iii. New investigator 21 CFR (c). Printer-friendly version. The addition of a new investigator must be reported to the FDA within 30 days of the investigator.
(c) New investigator. A sponsor shall submit a protocol amendment when a new investigator is added to carry out a previously submitted protocol, except that a.
21 CFR (a) (3) (e) A sponsor is required to submit protocol amendment  21 CFR (c) (1) Before permitting an investigator to begin.
21 cfr 312.30 c - march brackets
Investigational New Drug Application IND Educational Handout. Emergency Settings: Research in the Emergency Setting Planned Emergency Research vi. Click for human subjects research training info:. Investigoator-Initiated Research with Drugs or Biologics a. It is possible that some links will connect you to content only. A to Z Index. Emergency Use of an Investigational Drug or Device vii. Study Procedures — What will happen during the course of the study? Once the investigator is added to the study, the investigational drug may be shipped to the investigator and the investigator may begin participating in the study. Investigational New Drug Application IND Educational Handout. Examples of changes requiring an amendment under this paragraph include:. Washout Issues in Drug Treatment Studies E.