Rowan eIRB User Manual for Investigators and
Contents
1. For elRB conversion request re are two requirements 1 Please upload most recently apPaqved stamped versions of all rec http sttsomeirbstgO1 rowan edu postback 1 amp formID O0 amp valueField _Protocol customAt 2 Please upload a clean unstamped rd version non pdf of all re Submit a Document Name Study Protocol version 6 2 2014 History Tile if not provided the name of the file will be File Show Advanced Options Required Section 13 0 Informed Consent and Waivers Help 13 2 Consent Forms amp Process of Consent 1 0 Upload copies of the informed consentassent forms surrogate consent form information sheet departmental letterhead and verbal script documents that will be used for this study You may also upload a surrogate consent for subjects who regain capacity to consent PLEASE NOTE For elRB conversion requests there are two requirements 1 Please upload most recently approved stamped versions of all consent forms 2 Please upload a clean unstamped Word version non pdf of all consent form Name Submit a Document Help Upload Revigion Informed Consent Title if not provided the name of the file will be File Show Advanced Options Required C es OK and Add Another Cancel Version 1 0 dated 6 2 2014 RowanQ University Section 15 0 Additional Supporting Information ORowan Univer sity Edit Study Pro2014000059 lt lt2. There are no items to display Department Pre Submission My Activities IRB Review E No tify Team Members to Agree to Participate Clar f cation S Requested Requested Required vithdraw ss fss Edit Email List itApprovals Bee rerel cts Change Log ss Submit Changes Send Email to Study Team 5 Fiterby W Type lear Advanced o Send Email to IRBA Type Raona Date Date 4 Created Modified 7 IRB Staff Change Request RouterlRBAStratfordWIRBGlassboro 5 30 2014 5 30 2C Jump To 7 0 Study Summary Protocol Section 1 Test 6 51 AM 6 51 AK The protocol and survey must contact a version date and pagination in a footer on each page of the document LO IRB Staff Change Request Jump To 7 0 Study Summary Protocol Section 1 i ast 5 30 2014 6 55 AM ss Request Extension protocol and survey eT Response Reguired Click here to respond IRB Staff Change Request Jump To 5 01 Non RowanSOM Study Locations Please add the non Rowan study site where the study will take place Please u facility etter of approval allowing you to conduct the study at their CT Response Required Click here to respond es e You have 90 days to respond to the requested changes or your study with be automatically withdrawn from the system If know that you will need more than 90 days you may request an extension from the IRB by select
3. screen you can select the Principal Investigator for the study submission If you are signed in as the PI this will default to your name Only the users specified as the PI study coordinator co investigators or other study staff will be able to edit and save the study application If you would like to give a new person permission to edit the study later on you will have to add them to one of these questions at that time Principal Investigator PiGlassboro Test Select Clear 5 0 Study Coordinator 6 0 Co Investigators Last Name Abate 7 0 Other Study Staff Name Department Ds First Name Samantha Role There are no items to display PiGlassboro Test DepartmentDivision Primary Care Principal Investigator Interaction or access to individuals Institutional Status Student Institutional Status On Probation no Remove On Probation By clicking the Select button a search page will open that will allow you to search for a person by last name first name organization project ID or user ID An example search is shown below E https sttsomeirbstg0l rowan edu target ype Person amp actionlypelD Assign Select One or More Persons Filter by Last MAMED AM eae a ee Abello Poblete Abernathie Abid Abidin Abobise Abou Elenein Abraham Abraham Abreu Abruzzi Accardi Acharya Acharyya Acheampong Version 1 0 dated 6 2 2014 Advanced Ik
4. www rowan edu som hsp forms universityforms html After the form has been signed by all listed please upload into section 1 3 of the application Select Browse locate your document on your computer then upload Title the document you upload e g 2014 Financial Disclosure Form then select OK lt lt Back Save Exit Hide Show Errors Print Jump To 1 3 Conflict of interest a http sttsomeirbstgO1 rowan edu postback 1 amp formID O amp valueField _Protocol customAt o e 28 1 3 Conflict of Interest a Submit a Document Help 1 0 pload a study specific Rowan SOM F EASA If not provided the name of the file will be Title Sart used axe no items to display File 2 0 Do any of the participating investigat products used with this project Yes No Clear Show Advanced Options Required OK and Add Another Cancel Version 1 0 dated 6 2 2014 12 Rowan niversity 5 01 Non Rowan Study Sites ORowan University Edit Study Pro2014000059 Save Exe THide Show Errors IPmt l Jump To 501Non RowanSOM Study Locations e i continu Help 5 01 bn Rowan Study Sites 1 0 fy l I on Rowans tes engaged m thas research Srte Name Ste Address Subjects will be treated here Records wil be sta edlaccessedhere other study adMties take place here USA Normal Elementary Main Street Glassboro NJ 08028 yes yes yes NON ROWAN STIJDY SITE Ino truction e
5. 4d 1 25 of 3620 F Pl LEET Maria Veronica Brenon Raja Caitlin Okeoghene Rania Delcine Karen Marianela Amy Maria Mimish Sanchalika Edward er Dermatology Surgery School of Osteopathic Medicine Radiation Oncology Epidemiology Neurology amp Neurosciences School of Osteopathic Medicine Non Rowan Depanment Pediatrics Epidemiology Non Rowan Department NJ Institute for Successful Aging Epidemiology mM Public Health Research Institute PHRI Kk lt 1 25 of 3620 D D 11 Rowan Qg University How To Upload Documents to your Application Required documents that will need to be uploaded are the Financial Disclosure Form the Study Protocol surveys questionnaires data collection form if applicable informed consent assent with version dates and pagination Non Rowan study site studies taking place at Kennedy requires the PCP form In addition if your study involves biohazards and or radiation please upload the Institutional Biosafety Committee approval and or Radiation Safety Committee approval Click the Add button and a new window will appear Enter a Title and version date for the document you are uploading Click Brouse and select the file you want to attach Click Open Click Ok ee SS 1 3 Conflict of Interest The investigator must complete the Financial Disclosure Form and list all co investigators study coordinator and other
