Electronic records must be maintained securely and meet data integrity, retention, and inspection requirements.

The use of computerized data he use of computerized data in clinical trials has generally been limited to a centralized database with independent data entry from the paper case report form (CRF) into the database and subsequent analysis of the data.A sponsor’s present processes (especially if EDC is already in use) for protocol development, site management and study conduct may not prohibit the use of modern technology (such as e Source) in Clinical Trials.366 individuals from the clinical research industry attended: 31% from an Academic Medical Center, 23% from a Hospital or Health System, 12% from a Dedicated Research Site, 11% from a Cancer Center, 7% from a Physician Practice, and 5% from a Sponsor or CRO.Part 11 of the regulations applies to “records in electronic form that are created, modifi ed, maintained, archived, retrieved, or transmitted under any records requirements set forth in agency regulations . .” and defines electronic signatures as “computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.” Electronic signatures must be unique to the individual and require a user ID and password.Tom Haag, Novartis, explains how the adoption of e Source for clinical trials offers significant opportunities to improve data integrity Let’s start with what we mean by e Source.However, advances in the technology and acceptable methods of ensuring the relative security of the data have provided us with options, including the electronic case report form (e-CRF).Trials that use this technology have been dubbed “e-trials” or remote data capture (RDC) trials.