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# Bioresearch Monitoring FY 2017 Metrics Reported
- URL: https://www.fdaweb.com/bioresearch-monitoring-fy-2017-metrics-reported/
- Published: 2018-05-16T12:00:00.000Z
- Updated: 2026-09-15T00:05:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141452

FDA says there were 965 bioresearch monitoring inspections in FY 2017 — 97 performed by CBER, 581 by CDER, and 287 by CDRH. The numbers are included in a metrics [report](http://www.pacourts.us/assets/opinions/Superior/out/Memorandum%20%20Affirmed%20%2010353760436689258.pdf?cb=1&ref=fdaweb.com). The report says that common clinical investigator deficiencies were: 

- failing to follow the investigational plan/agreement or regulations or both;
- protocol deviations;
- inadequate recordkeeping;
- inadequate subject protection—informed consent issues or failure to report adverse events;
- inadequate accountability for the investigational product;
- inadequate communication with the institutional review board; and
- investigational product represented as safe/effective.

Other charts show classifications of various types of inspections and common deficiencies found in each type.