6. There are no items to display h l E Printer Version Co Investigators Who Have Not Accepted Participation There are no items to display Co Investigators Who Have Declined Participation 2 The panel displays thE raserna There are no items t Department 3 m r j 2 3 T h e Des Cri p tion p FO frr Submit Study Clarifications Clarifications Clarifications Requested Requested Required eB Notify Team Members to Agree to Participate Gss Withdraw Version 1 0 dated 6 2 2014 Fes Attachments Change Log Css Edit Email List This area displays instructions questions and important notifications regarding this study l Send Email to Study Team r Filter by Activity sd ar Advanced ss Change IRB of Record a Activity Author Activity Date f Created Study Gessner Patricia 2 20 2014 10 49 AM EST Initial A Rowan University 4 The Edit Study icon will open the application smart forms 5 The Printer Version icon will open all of the relevant smart form screens in one easy to print window 6 My Activities lists all of the available actions you can perform on the study Click on them and complete the opened screen to perform the action 7 The History tab records all actions performed on the study Each action is recorded with the date time and person performing the action You may click on the name of the activity to see the system details 8 The Attachments tab c
7. start a new IRB application from scratch Version 1 0 dated 6 2 2014 5 Rowan Qg University Top Navigation Bar 3 Your Name allows you to change personal information 4 My Home is the default user page which always returns you to this page view 5 Logoff ends your session and logs you out of the system Tabbed Area 6 The Inbox tab displays all studies you are a part of that require some task to be completed by the study team 7 The IRB Studies tab allows you to search through all respective IRB studies that you are a part of regardless of where the study is in the submission and review process 8 The All Submissions tab lists new studies continuing reviews modifications and reportable events you are listed on but do not require your attention 9 The Profile tab allows you to edit and view your personal training profile and research certifications Version 1 0 dated 6 2 2014 6 Rowan Qg University Overview of the eIRB Submission and Review Process The following steps illustrate the basic application review process Step 1 Pl and Study Staff Prepare and submit application Step 2 Dept Div Review If applicable the application is routed for approval and sign off Department Review This is a blocking review where the IRB will not see the project until it has departmental approval Step 3 IRB Staff Review An IRB Staff Member will be assigned
8. Bad lt J Sa elExt IHode Show Errors Pmt JumpTo _15 Addliona Supportl g Wiformabon Continue gt gt Help 15 0 Additional Support nginlonnation 1 0 Attach any other documents thathave not been specified in previous questions but are needed for IRB Revtew inical QA QI projects inctude dinical supervisor permission d Name Modified Version There are items to display 2 0 tf there is any additl alinfonnation thatyou wish to communicate about the study ease include it below Please note this section should not be usedin lieu or the standard application items http sttsom ei rostgOl rowan edu postback amp forml al ueField _Protocol customAt Submit a Document If not provided tile name of tile file will be Title wed File J Bows Show Advanced Options Required R Cancel K and Add Another Version 1 0 dated 6 2 2014 16 Rowan Qg University Submit the Application Please note you are required to include the Department s Division s for each study team member involved in this application This is completed in section 1 4 Required Departmental Division Reviews Please note that all Co investigators listed in your study must agree to participate in the study prior to submission An email with a direct link to your study can be sent directly to your co investigators by clicking on the Notify Team Members to Agree to Participate button as seen below Current State
9. E Edit Study E Printer Version H View SmartForm Progress My Activities fpr Submit Study Once logged into your study they will be required to use the Accept Participation activity in order to complete an affirmation of involvement Before the application is submitted it will be validated to check for common errors The application is also validated when the Principal Investigator submits the application to the IRB Exit the Smart Form version of the study by selecting Exit This will bring you to the Study Workspace Version 1 0 dated 6 2 2014 17 Rowan Qg University You can identify the workspace you are in by bolded word listed above the study description UANO IRB Studies User Profiles IRB Studies gt Bully among High School Students Current State Study Bully among High School Students Pro2014000068 Glassbo Description Testud Bullying among High School Students Pro2014000068 Principal Investigator PiGlassb E edit study Funding Sources Abel Foundation E Printer version Co Investigators Who Have Not Accepted Participation ColnvestigatorGlassboro Test Co Investigators Who Have Declined Participation There are no items to display H view SmartForm Progress Review Complete Pre Submission My Activitie pr Submit Study Department 7 J IRB Review Post Review Required a weer ta Agree to Participate ae ee My Activi
10. Rowan gt University Rowan eI RB User Manual for Investigators and Research Staff Version 1 0 dated 6 2 2014 Rowan Qg University Table of Contents oI lgme lala ACCE meee ene ne er eer eer ere eer te ae ern ee ee 3 Log in to Rowan SER aeuca there stemeeeoyraraste case tenneutanneeireesaabes uachesons vera Aa ET a 4 Overview of the Rowan elRB Submission and Review Process ccccsssssssecceeseeseeceeeeesaaeeeeeeeeseaas 7 Create a New Application and Specify Personnel ccccccsssccceesecceceeececceeceeeesceeeueceeeeneceeeeeeeeeeas 8 PSS IO SEU V PSL ONE oS T 10 Uploading DOCUMENTS sererai iin E E 12 UIE WI APPI Ctl O s T T 13 Application Validation and SUDMISSION cccccsssecccesecececenscccceecceeeeceeeueceeeeneceeseucetsuaeceeeneceeeens 18 TRES UOV NOR P E actin vse saves coccinea nace cessiaeoeananeesesonines ace teers shanna eananneetnee noes 20 Responding to Requested CHANGES siccassiaceceteveesesccouvatacesdttatusansvawtsnadesuatadiacbasbeatianesnscadsunisenatsenteaes 22 Submit a Reportable Event for the Study sseesssessenssresssrerssssressrrrssreresrenssrererreessrressrrressrresrereene 28 Submit a Modification to the Study sesssssssensesereserssrrrresrrrssreressressrereserrssrrerserersserserersseersererssero 29 When the Modification is complete the PI must submit the modification to the IRB by using the Submit to IRB Activity Submit a Continuing Review for the Study sessss
