MD-Led Safety Site Audit

Physician-led review of the records underlying eligibility decisions, safety reporting, and subject-level conclusions in clinical trials.

Eligibility supportability•AE/SAE traceability•Inspection readiness•On-site review

What the service does

Assesses whether key trial decisions remain supported by source records within a defined sample.

Covers eligibility, relevant protocol deviations, AE/SAE traceability, and inspection-facing documentation.

Determines whether subject-level conclusions remain clinically supportable, traceable, and defensible under regulatory scrutiny.

Enables physician-to-physician discussion where medical judgment is needed and issues cannot be resolved through downstream data review alone.

Verification of inclusion and exclusion criteria against source documentation, including deviations affecting subject eligibility.

Comparison of AE/SAE information across source records, eCRF, and safety systems, including timelines, seriousness classification, and narratives.

Review of the completeness, coherence, and defensibility of selected subject-level and site-level records.

Eligibility or safety decisions are difficult to defend.

High-risk sites trigger RBQM or governance concern.

Sponsors need added confidence before inspection.

Early-phase programs or due diligence require source-level clarity.

Protocol eligibility criteria mapped to supporting source records and corresponding trial data entries.

Structured summary of discrepancies, omissions, and inconsistencies across source records, eCRF, and safety-reporting systems.

Scope, sampling rationale, key observations, limitations, and inspection-facing implications from the reviewed sample.

Reviews are performed on-site at the investigational site or in a sponsor-approved secure review environment.

Where needed, investigators are engaged directly to assess whether the decision was reasonable based on the information available at the time.

Can support central medical monitoring when clinically important questions cannot be resolved through listings, trends, or downstream review alone.

Sample depth aligned to risk.

Review limited to what is needed for the defined scope.

Absent support remains absent.

Findings are documented clearly and escalated where required.