Office of Research Facilitation Clinical Research Operational Review

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Clinical Research Operational Review

According to Seton Policy 1000.30, all studies being conducted at any facility in the Seton Network and utilizing any Seton resource, must be submitted to, and approved by, the Clinical Research Operational Review - in addition to receiving Institutional Review Board approval. 

What does the Clinical Research Operational Review (CROR) do?

  • The CROR is responsible for reviewing the operational impact of a study on the Seton network. The CROR review includes (but is not limited to) resource utilization, study feasibility, financial impact, and legal implications.

How is the CROR Review different from an Institutional Review Board (IRB) review?

  • An IRB is responsible for protecting the rights and welfare of human subject study participants. Every decision that an IRB makes is driven by their mission to protect research participants from undue harm. The CROR, however, represents Seton and is responsible for determining what impact a study will have on the network. An IRB examines the risk and benefit for a study subject and in a similar function, the CROR examines risk and benefit for the institution.

CROR and Feasibility Review Process

In order to receive CROR approval, all studies will need to be assessed for operational impact on the Seton network through the feasibility review process.  In some cases, a study may require additional approval from all functional groups (departments) affected by the study.

Feasibility review will be conducted after receipt of the following:

  1. Viable SIRB submission or executed IRB Authorization Agreement (for external studies)
  2. Viable CROR submission
    • The CROR will send notifications regarding study viability.
  3. Research Budget Worksheet

Viable is the term given to a submission when the submission form and all its required documents have been collected and are error-free.  Once viability has been confirmed, the review process continues as such:

  1. Assign Feasibility Review Date
    • The Office of Research Facilitation (ORF) and CROR will assign a review date for the study protocol.
    • Reviews are typically held each Monday.
  2. Feasibility Review Follow-Up
    • After protocol review, typically within 1-2 business days, the CROR will contact the research team via email.
    • The email will contain feasibility assessment questions which will help clarify study and/or Seton needs and will aid the CROR in determining which functional groups will be affected.
    • In the event that there were no feasibility assessment questions, no email will be sent and the CROR will proceed with study approval.
  3. Feasibility Determination
    • Upon CROR receipt of the research team's response, the CROR will determine which functional groups at Seton will need to further assess the study for feasibility.
    • Determination meetings are typically held each Thursday. Therefore, the research team should expect to receive a determination email from the CROR within 1-2 business days from the Thursday after responses were received.
    • The determination email will include feasibility forms that will need to be completed by the research team and returned to the CROR via email.
    • If it is determined that feasibility is not needed, no follow-up email will be sent and the CROR will proceed with study approval.
  4. Departmental Feasibility Review
    The CROR will send the feasibility forms to the affected departments for review.
    • Departments are given two weeks to respond with questions, clarification requests, or approval.
    • A one-week reminder will be sent to each department.
    • If a department fails to respond within two weeks, departmental approval is assumed and study feasibility will be administratively approved by the CROR.
  5. CROR Approval
    CROR Approval will be granted if the following criteria have been met:
    • IRB approval has been granted.
    • All feasibility forms have been approved.
    • Any CROR requested Letters of Support have been received.

 

Direct Contact Information

Rena Summers, BA
Clinical Research Manager
Clinical Research Operational Review
Office of Research Facilitation
1400 N IH 35, Suite C3.433
Austin, Texas 78701
(512) 324-7000 ext. 88310
RLSummers@seton.org

Reggie Louis, MS
Project Coordinator
Clinical Research Operational Review
Office of Research Facilitation
1400 N IH 35, Suite C3.442
Austin, Texas 78701
(512) 324-7000 ext. 77326
RILouis@seton.org

CROR Form and Links

CROR Submission Form

CROR FAQ

Procedure Worksheet

Seton Policy
Approving and Conducting Clinical Research Studies
1000.30

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