11. ag Send Email to Study Team firea IRBA Withdraw M000187 Pre Submiszion Template es A Histo Attachments Continuing Reviews Reviewer Notes Change Log Activity Author amp Activity Date f Created Modification McLaughlin Matthew 4 3 2014 12 48 PM EDT Edit Modification El Print Friendly Modification CJ Edit Modified Study dE Print Friendly Study View Changes You can also Edit the Modification in this workspace Printer Friendly views of both the Modification and the Modified Study allow you to print and view in their entirety The View Changes button opens a window showing changes made to the original submission Version 2 0 dated 5 26 2015 30 Rowan Qg University Submit a Continuing Review for the Study e An email notification will be sent to the Principal Investigator and Study Coordinator 60 days prior to the Continuing Review due date to the IRB A second reminder email notification will be sent 30 days prior to the Continuing Review due date to the IRB if the Continuing Review has not yet been completed You should begin preparing an application for continuing review before your IRB approval ends If the study is currently approved in the paper system you must complete an Amendment before submitting a continuing review in the elRB system Create a New Continuing Review In the approved study s workspace click the New Continuing Review button to start the applicatio
12. an policies regarding the protection of the rights and welfare of human subjects will submit to the IRB for review any changes in the approved research prior to their implementation except when necessary to eliminate apparent immediate hazards to subjects agree to provide the required final progress report at the end of the study and or progress report for continuing review in time to have this study approved before the expiration date as determined by the IRB will report to the IRB within 24 hours of becoming aware of any deaths among study subjects when Rowan s IRB is the IRB of record within one week of becoming aware of any unanticipated problems which are serious adverse events and within two weeks of becoming aware of all other unanticipated problems will promptly inform the IRB of all protocol deviations violations will conduct the study using only the qualified personnel listed on the approved protocol will immediately notify the IRB upon termination of the study or departure of the Principal Investigator from this Institution Western IRB Investigator Assurances have reviewed this study protocol and acknowledge my participation agree to accept responsibility for the conduct of the study and to comply with federal and state laws and regulations and Rowan policies regarding the protection of the rights and welfare of human subjects will submit to WIRB for review any changes in the protocol prior to their implementat
13. e of the file will be Wisi Title File show Advanced Options Required C EK OK and Add Another 6 21 Radiation Safety Review Save Exit Hide Show Errors Print Jump To 6 21 Radiation Safety Review Continue He 6 21 Radiation Safety Review You have indicated that subjects will be exposed to radiation and or radioactive materials through participation in this study This protocol will require review by the Radiation Safety Committee or the Radiation Safety Officer 1 0 Please upload the Radiation Safety Committee s approval or Radiation Safety Officer s review for this protocol http sttsomeirbstg01 rowan edu postback 1 amp formID O0 amp valueField _Protocol customAt 2s Submit a Document gt RTI jfnot provided the name of the file will be Title sana File Browse _ Show Advanced Options S Required ok OKandAddAnother Cancel AN Version 1 0 dated 6 2 201 Rowan Qg University 7 0 Research Protocol lt lt Back Save Exit Hide Show Errors Print Jump To 7 0 Study Summary Protocol Section 1 Conti 7 0 Study Summary 1 0 Upload Protocol with version date Microsoft Word format is required Include screening instruments questionnaires data collection forms etc Please upload cons assent forms surrogate consent forms information sheets and verbal script documents in Section 13 2 Consent Forms amp Process of Consent
14. ect including the supervision of any co investigators research assistants house staff and students The Institutional Review Board only recognizes one principal investigator per human subjects research study Co Investigator SS Co Investigators are individuals involved with the PI in the scientific development or execution of a project A co investigator typically devotes a specified percentage of time to the project and is considered key personnel Study Coordinator SS An individual who organizes and coordinates the study and study documentation under the supervision and direction of a PI Dept Approvers Dept Department Division Approvers are the primary and secondary individuals within each department who have signatory authority for a department division The primary person is generally a Department Chair The secondary person may be someone who has been designated by the Department Chair or Division Chief The corresponding school Research Dean may also act as the signatory authority Version 2 0 dated 5 26 2015 33 Rowan University Contact Us RowanSOM Office of the Institutional Review Board University Education Center 4O E Laurel Rd Room 1106A Stratford NJ 08084 Tel 856 566 2712 Fax 856 566 7195 Website http www rowan edu som hsp index html Rowan University Office of Research Compliance IRB Office James Hall 3rd Floor Room 3123 Glassboro NJ 08028 Tel 856 256 4058 Websi
15. email notification when the study is sent back to them for requested changes Within the study workspace you must click on the Reviewer Notes tab to see requested changes 1 Select the Click here to respond link to respond to these requests 2 Navigate to the smart form application and make any needed changes Remember to save the changes before exiting the application 3 When you are ready to submit your response navigate back to the study workspace and click the Submit Changes activity 4 Paste the requested changes you copied into the text box Write your response after each requested change after each request change detailing the change made or your reason for disputing it When finished click the OK button Version 2 0 dated 5 26 2015 23 Rowan D University IAD IRB Studies Beihai ts IRB Studies gt The Second Current State Study The Second Pro2014000061 Glassboro CMSRU IRBA REVIEW CLARIFICATIONS Submission Type Research Protocol Study Sponsor Department Funded REQUIRED Description To assess reading attitudes when given the chance to select reading texts fo Edit Study Principal Investigator PiGlassboro Test Paid Faculty Study Coordinator Department College of Engineering Glassboro CMSRU Review Type Exempt E Printer version Co nvestigators Who Have Not Accepted There are no items to display Co Investigators Who Have Declined Participation 4 view Differences
