GCP Refresher

January 4, 2012

Services

This is a 1 day course with a maximum of 6 hours teaching time. At the end of the course a written assessment is done which requires a 70% passing score for a MCC recognized certificate.

Cost: R1900 (2017- Jan 2018) R2070.00 (from Feb 2018)  incl. VAT

Aim

This Refresher Course will start by assessing the basic knowledge of the more experienced learner regarding GCP. The SA GCP guidelines as well as the ICH GCP will be re-introduced to the learners. In particular, the Investigator’s competencies and responsibilities, as set out in the various guidelines and regulations will be highlighted.

It will further recap concepts around:

  • the history of GCP,
  • ethical and regulatory guidelines and documents in clinical research.
  • drug development
  • stakeholder roles and responsibilities
  • participant protection
  • safety reporting (AE’s, SAE’s, SUSAR)
  • essential documents

Objectives:

  • List the key international guidelines that were adopted and followed as part of the South African guidelines for the conduct of clinical research.
  • Identify the key stakeholder(s) responsible for ensuring that research is performed and data generated in compliance with GCP guidelines and other applicable regulations.
  • Discuss the phases of the clinical research process and the sequence of regulatory and ethical approvals required before initiating a trial.
  • State the protections given to human participants in clinical research focusing on the Informed consent process and safety reporting.
  • Define essential documents for the conduct of the clinical trial with specific focus on source documents, study contracts and agreements, the Investigator’s Brochure and the clinical study report.
  • Identify the various guidance and regulatory documents that outline the responsibilities of the investigator (MCC, FDA, ICH GCP, SA GCP etc.)
  • Describe the main responsibilities of the investigator
  • Clarify the role of the investigator as part of the research team and his/her supervisory role
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