Pharmacy AI · Module 5 · Unit 1 · Practical 3 — Data Quality & Audit Readiness

Clinical Trial Audit Readiness Challenge

Aim — To prepare a site for sponsor and regulatory inspection by identifying documentation errors, classifying their severity and ensuring GCP compliance before the auditors arrive. Duration 60 minutes · 6 departments · 14 items to inspect · 20-mark rubric · Pass 50%.

Inspected 0/14

Findings 0

Score —

Result —

◐ Theme

New to inspections? Start here

You are the Clinical Research Pharmacist preparing the hospital for a CDSCO / FDA / EMA inspection. The trial file contains deliberate mistakes. Inspect every item before the auditors arrive.

Open every document — in all six departments. A compliant record is a valid result; flagging a good record as defective is also an error.
Compare CRF against source — a value with no source record has no evidence behind it.
Reconcile the drug log — received = dispensed + returned + destroyed + remaining.
Check signatures and dates — especially on consent forms. Consent must be signed by the participant, before any study procedure.
Grade by consequence — participant safety or data integrity makes a finding Critical; administrative delay alone is Minor.

Remember the inspector’s rule: if it is not documented, it did not happen.

Student tasks

Classifying an audit finding

Grade	Definition	Example
Critical	Affects participant rights, safety or well-being, or the reliability of the trial data	Expired investigational product in usable stock; unreported serious adverse event; unsigned consent
Major	Could affect safety or data integrity if not corrected	Transcription error between source and CRF; staff missing from the delegation log
Minor	Administrative; does not affect safety or data integrity	Monitoring visit report filed late, content complete

Corrections rule: a single line strike-through, the correct value, then initials and date. Never overwrite, never use correction fluid, never obscure the original entry.

Faculty assessment rubric

Criteria	Marks

The Audit Readiness Report mark combines your written audit summary (2) with correctly stating the GCP principle breached by each finding (2). Audit failure: missing a Critical finding — or downgrading one to Minor — fails the station regardless of total marks.

Inspector & site

Candidate name

Registration no.

Inspection date · Site: Alizon Teaching Hospital, Clinical Trials Unit · Study: ALZ-CT-2026-01

Close the audit Audit summary

Summarise the site’s audit readiness — the key findings, the risk to participants and data, and the priority corrective actions.

You may close the audit at any time — items left uninspected count as missed findings.

Audit Readiness Report & assessment

Inspect the site and close the audit to generate your readiness report, then write and submit your practical report.