Clinical investigator
Encyclopedia
A clinical investigator involved in a clinical trial
is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation.
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation.
See also
- Clinical siteClinical siteA clinical site is a medical facility staffed with a clinical investigator and qualified for performing clinical research. To be qualified as a clinical site, strict regulations are to be adhered to...
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- Drug developmentDrug developmentDrug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery...
- Data monitoring committeesData Monitoring CommitteesA Data Monitoring Committee — sometimes called a Data and Safety Monitoring Board — is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.- Need for a DMC :...
- Food and Drug AdministrationFood and Drug AdministrationThe Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) - European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
(EMEA) - Japan Ministry of Health
- European Forum for Good Clinical PracticeEuropean Forum for Good Clinical PracticeThe European Forum for Good Clinical Practices is a European think tank which works on the ethical, regulatory, and scientific framework of clinical research in Europe...
(EFGCP) - American Society for Clinical InvestigationAmerican Society for Clinical InvestigationThe American Society for Clinical Investigation, or ASCI, established in 1908, is one of the nation's oldest and most respected medical honor societies.-Organization and Purpose:...
(ASCI) - European Society for Clinical InvestigationEuropean Society for Clinical InvestigationThe European Society for Clinical Investigation was founded on February 12, 1967 as a pan-European society of clinicians and scientists with a genuine interest in uncovering disease mechanisms...
(ESCI)