Conflicting Eligibility Criteria at Screening

The data manager should not make the eligibility decision; that is the investigator's responsibility. However, the data manager must ensure the data system captures both local and central lab results per protocol. Because the protocol does not specify which lab governs eligibility, the data manager should escalate to the medical monitor and sponsor for a documented decision. The data manager should also verify whether the CRF includes fields for both local and central labs and whether the central lab result is the source for the eligibility criterion. If the central lab is the designated lab for eligibility, the patient does not meet the criterion. The data manager should not alter or suppress the central lab value. The correct action is to query the discrepancy, document the resolution, and ensure the eligibility checklist reflects the correct source. The data manager should also check whether the protocol's silence on lab source is a design gap that requires a clarification memo.

Both values should be entered into the database as separate lab records with their respective collection dates and lab sources. The data manager should not reconcile them into a single value. A discrepancy query should be raised to the site asking them to confirm which value was used for eligibility and to provide the investigator's rationale. The query response should be documented in the audit trail. If the site confirms the central lab value was used and the patient was enrolled despite not meeting the criterion, that is a protocol deviation that must be captured in the deviation log. The data manager should also check whether the central lab value was available before first dose; if not, the eligibility assessment may have been based on the local lab, which could be acceptable if the protocol allows it. The data manager should ensure the database has a field for 'lab used for eligibility' or a comment field to capture this.