Data and Safety Monitoring

Cancer Consortium Data and Safety Monitoring Plan

This plan was developed to help study teams design appropriate data and safety monitoring plans for research protocols. It is maintained by Clinical Research Support.

Data Safety Monitoring Boards and Plans NIH and NCI Policies

NIH Policy requires that all grantees have in place procedures for data safety monitoring of clinical trials, to insure the safety of participants and validity of data. In 1999, the NIH issued a policy requiring that a Data and Safety Monitoring Board (DSMB) be established for all phase III randomized clinical trials funded by NCI.

According to that document, the DSMB was responsible to review interim analyses of outcome data and cumulative toxicity data summaries to determine whether the trial should continue as originally designed, should be changed, or should be terminated based on these data., review reports of related studies to determine whether the monitored study needs to be changed or terminated, and review major proposed modifications to the study prior to their implementation (e.g., termination, dropping an arm based on toxicity results or other reported trial outcomes, increasing target sample size). DSMB findings would be communicated to the study leadership, and the NCI Division Director.   

In their April 2001 guideline, the NCI clarifies the policy somewhat, stating that "there is no longer a blanket requirement for DSMB in the cases of low-risk behavioral and nutritional trials... All such trials should include a data and safety monitoring plan, but this may or may nor include a DSMB". This document goes on to define the Essential Elements of a DSM plan:

  1. Monitoring the progress of trials and safety of participants.
  2. Plans for assuring compliance with requirements regarding the reporting of adverse events.
  3. Plans for assuring that any action resulting in temporary or permanent suspension of an NCI_funded clinical trial is reported to the NCI grant program director.
  4. Plans for ensuring data accuracy and protocol compliance

NIH funded phase I and II clinical trials must also have a data and safety monitoring plan, which does not necessarily include a DSMB, but which is appropriate for the "potential risks, complexity and nature of the trial."

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