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Data and Safety Monitoring Committee

Purpose/Mission

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

At the time of the initial review, the Protocol Review Committee (PRC) evaluates the study to determine an adequate protocol specific Data and Safety Monitoring Plan in the context of the risk level of the study, the existence of a plan for external monitoring by the sponsor or an independent Data and Safety Monitoring Board (DSMB) and other special circumstances that the committee feels will impact on the safety of the participants.

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.

Committee Determinations

The Committee may decide to approve a study to continue as planned or request more information or clarification from the investigator prior to approval. PI’s of studies which have unresolved issues are required to submit a response within a given timeframe set by the Committee, usually allowing for re-review at the next meeting. If a corrective action plan is necessary, a timeframe will be set and a follow up schedule will be put into place to evaluate the corrective action plan.

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

During protocol review, the Data and Safety Monitoring Committee takes into consideration the overall scientific progress of the study as demonstrated by safety profiles, accrual rates, and the existence of any new data that could alter the study outcomes.   Protocols may be closed for any reasons that jeopardize the safety of the participants or indicate that the investigator cannot complete a study.

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