Yes. The "Clinical Research Steering Committee/PRC Submission Form" must be submitted for all cancer protocols. Protocols requiring YCC Clinical Research Services (CRS) must be reviewed by the full Clinical Research Steering Committee.
No. All protocols must be reviewed by the PRC prior to HIC submission.
Yes. The Data and Safety Monitoring Committee reviews all cancer treatment studies annually.
Yes. All amendments, including administrative changes and amendments to protocols that have been closed to accrual, must be submitted to the PRC prior to HIC.
The NCI mandates periodic auditing of studies conducted at NCI designated Cancer Centers in conjunction with the Cancer Center Support Grant. Audits are conducted based on a schedule determined by the PRC, in preparation for an external audit, or for cause.
Investigators and/or their designees are encouraged to attend the PRC meetings in order to facilitate the review process by answering questions raised by Committee members. Investigators leave the room during deliberations and vote.
Yes. All cancer studies are reviewed for accrual by the Data and Safety Monitoring Committee every six months. Any study not accruing 30% of the anticipated accrual will be recommended for closure and the PI will be required to respond to the Committee with a justification for continuing enrollment. The Committee will then determine if the study may remain open.
The Protocol Concept Submission Form is used for both the CRSC and the PRC.