Data and Safety Monitoring Committee
The purpose of the DSMC is to provide ongoing data and safety monitoring for all interventional cancer clinical trials. The Committee reviews all studies at least annually and has the authority to intervene in the conduct of these studies as necessary to ensure the safety of the participants and to maintain the highest quality in the clinical research performed at YCC. The Committee reviews safety data, audit findings, monitoring reports, reports of unanticipated events, protocol deviations, and requests for specific reviews from faculty, staff or study participants.
More information about the Committee:
Assignment of a Protocol Specific Data and Safety Monitoring Plan
For studies without external monitoring, the protocol specific Data and Safety Monitoring Plan has two components: a time frame for submitting safety data for review by the DSMC and an internal audit schedule. Higher risk studies may be assigned more frequent reviews. Internal audits are coordinated by the OPRM and are conducted routinely and for cause.
Submission of Data and Safety Monitoring Review to the DSMC
The Office of Protocol Review and Monitoring staff will notify protocol correspondents regarding the data and safety monitoring review of their studies a month prior to the assigned DSMC review date. Please review the guidance document for required documents.
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The DSMC Committee has the authority to require additional monitoring or more frequent reporting on study progress and serious adverse events, require the establishment of a DSMB, or require the appointment of a medical monitor or an ad hoc safety committee, external to the DSMC, during the course of the study.
Upon completing the review, the DSMC Committee will recommend whether the study should continue unchanged, require modification/amendment, or be closed. All Committee decisions are communicated to the investigator in writing within one week of the meeting. The DSMC Committee has the authority to close trials to patient accrual, should the risk outweigh the potential benefits.
Serious issues concerning safety, compliance, or scientific misconduct are referred to the YCC Executive Committee. Decisions made by DSMC may be appealed by the PI to the Executive Committee.
Criteria for Termination of a Protocol and Study Closure Indications
Protocols may be closed for the following indications:
- Serious unexpected adverse event(s) that significantly alter the risk/benefit ratio
- Serious or multiple deficiencies in study conduct (e.g., lack of informed consent, violation of patient eligibility criteria, failure to report an adverse event(s) in a timely fashion, etc.).
- Lack of compliance with IND obligations
- New data suggesting the active protocol cannot achieve study objectives, or significantly altering the risk/benefit ratio
- Principal Investigator leaves institution
- Multiple major deficiencies in an internal or external audit or monitoring report
- Evidence of serious scientific misconduct or unsafe practices