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Monday, December 11, 2017
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Good Clinical Practice - Basic Course

Introduction

Medical research involving human subjects is strictly controlled by the Medicines Control Council of South Africa and it is mandated that the study team be well versed with the International (ICH) and SA Good Clinical Practice guidelines. Each member of the team must be in possession of a valid, recognised GCP certificate.

Course Overview

The GCP Basic course is an introductory 1½ day course that will give a detailed overview of clinical research, the ICH and SA GCP guidelines and the process of conducting successful clinical trials from start to finish. Certificates of completion are issued on the successful completion of an open book post-course assessment.

Course Content

Day 1 Day 2
  • • Drug Development Process
  • • Historical Review of GCP
  • • South African GCP
  • • Regulatory process in South Africa
  • • Study Documents
  • • Patient Recruitment and Retention
  • • Informed Consent
  • • Investigational Product
  • • Safety Reporting
  • • Responsibility of the Study Team
  • • Standard Operating Procedures
  • • Laboratory Issues
  • • Monitoring
  • • Audits

  • Good Clinical Practice
    Basic Course

    Accreditation and Registration

  • Wits Health Consortium is a SACRA registered GCP training provider
  • The course is HPCSA accredited—11 points plus 4 Ethics points
  • The certificate is recognised by the Ethics Committees and Medicines Control Council of South Africa
  • Target Audience

    Investigators, study coordinators, scientists and project or site managers new to clinical trials.

    Registration Fee

    R2 700 per person (including VAT)

    Course Duration

    Day 1: 08h30-15h30

    Day 1: 08h30-15h30

    (Start and end times may vary slightly, confirmation will be provided on registration)

    Venue

    Courses are usually held at the Wits Health Consortium (Pty) Ltd Parktown offices. The course is also offered at regular intervals in Durban and Cape Town.

    Special requests will be considered, subject to viability.

    Registration

    Please complete the course registration form, e-mail to training@academicadvance.co.za

    Contact Details

    Melody Maddocks           +27 11 274 9256

    Janine Roper                    +27 11 274 9256

    Email address:                   training@academicadvance.co.za

    Further Information

    For further information, please go to our website:   training@academicadvance.co.za