December 6, 2012

Electronic Clinical Source Data Draft Guidance Published by FDA

On November 19, 2012, FDA issued a draft Guidance entitled, "Electronic Source Data in Clinical Investigations." The Guidance recommends various procedures relating to the electronic capture of source data in clinical investigations in an effort to reduce errors, to provide real-time data access, and to maintain accurate records for inspection by study investigators and FDA.

Clinical Data Guidance

Source data includes all information found in original clinical investigation documents (or certified copies of original documents) and this information is used for the reconstruction and evaluation of clinical trials. Accurate transcription of source data is extremely important, and the Guidance discusses methods of identifying source data, creating easy identification methods for auditing, capturing source data, and reviewing and retaining the data. The Guidance discusses the identification of source data originators, the capture of source data, the creation of data element identifiers, and the investigator's duty to review and retain electronic data.

The Guidance focuses on data entered into electronic case report forms ("eCRFs"). An eCRF is an electronic record, created for all clinical study subjects, that is reported to the study sponsor as per the study protocol. eCRFs contain data elements that are entered into the system by data originators such as investigators, medical devices, and clinical investigation subjects. Data elements are the smallest units of observation made during a clinical investigation and they include observations such as weight, birth date, race, or body temperature. The Guidance recommends that each sponsor and investigator maintain a list of data originators (e.g., people and devices) authorized to enter data elements for each study protocol. These lists limit access to data entry by creating unique user names, passwords, and identifications and by setting time periods for when each data originator can enter data.

The Guidance also recommends methods of source data capture such as: direct entry by an authorized data originator into eCRF, automatic transmission to eCRF from a medical device or instrument, transcription of data to the eCRF from paper or electronic sources, and direct transmission of data into the eCRF from medical devices or instruments or from an Electronic Health Record. For each of these methods of source data capture, the data (e.g., the electronic health forms, lab reports, and instrument printouts) must be maintained and available for inspection by an FDA inspector.

Further, the Guidance suggests that computer-generated identifiers be attached to each data element once the element is transmitted to the eCRF. These identifiers should reference the data originator, date and time of entry, and should identify the relevant study subject. If the identifiers need to be modified, a new identifier should be created so that both entries remain in the system, and the date, time and the originator of the change are recorded. The use of these identifying tags assists with the examination of the data and the reconstruction of the clinical study. These tags also document which data elements have been reviewed by the study investigator, as well as data elements that may be exempt from review.

The Guidance is designed to be used with the FDA guidance entitled, "Computerized Systems Used in Clinical Investigations," and together, these guidances aim to "ensure the reliability, quality, integrity, and traceability of electronic source data.