(a) A sponsor shall maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug. These records are required to.
Briefly, under 21 CFR Part 312, a sponsor must: maintain adequate records paid to clinical investigators by the sponsor of the study [ 21 CFR (b)]; retain.
The sponsor-investigator is responsible for maintaining study records, as described above. Inspection of sponsor's records and reports 21 CFR.
Investigoator-Initiated Research with Drugs or Biologics a. The University of Iowa Directory A-Z Search About Iowa Contact Us Calendars Privacy Information. Parallel Table of Authorities and Rules for the Code of Federal Regulations and the United States Code Text PDF. Quick Links: Skip to main page content. Behavioral intervention studies G. FDsys: GPO's Federal Digital System.