Study management and Good Clinical Practice (GCP) course
Every investigator conducting clinical studies is required to follow the Good Clinical Practice (GCP) guidelines. In many countries, attending a GCP course is a legal requirement for those involved in conducting clinical research, such as investigators, study coordinators, clinical research associates, quality assurance managers, sponsor representatives, etc.
In this accredited two-day course, participants will learn how to
- Recognize the importance of conducting research involving human participants.
- Explain the importance of protecting human participants in the design, conduct and follow- up of research projects involving human beings.
- Describe the principles of human research participant protection.
- Identify and describe the basic documents of reference in research ethics
- Explain how conflicts of interest, fraud, and science misconduct can impact design, conduct, and follow up and the measures to counter them.
- Apply the basic rules of research ethics to assess risks,
- obtain informed consent, respecting the participant privacy, obtain ethical clearance
- obtain ethical clearance from the competent Research Ethics Committee (REC)
- Describe the responsibilities of investigators in the protection of human participants and how they have the capacity to face them.
- Apply the most relevant project management tools in a clinical study