Who monitors clinical trials?
A Principal Investigator (PI) is the person in charge of conducting a clinical trial. The PI is responsible for ensuring that the study is following all regulatory requirements and meeting the internationally recognized standards for Good Clinical Practice (GCP).
Which organization monitors clinical trials in the United States?
Each federally supported or conducted clinical study and each study of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB). An IRB is made up of doctors, researchers, and members of the community.
What is site monitoring in clinical trials?
Monitoring is defined as 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, SOPs, The Principles of GCP, and the Medicines for Human Use (Clinical Trails) Regulations – where applicable.
What organizations are involved in clinical trials?
The top clinical research organizations (CRO) in the United States are Covance (LabCorp), IQVIA, Syneos Health, PPD, PRA Health Sciences, and Parexel.
Who is responsible for the conduct of the clinical trial at a trial site?
clinical trial investigator
A clinical trial investigator is the person responsible for the conduct of the clinical trial at a trial site. If the clinical trial is conducted by team of individuals at the trial site, then the investigator is the responsible leader of the team and is known as the Principal Investigator.
When should the sponsor monitor conduct?
When should the sponsor-monitor conduct the most detailed review of the study protocol with the site’s study staff? At least two years after the investigational drug’s approval by the FDA.
What is a CRO company?
A CRO (Contract Research Organization) is a company that provides clinical trial management services for the pharmaceutical, biotech, and medical device industries.