Good Clinical Practice ICH GCP - Full Certificate Course

Explore the roles and responsibilities of the IRB and IEC, including independent review, protocol approval, informed consent oversight, and ongoing protection of participants' rights and safety.

The IRB/IEC comprises at least five members, including one non-medical and one independent, to review science, medical, and ethics aspects, and they vote, maintaining minutes under documented procedures.

Explain IRB/IEC procedures for committee composition, meetings, initial and continuous trial reviews, approvals, deviations, expedited reviews, and maintaining records and regulatory submissions.

Identify the investigator as the trial's responsible leader with required education, training, experience, and resources, and outline communication with IRB/IEC, protocol compliance, safety reporting, informed consent, and randomization.

Learn how investigators and sponsors submit and obtain IRB/IEC approval for trial protocols and investigator brochures, consent materials, and recruitment, and how they report updates and deviations under GCP.

Notify trial participants promptly of premature termination or suspension and ensure medical care and follow-up. Inform sponsor, IRB/IEC, and regulators of reasons; report adverse events and SAEs per safety requirements.

Informed consent is a voluntary, well-informed agreement to participate in a trial, documented by written or electronic signature and delivered through text, images, videos, or remote discussions, with IRB approval.

Follow randomization procedures and emergency unblinding per protocol to protect patient safety, and maintain data integrity with adequate source records, timely reporting, and retention accessible to monitors and regulators.

Learn how sponsors initiate, manage, and fund clinical trials, ensure safety and quality, allocate resources and activities, and document agreements with investigators and service providers.

The sponsor submits required regulatory applications before starting clinical trials and engages IRB/IEC review with initial and subsequent approvals and favorable opinions, reporting terminations or suspensions as required.

The sponsor oversees trial design and conduct, ensures quality and protocol compliance, and facilitates timely issue escalation with IDMC and endpoint adjudication committees to protect participants' rights and trial reliability.

Learn how sponsors implement quality management across trial stages, design efficient protocols, and apply risk-based approaches with quality assurance, monitoring, and data management to protect participants and ensure reliable results.

Explore how noncompliance with protocol, SOPs or GCP triggers sponsor action, root-cause analysis, and CAPA to safeguard trial safety and data integrity, and safety reporting to regulatory authorities and IRBs.

This lecture outlines sponsor responsibilities for investigational products, data and records management, and reporting in clinical trials, including investigator brochures, blinding, quality control, and regulatory reporting.

Learn how the investigator brochure compiles clinical and non-clinical data for the investigational product, detailing safety, dosage, administration, and monitoring to support trial management and risk-benefit assessment.

Explore the clinical trial protocol and amendments, detailing how a clear, operational protocol guides conduct, safeguards safety, protects data integrity, and incorporates stakeholder input across design and endpoints.

Identify essential records for clinical trial conduct, including protocol, IRB approvals, informed consent, enrollment logs, and safety notifications, and learn how to manage and retain them in TMF or ECF.

Congratulations on completing the course; retrieve your certificate from your profile and share it on LinkedIn to motivate others, while accessing downloadable materials in the resources section.