Determining a feasible and acceptable data monitoring plan can be a major barrier to getting an embedded (ePCT) through the planning phase (see SPOT investigator interview). ePCTs may use cluster-randomized designs, which raise special statistical issues. DMCs for cluster-randomized trials need one or more statistical members who are knowledgeable about these issues. Training for all DMC members on the particular issues of monitoring ePCTs is also expected to be helpful.

As described throughout this chapter, some typical monitoring practices used for traditional trials may need to be rethought when applied to ePCTs. The NIH Collaboratory plans to develop training resources that can be used to educate DMCs on the intricacies of monitoring ePCTs. Until such training is available, the investigator may need to expend extra effort holding open discussions with the sponsor and DMC during the planning phase to reach a satisfactory monitoring plan.

The NIH Collaboratory Ethics and Regulatory Core has developed a DMC charter template that can be used for ePCTs. 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. A charter customized for ePCTs may include specific requirements, such as the need for at least one DMC member to have prior experience in conducting and interpreting data from ePCTs.

Data monitoring for ePCTs is evolving, as more ePCTs are conducted and more is learned about special issues that might need to be considered.