Clinical Trials
What the exam tests
Questions test approval sequence, ethics oversight, consent, safety reporting and accountability for the investigational product. The exam wants the Pakistani pathway plus ICH-GCP discipline.
Approval and oversight
- A clinical trial in Pakistan requires authorisation from DRAP under the Clinical Trials Rules 2017, preceded by approval from an ethics committee/IRB acceptable to DRAP and, where applicable, national bioethics review.
- The sponsor needs a local contact or legal representative; sites and investigators must be qualified and named; the trial is registered before enrolment.
- Conduct follows ICH-GCP: protocol adherence, documented informed consent before any trial-related procedure, source documents supporting the CRF, and an audit trail for any correction.
Safety and product
Serious adverse events are notified to the sponsor within 24 hours; the sponsor reports serious unexpected suspected adverse reactions to the authority and ethics committees within the regulatory clock (7 days for fatal or life-threatening, 15 days for other serious cases). Investigational products need labelled packaging, storage at the specified conditions, accountability records, and documented return or destruction. Essential documents are retained after the trial as the authority requires.
Worked example
At a site, consent is signed after the screening blood draw. That is a GCP breach: no trial procedure may occur before consent. The remedy is not a new consent form but reporting the deviation, assessing subject risk, and correcting the process.
Traps
Confusing ethics approval with DRAP authorisation; using an ethics committee not acceptable to the authority; treating verbal consent as adequate; not reporting a serious unexpected reaction because it was absent from the investigator brochure; releasing unused product without accountability records.