The NIH Collaboratory Regulatory/Ethics Core has published a charter template that can be used to help establish a data monitoring committee (DMC) and associated procedures appropriate for oversight of pragmatic clinical trials. DMCs play an important role in protecting the welfare of trial participants and ensuring the integrity of a trial so that it can yield useful results. A charter defines the primary responsibilities of a DMC, its membership, the purpose and timing of its meetings, and its procedures and statistical monitoring guidelines.
In addition to procedures and guidance for DMCs generally, this new charter template contains suggested practices specifically for DMCs for pragmatic clinical trials, such as the recommendation that at least one DMC member have prior experience in conducting and interpreting data from this type of trial.
The charter template can be downloaded and customized by organizations to set up DMCs for pragmatic clinical trials and clearly outline their operations. For more information on special considerations in data and safety monitoring for pragmatic clinical trials, please see the Data and Safety Monitoring Living Textbook chapter.