FDAnews Drug Daily Bulletin

EMA: Sites Must Retain Copy of Electronic Trial Data

Aug. 27, 2010
Before transferring trial data to the sponsor, sites should make a certified copy and retain it for their records, according to the European Medicines Agency’s (EMA) final guidance on the use of electronic data in drug clinical studies. Storage of electronic source documents should allow for easy retrieval by authorized individuals, such as the investigator, trial monitors, auditors and inspectors, the EMA says in the guidance, which became effective this month.
Clinical Trials Advisor