Protocol Submission Process

Protocol Submission Process

  1. Develop protocol idea
  2. Obtain IRB Approval of Grant (if study funded by non common rule agency ( e.g. Dept of Justice)
  3. If the study will require Expedited or Full Board review use Clinical Research Connect (CRConnect) to obtain UVA Study Tracking # and provide initial information about the study.  If you have never used CRConnect, contact the CRConnect support staff for assistance (CRConnectSupport@hscmail.mcc.virginia.edu
  4. Use Protocol Builder
  5. Pre-Review: Full Board Review and Expedited Review
  6. Pre-Review: Exempt, or Non-Engaged Application
  7. Review Outcomes
  8. Enrollment of subjects following approval
  9. Advertising for subjects
  10. Notice of Privacy Practices

1.Develop protocol idea

  • If you are a medical, nursing or BIMS student, or are employed by the Health System, you may obtain assistance with protocol development, statistical plans or data management from Public Health Sciences @ the Library.

2.Obtain IRB Approval of Grant (Not required if the study is funded by the FDA or a federal agency that follows the Common Rule). This is rare for the IRB-HSR (e.g. grant from Department of Justice). COMMON RULE AGENCIES

  • If required follow the Grant Submission Summary to submit the grant for IRB-HSR approval. The IRB-HSR cannot approve the protocol before approving the grant. They can be submitted to the IRB-HSR at the same time.

3.Use Protocol Builder and CRConnect

If the study will require Expedited or Full Board review use Clinical Research Connect (CRConnect) to obtain UVA Study Tracking # and provide initial information about the study.  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 here 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.

 

4.Pre-Review: Full Board Review and Expedited Review

  • You MUST upload the documents into Clinical Research Connect (CRConnect) and follow the instructions in CRConnect to submit the documents 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 documents will be returned to the individual that submitted the initial documents for pre-review via email with tracked changes and comments within 7-10 working days.
  • After all changes have been made- resend the revised documents to the IRB administrative staffer that performed the pre-review.
  • You will receive communication from the IRB staff member within 1-2 working days for studies going to the full board to confirm you have made all required changes. This step must be completed by Thursday at 5 pm PRIOR to the agenda deadline, in order for the protocol to be considered for the next full board agenda.

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

  • To submit a protocol for exempt, or non-engaged pre-review, email the following documents to IRBHSR@virginia.edu
    • Protocol Cover Sheet
    • Exempt, or Non-Engaged Application
    • Protocol (if applicable)
    • HIPAA Authorization (if applicable)
    • Manual of Operations (if applicable)
    • Non-UVA IRB approvals (if applicable)
    • Proposed study specific research tools (questionnaires, surveys etc.) (if applicable)
  • The completed pre-review will be returned to the individual that submitted the initial documents with comments within 10 working days.
  • After all changes have been addressed, resend the revised documents to the IRB administrative staff that performed the pre-review. All revisions recommended by the IRB-HSR must be made prior to final submission to the IRB-HSR.
  • The study team will be notified by email when the final documents with the determination have been posted to IRB Pro.

6.Review Outcomes

  • For full board review submissions, following the meeting you will receive a letter from the IRB-HSR explaining any changes which need to be made prior to final approval. (See "Possible Outcomes of IRB-HSR Review")

7.Enrollment of subjects following approval

  • If the protocol is approvable with conditions, you will receive an assurance form noting items to be changed prior to the protocol being open for 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. At that time, you may begin to advertise 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.
    If approval of the protocol is deferred, you will receive a letter noting the revisions that are required.

8.Advertising for subjects

9.Notice of Privacy Practices