Vanderbilt-Ingram Cancer Center

Scientific Review Committee (SRC)

Submitting Your Protocol

Procedure for submission of protocols to the SRC

1. Protocols are submitted to the SRC for review via the Cancer Center Clinical Trials Shared Resource (*CTSR) Protocol Submission Form. Items which are required for submission include: (1) name of the principal investigator (PI), (2) identification of the Cancer Center Clinical Team which is sponsoring the protocol, (3) expected duration of the study, (4) expected accrual to the study at each of the sites associated with the Cancer Center, (5) objective evidence for the expected accrual, (6) an indication as to whether eligibility criteria overlap with other open protocols, and (7) the signature of the Cancer Center Clinical Team Leader.
   
   
2. To be considered for review by the SRC, each protocol must include: (1) scientific rationale with appropriate supporting references to the medical literature, (2) one or more clearly stated scientific aims, (3) clearly stated protocol eligibility criteria, (4) a clearly stated treatment plan, (5) one or more clearly stated study endpoints, and (6) copies of the data forms to be used. All protocols must also include valid statistical design and analysis where appropriate. The VICC Biostatistician, who serves as a member of the SRC, is available for consultation to PIs in regard to studies, which require statistical design or revision. A grant application or completed CPHS/IRB proposal does not meet the above criteria for consideration as a protocol by the SRC. Proposals submitted without a protocol meeting the above criteria will be returned to the PI and will not be reviewed until a valid protocol is submitted.

The typical layout for a clinical trial protocol:

1. Title page:
   Listing PI and co-investigators (so we know that appropriate disciplines are represented if needed), Version number with date
   a. Table of contents
   b. +/- abstract
2. Primary and Secondary objectives
3. Background/Rationale
4. Eligibility criteria (no exclusion is okay)
5. Study design / Intervention
6. Data to be collected
7. Statistical analysis, including # subjects and rationale for same (even for pilots)
8. References
9. Appendices (include questionnaires etc.)

See also:

• Study Parameter Chart indicating what is not standard of care
• Clinical Trials Shared Resource Flow Charts
• Protocol Submission Form (PDF)
• Electronic Submission Instructions (PDF)
• Protocol Submission Sheet Definitions