Clinical investigator

From Wikipedia, the free 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.

[edit] 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 (EMEA)
• Japan Ministry of Health
• European Forum for Good Clinical Practice (EFGCP)

[edit] External links

• Information for Clinical Investigators (FDA CDER)
• Federal Regulations for Clinical Investigators
• European Society for Clinical Investigation (ESCI)