A clinical trial is a prospective study involving human subjects, which is designed to answer questions about the effects of a biomedical or behavioral intervention. This includes interventions whose goal is to initiate or change behavior in a target population (such as physicians or consumers) by introducing information resources and services. A decision tree for determining whether you need a DSM plan is available from NIAID. An observational study, or a study that does not test an intervention, is not a clinical trial and does not require a DSM plan.
The monitoring of a clinical trial should be commensurate with risks and the size and complexity of the trial. For example, in a clinical trial which involves only a small number of human subjects and low risk, close monitoring by the study investigator may be adequate, while a multi-site or large clinical trial might require a central reporting entity; check here for details.
The essential elements of a Data Safety and Monitoring plan are:
- Monitoring the progress of trial and the safety of participants
- Description of the mechanism for reporting adverse events to the IRB, FDA and NIH (that is, to the NLM program official responsible for the grant)
- Plans for assuring data accuracy and protocol compliance.
Instructions on preparing a DSM Plan are provided in section 4.1.5 of the SF424 (R&R) Supplemental Grant Application.
Any investigator who plans to seek NLM funding for a clinical trial, should consult with the appropriate NLM grant program official to discuss the Data Safety and Monitoring plan and frequency of reports to NLM before the grant application is submitted.