Determining Eligibility

Ensuring that a participant meets the protocol eligibility requirements is important for participant safety and data integrity of the study. To document eligibility and to ensure compliance with screening requirements, utilize a study-specific eligibility checklist that matches the current version of the protocol. Protocols usually have an inclusion/exclusion list or chart of the eligibility requirements that can easily be copied to a checklist. 

Maintain a completed eligibility checklist in the research record for each participant. The checklist should have a signature line for the person completing the checklist and another line for the person verifying eligibility (if it is not the same person completing the form). The person verifying eligibility must be qualified to make the eligibility assessment, IRB-approved to conduct the research, have documented study-specific training, and have eligibility determination activity on the delegation of authority log.

Eligibility Source Documentation

Just like the rest of the research data, source documentation to support eligibility should be easy to locate in the research record. Consider keeping the supporting eligibility source documents behind the eligibility checklist in the participant electronic or paper chart.

Maintaining Eligibility

If a participant becomes ineligible while participating in the study, consider holding the study intervention until the participant can be evaluated for safety by a qualified member of the study team.  The PI should consult with the sponsor, medical monitor, or data and safety monitoring committee to determine whether the participant should remain in the study. If the sponsor or PI determines that the participant should no longer participate in the study, the participant must be withdrawn.

There are some situations where the participant may have to be withdrawn from the study but the participant may still be able to obtain the drug/device outside of the study. If the drug or device can be obtained outside of the study (e.g., a drug that is already FDA-approved but is being used for another indication for the clinical trial), the PI may consider off-label use for the practice of medicine. If this occurs, data cannot be collected for research.