Incomplete Digital

1. Approval letter from the Institutional Review Board (IRB) for the modification.

2. Amended recommendation letter from the Data Safety and Monitoring Committee (if applicable).

3. Amended clinical trial protocol (if applicable).

4. Amended informed consent form (if applicable).

5. Updated list of the research team participating in the clinical trial, along with their Good Clinical Practice (GCP) certificates (if applicable).

6. Amended Good Manufacturing Practice (GMP) certificate (if applicable).

7. Amended Certificate of Analysis (CoA) for the medical product used in the clinical trial (if applicable).

8. Amended approvals from other countries for conducting the clinical trial (if the trial is international).

1. The clinical trial must be approved by the Health Research Governance Department.

2. The research institution must have a valid accreditation from the Health Research Governance Department.

3. The Institutional Review Board (IRB) affiliated with the research institution must have a valid registration with the Health Research Governance Department.

4. The modification must be substantial and must significantly impact:

- The scientific and ethical principles of the trial.

- The safety and rights of clinical trial participants.

- The organization and execution of the trial.

- The quality of the research product used in the trial.

Free

44070000

22 days and 50 minutes