An investigator in clinical studies is a qualified individual responsible for overseeing and conducting the research according to the study protocol and applicable regulations. In summary, investigators in clinical studies play a pivotal role in conducting research ethically, efficiently, scientifically valid and correct, and in compliance with regulatory standards, ultimately contributing to the advancement of medical knowledge and patient care.
- Feehan AK, Garcia-Diaz J. Investigator Responsibilities in Clinical Research Ochsner J. 2020;20(1):44–49: https://www.ochsnerjournal.org/content/ochjnl/20/1/44.full.pdf
More resources
- Food and Drugs Administration (FDA) definition of ‘Investigator responsibilities’: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigator-responsibilities-protecting-rights-safety-and-welfare-study-subjects
To go in-depth
Investigator Responsibilities in Clinical Research
This paper highlights the multifaceted responsibilities of clinical investigators. They emphasize that these individuals not only play a pivotal role in generating valuable scientific research, but also carry the weight of maintaining public trust.
- Feehan AK et al. Investigator Responsibilities in Clinical Research. Ochsner Journal 2020;20:44–49: https://www.ochsnerjournal.org/content/ochjnl/20/1/44.full.pdf
Clinical Investigator Responsibilities
This article delves into key investigator responsibilities and offers practical advice on promoting compliance in practice. Baer AR et al. Clinical Investigator Responsibilities.J Oncol Pract. 2011;7(2):124-128
Video
What are investigator meetings in clinical trials?
The following video, produced by GCP-Mindset, explains the roles of an investigator:
It dives into the world of clinical trials to unravel the significance of investigator meetings and to discover their critical function in clinical trials.
