AGCP E-learning program outline
Unit 1 – What is research?
Learning outcome
Interpret Good Clinical Practice in relation to the features, phases, purpose and protocol of health research in order to apply these elements of Good Clinical Practice in research practice.
Assessment criteria
Define health research in relation to the clinical trial environment
Topics covered
• What is research?
• What is clinical research?
Assessment criteria
Identify the phases of clinical trials
Topics covered
• What is a clinical trial?
• Key participants in a clinical trial
• What is a pre-clinical study?
• Phase 0 of the clinical trial
• Phase I of the clinical trial
• Phase II of the clinical trial
• Phase III of the clinical trial
• Phase IV of the clinical trial
• Stages of drug development flow diagram (printable document housed in the reference library)
Assessment criteria
Identify the features of a clinical trial
Topics covered
• Features of clinical trials: control; randomisation; study configuration; blinding (For all four features, basics onscreen; link to further details)
Assessment criteria
• Define an investigator’s brochure
• Explain the purpose of an investigator’s brochure
Topics covered
• What is an investigator’s brochure (definition)?
• Summary of contents of the investigator’s brochure (link)
• What is the purpose of the investigator’s brochure?
• What is the process involved relating to the investigator’s brochure? (link)
Assessment criteria
• Define what a protocol is
• Explain the function of a protocol
Topics covered
• Definition of a protocol
• What are the functions of protocol?
• Protocol contents (link)
Self-check assessment
• Drag and drop matching exercises
Unit 2 – Regulatory and ethics committee