Clinical Research Services Frequently Asked Questions
- Does a protocol have to go to the Clinical Research Steering Committee (CRSC) before going to the PRC?
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.
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- Can a protocol go to the PRC and HIC at the same time?
No. All protocols must be reviewed by the PRC prior to HIC submission.
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- Does the Data and Safety Monitoring Committee review all studies annually? Even those studies closed to accrual?
Yes. The Data and Safety Monitoring Committee reviews all cancer treatment studies annually.
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- Does an administrative amendment have to go to the PRC before going to the HIC?
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.
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- Why is a study being audited by the OPRM?
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.
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- Can I, or my research staff, go to the PRC meeting when my study is being reviewed?
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.
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- Do non-treatment protocols have to go to the PRC?
Yes.
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- Can the Data and Safety Monitoring Committee close a study for low accrual?
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.
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- Where can I find a Clinical Research Steering Committee or Protocol Review Committee Submission Form for the CRSC?
The Protocol Concept Submission Form is used for both the CRSC and the PRC.
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- Where can I find an Amendment Form for the PRC?
You can download the Amendment Request Form here.
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