Administrative and Financial Policies and Procedures

Policy for Review of Approved Studies when Changes are requested in Protocol, Resources, or Support

This policy streamlines processing of minor changes in approved protocols in order to expedite research. Any requests for changes in an approved protocol must be submitted in writing with IRB materials (if relevant) and detailed explanations of the request and rationale. The Investigator should indicate rationale and relevance of the requested change with respect to the:

  1. Science
  2. Safety
  3. Resources requested

This request will undergo administrative review and triage (Administrator, Medical Director and/or Assistant Director, RSAs as indicated, Nurse Manager as indicated). If changes are viewed as minor, approval will be granted and a summary submitted to the CRC-SAC. If there is disagreement about administrative approval, the Chair of the CRC-SAC will be asked to provide additional review. If administrative or CRC-SAC Chair review results in a concern about the requested change, then the materials will be submitted for full review by the CRC-SAC.

Policy for Re-review of Previously Approved Protocols after Five Year

The purpose of this policy is to ensure that utilization is appropriate for long-standing protocols. PIs of studies that have been in effect and active for more than five years without full review will be requested to reapply (on the current application form). In addition to the standard application materials, all updated IRB materials will be concurrently submitted for CRC-SAC review and the PI will be requested to present a narrative describing progress and plans. This re-application will be reviewed for approval of continuation or requests for revision will be presented. An in-service may be waived upon approval unless the CRC staff requests a refresher in-service. The study will not be halted during the review process. Rollout of the policy will be triaged toward studies that are CRU funded and of longest time since previously reviewed.

Policy for Review of CRC-SAC Pilot Studies

This policy ensures that resources for pilot projects are distributed equitably, and it monitors (and mentors) the progress of PIs with pilot studies toward independent funding. Investigators with studies that are supported solely by the CRC/CRU will be required to present a progress report on a yearly basis. A narrative will include a brief synopsis of the goals of the study, progress, pitfalls, and plans. The PI will list publications and plans for moving the study toward independent funding. This material will be reviewed by the CRC-SAC who will present, as appropriate, feedback concerning the research plans (mentoring) and may also use these reports for triage of resources. Investigators with multiple projects will be reviewed in context of their multiple awarded projects so that the SAC can consider each award in the broad aims of their work.

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Clinical Research Centers
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