Incomplete Digital

1. Application form for clinical trial approval.

2. Approval letter from the Institutional Review Board (IRB).

3. Recommendation letter from the Data Safety and Monitoring Committee.

4. Clinical trial protocol.

5. Informed consent form.

1. The research institution must be accredited by the Health Research Governance Department.

2. The research institution must have a registered Institutional Review Board (IRB) under the Health Research Governance Department.

3. The research institution must be conducting one or more of the following clinical trials:

-A clinical trial for a medical product being tested on humans for the first time.

-A clinical trial for a medical product that is not registered in Qatar but is being tested on humans.

-A clinical trial for a combination of registered pharmaceutical products.

-A clinical trial for a medical product (including drugs or medical devices) that is registered in Qatar but is being tested in a manner inconsistent with its registered use, such as testing it through a new dosage route.

Free

44070000

24 days and 50 minutes