Tip of the Week Archive

The Participant Flow module is the first module in the Results section of the record. It shows how participants assigned to each arm “flowed” through the stages of the study, and must account for every enrolled participant.

For clinicaltrials.gov purposes, the number of participants in the Protocol Enrollment data element must match the number of participants in the Started element for the first Period in the Participant Flow module, or an explanation must be provided.

If the “Protocol Enrollment” and “Started” numbers differ because participants were excluded after enrollment, but before they were assigned to an arm or group, explain what happened in the “Pre-assignment Details” data element within the Participant Flow module.