16. events are used to report any of the following to the IRB Acknowledgement Request Unanticipated Event Data Safety Monitoring Report Protocol Deviation Create a New Reportable Event 1 Inthe approved Study s Workspace click the New Reportable Event button to start the application for a new reportable event 2 Complete the first page of the application and select the type of reportable event 3 Click the Continue button and complete the rest of the application TIP If this reportable event requires you to also submit an amendment to the study click the Create Related Modification activity in the reportable event workspace 4 Amember of the study staff must submit the reportable event to the IRB using the Submit to IRB activity Version 2 0 dated 5 26 2015 Click on New Modification for proposed changes amendments study modifications and paper file conversions New Modification Click on New Continuing Review for Study Continuations and Final Reports study closures New Continuing Review Click on Mew Reportable Event for Unanticipated Problems Adverse Events Protocol Deviations DSMB reports and Acknowledgement Requests Oo New Reportable Event 28 Rowan Qg University Submit a Modification to the Study When you need to make a change to an approved study you must submit a modification to the IRB for approval When
17. he study MUST be made in the modified study Version 2 0 dated 5 26 2015 29 Rowan Qg University Edit the Modified Study 1 Inthe Modification Workspace click the Edit Modified Study button to open the study smart forms e Note this is a copy of the approved study that can be used to make your changes 2 Make all the changes you detailed in the modification application 3 To return to the modification workspace click the Exit button elRB Home Committees IRB Studies User Profiles Reports IRB Studies gt Faculty Attitude Survey gt Modif caie Ie Study Pro2014000057 Modification Modification Wor IRB Study Pro2014000057 Stratford ee Jacqueline Kaari Coordinator Matthew McLaughlin PRE SUBMISSION edification Mod201400000017 Degree of Change Minor Non Substantive Change E Edit modification J reated 41312014 12 48 PM Date Submitted Unsubmitted l Print Friendly Modification pstigators Who Have Not Accepted Participation gg Jennifer DeGennaro Co Investigators Who Have Declined Participation E Edit Modified Study E Print Friendly Study Curren There are no items to display igen Summary of Changes ould like to make two changes to the study i 1 Add Jennifer DeGennaro as a Co Investigator My Activities 2 Designate Jennifer DeGennaro as Study Coordinator PEELE List of Changes rren Administrative Submit Changes to Protocol Document s l
18. incipal Investigator 3 PiGlassboro Test Study Coordinator E Edit Study 4 Funding Sources Abel Foundation E Printer Version 5 Co Investigators Who Have Not Accepted Participation ColnvestigatorGlassboro Test Co Investigators Who Have Declined Participation 7 There are no items to display i View SmartForm Progress VA ISTE Department A 7 For Submit Siudy Clarifications Clarifications Clarifications Requested Requested Required g Notify Team Members to Agree to Participate 7 8 9 ss Withdraw Attachments ChangeLog ss Copy Study sg Edit Email List This area displays instructions questions and important notifications regarding this study o Send Email to Study Team T l Filter by Activity v Clear Advanced ss Change IRB of Record ae Activity Author Activity Date ron Created Study est PIGlassboro o reated Study Test PIGlassboro 5 28 2014 1 35 PM EDT The workspace displays important information about the study and contains links to help navigate to any information contained in the study TEST SITE elRB Home Committees User Profiles Reports J J i Studies gt otocol eb 20 10 49 57 EST 20 1 The current state dis Studies gt _Protocol Thu Feb 20 10 49 57 EST 2014 Current State Study _Protocol Thu Feb 20 10 49 57 EST 2014 Pro2014000052 Stratford depending on the stu qm gt gt Principal Investigator Patricia Gessner Study Coordinator E aswy E Funding Sources
19. ing the Request Extension activity to call for another 90 days to respond The IRB will receive your request and either approve or deny you another 90 days You may apply for up to 3 extensions or an additional 270 days to respond Version 2 0 dated 5 26 2015 24 Rowan Qg University Edit an Application A study application may be edited before it is submitted during Pre Submission or any time if changes are requested by reviewers or the IRB The study will appear under the My Inbox tab in all these occasions To open a study to make changes 1 From your Personal folder My Home click on the title of the study you wish to select listed in My Inbox 2 Inthe study workspace click the Edit Study button The first study application screen appears in edit mode 3 Make any necessary changes and save the study by clicking the Save or Continue button USING IRB Studies GAIE IRB Studies gt Test EG I Current State Study Descrip PRE SUBMISSION PRE SUBMISSON Princip lt lt Back Save Exit Hide Show Errors Print Jump To 1 Study identification LL LE aswy SS Funding E Printer version x View SmartForm Progress Co Inve 1 0 Study Identification IRB Glassboro CMSRU Pre Su This is the first step in your Research Application You will be automatically guided to the appropriate forms needed to complete your submission Study 1 0 Select the type of sub
20. ion agree to provide the required Study Closure Report at the end of the study and or Continuing Review Report Form in time to have this study approved before the expiration date as determined by WIRB will report to the pertinent Rowan IRB within 24 hours of becoming aware of any deaths among study subjects at Rowan study sites in addition to reporting to WIRB will promptly inform WIRB of all protocol deviations iolations Required Department Approvals College of Engineering Glassboro CMSRU If you have finished filling out your application and selected the department s to review it then click OK After you click OK you will no longer be able to edit the application You will receive email when each approval is granted or refused and again when all the required approvals are received lf you are not ready to submit your application click Cancel agree with the above statement agree with the above statement Check the Status of the Application and Respond to Requested Changes Once the application has been submitted to the IRB the application is automatically routed to the required personnel in the review process As part of the study team you will receive notifications from the system indicating the completion of certain elements of the review process or requesting changes to be made to the application You can also check the progress of your application by opening the Study Workspace in elRB Receiving Prog
