Fda definition of sub investigator

• [DOC File]: RP-103 - INVESTIGATOR MANUAL

  https://info.5y1.org/fda-definition-of-sub-investigator_1_ea9f8b.html

  An investigator must administer the drug only to participants under the investigator's personal supervision or under the supervision of a sub-investigator responsible to the investigator. The investigator must not supply the investigational drug to any person not authorized under this part to receive it.

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• Drug Study

  An investigator must administer the drug only to subjects under the investigator's personal supervision or under the supervision of a sub-investigator responsible to the investigator. The investigator must not supply the investigational drug to any person not authorized under this part to receive it.

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• POLICY AND PROCEDURES

  The Investigator will review subject safety data as it is reported and documented. The Investigator, sub-investigators, and the research staff will meet on a monthly basis to review subject recruitment, data, source documentation and identification of adverse events, complaints and confidentiality of subjects.

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• [DOCX File]INVESTIGATOR MANUAL

  https://info.5y1.org/fda-definition-of-sub-investigator_1_0de810.html

  Principal Investigator Curriculum Vitae (CV) and/or appropriate Sub-Investigator (e.g., the Medical Advisory Investigator) ... Evidence that protocol has been submitted to FDA. Copy of Investigator’s Brochure, package insert, or other product summary as applicable.

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• [DOCX File]HRP-103 - INVESTIGATOR MANUAL

  https://info.5y1.org/fda-definition-of-sub-investigator_1_b0c12a.html

  An investigator must administer the drug only to subjects under the investigator's personal supervision or under the supervision of a sub-investigator responsible to the investigator. The investigator must not supply the investigational drug to any person not authorized under this part to receive it.

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• [DOCX File]Regulatory Binder Checklist

  https://info.5y1.org/fda-definition-of-sub-investigator_1_574e1b.html

  An investigator must administer the drug only to subjects under the investigator's personal supervision or under the supervision of a sub-investigator responsible to the investigator. The investigator must not supply the investigational drug to any person not authorized under this part to receive it.

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• [DOCX File]SOP FDA-Regulated Research - Washington

  https://info.5y1.org/fda-definition-of-sub-investigator_1_7777cf.html

  May 01, 2020 · An investigator must administer the drug only to subjects under the Investigator's personal supervision or under the supervision of a sub-investigator responsible to the Investigator. The Investigator must not supply the investigational drug to any …

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• [DOCX File]What is the purpose of this manual?

  https://info.5y1.org/fda-definition-of-sub-investigator_1_e645cb.html

  Jul 17, 2015 · Updated investigator and sub-investigator CVs (signed/dated within 2 years) A clinical (dental, medical, etc.) license for the PI and co-investigators, if licensed Clinical Investigator’s Brochure

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• [DOCX File]Essential Document Checklist Clinical Trials Interventional v2

  https://info.5y1.org/fda-definition-of-sub-investigator_1_0e1e89.html

  Jun 26, 2020 · Investigator: The individual conducting the research. ... single sub-therapeutic doses of the drug are given to a small number of individuals (10-15) to gather preliminary data about pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drug). ... Citation showing that the FDA’s definition of ...

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