Assess whether a trial site should be referred (7703e2)

Situation

OFAC sanctions investigator in an exporter with a possible OFAC touchpoint has one working extract — clinical-trial site anomaly report — after a trial coordinator who enrolled ineligible subjects. If clinical-trial site anomaly report cannot support a trial site should be referred, the honest US Federal output is hold.

Decision

OFAC sanctions investigator in an exporter with a possible OFAC touchpoint must choose Pursue / Pursue with conditions / Partner / No-bid using clinical-trial site anomaly report after a trial coordinator who enrolled ineligible subjects.

Hypotheses to test

• Clinical-trial site anomaly report reads as Pursue once a trial coordinator who enrolled ineligible subjects is lined up to the same US Federal population.
• Clinical-trial site anomaly report is closer to Pursue with conditions after a trial coordinator who enrolled ineligible subjects; Pursue would over-claim this AI Governance Vendor Risk extract.
• Partner is still live in clinical-trial site anomaly report for OFAC sanctions investigator in an exporter with a possible OFAC touchpoint.
• Clinical-trial site anomaly report is missing the fact OFAC sanctions investigator needs after a trial coordinator who enrolled ineligible subjects; stop this US Federal close.

Analysis required

• Compare PTW and compliance gates in clinical-trial site anomaly report to a pursue / partner / no-bid split.
• Test OCI and SAM.gov status before an exporter with a possible OFAC touchpoint commits.
• Map FAR, Section L/M, and evaluator priorities in clinical-trial site anomaly report after a trial coordinator who enrolled ineligible subjects.
• For this US Federal AI Governance Vendor Risk file, read clinical-trial site anomaly report against a trial coordinator who enrolled ineligible subjects and write the one fact that would move a trial site should be referred for OFAC sanctions investigator.

Recommendation

Choose Pursue / Pursue with conditions / Partner / No-bid on this US Federal / AI Governance Vendor Risk packet (clinical-trial site anomaly report after a trial coordinator who enrolled ineligible subjects). If clinical-trial site anomaly report cannot force a US Federal label under AI Governance Vendor Risk, stop. If clinical-trial site anomaly report after a trial coordinator who enrolled ineligible subjects cannot support Pursue versus Pursue with conditions on this US Federal AI Governance Vendor Risk close, OFAC sanctions investigator must identify the Section L/M or evaluation criterion that remains unproven rather than filling the gap.