21. making changes the approved study application is the working document and all required changes must be made in the Modified Study which is a copy of the approved study When the IRB approves the modification the Modified Study becomes the approved version of the study All previously approved versions of the study are stored in the system for record keeping and audit purposes in the History folder Create a New Modification 1 Inthe approved study s workspace click the New Modification button on the left navigation pane to start the application for a new modification Complete the first page and click the Continue button Click on New Modification for proposed changes amendments study modifications and paper file conversions T Mew Modification Click on New Continuing Review for study Continuations and Final Reports study closures New Continuing Review Click on New Reportable Event for Unanticipated Problems Adverse Events Protocol Deviations DSMB reports and Acknowledgement Requests oO New Reportable Event e NOTE The elRB system only allows one modification to be in process at a time All Modifications must be approved rejected or withdrawn before a new one is created 2 Provide justification for any changes that need to be made in the study application 3 When finished explaining the changes save and exit to the Modification Workspace 4 All changes to t
22. mission for your study y Tagm Members to Research Protocol Study a Facilitated Review E Edit Study i i Emergency Permission Fes Edit Email List is are gt Humanitarian Use Device HUD Send Email to Study Team Quality AssurancelQuality Improvement Only Change IRB of Record ss Western IRB WIRB Initial I Clear 2 0 Full Title of Research Title Test EG eo 0 Short Title Study Name TestEG gt 0 Principal Investigator PiGlassboro Test Version 2 0 dated 5 26 2015 25 Rowan University View the Approval Letter and Approved Consent Forms When your study has been approved by the IRB you will receive an email notification containing the approval letter The approval letter will also be posted in the study workspace and will be available for download at any time View the Approval Letter 1 From your Personal My Home folder select the IRB Studies tab and click on the title of the approved study 2 In the study workspace the summary panel will now have an item for Letter of Approval Click on the View link to the right Study sstest Glassboro Pro2014000065 Glassboro CMSRU Description summary Principal Investigator PiGlassboro Test Paid Faculty Study Coordinator Review Type Exempt Next CR Letter of Approval Funding Sources View AbbVie Inc Vulnerable Population Code s a Children Prisoners Approval Date 4114 2014 Lett er of App royal 3 The a
23. n There are no items to display There are no items to display f Display Reviewer Notes Bpa Tae Clarifications Clarifications Clarifications rea Re assign Owner Requested Required rea Edit Supporting Documents firea IRBA Withdraw Attachments Stamped Documents Deparment Approvals Reviewer Notes Reviews Change Log IRB Only oF Log Private Comment FEF Log Public Comment er by Activity i lear advanced ss Edit Email List Activity Author Activity Date Attachments Stamped Documents Department Approvals Reviewer Notes Reviews Change Log IRB Only Filter by Activity X Go clear Advanced Activity Author Activity Date Acknowledged Review Test IRBCommitteeMemberGlassboro 5 21 2014 10 58 AM EDT firea Forwarded to Expedited Review Test RouterlIRBAStratfordWIRBGlassboro 5 21 2014 10 57 AM EDT Trea Selected IRB Committee Test RouterlIRBAStratfordWIRBGlassboro 5 21 2014 10 57 AM EDT El Assigned to Glassboro CMSRU Board 1 firea IRB Administrator Ownership Re assigned Test RouterliIRBAStratfordWIRBGIassboro 5 21 2014 10 57 AM EDT zi 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 E Created Study Test PiGlassboro 3 28 2014 11 03 AM EDT Version 2 0 dated 5 26 2015 22 Rowan University Responding to Requested Changes The study team will receive an automated
24. n for a continuing review 1 Complete the first page of the application and select the status of the study Continuing Review or Final Report 2 Click the Continue button and complete the rest of the application 3 When the continuing review is complete any member of the study team may submit the continuing review to the IRB using the Submit to IRB activity Version 2 0 dated 5 26 2015 31 Rowan Qg University Frequently Asked Questions Visit the elRB Home Page for answers to frequently asked questions TEST SITE eiRB Home EEan sted C t stom Ut a 1 com TEST SITE eIRB Home Frequently Asked Questions Departmental Approvers Frequently Asked Questions elRB Personal Account Questions How can obtain my elRB username and or password Related Links What can do if forget my password do not work at RowanSOM How do get an ID so can use the elRB system System Requirements Institutional Review Board Frequently Asked Questions elRB Basic Terminology Whatis a Project What is a Workspace What is an Activity Whatis a Form Whatis a State t t t Contact Us Whatis a Continuing Review What is a Reportable Event What does it mean when my projectis in the Presubmission state Navigating the elRB System The protocol disappeared why can no longer see it How do figure out the status of my project received an email that needed to do something but when log in
25. nformation from another application such as Word Select the Continue button in the navigator bar to save and move to the next screen e If you need to finish an application at a later time you can use the Save button at the top of the screen Simply exiting will not save changes Version 1 0 dated 6 2 2014 8 Rowan University Study Identification Section 1 0 Study Identification Save Exit Hide Show Errors Print Jump To 1 Study Identification 1 Study Identification 1 Study Identification 1 2 IRB Researcher Training Records 1 3 Conflict of Interest 1 4 Required Departmental Division Reviews i eee ieee BE Se ote i Fep rH HER i pape Higin Be tg ee k E r brag a Be hpr of pee for p HeT en Prok o i E Jhi Partagas Hirn amp re HE 15 Revi ew Type eva hg do ee is ie eee Tee rey Gitte Ell Wen 3 Review Type Risk Determination t Fe Titi o Aei 3 0 Review Type Risk Determination 4 Study Funding 4 0 Funding ha tema Tee Goeeaty genes E Ceempurisst LAA ind led baal Cun in Coser bey Bye 4 1 Adding Sponsors l 4 2 Other Funding Source io Pr i a r ie Cikk 43a Coverage of Study Related Costs 1 4 3b Coverage of Study Related Costs 2 5 0 Shoes Corto a Ce iman Use the Back and Continue buttons to move back and forward on the screen The Save button will allow you
