Requirements for Data Safety and Monitoring Plans: Guidelines for NLM Grant Applications

If you seek funding from the National Library of Medicine (NLM) for a research project that involves a clinical trial, your application must include a Data Safety and Monitoring (DSM) plan. The purpose of this plan is to assure (1) safety of participants and (2) validity of the data. (See NIH Guide //grants.nih.gov/grants/guide/notice-files/not98-084.html). Review of the DSM plan will be part of the initial merit review of your application. The DSM plan should also be part of the research protocol submitted to your local IRB. Some institutions have developed standard monitoring policies. These may be used in place of an investigator-defined plan if they fit the project's needs.

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. For a more complete definition of clinical trials and their phases, see: //www.nci.nih.gov/clinicaltrials/conducting/dsm-guidelines/page2#op_def. A decision tree for determining whether you need a DSM plan is available from NIAID at //www.niaid.nih.gov/researchfunding/sci/human/decisiontrees/pages/datasafety.aspx. 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; for more details, see //grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html). For a Phase III clinical trial, a Data Safety Monitoring Board (DSMB) is required. Examples of appropriate levels of monitoring for different phases, and details about the composition of a DSMB, are available at NIAMS web site at //www.niams.nih.gov/Funding/Clinical_Research/NIAMS_guidelines.asp.

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.

These features are described in greater detail on the NCI website at //www.nci.nih.gov/clinicaltrials/conducting/dsm-guidelines/page3/.

NIAID provides a tutorial, "Create a Data and Safety Monitoring Plan," at //www.niaid.nih.gov/researchfunding/sci/human/pages/default.aspx. Sample DSM plans are available from NCI at //www.nci.nih.gov/clinicaltrials/conducting/dsm-example-plans.

Any investigator who plans to seek NLM funding for a clinical trial, should consult with the appropriate NLM grant program contact to discuss the Data Safety and Monitoring plan and frequency of reports to NLM before the grant application is submitted