Tip of the Week Archive

The Difference Between Participants “Enrolled” vs. “Started”

The number of participants Enrolled is the number of participants who agreed to participate in the study following completion of the informed consent process. 

Enter the number Enrolled within the Study Design Module:  

Depending on the study status (e.g. Enrolling, Completed), the Enrollment field should indicate:

• Actual if enrollment has been completed, or
• Anticipated if enrollment is ongoing.

Potential participants who are screen-fail and aren’t consented are NOT considered enrolled unless otherwise specified by the protocol.  

The number of participants Started, is the number of participants who were assigned to an Arm/Group.

Enter the number of participants Started within the Participant Flow module, which is part of the Results section of the record:

This number may be fewer than the number of participants enrolled if participants were screened and consented, but then dropped out of the study before being randomized to a study Arm/Group.

If the “Enrolled” and “Started” numbers differ, provide an explanation in the Pre-assignment Details data element (an example is shown in the screenshot above).