26. nothing is there Why am receiving a 1 error message Performing Actions in the elRB System How do add study team members notin the pick list How do withdraw my Protocol Continuing Review Modification How do make and submit changes How do create a Renewal or Final Report Study Closure How do create a Protocol Deviation or Reportable Event How do submit my project for review Questions Regarding Consent Forms and Attachments need to edit an approved consent form but it s locked Why are the approved consent forms locked can edit parts of the form but have a problem attaching documents receive a The page cannot be found error when trying to open an attachment Where can find consent form templates and other university forms thor Version 2 0 dated 5 26 2015 32 Rowan Qg University Roles and Abbreviations Study Staff SS All individuals involved in research processes under a proposed or approved research study for which a Rowan University IRB is the IRB of record are considered study staff These personnel may include individuals who will have responsibility for the consent process interactions or interventions with subjects data collection data analysis etc or those who will have access to identifiable private information for research purposes Principal Investigator PI A principal investigator is the individual who assumes full responsibility for a research proj
27. ontains all documents for a study 9 The Change Log tab lists all changes made to a submission Version 2 0 dated 5 26 2015 21 Rowan Qg University The Study History Log Every study has a detailed history log For auditing purposes every action performed on the study is recorded in the history log This information is viewable under the History tab This is sorted in chronological order and displays only the actions you have permission to see Each activity when performed is recorded in the history log with a data time stamp and the name of the performing the activity You can click on the name of the activity to view the system details The history is updated after a new activity is completed by anyone working on the study T TEST SITE elRB Home Committees IRB Studies User Profiles Reports IRB Studies gt bullying among middle school Current State Study bullying among middle school Pro2014000057 Glassboro CMSRU Description middle school age children and their responses to questionnaire PI PiGlassboro Test Paid Faculty IRB Admin RouteriRBAStratfordWIRBGlassboro Test E Edit Study Committee Glassboro CMSRU Board 1 Review Type Expedited Printer version Type of Submission Research Protocol Study Sponsor There are no items to display BE view Differences Co Investigators Who Have Not Accepted Participation Co Investigators Who Have Declined Participatio
28. pproval letter will open in a new window You can then print the letter by selecting File Print from the menu bar 4 The approval letter will also be saved for recordkeeping in the history log under the activity as Study Approved You can view the letter by clicking on this link then View Approval Letter in next window Version 2 0 dated 5 26 2015 26 Rowan Qg University View the Approved Consent Form 1 Access approved consent forms Once your study has been approved the consent forms will be accessible from the study workspace under the Stamped Documents tab All documents from the approved application will be available under this tab 2 The Approved Consent Forms section will list all of the consent forms approved for use in the consent process These Word documents will be locked in read only mode The Clean and Strikethrough Copies of Consent Forms found in the Attachments tab will contain unstamped versions of the approved consent form These documents will be editable in MS Word and should be used if there is a future need to amend the consent forms The remainder of the Stamped Documents tab displays any question in the application that allows you to upload a document or file Use the tab to quickly locate any document in the application Version 2 0 dated 5 26 2015 27 Rowan Qg University Submit a Reportable Event for the Study Reportable
29. r review and signoff to the appropriate organizations department heads before being received by the IRB Receive email notifications anytime a reviewer sends the application back for requested changes Receive the approval letter via email once the study is approved A copy of the approval letter and approved consent forms will be posted online with the study and available for download at anytime View a time stamped log of all changes made to the application and any correspondence sent between the study team and the IRB Version 1 0 dated 6 2 2014 3 Log in to eIRB Rowan Qg University You can log into the elRB website using your core username and password TEST SITE elRB Home TEST SITE elRB Home Departmental Approvers System Requirements Institutional Review Board Related Links Frequently Asked Questions Contact Us Login as Please note This elRB application has moved to https eirb rowan edu Please update your bookmarks to reference this new address The elRB system is the new web based application routing and tracking system The system will increase the efficiency of the approval and administrative processes for User Name projects and protocols involving human subjects in research Itis designed to replace the cumbersome and paper intensive process under which applicants currently apply for IRB approval of study proposals elRB has been developed to
