Starting a VA Cooperative Study

The following outlines the process for how a CSP study begins. For specific details, please read the CSP Guidelines (469 KB,PDF).

1. A Letter of Intent (LOI) (or Planning Request) is submitted to CSP Central Office by an eligible VA investigator (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 Coordinating Center (CSPCC) 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.
• After the first planning meeting, the CSPCC Director submits a request to CSP Central Office for a second planning meeting based on study progress.
5. Upon completion, the full proposal is submitted for peer review to the Cooperative Studies Scientific Evaluation Committee (CSSEC).
   • CSSEC is an independent panel of clinicians, research methodologists, and statisticians who all have expertise in clinical trials.
   • CSSEC meets twice a year, usually in May & October.
6. After a face-to-face review between CSSEC and the study proponent, biostatistician, CSPCC Director, and health economist (if needed), 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 *
   • Defer consideration of the study with a recommendation for resubmittal
   • Rejection of study
   * Note: Approval by CSSEC does not ensure funding. Funding will be 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 CSPCC to move into a "Study Initiation" phase.