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Good clinical practice can be seen as a general framework ensuring that all stakeholders will be respected, listened to, taken into account, and accountable in the complex process of discovering new medical treatments, whether they be investigative drugs, improved treatments or medical devices. Compliance with GCP principles is required by regulatory authorities (FDA, EMA) in many countries for the authorization of clinical trials and the validation of their data.
This module introduces GCP. Our expert discusses the role and goals of the ICH (International Council for Harmonization) and the principles of GCP. Our expert describes the roles of members of a team working on a clinical trial. She sets out the documentation that must be written and validated. She defines the responsibilities of trial sponsors, clinical investigators and monitors. She explains the rationale and execution of the informed consent process, and discuss issues that arise in practice.
Lesson 1: Why do we need Good Clinical Practice ?
Lesson 2: Concern about the safety of drugs
Lesson 3: Ethical Principles
Lesson 4: The four phases of Clinical Research
Lesson 5: International Council for Harmonization
Lesson 6: Principles of ICH GCP
Lesson 7: Code of Federal Regulations