GCP Certification Quiz

What is GCP?

• International ethical and scientific quality standard for trials involving humans.

• A type of clinical trial.

• A regulatory body in Malaysia.

• A method for data collection.

Core GCP Principles

• Trials must follow ethical standards (e.g., Declaration of Helsinki)

• Risk-benefit balance must favor the participant

• Informed consent is required

• All of the above

Key Stakeholder Responsibilities - Investigator

• Conduct study as per protocol

• Obtain informed consent

• Ensure participant safety

• All of the above

Malaysian Clinical Trial Approval Process

• Ethics approval: MREC or institutional EC

• Regulatory submission: CTIL/CTX for investigational product import

• INV for academic trials using registered drugs

• All of the above

Informed Consent Process (ICP)

• Must be voluntary, informed, and documented before any trial procedure

• Participants must be allowed to ask questions

• For illiterate subjects: use an impartial witness

• All of the above

Safety Reporting - AE

• Document only

• Report to NPRA/MREC

• No

• All of the above

Trial Documentation - Essential documents include:

• Protocol

• Investigator's Brochure (IB)

• Informed Consent Forms

• All of the above

Monitoring, Audit & Inspection - Activity Conducted By

• Sponsor/CRO

• Sponsor

• NPRA/Regulators

• All of the above

Data Management - ALCOA-C

• All trial data must follow ALCOA-C standards

• CRFs must match source data exactly

• Corrections must be dated, signed, and explained

• All of the above