Included is a description of a new informational/educational program for clinical investigators using an “Investigator's Manual” specifically written to answer FDA regulatory questions from the clinical investigator's point of view. In addition, the concept of a “maintenance free” filing system for required on-site clinical study documents is presented. This system incorporates the use of color-coded documents categorized so that FDA Compliance Program questions can readily be answered during FDA inspections of on-site data.
Food and Drug Administration: Clinical investigations, proposed establishment of regulations on obligations of sponsors and monitors. Federal Register1977;42:49612–49630.
2.
Food and Drug Administration: Obligations of clinical investigators of regulated articles, proposed establishment of regulations. Federal Register1978;Obligations of clinical investigators of regulated articles, proposed establishment of regulations43:35210–35236.
3.
Food and Drug Administration (21 CFR §56). Institutional review boards.
4.
Food and Drug Administration (21 CFR §50). Protection of human subjects.
5.
Food and Drug Administration: Human drugs—- bioresearch monitoring, Program 7348.811, Compliance Program Guidance Manual, 1981, chap 48.
6.
Food and Drug Administration (21 CFR §312.20). Subpart C—- International research.
