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# FDA Cites 2 Minn. Clinical Investigators
- URL: https://www.fdaweb.com/fda-cites-2-minn-clinical-investigators/
- Published: 2021-06-10T12:00:00.000Z
- Updated: 2026-09-14T17:02:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149505

FDA has just released the FDA-483s issued following 2019 inspections of two trial investigators at the Hennepin County Medical Center Department of Emergency Medicine in Minneapolis, MN.

A 4/10-4/26/19 investigation of **Jon Cole**, clinical investigator, [found](http://www.fda.gov/media/149938/download?ref=fdaweb.com) these observations: 

- failing to submit an IND to FDA before conducting a clinical investigation with an investigational new drug;
- failing to obtain legally effective informed consent from a subject of the subject’s legally authorized representative in a situation that did not meet criteria for an exception;
- failing to conduct an investigation in accordance with the investigational plan;
- failing to ensure proper monitoring of the study;
- failing to maintain adequate investigational drug disposition records with respect to dates, quantity, and use by subject; and
- failing to have all changes in research activity approved by an institutional review board before implementation.

A 4/9-4/23/19 investigation of **Lauren Klein**, sponsor-investigator, [found](http://www.fda.gov/media/149873/download?ref=fdaweb.com) these observations: 

- failing to submit an IND to FDA before conducting a clinical investigation with an investigational new drug;
- failing to obtain legally effective informed consent from a subject or the subject’s legally authorized representative in a situation that did not meet criteria for an exception;
- failing to have all changes in research activity approved by an institutional review board before implementation;
- failing to conduct an investigation in accordance with the investigational plan;
- failing to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation and informed consent; and
- failing to ensure proper monitoring of the study.