Compliance is the adherence to ethical, regulatory, and quality standards and guidelines throughout the design, conduct, and reporting of clinical trials. It encompasses strict adherence to protocols, informed consent processes, regulatory requirements, data integrity, and Good clinical practice (GCP) principles to ensure the safety and well-being of study participants and the reliability of research outcomes.
Definitions
ICH E6
ICH E6 1.15 Compliance (in relation to trials):
Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements [1].
Treatment compliance
Extent to which study participants follow the prescribed treatment regimen or interventions as outlined in the trial protocol. It assesses whether participants adhere to medication schedules, lifestyle changes, or other therapeutic measures mandated during the clinical trial. Adequate treatment compliance rate is vital for accurate evaluation the safety and efficacy of investigational treatments.
See also
Links to this page
- Contract Research Organization (← links)
- Glossary:Compliance (redirect page) (← links)
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