Definition:
A Clinical Trial Authorization is a formal regulatory approval granted by a competent regulatory authority (or authorities) that permits a clinical trial involving human participants—particularly those testing investigational medicinal products—to commence under defined conditions. It is based on evaluation of the proposed trial protocol, the investigational product(s), safety (including risk/benefit balance), ethical aspects (including subject protection, informed consent), and associated pharmacovigilance plans.
Key features include:
- Ensuring legal and ethical compliance with applicable laws, regulations, and good clinical practice.
- Assessment of scientific validity and justification of the trial design.
- Specification of safety monitoring and adverse event reporting procedures.
- Review of investigators’ qualifications and site capability.
- Oversight by both regulatory authority and ethics committees / institutional review boards.
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