recordkeeping

Abstract

In USA records of a clinical trial have to be retained for a period of 2 years following the date on which: a) the test article is approved by the FDA for marketing for the purposes which were the subject of the trial, b) the entire trial is discontinued or terminated; records of institutional review boards must be kept for a minimum of 3 years after completion of the research; EC: retention of patient identification codes, patient files and other source data by investigator for at least 15 years, all relevant documentation by sponsor or subsequent owner for the lifetime of the product, the final report for 5 years beyond the lifetime of the product; archived data may be held on microfiche or electronic record.