The US Food and Drugs Administration (FDA) has issued norms on guidance for Industry on the Electronic Source Data in Clinical Investigations. It has  clearly defined its recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations.

In an effort to streamline and modernize clinical investigations the guidance promotes capturing source data in electronic form. It is intended to ensure  the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.

The guidance addresses sourcing data in clinical investigations used to fill the pre-defined fields in an electronic case report form (eCRF), according to the protocol. The recommendations covers identification and specification of authorized source data originators, creation of data element identifiers to facilitate examination of the audit trail by sponsors and FDA.

With the use of computerized systems to capture clinical investigation data, it is common to find at least some source data recorded electronically. For instance, such information is not limited to clinical data initially recorded in electronic health records maintained by healthcare providers, electronic laboratory reports, digital medical images from devices, and electronic diaries completed by study subjects. “Our regulations define an electronic record as any combination of text, graphics, data, audio, pictorial, or other information represented in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system. An eCRF is an example of an electronic record,” said the regulatory authority.

“The eCRF is an auditable electronic record of information that generally is reported to the sponsor on each trial subject, according to a clinical investigation protocol. It enables clinical investigation data to be systematically captured, reviewed, managed, stored, analyzed, and reported,” said the regulator.

Source data includes all information in original records and certified copies of original records of clinical findings, observations, used to evaluate the investigation. Access to source data is critical to the review and inspections of clinical investigations by both the FDA and sponsor to ensure adequate protection of the rights, welfare and safety of human subjects.

Further, the regulator has insisted that the source data should be attributable, legible, contemporaneous, original, and accurate (ALCOA) and adhere to  regulatory requirements for record keeping. Capturing source data electronically and transmitting it to the eCRF should be able to eliminate unnecessary duplication of data. It should reduce the possibility for transcription errors, encourage entry during a subject’s visit. It should do away with transcription of source data prior to entry into an eCRF, facilitate remote monitoring of data, promote real-time access for data review and assist the collection of accurate and complete data.

“Now with the Indian government reviewing the Prof Ranjit Roy Chaudhury recommendations on the clinical trials, the US FDA guidance would ensure that companies which have preferred global sites to India following the stalling of human studies since January 30, 2013 to adhere to these standards,” said industry sources.