30. ress Notifications and Update E mail The elRB system automatically generates email notifications and sends them to the study team when significant events have occurred in the review process The study team will always receive a notification when a reviewer requests changes be made to the application In addition the study team will receive notifications at the following times Confirmation that the application has been submitted Receipt at the IRB office _ Official action letter form the IRB Version 1 0 dated 6 2 2014 19 Rowan Qg University Since the system uses this email address to send notifications about review progress it is important that your email address recorded in the elRB system is current You can update your information by returning to Wy Home and selecting the My Profile tab Select your name open you profile Choose Edit Profile located in the left navigation bar Change any outdated contact information Select Save Exit to return to My Home Ss a a i se The Study Workspace Every study created in the elRB system is assigned a folder or workspace When you click on a study to view it from your My Inbox the study s workspace is opened IAO IRB Studies User Profiles IRB Studies gt Bully among High School Students Current State Study Bully among High School Students Pro2014000068 Glassboro CMSRU 2 1 Description Test study summary Pr
31. rterization in Coronary 9 41 AM 11 53 AM Review Artery Bypass Patients Pro0320090010 A Comparison of Echocardiography and Right 8 28 2010 3 15 2011 Study Closed Stratford Heart Catherterization in Coronary Artery Bypass 6 39PM 11 53 AM Patients Mod2010000005 Modification 1 for IRB Study Pro0320070008 9 2 2010 11 5 2010 Modification Approved Stratford An Investigation of the Role of Shame and Attributions in Adjustment Following 1 36 PM 3 36 PM CPA Mod2010000004 Modification 2 for IRB Study Pro0320100027 8 31 2010 8 31 2010 Modification Approved Stratford Exploring the Differences in Patients who have designated their Code Status as 11 31 AM 3 45 PM Do Not Resuscitate vs those who have chosen to be Full Code at Life at Lourdes A Program of All inclusive Care Mod2010000003 Modification 1 for IRB Study Pro0320100027 8 30 2010 8 31 2010 Modification Approved Stratford Exploring the Differences in Patients who have designated their Code Status as 1 30 PM 11 30 AM Do Not Resuscitate vs those who have chosen to be Full Code at Life at Lourdes A Program of All inclusive Care Create ID Name Date Created Type State Campus Study Consent Forms Left Navigation Bar 1 My Roles allows you to select between user roles if you have more than one Select the correct role as each role has its own inbox Your role determines your access level or what you are able to view edit 2 The Create New Study button allows you to
32. sssesssensssressrsrrrssrersrrresrereseressrrreseressrereseresseeresne 31 Freguentiy Asked QUESTIONS iceocssirnera ai E E S 32 Roles ANd ADDreviatiONs ccccsesssceccccccessseecccccssusseccceessueuseeceesecssueuseeeeesssauaeseeeeeesauseseeeeeeesauagees 33 SU I soe eac sets E E T ns ne Seuss wena Ge neee aetna cupsedeo E ee 34 Version 1 0 dated 6 2 2014 Rowan Qg University Rowan elIRB Access The website is available via any Internet connection anytime with a supported browser http eirb rowan edu Getting Help If you have problems need help or have questions about the Rowan elRB please contact the Rowan Stratford IRB office at 856 566 2712 or the Glassboro IRB Office at 856 566 4058 Using the new eIRB website you can Create and edit an electronic application for IRB studies Add other investigators and study personnel to assist in editing the study application Prepare the study application via SmartForms that present only those sections that are applicable and relevant to your study Attach scanned or electronic documents to the study Print out the application in a printer friendly version Validate the application before submission to catch common mistakes and reduce the number of changes required after submission Submit a single application electronically to the IRB Track the progress of the application as it is automatically routed fo
33. standardize and computerize the Institutional Review Boards IRBs at Rowan University Password After signing into this site you are bound by the terms and conditions set forth when you received your account Having trouble logging in LOGIN INFORMATION Visit our FAQ section for help Frequently Asked Questions All new initial applications must be submitted electronically via elRB Click on the following for elRB help training and guidance information For questions regarding RowanSOM submissions please call 856 566 2712 or email eiro rowan edu For questions regarding Glassboro CMSRU submissions please call 856 256 4058 or email eiro rowan edu For help with account registration or logging in please send an email to eiro rowan edu Ifyou know your Rowan Network username and password enter it and click login Your username is the 1st part of your Rowan email address For example if your email address is jdoe rowan edu then your username is jdoe Please Note Users will receive a registration page upon initial logon Upon completion of the registration process an elRB account will be created within 1 to 3 business days GUEST ACCOUNTS Ifyou do not have a Rowan University email account you can still request a guest account for elRB Please send an email to eiro rowan edu A form will be e mailed back which you will need to fill out and return FORGOT PASSWORD Users with a Rowan University email account click here ht
34. te http www rowan edu som hsp index html Version 2 0 dated 5 26 2015 34
35. ties sg Withdraw i j Fes Copy Stuth peer Submit Study ss Edit Email List This aea orspraySTnouuvuvna yuvsuvno anu punan nvuncauuno teyarumiy uns Study send Email to Study Team FS Filter by Activity Y lear Advanced ss Change IRB of Record Activity Author Activity Date 2 Created Study Test PiGlassboro 5 28 2014 1 35 PM EDT nit Initial we Application Validation and Submission In the Study Workspace select Submit Study located in the left navigation bar Only the Principal Investigator on the study can submit the application The system will run a final validation check on the entire application before submission If there are any errors they will be displayed on the submission screen that opens up and your application will not be submitted The application must be error free and have all co investigators agreed to participation before it can be submitted On the new screen that opens up read the Principal Investigator s assurances and check next to I agree with the above statement Select the OK button at the button of the screen to submit the application for the study Version 1 0 dated 6 2 2014 18 Rowan Qg University Submit Study INVESTIGATOR ASSURANCES have reviewed this study protocol and acknowledge my participation agree to accept responsibility for the conduct of the study and to comply with federal and state laws and regulations and Row
