Clinical Trials
What this domain tests
Clinical-trial questions test approval pathways, ethical oversight, GCP, investigational-product accountability and safety reporting.
Core rules and concepts
- A clinical trial needs PPB authorisation and ethics-review-committee approval before starting. Import of investigational products needs authorisation.
- The sponsor and investigator must follow GCP, the approved protocol, informed-consent requirements and the investigator’s brochure.
- Investigational products need receipt, storage, dispensing, accountability and destruction records.
- Adverse events and serious adverse events are recorded and reported within protocol and PPB timelines; the sponsor assesses causality and expectedness.
- Monitoring, audit and trial-master-file documentation support data integrity.
Worked example
A site dispenses an investigational product without recording batch numbers. Reasoning: this breaches accountability and traceability. The pharmacist should stop, reconcile stock, document the discrepancy, assess whether participants were affected, and report through the trial’s deviation and safety systems. If the event affects participant safety or data integrity, it may be a serious breach requiring prompt notification.
Traps that cost marks
Starting before ethics or PPB approval. Treating verbal consent as sufficient when written consent is required. Storing investigational products with commercial stock. Failing to report a serious adverse event because causality is uncertain. Ignoring accountability records.