Series: Helpful Information from BRANY’s Quality Assurance Team Eligibility Criteria
Today we will be discussing the second topic in the BRANY QA team’s series discussion of common findings from our Quality Assurance Reviews: eligibility criteria. When the BRANY QA team is reviewing a participant’s study eligibility during a Quality Assurance Review, we check the source documents to confirm all eligibility criteria are met. The source documents can include electronic medical record (EMR) notes, lab reports, ECG printouts, imaging reports, and inclusion/exclusion checklists. Our most common eligibility criteria finding is that the source documents do not adequately confirm all inclusion criteria were met and all exclusion criteria were not met. Examples of inadequate source documentation include that the medical records do not capture the patient’s medical history or a physical exam was unsigned. Please ensure lab reports, ECG printouts, imaging reports, physical exams, vital signs, and RECIST forms necessary for eligibility criteria review are signed by an investigator delegated this responsibility and there is a clinical significance assessment documented for abnormal results, as applicable. Although this is not a required document per the regulations, we recommend utilizing an inclusion/exclusion checklist signed by a delegated investigator as it documents a review of all protocol inclusion criteria and exclusion criteria by an investigator. Inclusion/exclusion checklists, or eligibility checklists, record all protocol inclusion criteria and exclusion criteria and confirm if each criterion was met. The inclusion/exclusion checklist can be a separate paper case report form, or it can be embedded in an electronic medical record note by the investigator. An inclusion/exclusion checklist can also document confirmation of eligibility criteria not explicitly represented in the source documents, such as criterion that require the investigator’s opinion to confirm or medical conditions that are exclusion criterion. Inclusion/exclusion checklists should not be used as source documents to confirm eligibility criteria that require specific lab results or assessments that result in scores.
As an exercise, try selecting a participant for your own review. For each inclusion criterion and each exclusion criterion, ask yourself, “where is there written documentation confirming if this eligibility criterion was met?” You may also consider checking that the date of the assessment was prior to the participant’s date of randomization, all the source documents are signed/dated prior to the date of randomization, and that the assessment was done per protocol.
If you would like further help with assessing compliance around eligibility criteria documentation, the BRANY QA team has developed an eligibility criteria compliance checklist. To download the checklist and other tools developed to aid in compliance checks, please https://www.brany.com/research-auditing-and-monitoring/.
Any questions? Please reach out to QA@brany.com.
