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).
- A Letter of Intent (LOI) (or Planning Request) is submitted to CSP Central Office by an eligible VA investigator
- 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.
- 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.
- Based on LOI reviews and recommendations, a decision to fund a study planning meeting is made by the Director, Cooperative Studies Program.
- 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.
- 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.
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:
* Note: Approval by CSSEC does not ensure funding. Funding will be based, in part, on the priority score assigned and CSP budgetary considerations.
- Unconditional Approval *
- Conditional Approval *
- Defer consideration of the study with a recommendation for resubmittal
Rejection of study
- If a study is funded by CSP Central Office, the study proponent works with the CSPCC to move into a
"Study Initiation" phase.