Monitoring – is process of overseeing and supervising a clinical trial to ensure that it is conducted according to the study protocol, regulatory requirements, and ethical principles.
Definitions
ICH E6(R2)
- 1.38 Monitoring:
- The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s) [1].
Role of clinical monitoring
Monitoring activities typically involve regular site visits by monitors or clinical research associates (CRAs) who review study documentation, verify data accuracy, assess participant safety, and ensure compliance with Good clinical practice (GCP) guidelines.
The primary goal of monitoring is to safeguard the rights and well-being of trial participants and to maintain the integrity and reliability of the trial data.
See also
Another relevant pages
Links to this page
- Monitoring report (← links)
- Quality assurance (← links)
- Corrective and Preventive Action (← links)
- Sponsor (← links)
- Standard operating procedures (← links)
References
- ↑ ICH, 2016, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf Accessed Sep 2023
External links