Test Study Coordinator D view Reportable Event Depa View Reportable Event of Engineering Glassboro CMSRU Action Letter E Printer version Subm pated Problem Review Type Expedited Si n sstest st p View Differences ei ibis 4 udy Relate Nami view Differences My Activities There e Log Private Comment Acknowledge Review Attachments Reviewer Notes Change Log Defer Review m
53. t you can perform at this point Log Private Comment allows you to add a comment or upload a document only viewable by IRB Staff and Committee Members My Committees Provides quick link to the IRB committees you serve on My Home Default user page Always takes your back to personal workspace page My Roles Shows your current role and lists multiples roles if applicable This section determines your access level and personal workspace Navigation Pane The location on every workspace which holds all available activities for the project 41 Version 1 dated 6 2 2014 Rowan Qg University Printer Version Opens page to view entire document that displays all sections in its entirety and prints easily on most printers The printer version view contains clickable links to certain study documents which opens ina new window You cannot add reviewer notes to this version Reviewer Notes Lists notes left by the reviewer Reviews Lists Assigned reviews for reviewer Stamped Documents This section lists all IRB stamped documents These PDF documents are watermarked with an IRB approval and expiration date User Profile Lists your personal profile and contact information View Differences Opens page to view and compare changes made to the original application View Study Opens smart form applications and allows committee member to submit reviewer notes Your name Access Modify personal contact information Change your password 4
54. vestigatorGlass boro College of Engineering Paid Faculty no Pbk e Pee Moe EE Moe EE The Study Identification page will always appear regardless of whether there are changes to that page You will be able to see at a glance the changes on each page in the upper right hand corner To navigate to the other revised pages click Next You will only see the pages that have been revised 29 Version 1 dated 6 2 2014 Rowan University r Snipping Tool File Edit Tools Help Sue 2 8 7H 9 TEST SITEeIRBHome IRB Studies Back to Change Log urrently Approved Pro2014000054 0 Study Summary 1 0 s Upload Protocol with version date Microsoft Word format is required Include screening instruments Proposed Modifications 7 0 Study Summary 1 0 Upload Protocol with version date Microsoft Word format is required Include questionnaires data collection forms etc Please upload consent assent forms surrogate consent forms information sheets and verbal script documents in Section 13 2 Consent Forms amp Process of Consent For elRB conversion requests there are two requirements 1 Please upload most recently approved stamped versions of all recruitment materials questionnaires etc 2 Please upload a clean unstamped Word version non pdf of all recruitment materials questionnaires etc Questionnaire testing Histor
55. y 4 14 2014 12 37 PM 0 01 Study Protocol version 4 2 2014 History questionnaires data collection forms etc Please upload consent assent forms surrogate consent forms information sh documents in Section 13 2 Consent Forms amp Process of Consent For elRB conversion requests there are two requirements 1 Please upload most recently approved stamped versions of all recruitment mz 2 Please upload a clean unstamped Word version non pdf of all recruitment Name Modified Questionnaire revised 5 21 2014 History 5 21 2014 2 4 2 2014 2 10 PM 0 02 Questionnaire testing History 4 14 2014 12 Name Questionnaire testina History Modified 4 14 2014 12 37 PM Study protocol revised 5 21 2014 History Study Protocol version 4 2 2014 History Name Questionnaire revised 5 21 2014 History Questionnaire testing History This page highlights a change in which a revised document was uploaded Note The view differences feature may show differences in documents and in certain lists that may not always be accurate If you are unsure about a change please contact the IRB for clarification To exit the View Differences application click the Back to Changes Log button Version 1 dated 6 2 2014 5 21 2014 2 4 2 2014 2 11 Modified 5 21 2014 2 49 PM 4 14 2014 12 37 PM 30 Rowan Qg University After you have used the View Differences feature you may cl

Rowan University eIRB User Manual for Committee Members

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