groups » Trial Management » Help needed - information about running Clinical Trial in East and South Africa
Will you please be able to help me to find answers to below questions as we need to conduct study in EA and SA.
I came across some information stating that the regulations in East Africa for different countries like, Tanzania, Kenya, Uganda, Burundi, Rwanda, Ethiopia, Somalia etc. follow different guidelines and regulations. ICH GCP has not been accepted widely here. And these are the countries, where we are trying explore the clinical trials from our organization but lack of information is resulting into dilemma to really go or not to go to EA.
1. What Regulatory Authority laws/ Guideline for conducting clinical trials for drugs and devices for phase 1 to Phase IV studies.
2. What is the structure of Ethics committees in EA countries. Is it Institutional or Central.
3. What is the process to apply for clinical trial submission and approval.
4. How long does it to take, to get an approval from EC and RA for clinical trial.
5. What is the fee structure for both EC and RA
6. Is it hard copy submission or electronic submission
7. Which cities should we select for clinical studies
8. How is the hospital structure their in EA countries
9. What is the list of documents required for submission to EC and RA. Are there any documents which we need to translate and in which languages. Eg for ICF.
10. How to apply for import license and what are the guideline/ regulations to import drug/devices/accessories required for clinical trials
11. What is the criteria for export of sample. What is the process to get export license for blood and other samples for clinical trials of subject
It would be grateful if you can help us in any best possible way.
Dear Mr Tak
There is a very big population of East African researchers on Global Health Trials so I am sure we can all help you! Could you tell us a bit more about your study? Which countries do you want to run the research in, you have not said? Also what sort of research is it? A lot of the information will vary depending on the type of research you are running so if you can give us some more details, we will be happy to help you!
Also I see you are a new member, and I wish you a very warm welcome!
A number of trials have been undertaken in EA, and many still ongoing. These include both vaccine and drug trials.
Link for Pharmacy and Poisons Board, the RA in Kenya (Expert Committee for Clinical Trials -ECCT : http://www.pharmacyboardkenya.org/index.php?id=15
Hello - I wasn't sure from your post whether you wanted information about South Africa itself. If so, I can direct you to various resources.
Please visit the following site for more guidance on Kenyan review systems. http://www.kemri.org/index.php/research-committees/research-regulation/scientific-steering-committee. We have both institutional and a national ethics review committee. The institution you are collaborating with could alos provide you with some guidance.