DYKtest - Society for Clinical Research Sites – SCRS
DYKtest

DYKtest

July 2018

Discussion

Per 21CFR312.58, you are required to allow the FDA to “have access to and copy and verify any records and reports relating to a clinical investigation conducted under [an IND].”  This means ALL study records, subject charts, recruitment materials, emails – anything related to the study.

It is standard practice for the FDA inspector to notify you in advance what study they will be reviewing. They may even tell you which subject records they specifically want.  However, regardless of what is requested at the onset of the inspection, the FDA can request additional information at any time.

To minimize delays during an inspection, all study material should be organized and prepared for the FDA at all times.

The agency does not have the right to personnel records, but would need to verify study personnel’s qualifications and credentials.

Solution

At the onset of the study, all study personnel should create an electronic folder and place ALL correspondence in that folder.  Items of importance should be reviewed and filed accordingly during the study.  At the completion of the study, the electronic folder(s) should be saved to a thumb drive which is then placed in a sealed, marked envelope.  The envelope can then be placed in the regulatory binder.

Study personnel should keep copies of CVs in the regulatory binder.  Maintaining training records for all study staff in a site training binder as opposed to within personnel files will eliminate the need for the FDA to view private information within personnel records, which the FDA does not have the right to review.

Reference: FDA 21CFR312.58(a)

Disclaimer: This article and the SCRS website are public resources of general material and do not constitute legal or professional advice.