(Redirected from Researcher)
Investigator – is qualified individual responsible for conducting a clinical trial at a study site. Investigator is typically a physician, scientist, dentist, or other healthcare professional who oversees patient recruitment, implementation of study procedures, data collection, and safety monitoring. Investigator bears ultimate responsibility for the study and must ensure that the trial is conducted in compliance with the study protocol, regulatory requirements, and ethical principles.
Definitions
ICH E6(R2)
- 1.34 Investigator:
- A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator [1].
- 1.35 Investigator/Institution:
- An expression meaning "the investigator and/or institution, where required by the applicable regulatory requirements" [1].
See also
Another relevant pages
Links to this page
- Clinical research (← links)
- Phases of clinical trials (← links)
- Phase II clinical trials (← links)
- Institution (← links)
- Interim Clinical Trial (Study) Report (← links)
- Researcher (redirect page) (← links)
- Multicentre trial (← links)
- Protocol (← links)
- Safety (← links)
- Sponsor (← links)
- Sponsor-investigator (← links)
- Sub-investigator (← links)
- Subject identification code (← links)
- Trial site (← links)
- Vulnerable subjects (← links)
References
- ↑ 1.0 1.1 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
- FDA, 2009, FDA Guidance for Industry: Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigator-responsibilities-protecting-rights-safety-and-welfare-study-subjects Accessed Jul 2024