Regulatory Approvals Submission

Regulatory approvals submission

You will need to seek approvals from the various regulatory authorities that govern clinical trials in your country and institution. This will usually involve gaining clinical trial authorisation from the national clinical trial authority, ethical approval from a national or local body and may also involve institutional approvals depending on the institutions that are sponsoring your research or hosting your trial site.
ICH-GCP lists these documents as the minimum required for regulatory approval submission. However, there are likely to be specific requirements for each authority:
• Trial protocol(s)/amendment(s)
• Written informed consent form(s) and consent form updates that the investigator proposes for use in the trial
• Subject recruitment procedures (e.g. advertisements)
• Written information to be provided to subjects
• Investigator's Brochure (IB)
• Available safety information
• Information about payments and compensation available to subjects
• The investigator’s current curriculum vitae and/or other documentation evidencing qualifications
• Any other documents that the IRB/IEC may need to fulfil its responsibilities

Useful resources:
1. http://www.globalhealthtrials.org/articles/clinical-trial-governance/
2. http://www.globalhealthtrials.org/articles/regulations-and-guidelines/
3. http://www.globalhealthtrials.org/community/blog/post/HMM/2010/07/irbiec-approval-timelag/
4. http://www.globalhealthtrials.org/community/blog/post/kclspansis/2010/05/irb-approval-in-sri-lanka/
5. http://www.globalhealthtrials.org/community/groups/group/ethics/

To return to the Global Health Research Process Map click the following link:
https://processmap.tghn.org/

Please use the comment box to explain any problems that you have with this process step or any solutions that you have found to make this step easier for others. If you have any suggestions for additional resources or guidance, please provide these below.

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