The first document you should think about when the independent data monitoring committee is planned is the IDMC Charter, which is crucial for outlining the standard operating procedure of the committee. The Charter purpose is describing of processes during the IDMC activities (including close and open sessions), presenting agreed roles and responsibilities of committee members and outlining the procedures related to blinded / unblinded data works.

The content of the charter may vary from trial to trial, as it addresses specifics of each given research project. Similar to the protocol and statistical analysis plans, the charter is an important document and depending on the trial — may be required by regulatory bodies prior to the initiation of a trial:

• – FDA: https://lnkd.in/dGBb5mxD
• – EMA: https://lnkd.in/dvD3rjeQ

Data monitoring committees have a significant role in modern clinical research and are increasingly recommended for any clinical trials, not just big, complex or clinical trials involving life-threatening diseases. Such committees play an important role in trials evaluating treatments with the potential to prolong life or reduce the risk of major adverse health outcomes.

There are no regulatory requirements for IDMC training, but because of the importance of the role of the IDMC and the complexities of the decisions that may be required of the IDMC members, it is recommended that IDMC members either have previous IDMC experience or have some training / mentorship / or guidelines provided to them. It is particularly important that the committee chair has prior IDMC experience. (https://lnkd.in/df6sEqex)

In TUNECT the inclusion of at least one member without prior experience on IDMCs, particularly early career individuals, is the our routine company intention. It should be encouraged for growing the pool of ‘qualified’ IDMC member to meet the increasing demand, but sometimes it can be a problem in case of risk minimization. So we have always to think first about how to best fit Good IDMC Practice and then think about the new member’s education.