Applicable Regulatory Requirement(s) in clinical research denotes the set of rules, standards, and legal obligations imposed by governmental and non-governmental regulatory bodies that must be adhered to during the planning, conduct, and reporting of clinical trials.
These requirements encompass a spectrum of regulations related to participant protection, data integrity, and overall trial conduct. Compliance with applicable regulatory requirements is fundamental to the ethical and scientific integrity of clinical research.
Definitions
ICH E6
Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products [1].
See also
References
- ↑ ICH website, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf