POLICY OF THE NATIONAL CANCER INSTITUTE
FOR DATA AND SAFETY MONITORING
OF CLINICAL TRIALS

Introduction

All clinical trials supported or performed by NCI require some form of monitoring. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff to a data and safety monitoring board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB).

Throughout this policy, the term "awardee" means the awardee institution. In the case of NCI intramural research, the comparable institutional unit is the NCI.

Responsibility for Data and Safety Monitoring

Responsibility for data and safety monitoring depends on the phase of the study and may be conducted by NCI program staff or contractor, by the principal investigator/project manager conducting the study, or by a DSMB. Regardless of the method used, monitoring must be performed on a regular basis. Oversight of the monitoring activity is the responsibility of NCI program staff. In the case of extramurally funded research, adherence to this NCI policy and any data and safety monitoring policies of the NCI Division making the award will be made a condition of the award.

Phase I and Phase II studies may be monitored by the principal investigator/project manager, by NCI program staff or a designee, or jointly. When conducted by the principal investigator/project manager, the awardee must have written policies and procedures describing the monitoring and reporting processes in place. The awardee's policies must be consistent with any policies of the NCI Division making the award. NCI program staff from the awarding NCI division will determine the acceptability of the awardee's policies and procedures. These will be documented in the grant, cooperative agreement or contract file and become part of the award.

All Phase III randomized clinical trials supported or performed by NCI require monitoring by a DSMB. The organization, responsibilities, and operation of the DSMB are described below.

For studies co-funded with other NIH Institutes or Centers (IC), the lead NIH IC will be responsible for monitoring the study and establishing a DSMB if necessary. Oversight of the DSMB will be the collaborative responsibility of the lead NIH IC and NCI.

Requirement for Data and Safety Monitoring Boards

Data and Safety Monitoring Boards must be established to monitor all Phase III randomized clinical trials supported or performed by NCI. Funds to support the functions and operations of the DSMBs will be provided by NCI in a fashion to be determined by each NCI Division.


1 "Institution" is defined for this purpose as the awardee(s) institution and any institutions collaborating scientifically in the conceptual design or analysis of the study (beyond merely referring patients), including Cooperative Group member institutions participating in the trial, or consortia member institutions participating in the trial.
2 "Trial principal investigator/project manager" means the individual primarily responsible for the project, i.e., the principal Chair of a Cooperative Group, the principal investigator listed on a U10, P01 or R01 award, or the project manager listed on a contract award.
3 This policy in no way affects any legal appeal rights of the awardee.
4 "Professional interest" is used in the sense of the trial outcome benefiting the individual professionally.

The above was approved by the NCI Executive Committee on 6/22/99.