Regulatory and Ethics Submissions Training

This 1-day accredited course equips regulatory staff at Sponsors, CROs, and clinical sites with the knowledge and practical skills to prepare, submit, and track SAHPRA and HREC approvals, ensuring compliance and successful clinical trial conduct in South Africa.

Regulatory & Ethics Submissions for Clinical Trials

This course is aimed at regulatory staff at Sponsors, CROs, or clinical sites submitting protocols to Ethics Committees and the Regulatory Authority in South Africa. It equips delegates with the knowledge and skills to ensure successful trial approvals and compliance throughout the trial lifecycle.

Participants will:

  • Understand the essential requirements for regulatory and ethics submissions.
  • Learn to navigate SAHPRA and HREC submission formats and guidelines.
  • Gain practical skills to prepare, submit, and track approvals for clinical trials in South Africa.
  • Receive a certificate of attendance for Regulatory and HREC Training.
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Course Format

  • Understand the essential requirements for regulatory and ethics submissions.
  • Learn to navigate SAHPRA and HREC submission formats and guidelines.
  • Gain practical skills to prepare, submit, and track approvals for clinical trials in South Africa.
  • Receive a certificate of attendance for Regulatory and HREC Training.
Contact Us

Course Format

The course covers the essential aspects for approval of a clinical trial: the required submissions to the regulatory authority and human research ethics committee/s in South Africa, ensuring successful approval of a trial and thus ensuring compliance with the reporting requirements during the clinical trial life cycle. It also provides a platform to become fully equipped with the skills required for submissions of all the forms/formats/guidelines of SAHPRA and HRECs, as well as other submissions to enable all the required approvals of a clinical trial.

Attendees will receive a certificate for attending the Regulatory and HREC Training for Clinical Trials to be conducted within South Africa.

CPD Accreditation

Certification is valid for 3 years, and CPD points will be issued.

Cost

Classroom training: R3500.00 pp

Booking/Registration

Complete our registration form online, or use the contact details below, and we’ll provide you with more information.

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HPCSA-Accredited Training Provider

With a professional learning environment and all the resources you need, we are confident this course will be a valuable fit for your professional development—whether you are here to build foundational knowledge or to renew your GCP certification.

“For any questions or support, please reach out—we’re here to assist and look forward to your participation.”

Frequently Asked Questions

1. Who should attend this course?

Regulatory staff involved in preparing and submitting clinical trial protocols.

2. What does the course cover?

Required submissions to ethics committees and regulatory authorities in South Africa for clinical trials.

3. How is the course delivered?

1-day classroom-style, arranged on request.

4. Is certification provided?

Yes, attendees receive a certificate for completing the training.

5. What is the cost?

R3,500 per person (VAT not applicable).

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Quick Course Summary

  • For Who:
    Aimed at regulatory staff at Sponsors, CROs, or sites submitting clinical trial protocols in South Africa.
  • Covers:
    Covers essential regulatory and ethics submissions for SAHPRA and HRECs.
  • Certification:
    Certificate awarded upon completion. Cost: R3,500 (VAT not applicable).
  • Format:
    Delivered 1-day classroom-style (on request).
  • Important:
    Prepares attendees for successful clinical trial approvals and compliance.

Ready to get started?

Should you require any information, if you want to book your place on a course, or would like to discuss training options, please contact us.

Contact Details

Phone: +27 83 225 9656
Email: info@rrtraining.co.za

Course Registration

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