GCP Beginner

January 4, 2012

Services

The course is presented over 2 days and ends with a written test. Passing score for a MCC recognized certificate is 70%.

Cost:  R3950 (2017 -Jan 2018)  R 4300.00 (from Feb 2018),  incl. VAT

Aim

This course will provide you with an overview of clinical research, various concepts of research and introduce you to Good Clinical Practice (GCP) from a local and international perspective. It will further provide an in depth understanding of the Investigator’s competencies and responsibilities as set out in the various guidelines and regulations. The importance of participant protection and valid, credible data within the environment of clinical trials will be highlighted.

Objectives

  • Define clinical research and explain why we perform clinical research.
  • Identify the primary areas of clinical research.
  • Outline the drug development process from idea to post-market with special reference to the various phases of the trials.
  • Name the key role players and their responsibilities in clinical research.
  • Name some of the key events and documents which led to the publication of the various International guidance documents. Focus specifically on the Good Clinical Practice (GCP) E6 document and the standards and ethical principles that guide the conduct of clinical research today.
  • Outline the origins and scope of the SA GCP, 2006, version 2- document.
  • Recognize the differences between the SA GCP document and the ICH GCP E6 document.
  • Identify some important concepts used in clinical research.
  • Discuss the Life Cycle of clinical research.
  • Discuss the steps in the conduct of clinical research.
  • Discuss ongoing Informed Consent, Safety reporting, Data and Safety monitoring and IRB review as the primary methods of protection offered to study participants.
  • Identify the various guidance and regulatory documents that outline the responsibilities of the investigator (MCC, FDA, ICH GCP, SA GCP,EU)
  • Describe the main responsibilities of the investigator as featured in the SA GCP.
  • Identify areas of overlap related to responsibilities with regards to the various role players in the CR process.
  • Clarify the role of the investigator as part of the research team and his/her supervisory role
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