IMARC Research, a contract research organization (CRO) recently published a list of the “Top Five FDA Warning Letter Findings for Clinical Investigators.” Warning letters are issued when FDA finds objectionable conditions upon inspection. IMARC’s top 5 noted citations are below.
1) Failure to ensure that the investigation was conducted according to the investigational plan, the signed agreement, applicable FDA regulations, and conditions of approval imposed by the IRB or FDA
2) Failure to maintain adequate, accurate, and complete records
3) Failure to ensure that informed consent was obtained in accordance with 21 CFR Part 50
4) Failure to ensure that an IRB that complies with the requirements set forth in part 56 was responsible for the initial and continuing review and approval of the proposed clinical study
5) Repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report
For more details, download IMARC’s whitepaper here.