21 cfr 312 investigator responsibilities

21 cfr 312 investigator responsibilities

Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring.
There is 1 Update appearing in the Federal Register for 21 CFR Part 312. - · Subpart D - Responsibilities of Sponsors and Investigators.
PART 312 -- INVESTIGATIONAL NEW DRUG APPLICATION. Subpart D-- Responsibilities of Sponsors and Investigators. Quick Links: Skip to main page content. For a 21 cfr 312 investigator responsibilities list of all Rules, Proposed Rules, and Notices view the Rulemaking tab. A sponsor shall select only investigators qualified by training and experience as appropriate experts to investigate the drug. If the reference is made to supporting information already in the IND, the sponsor shall identify by name, reference number, volume, and page number the location of the information. Subpart G-Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests. GPO FDSys: XML Text. The GCPs of Essential Documents Trailer 21 cfr 312 investigator responsibilities

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Subpart E--Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses. A sponsor shall ship investigational new drugs only to investigators participating in the investigation.. Subpart B--Investigational New Drug Application IND. Note: If you need help accessing information in different file formats, see. Note: If you need help accessing information in different file formats, see.

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Links on this page:. Skip to Topics Menu. More limitations on accuracy are described at the GPO site. Training and Continuing Education. A sponsor shall select only investigators qualified by training and experience as appropriate experts to investigate the drug.. GPO FDSys: XML Text. Federal Rules of Criminal Procedure.