This module introduces GCP and sets it in the context of typical collaborative work in clinical research. We discuss the role and goals of the International Conference on Harmonisation and the principles of GCP. We describe the roles of members of a team working on a clinical trial. We set out the documentation that must be created and maintained. We specify the responsibilities of trial sponsors, clinical investigators and monitors. We explain the rationale and execution of the informed consent process, and discuss issues that arise in practice.
Explain why and how the ICH influences clinical research practice through its guideline on GCP, and summarise the principles of GCP.
Identify the major roles in a clinical trial team, outline the responsibilities of each, and discuss how they work together.
Describe the responsibilities of a trial sponsor.
Describe the responsibilities of a clinical investigator.
Explain the rationale and execution of the informed consent process, and discuss issues that arise in practice.
Describe the responsibilities of a trial monitor.
Sets out the module's scope, objectives and notes on terminology.
ICH, harmonisation, and principles of GCP
Describes the ICH's role in the harmonisation of regulations, introduces its guideline E6, and sets out the principles of GCP.
Clinical research teamwork
Introduces the major roles in a typical clinical research project and outlines their duties and relationships.
Identifies the documents designated by ICH GCP as essential to the conduct of a clinical trial, describes important examples, and outlines how they should be maintained.
Duties and functions discussed in this session include trial design, selection of investigators, QA and QC, data handling and record keeping, finance and compensation, regulatory submissions, management of investigational product(s), safety reporting, monitoring, audit, dealing with noncompliance, and clinical trial reports.
Duties and functions discussed in this session include: provision of adequate resources; liaison with institutional review boards / independent ethics committees; compliance with protocol; management of investigational product(s), informed consent and data records; and safety reporting.
Sets out the principles and requirements of informed consent, describes the process, and provides examples of practical issues confronting healthcare professionals and subjects.
Explores the responsibilities of the monitor and provides insight into key challenges. Describes assessment of investigators and investigational sites, education and trial initiation, monitoring of clinical conduct, including CRF review and source document verification, and trial close-out. Discusses noncompliance and how to deal with it
Multiple-choice mastery assessment.