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Step 3: Monitoring a Cancer Prevention Clinical Trial

Data and Safety Monitoring Policies and Guidelines

A Data and Safety Monitoring Plan must be included with each protocol and must address the "Essential Elements of a Data and Safety Monitoring Plan for Clinical Trials Funded by the National Cancer Institute". An IRB and NCI-approved institutional plan may be referenced, however, it must appropriately address any unique needs of the chemoprevention trial.

NCI's policy for data and safety monitoring mandates that all clinical trials supported or performed by NCI conduct some form of monitoring in accordance with a Data and Safety Monitoring (DSM) plan.

The method and degree of monitoring is commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring can be conducted by the principal investigator, project manager, NCI program staff, or a data and safety monitoring board (DSMB). DSMB activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB).

Essential elements of a Data Safety and Monitoring Plan for all phases of cancer clinical trials are:

1. Monitoring the progress of trials and the safety of participants should include a number of elements:
   • Who actually monitors the trials?
   • How often are the data examined in the course of trial conduct?
   • What do the monitors look for?
   • What procedures are in place to insure adequate feedback of information to researchers and medical decision-makers, so that trials involving excessive risk in relation to anticipated benefits are terminated appropriately?
   • What is the oversight or supervisory role of institutional committees, if appropriate?
   • What procedures does the institution have for coordinating multi-center trials, if applicable?
2. The Data and Safety Monitoring Plan should describe the processes and oversight that the institution has in place for assuring that AE reporting requirements are actually met.
3. For multi-center trials coordinated by the institution, the plan should outline procedures by which the institution establishes a central reporting entity that collects and reports AEs to all necessary destinations, including co-investigators at participating institutions.
4. The plan should include a process for assuring that any action resulting in a temporary or permanent suspension of an NCI-funded clinical trial is reported to the NCI grant program director responsible for the grant - These actions include, for example, any FDA actions that affect NCI-funded trials. It also includes actions by an IRB or by a commercial sponsor, or by the investigator, if an NCI-funded trial is involved.
5. The plan should describe what quality-control procedures are in place for assuring data accuracy and completeness in studies funded by NCI. If an IND is in place, quality-control procedures are generally stipulated by the IND sponsor and may be simply referenced or summarized in the DSM plan. For studies not done under an IND, the institution should describe whatever procedures are in place to assure data integrity and protocol adherence. Appropriate procedures may range, for example, from regular data verification and protocol compliance checks performed by a data manager and a principal investigator, to a formal external data-audit process by an agent external to the institution.

Institutions sponsoring a significant number of clinical trials are guided to formulate institutional DSM plans that can be broadly applied to the individual trials in their portfolio. Investigators from institutions or organizations without institutional DSM policies may use the guidelines for fashioning suitable DSM plans for their individual trials.

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