How to Conduct a U.S. Clinical Trial in South Africa

To sponsor a clinical trial in South Africa, certain regulatory requirements must be met. Read on and find out some of the requirements to sponsor a clinical trial in South Africa.

Difficulty: Moderate

Instructions

Things You'll Need:

• Basic knowledge of clinical trials

1. Before implementing the clinical trial, submit a clinical trial application (CTA)to the South African Regulatory Agency called Medicines Control Council (MCC) for approval. The protocol, included with the application, must be submitted in triplicate. Review the CTA checklists and include all of the requested information in the MCC Clinical Trial Application checklists. (See resource section for link to checklists).

2. Once approved, register the clinical trial with the South African National Clinical Trial Register (SANCTR). This register allow authorities to track clinical trials in the country. It also allow other doctors and researchers find out what alternatives are available as the system can be accessed publicly.

3. Ensure each clinical trial site has at least one South African-based scientist as the Principal Investigator. The selected scientists must also have current residency in South Africa.

4. Make sure the clinical trial is reviewed and approved by the Research Ethics Committees (REC). Confirm that the REC is approved by the The National Health Research Ethics Council (NHREC).

5. Verify that any incentive, compensation or gift planned for the patients are all listed in the protocol.

6. If hiring a Contract Research Organization (CRO), make sure they are registered with the MCC.

7. Make sure the investigational product (specifically drug product) can and will be maintained in accordance with South Africa's Good Pharmacy Practices.

8. Become familiar with South Africa's regulations and requirements by reviewing the South African Good Clinical Practices guidelines.

Tips & Warnings

• Samples of the investigational product imported before clinical trial approval requires a permit from the MCC.
• Differences in patient incentives across sites in multi-centered clinical trials must be explained.
• The REC must have at least 7 members that is representative of the communities they serve and reflect that areas demographics.
• The REC membership must have both male and female representatives. No one gender can exceed 70% of the membership.
• The CRO must be registered with the MCC.

Resources

• Plan a Successful Clinical Trial COllaboration
• South African Good Clinical Practice Guidelines
• Plan a Clinical Investigator Meeting
• How to Choose a Good CRO
• How to Know and Understand Clinical Trial Basics if You Are a Patients

[ebnickiea]

on 9/12/2008 interesting article. thanks

[purrfect1969]

on 9/12/2008 Interesting.

[vikki9]

on 9/11/2008 Our world keeps getting smaller - we're able to help and support each other in new ways. Thank you.

[klnygaard]

on 9/9/2008 neat topic- 5 stars

[Desula]

on 9/8/2008 This is very good information on testing clinical trials in South Africa.