What records should help to ensure scientific soundness of an IVD investigational study?
Unless a study falls within the exemption at 21 CFR 812.2(c), specific record requirements are listed in 21 CFR 812.140. In general, the records that are needed are those that provide the data for testing the study hypotheses. Records should contain sufficient detail to allow the study to be reproduced when the same protocol is followed. We recommend that investigators maintain detailed records because a review of the study may indicate the need for other analyses of the collected data.
