Technical Notes p. 1 Submit your IRB Application Short paragraph of introductory text here. Date:[prepopulated with today’s date] Applicant:[name prepopulated.

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Presentation transcript:

Technical Notes p. 1 Submit your IRB Application Short paragraph of introductory text here. Date:[prepopulated with today’s date] Applicant:[name prepopulated from LDAP] Research Advisor ID:* Title of Research:* ATTACH YOUR DOCUMENTS: IRB Application:* Consent Form:* Attach another document SIGNATURE: I verify that I am the Applicant named above and I approve the submission of this application. Carleton login required to reach this page, for identification, security and pre-population of some data. Upon submit, notification with web link is sent to Faculty Research Advisor. The first portion of the person’s Carleton address, e.g. “jsmith” Browse… Save to Complete LaterSubmit to IRB Now Application – Student Version

Technical Notes p. 2 Submit your IRB Application Short paragraph of introductory text here. Date:[prepopulated with today’s date] Applicant:[name prepopulated from LDAP] Research Advisor ID:* Title of Research:* ATTACH YOUR DOCUMENTS: IRB Application:* Upload a different file: Consent Form:* Upload a different file: Attach another document SIGNATURE: I verify that I am the Applicant named above and I approve the submission of this application. Previous answer displayed here The first portion of the person’s Carleton address, e.g. “jsmith” previousfilename.doc Browse… Save to Complete LaterSubmit to IRB Now Previous answer displayed here Application – Student Version – Saved for Later Completion previousfilename.doc Browse…

Technical Notes p. 3 Submit your IRB Application Short paragraph of introductory text here. Date:[prepopulated with today’s date] Applicant:[name prepopulated from LDAP] Title of Research:* ATTACH YOUR DOCUMENTS: IRB Application:* Consent Form:* Attach another document SIGNATURE: I verify that I am the Applicant named above and I approve the submission of this application. Carleton login required to reach this page, for identification, security and pre-population of some data. Upon submit, Faculty/Staff apps go to IRB Drop Box with notification to Melissa Thomas. Browse… Save to Complete LaterSubmit to IRB Now Application – Fac/Staff Version

Technical Notes p. 4 Confirmation Page Versions (if “Save to Complete Later”) Your application has been saved for completion later. Your application in progress has been saved. You will soon receive a confirmation with a link you may use to return and finish your application. Additional paragraph here with links back to related info on main IRB site. (if Student submitter & “Submit to IRB Now”) Your application has been sent to your Research Advisor for review. Your application has been saved, and we have notified your Research Advisor to review it. Once he or she approves it, your application will be forwarded to the IRB for processing. You will soon receive a confirmation with a link you may use to return to check the status of your application. Additional paragraph here with links back to related info on main IRB site. (if Faculty/Staff submitter & “Submit to IRB Now”) Your application has been sent to the IRB for review. Your application has been saved, and the IRB will begin reviewing it Thursday by 5:00 p.m. You will soon receive a confirmation with a link you may use to return to check the status of your application. Additional paragraph here with links back to related info on main IRB site. confirmation with link sent to applicant. If student, notify sent to Research Advisor with link to review application online. If faculty/staff, notify sent to IRB that application has been added to Drop Box.

Technical Notes p. 5 Please Review Your Advisee’s IRB Application Your research advisee, [Firstname Lastname], has submitted an IRB Application for research on human subjects. Please review the advisee’s application materials and indicate whether they are approved for submission to the IRB or need to be returned to the student for further revision. Application Date:[prepopulated with submitted date] Applicant Name:[prepopulated from LDAP] Research Advisor Name:[prepopulated from submitted data] Title of Research:[prepopulated from submitted data] APPLICATION DOCUMENTS: IRB Application:Link to application document Consent Form:Link to consent form document Additional Document 1:Link to additional document 1 Additional Document 2:Link to additional document 2 Additional Document 3:Link to additional document 3 Additional Document 4:Link to additional document 4 REVIEW COMMENTS TO STUDENT (these will be ed to student): SIGNATURE: I verify that I am the Research Advisor named above and I approve the submission of this application. Approved – Submit to IRBRevisions Needed – Return to Student confirmation with link sent to applicant if revisions needed. confirmation with advisor approval notice sent to applicant if approved. Added to IRB Drop Box if approved, with notification to Melissa Thomas.

