Determining Eligibility

It is very important to ensure that a subject meets the protocol eligibility requirements.  To document eligibility and to help ensure you don’t miss any requirements it is a good idea to develop and use a study-specific eligibility checklist that matches the current version of the protocol.  Protocols usually have a list or chart of the eligibility requirements, which can easily be copied to a checklist. 

You should maintain a completed eligibility checklist in the research record for each subject.  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 properly qualified to make the eligibility assessment, be IRB-approved to conduct the research, have documented study-specific training, and have been delegated by the PI to assess eligibility per 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. 

Maintaining Eligibility

If a subject becomes ineligible while participating in the study, consider holding the study intervention until the subject 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 subject should remain in the study.  If the sponsor or PI determine that the subject should no longer participate in the study, the subject must be withdrawn.

There are some situations where the subject may have to be withdrawn from the study but the subject may still be able to obtain the drug/device even though not in the trial.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