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Good Clinical Practice (GCP) for Clinical Staff

Good Clinical Practice (GCP) in South Africa encompasses the ethical and scientific standards that guide the conduct of clinical trials involving human participants. It ensures participant safety, data integrity, and regulatory compliance, ultimately contributing to the advancement of medical knowledge and the improvement of patient care.

Compliance with these guidelines is mandated.

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This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial Sponsors.

Description

The Good Clinical Practice (GCP) Basic Course for Clinical Staff is an introductory course that provides a detailed overview of clinical research, the current ICH and SA GCP Guidelines, NDoH 2024 – Ethics in Health Research Guidelines, as well as the process of conducting successful clinical trials from start to finish.

Available as classroom or virtual-led (for delegates residing outside of Gauteng) training

Cost

Classroom - R4,350 (VAT inclusive)

Virtual-led (for delegates residing outside of Gauteng) - R3,000 (VAT inclusive)

WHC Divisions | Projects:

Classroom - R2,960

Virtual-led (for delegates residing outside of Gauteng) - R2,550

For group discounts, please contact us at training@academicadvance.co.za

Duration

The classroom training is two full days (from 08h30 to 16h00).

Target Audience

Investigators, Clinicians, Study Coordinators, Scientists and Project or Site Managers new to clinical trials.

Certification

Delegates are required to complete a final assessment with at least 70% accuracy.

Upon successful completion of the course, the delegate will be given access to the GCP Certificate of Completion, valid for 3 years.

CPD Points

CPD points will be issued with the certificate of completion.

In-house Training

In-house training will be considered, subject to viability.