US Food and Drug Administration (FDA) has issued the guidance for industry on Electronic Source Data in Clinical Investigations. This guidance provides recommendations to sponsors, Contract Research Organisations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations.

At a time when the Union health ministry is trying to make conduct of clinical trials more transparent, the US FDA norms will now come in as a platform document for verification. It is intended to ensure reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission, point out Indian CROs.

In an effort to streamline and modernize clinical investigations, the US FDA guidance helps capturing source data in electronic form. It addresses source data in clinical investigations used to fill the predefined fields in an electronic case report form (eCRF), according to the protocol.

It mandates the identification and specification of authorized source data originators, creation of data element identifiers to facilitate examination of the audit trial by sponsors, FDA, and other authorized parties. Guidance is given on ways to capture source data into the eCRF using either manual or electronic methods. It states the clinical investigators’ responsibilities to review and retain the electronic data. Further it also provides the use and description of computerized systems in clinical investigations.

“This guidance is intended to be used together with the FDA guidance for industry on Computerized Systems Used in Clinical Investigations covering the regulation on Electronic Records and Electronic Signatures,” said the regulatory authority.

With the use of computerized systems for capturing clinical investigation data, it is easy to trace source data recorded electronically. There are currently electronic health records (EHRs) maintained by healthcare providers and institutions, electronic laboratory reports and digital medical images from devices completed by study subjects, said the regulatory authority.

FDA regulations define an electronic record as any combination of text, graphics, data, audio, pictorial, that is created, modified, maintained, archived, retrieved, or distributed by a computer system. An eCRF is an auditable electronic record of information reported to the sponsor on each trial subject. It enables clinical investigation data to be systematically captured, reviewed, managed, stored, analysed, and reported.

Source data includes all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical investigation used for reconstructing and evaluating the investigation. Access to source data is critical to the review and inspections of clinical investigations. The review of source data by both the FDA and sponsor is important to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality and integrity of the clinical investigation data. Moreover, source data should be attributable, legible, contemporaneous, original, and accurate (ALCOA) and must meet the regulatory requirements for record keeping. The key benefits of electronic source data is that it helps eliminate unnecessary duplication of data. It reduces the possibility for transcription errors. It encourages entering source data during a subject’s visit, where appropriate. It eliminates transcription of source data prior to entry into an eCRF. It facilitate remote monitoring of data, promote real-time access for data. The clinical investigators should retain control of the completed and signed eCRF copy and should provide FDA inspectors with access to the records.