ACCESS TO IRB-HSR ONLINE SYSTEMS WHILE OFF GROUNDS

Protocol Builder and IRB Online

Protocol Builder and IRB Online are only accessible off grounds via a UVA Anywhere VPN (this is different from a VPN from UVA Health). A digital certificate is required before you can obtain a UVA Anywhere VPN.  Contact your department IT personnel for assistance with setting this up.

IRB PRO

IRB PRO is accessible off grounds via a Netbadge login.  A UVA Anywhere VPN is not required.

 

1.Use Protocol Builder and CRConnect

If the study will require Expedited or Full Board review the study team is required to process the application through Clinical Research Connect (CRConnect) and provide initial information for study start-up.  If you have never used CRConnect, contact the CRConnect support staff for assistance (CRConnectSupport@hscmail.mcc.virginia.edu)

  • If you have never used Protocol Builder before, go to IRB PRO-Personnel Changes to create an account
  • IRB-HSR staff will review the account request and either grant or deny an account. You will be notified of this by e-mail.
  • If you have a Protocol Builder account, go here to start.

2.Pre-Review of Full Board Studies:

You MUST upload the documents into Clinical Research Connect (CRConnect) and follow the instructions in CRConnect for submission to the IRB-HSR for pre-review. If you need assistance with CRConnect please contact the CRConnect support staff in the School of Medicine Clinical Research Office at CRConnectSupport@hscmail.mcc.virginia.edu

  • The goal of the IRB is to conduct a prereview of the submission within 10 business days. There are times when the volume of work will require additional time to conduct the prereview.   IRB staff will communicate with the study team via email.  
  • You will receive communication from the IRB staff member regarding required revisions and a timeline for submission to be considered for the next available full board meeting. 
  • Please note the Submission Deadlines
  • Following the full board meeting you will receive an assurance form from the IRB-HSR outlining the approval status of the submission and/or any revisions which need to be made prior to final approval. (See "Possible Outcomes of IRB-HSR Review")
  • The study team will be notified by email when the final documents with the determination have been posted to IRB Pro
  • If the protocol is approvable with conditions, you will receive an assurance form noting items to be changed prior to the protocol being opened to enrollment. After those changes have been completed, submitted, and confirmed by the IRB-HSR, you will receive an additional assurance form noting the study is open to enrollment along with access to the approved consent forms in IRB PRO. At that time, you may begin to recruit and enroll subjects. Note that you are approved to enroll a specific number of subjects. If you wish to enroll more subjects than approved, you MUST obtain approval from the IRB-HSR prior to enrolling additional subjects beyond that approved.

3. Prereview of Expedited Review

You MUST upload the documents into Clinical Research Connect (CRConnect) and follow the instructions in CRConnect for submission to the IRB-HSR for pre-review. If you need assistance with CRConnect please contact the CRConnect support staff in the School of Medicine Clinical Research Office at CRConnectSupport@hscmail.mcc.virginia.edu

  • The goal of the IRB is to conduct a prereview of the submission within 10 business days. There are times when the volume of work will require additional time to conduct the prereview.   IRB staff will communicate with the study team via email. 
  • There are no submission deadlines for expedited studies.

  • The study team will be notified by email when the final documents with the determination have been posted to IRB Pro

    See also Expedited Review

4.Pre-Review: Exempt, or Non-Engaged Application

Exempt and Non-Engaged applications DO NOT require that you submit documents through CRCONENCT, however, a prereview of these documents is still required.

To submit a protocol for exempt, or non-engaged pre-review, email the following documents to the IRB HSR via IRB PRO-Submit Documents:

  •  
    • Protocol Cover Sheet
    • Exempt, or Non-Engaged Application
    • Protocol (if applicable)
    • HIPAA Authorization (if applicable)
    • Outside IRB approvals (if applicable)
    • Proposed study specific research tools (questionnaires, surveys etc.) (if applicable)
    • Recruitment tools
  • The goal of the IRB is to conduct a prereview of the submission within 10 business days. There are times when the volume of work will require additional time to conduct the prereview.   IRB staff will communicate with the study team via email. 
  • After all changes have been addressed, resend the revised documents to the IRB administrative staff that performed the pre-review.
  • The study team will be notified by email when the final documents with the determination have been posted to IRB Pro

5.Recruitment for subjects

6.Notice of Privacy Practices