- Source: Clinical investigator
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. The Clinical Investigator must also meet requirements set forth by the FDA, EMA or other regulatory body. The qualifications must be outlined in a current resume and readily available for auditors.
See also
Clinical site
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
Drug development
Data monitoring committees
Food and Drug Administration (FDA)
European Medicines Agency (EMA)
European Forum for Good Clinical Practice (EFGCP)
American Society for Clinical Investigation (ASCI)
European Society for Clinical Investigation (ESCI)
External links
Clinical Investigator Responsibilities at the Wayback Machine (archived 2012-01-26)
Information for Clinical Investigators (FDA CDER) at the Library of Congress Web Archives (archived 2006-10-28)
Federal Regulations for Clinical Investigators at the Library of Congress Web Archives (archived 2001-11-16)
Kata Kunci Pencarian:
- William Kaelin Jr.
- Dewi Nur Aisyah
- Hidrogen peroksida
- Wabah virus Nipah Malaysia 1998–1999
- Keith Dobson
- John Hunter (ahli bedah)
- Clinical investigator
- Investigator
- Clinical trial
- Journal of Clinical Investigation
- Preclinical development
- A. V. Gurava Reddy
- Principal investigator
- Investigator's brochure
- Clinical trial portal
- MEK inhibitor
