Clinical investigator
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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.
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)
External links
- Information for Clinical Investigators (FDA CDER)
- Federal Regulations for Clinical Investigators
- European Society for Clinical Investigation (ESCI)
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