This course provides essential learning for clinical research associates, project managers and other employees of companies sponsoring clinical research, as well as all healthcare professionals involved in conducting clinical trials. Anyone who needs to develop an understanding of the importance of Good Clinical Practice and its application should take this course.
- 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.
CPD Points: 3
Assessment: Multiple-choice mastery assessment
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.
Documentation - 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.
Sponsor responsibilities - 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.
Investigator responsibilities - 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.
Informed consent - Sets out the principles and requirements of informed consent, describes the process, and provides examples of practical issues confronting healthcare professionals and subjects.
Monitor responsibilities - 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.