Good Clinical Practice Refresher for Investigators

Learn how investigators must be qualified by education, training and experience, document credentials, and receive sponsor-led training on the proper use of the test product in the approved protocol.

Ensure adequate resources by estimating recruitment potential, staff, and facilities, plan sufficient time, and transparently coordinate with the sponsor to rent or buy needed equipment under ICH-GCP contracts.

Learn how investigators delegate trial activities while retaining responsibility, ensuring qualified supervision and training; maintain delegation logs, service provider records, and agreements, with sponsor monitoring and regulatory inspections.

Investigators and sponsors must submit trial documents to the ethics committee before initiation and report changes affecting risk, with approved protocol, consent, recruitment materials, and participant information per local regulations.

Investigators must conduct trials in compliance with the protocol, with signed agreements and documented deviations. Explain deviations, prevent recurrence, and inform sponsor and ethics committee; the monitor facilitates this communication.

Inform trial participants promptly and ensure appropriate therapy and follow-up when a trial is prematurely terminated or suspended, while transparently notifying sponsors, ethics committees, and regulators with detailed reasons.

The lecture outlines participants' rights to medical care and safety reporting, detailing five aspects including physician-led care, involvement of qualified professionals, adverse events, and safety reporting to sponsors.

Clarify the informed consent process: obtain ethics-approved materials, use plain language and multimedia tools, ensure voluntary, well-informed participation, and address special cases like reconsent, emergencies, and minor assent.

Investigators manage end of participation by following protocol and sponsor guidance, seek reasons respectfully, protect collected data, and inform participants of results after unblinding.

Understand investigational product management, including accountability, dispensing, administration, return, and destruction, with pharmacist delegation under the investigator's supervision, plus essential record-keeping and protocol compliance.

Learn to manage randomization and unblinding in blinded trials, ensure protocol-based identification code handling, emergency unblinding readiness, and prompt sponsor documentation for premature unblinding and good clinical practice.

Learn how to maintain accurate, timely source records and reports, safeguard data privacy, and ensure traceable audit trails from data capture to regulatory reporting.