36. to save any changes made to the application Exit will close the application screen without saving changes Always save the application before exiting Print will produce a printer friendly view that can be printed a link from the drop down box Version 1 0 dated 6 2 2014 9 Jump To allows you to select a screen within the application process and go there directly by selecting Rowan Qg University e Hide Show Errors will show any errors and mandatory fields not yet completed e Below is an example of the results of Hide Show Errors This can be used to gauge your progress and determine any additional fields that will need to be completed in the application Error Warning Messages Message Field Name This is a required field therefore you must Full Title provide a value Jump To 1 Study Identification This is a required field therefore you must name 1 Study Identification provide a value This is a required field therefore you must Upload Management Plans 1 3 Conflict of Interest provide a value This is a required field therefore you must Do study investigators have a financial interest 1 3 Conflict of Interest Version 1 0 dated 6 2 2014 10 Assign Study Personnel Rowan University As the creator of a new study application you will specify who has permission to edit and view the study On the Study Identification
37. to the study The IRB Staff Member will conduct an administrative staff review and manage the scheduling of the study Step 4 IRB Review The IRB committee will review the application and provide an approval Committee decisions and approval letter are recorded by the IRB Staff Member in elRB and sent to the PI Step 5 Pl and Study Team Conduct research Report adverse events Submit requests for continuing reviews Submit modifications to initial submissions Version 1 0 dated 6 2 2014 7 Rowan Qg University Create a New Application and Specify Personnel TEST SITE elRB Home Conwnitiees IRB Studies User Profiles Reports essner Welcome to your Personal Page the starting point for all interactions with t Current Role Current Role Please note Investigators and Research Staff Investigators and tlemsa our inbox require your immediate attention You can monitor te pro Qur SUBMISSIONS USING the oiher tads Nems on Mese tads do not require any a Resea rch Staff initiate a new study application by cican Create New Study activity My Roles When you are using elRB you must tell the system which ROLE you When you are using elRB you must tell the system which ROLE you want to workin in order to update your contact information your first step is to click on the My Pro Investigators and Research Staff indor RBSudes BUR uua MyProfile want to
38. tps Jid rowan edu Version 1 0 dated 6 2 2014 4 Rowan Qg University Personal Folder Your elRB experience is personalized allowing you access to all of the studies you are working on or reviewing When you log into elRB you are taken to your person folder which displays links to the items applicable to you TEST SITE elRB Home Committees IRB Studies User Profiles Reports Page for Patricia Gessner Welcome to your Personal Page the starting point for all interactions with this site Current Role se note Investigators and Research Staff items appearing in your Inbox require your immediate attention My Roles e You can monitor the progress of your submissions using the other tabs Items on these tabs do not require any action by you e Initiate a new study application by clicking on the Create New Study activity When you are using elRB you must tell the system which ROLE you want to work in In order to update your contact information your first step is to click on the My Profile tab Investigators and Research Staff Inbox IRB Studies Fag My Profile Filter by 7 ID zlear Advanced Date Modified E New Study Pro0320070014 Impaired Glucose Challenge Test and Maternal 8 28 2010 4 21 2011 Study Closed Stratford Fetal Outcomes 6 38 PM 2 28 PM Quick Links CR00000028 2011 Review for Pro0320090010 3 9 2011 3 15 2011 Continuing Approved Stratford A Comparison of Echocardiography and Right Heart Cathe
39. ua thfom to compl ete theinformation a out a study s ia 11Oagad_ n this rese uch where RopN n is notthe iRS of record e You may idd multigid o tuc ty si a i by ctidcing th OK Add Another button e Site Name z e Site Address e SUbiects will be r ecruitedllreated here Yes No Clear e Records speamens or data wilbe stored or accessed here Yes No Cear Other litudy activit liwlltake placehen Yeo No Clear Hother study activities Ulke place here please deMribe Upk gt odRDo OYo authorization agreementor other proof of agreement 1 nn 0o m lt mU Y Requred N g OKand AddAncther Cancel C http sttsomerbstgUI rowan eduffpostback amp tormiU U amp valuelveld _I K UMU Srte cust Submit a Document If notprovided the name ofthe file will be used Title Show AdVanced Options Required okanciaa An other Version 1 0 dated 6 2 2014 13 Rowan Qg University 6 01 Rowan required Pre Approvals 6 11 Institutional Biosafety Committee Approval Save Exit Hide Show Errors Print Jump To 6 11 Institutional Biosafety Committee Approval Help 6 11 Institutional Biosafety Committee Approval You have indicated that the study involves any of the following infectious agents recombinant DNA human gene transfer biologically derived toxins include the collection of human blood body fluids specimens and or cell lines Help j if not provided the nam
40. work in 8 o Go Advanced H ih Mane Investigators and Date Create 1D Name Date Created ad Type State X sae Research Staff fo New Study E Pro0320070014 Impaired Glucose Challenge Test and Matemal 8 28 2010 4 21 2011 Study Close Fatal Outcome 6 38 PM 2 28 PM CRO0000028 2011 Review for Pro0 320090010 39 2011 3 15 2011 Continuing Appro Catherterization in Coronary Quick Links 9 41AM 11 53AM Review Pro0320090010 AComparsonofEchocardiography and Right 8282010 3 19 2011 Study Closes Heart Cathertorzation in C lary Artery Bypass 6 39PM 1153 AM Mod2010000005 Nodiicalion 1 for IRB Study Pro0320070008 92 2010 11 5 2010 Modification Appro 5 in Adjustment Following 1 36 PM 3 36 PM Mod2010000004 Noaication 2 for IRB Study Pro0320100027 83172010 8 31 2010 Modification Appro nated their Code Status as 11 31 AM 3 45 PM be Full Code at Life at M0d2010000003 Modification 1 tor IRS Study Pro0320100027 8730 2010 8 31 2010 Modification Appro nated their Code Status as 1 30 PM 11 30 AM Full Code at Life at Lourdes A Program of All inclusive Care Create a new study by using the New Study button in your personal folder This will open a new application so you can fill in the identifying information for this study Once the smart form opens enter at least the required fields those marked with a red asterisk are mandatory You can answer the text questions by typing directly within the form or by pasting in i
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