FDA issues electronic trial data guidance to support accuracy

By Nick Taylor

- Last updated on GMT

Related tags Clinical trial Computer Food and drug administration

The FDA has issued guidance on electronic data in clinical trials to help eliminate duplication, reduce transcription errors and promote real-time entry.

Increased computer use in clinical trials creates problems because data can be easily copied, transferred, changed or deleted without obvious evidence. To help ensure accurate, original and attributable data is available for clinical review and site inspection guidance has been issued​.

The US Food and Drug Administration (FDA) draft guidance breaks handling electronic clinical trial data down into three phases: entry; review; and processing and transmission. An FDA chart showing how data might flow between the three phases is pictured below.

FDA EDC guidance pic

Data entry is the focus of the majority of the guidance. In the guidance the FDA identifies two types of data: information generated at a study visit and entered directly into electronic case report forms (eCFR); and elements transcribed from a source document, such as a lab report.

When looking into information entered directly into eCRFs the FDA may request documents to corroborate the data. For transcribed data the FDA says source documents should be kept and made available, if requested, to inspectors.

Complying with these, and a number of other, recommendations in the guidance should help ensure data is traceable. These measures ensure electronic information can be “traced through complex data capture, transmission and archival processes​” for regulatory purposes.

Data element identifiers are part of creating an audit trail. These should identify: the originators of the information, including those entered manually by an investigator and automatically by a device; the date and time of submission; and the study subject referred to by the data.

Comments and suggestions regarding the draft should be submitted to the FDA by April 7.

Related news

Show more

Related products

show more

More Data, More Insights, More Progress

More Data, More Insights, More Progress

Content provided by Saama | 04-Mar-2024 | Case Study

The sponsor’s clinical development team needed a flexible solution to quickly visualize patient and site data in a single location

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Related suppliers

Follow us

Products

View more

Webinars