Clinical investigator: Difference between revisions
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* [[European Forum for Good Clinical Practice]] (EFGCP) |
* [[European Forum for Good Clinical Practice]] (EFGCP) |
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== External links == |
<nowiki>Insert non-formatted text here</nowiki>== External links == |
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* [http://fermish.com/GCP/investigator.htm Reponsibilities of Clinical Investigator] |
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* [http://www.fda.gov/cder/about/smallbiz/clinical_investigator.htm Information for Clinical Investigators] (FDA CDER) |
* [http://www.fda.gov/cder/about/smallbiz/clinical_investigator.htm Information for Clinical Investigators] (FDA CDER) |
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* [http://www.fda.gov/cder/about/smallbiz/CFR.htm Federal Regulations for Clinical Investigators] |
* [http://www.fda.gov/cder/about/smallbiz/CFR.htm Federal Regulations for Clinical Investigators] |
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Revision as of 06:22, 6 December 2007
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)
Insert non-formatted text here== External links ==
- Reponsibilities of Clinical Investigator
- Information for Clinical Investigators (FDA CDER)
- Federal Regulations for Clinical Investigators
- European Society for Clinical Investigation (ESCI)
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