FDA Draft Guidance “Electronic Source Data in Clinical Investigations”

The revised FDA draft guidance document  “Electronic Source Data in Clinical Investigations” provides guidance to clinical trial sponsors, CROs, data managers, clinical investigators and others involved in the capture, review and archiving of electronic source data in FDA-regulated clinical investigations.

The original January 2011 draft guidance has been updated to clarify a number of points made to the FDA by commentators in the industry and the new draft guidance is published to collect additional public comments.

It's good to see industry and regulators working to develop guidance on the use of electronic Case Report Forms (eCRFs), recognising that capturing clinical trial data electronically at source significantly reduces the number of transcription errors requiring resolution, does away with unnecessary duplication of data and provides more timely access for data reviewers.

While much of the guidance contained in the draft would be seen as common sense in much the industry it does start to provide a consensus on important issues such as associating authorised data originators with data elements, the scope of 21CFR Part 11 with respect to the use of such records, interfaces between medical devices or Electronic Health Records and the eCRF.

No doubt a number of the recommendations contained in the draft guidance document will be of concern to software vendor's whose systems do not currently meet the technical recommendations provided. We will therefore surely see a variety of comments from “non-compliant” vendors trying to water down the recommendation until such a time their systems can meet what is already accepted good practice.

One key issue that would appear to be missing is the use of default values on eCRFs, which we know has been a concern in a number of systems and clinical trials i.e. where the investigator has skipped over a field leaving the data element at the default value. This is something we have provided feedback on and we would encourage everybody in the industry to review the new draft guidance and provide comments.

You can view a copy of the new draft guidance at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM328691.pdf and comment through the usual FDA process at https://www.federalregister.gov/articles/2012/11/20/2012-28198/draft-guidance-for-industry-on-electronic-source-data-in-clinical-investigations-availability