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VA Cooperative Studies Program (CSP)

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Start A Trial

This is the process for starting a CSP study. Details are available in the CSP Investigator Guidelines.

  1. A Letter of Intent (LOI) or Planning Request is submitted to CSP Central Office by an eligible VA investigator, also called a Principal Proponent. Key elements in the LOI include: objectives of the proposed research, importance of the study to VA and its patients, justification for a multi-site study and the feasibility of conducting it within VA, summary of preliminary research and data to support a large-scale evaluation, proposed study design, anticipated size of the study. VA investigators must have a 5/8ths appointment at a VA facility. While rare, an investigator may request and be given an eligibility waiver.

  2. After an administrative review for appropriateness, the LOI is sent for external review of the scientific/clinical merit and feasibility by independent experts in the field.

  3. Based on LOI reviews and recommendations, a decision to fund a study planning meeting is made by the Director, Cooperative Studies Program

  4. If the LOI is approved for planning, a CSP Center is assigned to assist the study proponent in developing a full proposal. If necessary, a clinical research pharmacist and/or health economist is included on the study team. Typically, two planning meetings are required to develop a full proposal.

  5. Upon completion, the full proposal is submitted for peer review to the Cooperative Studies Scientific Evaluation Committee (CSSEC). CSSEC typically meets twice a year and is an independent panel of clinicians, research methodologists, and statisticians who all have expertise in clinical trials.

  6. After a face-to-face review between CSSEC and the study proponent, biostatistician, and CSP Center Director, a recommendation and priority score is given to the Director, Cooperative Studies Program. Generally, one of the following four recommendation are made: unconditional approval, conditional approval, approval with recommendation for resubmittal, rejection of study. Note: Approval by CSSEC doesn’t ensure funding. Funding is based, in part, on the priority score assigned and CSP budgetary considerations.

  7. If a study is funded by CSP Central Office, the study proponent works with the CSP Center to move into a "Study Initiation" phase.
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