A. Behavioral and Nutritional Studies
For behavioral and nutritional Phase I-III trials, the NCI requires that a DSM plan be in place appropriate to the anticipated level of risk involved in the particular study. A DSMB can be constituted at the investigator’s discretion and seems particularly appropriate when investigators anticipate the possibility of early stopping based on emerging differences in either risk or benefit.
B. Training Grants
Certain types of NCI career and training awards may support clinical trials, directly or indirectly. NCI's DSM policy covers those career and training awards in which the trainee has direct responsibility for conduct of the clinical trial or in which award funds directly support the trial. Responsibility for compliance with NCI's DSM policies rests with the grant recipient; this may be either the trainee or the training program director, depending on the award (individual versus institutional). Trainees in a mentored career program should consult with their mentors about adapting or designing suitable DSM plans for their clinical trials. In most cases the trainees will be in a mentored stage of their career and will lack the experience needed to provide appropriate oversight of the trial. The DSM plan must therefore clearly identify the senior individual responsible for monitoring the trial and the function of the trainee in this process.
For institutional career development programs (e.g., K12, R25T) in which clinical trials are an integral part, applicants should provide with their application a "Special Institutional Statement Regarding Human Subjects Research under K12 or R25T Support". This statement must be provided to NCI Program staff for evaluation and approved before the initial grant award can be issued, and submitted for evaluation and approval with each "Application for a Continuation Grant."
More information about these awards is available on the NCI's Cancer Training Branch (CTB) Web site. Specifically,
- K12 Special Institutional Statement Regarding Human Subjects Research (PDF file).
- R25T Special Institutional Statement Regarding Human Subjects Research (PDF file).
For individual career development awards in which the grantee has direct responsibility for trial conduct or in which award funds directly support the trial, the DSM plan covering the trial may NOT be an institutional plan. The DSM plan must be tailored specifically to the clinical trial. Guidance on the content and organization of an NCI DSM plan may be found under the Essential Elements section of the Data and Safety Monitoring Guidelines.
A DSM plan does not need to be provided for individual career development awards in which:
- The trial is a component of an NIH Cooperative Group trial;
- The trial is a CTEP-supported protocol;
- The trial is being partially or completely supported by an investigator-initiated NIH R-grant, viz. R21, with an approved DSM Plan.
For individual career development awards in which a clinical trial will be conducted that does not require the submission of a DSM plan, the grantee must submit for evaluation a letter to NCI program staff describing their situation and explaining why a DSM plan is not needed. This letter must be co-signed by the institutional official authorized to evaluate issues pertaining to data safety and monitoring; and, in the case of mentored awards, by the grantee's mentor.
If the clinical trial is not to be started immediately upon award of an individual career development award but will follow after a considerable lapse of time (years), submission of a DSM plan to NCI for approval may be delayed until the nature of the trial is clear and its initiation is in the near future. This will insure that the DSM plan suits the needs of the trial.
For NCI career development awards for established investigators (K05, K24), a DSM plan does not need to be provided. However, a Restriction term (Appendix C) will be included in each Notice of Grant Award requiring that the grantee remain in compliance with the NCI's policy on data and safety monitoring throughout the project period.