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