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
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, Clinical Science Research & Development Service.
If the LOI is approved for planning, a CSP Coordinating Center (CSPCC) is assigned to assist the study
proponent in developing a full proposal.
- 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.
Upon completion, the full proposal is submitted for peer review to the Cooperative Studies Scientific Evaluation Committee (CSSEC).
- 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.
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, Clinical Science Research & Development Service.
Generally one of the following four recommendation are made:
- 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.
* Note: Approval by CSSEC does not ensure funding. Funding will be based, in part, on the priority score assigned and CSP budgetary considerations.
If a study is funded by CSP Central Office, the study proponent works with the CSPCC to move into a
"Study Initiation" phase.
- Unconditional Approval *
- Conditional Approval *
- Defer consideration of the study with a recommendation for resubmittal
Rejection of study