Technical Notes p. 6 IRB Application Pending [Name] – [Role] Application Date:[prepopulated with submitted date] Applicant Name:[prepopulated from LDAP] Title of Research:[prepopulated from submitted data] Approved by Research Advisor:[prepopulated with advisor’s approval date] APPLICATION DOCUMENTS: IRB Application:Link to application document Consent Form:Link to consent form document Additional Document 1:Link to additional document 1 Additional Document 2:Link to additional document 2 Additional Document 3:Link to additional document 3 Additional Document 4:Link to additional document 4 ASSIGN TO IRB REVIEWER Assigned Reviewer ID:* This screen is reached via the IRB Drop Box or the ed link in notification sent to IRB staff member. “Approved by Research Advisor” field will only appear if applicant is a student. Pulldown choices for Reviewer ID are controlled by a group defined in Reason. (choose one) Submit to Reviewer

Technical Notes p. 7 IRB Application in Process [Name] – [Role] Application Date:[prepopulated with submitted date] Applicant Name:[prepopulated from LDAP] Title of Research:[prepopulated from submitted data] Case Number:[prepopulated from submitted data] Assigned Reviewer ID:[prepopulated from submitted data] Research Advisor Name:[prepopulated from submitted data] Research Advisor [prepopulated from submitted data] Approved by Research Advisor:[prepopulated with advisor’s approval date] APPLICATION DOCUMENTS: IRB Application:Link to application document Consent Form:Link to consent form document Additional Document 1:Link to additional document 1 Additional Document 2:Link to additional document 2 Additional Document 3:Link to additional document 3 Additional Document 4:Link to additional document 4 IRB REVIEWER RESPONSE: Upload IRB Case Summary: (click here for blank Summary) This screen is reached via the IRB Drop Box or the ed link in notification sent to IRB staff member. “Research Advisor Name,” “Research Advisor ” and “Approved by Research Advisor” fields will only appear if applicant is a student. “Open for IRB Comment” button changes the document’s state in the IRB Drop Box and sends notification to IRB members. Version 1: Initial Review Browse… Save for LaterContact ApplicantOpen for IRB Comment

Technical Notes p. 8 Type of Contact: O Send comment only (no response required from applicant) O Ask a question/request clarification (response required from applicant) O Request modifications to application documents (this re-opens application for editing by applicant) Notes to Applicant: Send Contact Applicant [Name] – [Role] When form is submitted, is sent to applicant with link to IRB Communication screen. Contents of all communication between applicant and reviewer remain appended to application. See next page for sample messages to applicants.

Technical Notes p. 9 Contact Message Versions (if “Send comment only”) Subject: Your IRB Application – Case #XXXXX The IRB has sent you the following message regarding your research application. This is for your information only. No reply is required [Insert message content from Notes to Applicant field on Contact Applicant screen.] (if “Ask a question/request clarification”) Subject: Your IRB Application – Case #XXXXX The IRB needs more information from you to complete the review of your research application. Please use the link below to read the reviewer’s request and submit your reply: [link to communications screen] Your prompt attention to this request will help ensure that your application is processed as quickly as possible. (if “Request modifications to application documents”) Subject: Your IRB Application – Case #XXXXX The IRB has requested that you make revisions to your research application. Please use the link below to read the reviewer’s request and revise your application: [link to communications screen] Your prompt attention to this request will help ensure that your application is processed as quickly as possible.

