archiving

Abstract

According to EC guidelines, the following documents pertinent to a clinical trial have to be archived by the investigator for at least 15 years after completion of the trial: patient identification list, correspondence with the ethics committee and sponsor company, protocol including addenda/amendments, copies of CRFs (case record forms); the sponsor has to archive the trial master file for lifetime of the product, reports 5 years beyond lifetime of the product; according to US regulations “an investigator shall retain records required to be maintained… for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified”.