Technical Notes p. 10 Question/request from the IRB: [Insert reviewer’s question/request for clarification here.] Respond to this request: Previous messages: On mm/dd/yyyy, the IRB wrote: [IRB message text] On mm/dd/yyyy, Applicantname wrote: [applicant response text] On mm/dd/yyyy, Applicantname wrote: [IRB message text] Send Communication About IRB Application: [Name] – [Case #] Version 1 – Question/clarification

Technical Notes p. 11 Question/request from the IRB: [Insert reviewer’s request for revision of the application here.] To revise your application, go to: [insert application link here] Respond to this request: Previous messages: On mm/dd/yyyy, the IRB wrote: [IRB message text] On mm/dd/yyyy, Applicantname wrote: [applicant response text] On mm/dd/yyyy, Applicantname wrote: [IRB message text] Send Communication About IRB Application: [Name] – [Case #] Version 2 – Revise application

IRB Application in Process [Name] – [Role] Application Date:[prepopulated with submitted date] Applicant Name:[prepopulated from LDAP] Title of Research:[prepopulated from submitted data] Case Number:[prepopulated from submitted data] Assigned Reviewer ID:[prepopulated from submitted data] Research Advisor Name:[prepopulated from submitted data] Research Advisor [prepopulated from submitted data] Approved by Research Advisor:[prepopulated with advisor’s approval date] APPLICATION DOCUMENTS: IRB Application:Link to application document Consent Form:Link to consent form document Additional Document 1:Link to additional document 1 Additional Document 2:Link to additional document 2 Additional Document 3:Link to additional document 3 Additional Document 4:Link to additional document 4 IRB REVIEWER RESPONSE: IRB Case Summary:Link to Case Summary document COMMENTS FROM OTHER IRB MEMBERS: Version 2: IRB Comment Period Submit Comment

IRB Application in Process [Name] – [Role] Application Date:[prepopulated with submitted date] Applicant Name:[prepopulated from LDAP] Title of Research:[prepopulated from submitted data] Case Number:[prepopulated from submitted data] Assigned Reviewer ID:[prepopulated from submitted data] Research Advisor Name:[prepopulated from submitted data] Research Advisor [prepopulated from submitted data] Approved by Research Advisor:[prepopulated with advisor’s approval date] APPLICATION DOCUMENTS: IRB Application:Link to application document Consent Form:Link to consent form document Additional Document 1:Link to additional document 1 Additional Document 2:Link to additional document 2 Additional Document 3:Link to additional document 3 Additional Document 4:Link to additional document 4 COMMUNICATION ABOUT THIS CASE: Communication with applicant Comments from other IRB members IRB REVIEWER RESPONSE: IRB Case Summary: Upload a different file: Case Disposition: Version 3: Closed to comments Close Browse… previousfilename.doc Re-open for Applicant EditingSave for Later

Technical Notes p. 14 IRB Application Drop Box APPLICATIONS SUBMITTED Received ApplicantRoleTitle mm/dd/yyyy Firstname LastnameStudentTitle of Research mm/dd/yyyy Firstname LastnameFacultyTitle of Research mm/dd/yyyy Firstname LastnameStaffTitle of Research mm/dd/yyyy Firstname LastnameStudentTitle of Research REVIEW IN PROGRESS Assigned ApplicantRoleTitleCaseReviewer mm/dd/yyyy Firstname LastnameStudentTitle of ResearchCase #Reviewer Name mm/dd/yyyy Firstname LastnameFacultyTitle of ResearchCase #Reviewer Name mm/dd/yyyy Firstname LastnameStaffTitle of ResearchCase #Reviewer Name mm/dd/yyyy Firstname LastnameStudentTitle of ResearchCase #Reviewer Name OPEN FOR COMMENT Assigned ApplicantRoleTitleCaseReviewer mm/dd/yyyy Firstname LastnameStudentTitle of ResearchCase #Reviewer Name mm/dd/yyyy Firstname LastnameFacultyTitle of ResearchCase #Reviewer Name COMPLETED See past applications in the IRB Application Archive In Applications Submitted, clicking on applicant name brings up the detail view of IRB Application Pending. In Review in Progress, clicking on applicant name brings up detail view of IRB Application in Process.