Regulatory Focus™ > News Articles > FDA Finalizes Widely Anticipated Guidance on Use of Electronic Source Data in Clinical Investigation

FDA Finalizes Widely Anticipated Guidance on Use of Electronic Source Data in Clinical Investigations

Posted 19 September 2013 | By Alexander Gaffney, RAC

US Food and Drug Administration (FDA) officials have finalized a November 2012 draft guidance on the use of electronic source data in clinical investigations, calling for its greater use to promote the reliability, quality, integrity and traceability of clinical data.


The guidance, Electronic Source Data in Clinical Investigations, was first released in January 2012, but after FDA received a deluge of comments-42 in all-it revised and re-released the draft guidance on 19 November 2012. At the time, FDA said it was intended to be used by members of industry, as well as clinical research organizations (CROs), data management centers and clinical investigators.

The premise of the guidance is relatively simple: It's better for all parties involved to capture clinical data in electronic form. Why? FDA believes it eliminates unnecessary duplication of data, reduces transcription errors, encourages timely reporting of data (i.e. at the time of the patient's visit), eliminates transcribing errors between non-electronic and electronic systems, promotes real-time review of trials and ensures data collected is both accurate and complete.

But industry generally already knows the benefits of collecting electronic source data. What it wants, surmised FDA at the time, is instruction on how to do so in a way that ensures regulatory compliance, adherence to best practices and a certain degree of harmonization.

Unlike paper source documents, eSource electronic source documents and data can be easily copied, transferred to other computerized systems or devices, changed or deleted without obvious evidence of these events.

Electronic Data in Clinical Investigations provides instruction for companies on how to use electronic case report forms (eCRFs), medical images, lab reports and diaries provided by subjects, among numerous other examples.

"The revised draft guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of electronic source data," FDA explained in the November 2012 Register posting.

Perceived Problems

FDA had received a bevy of comments from industry on the January 2011 guidance. CRO Quintiles said the guidance lacked specificity when it came to the characteristics of the electronic data systems themselves and the data security measures required to be put into place. The Pharmaceutical Research and Manufacturers of America (PhRMA) mirrored those concerns, saying the lack of specificity regarding electronic systems hurt the effectiveness of the guidance and could stifle the development of new systems to replace existing paper-based ones.

FDA also received a large number of comments on the most recent iteration of the guidance, which generally reflected a more positive view of the document relative to its predecessor. Quintiles, for example, commended FDA for making a number of changes it had called for, though the company also called for a number of additional changes as well.

PhRMA called the updated draft guidance "an improvement" over the 2011 draft guidance, but said it believes the guidance "may not fully clarify FDA's plans to ensure that all parties with responsibility for source data have adequate access to electronic data capture systems." In addition, PhRMA said revisions are needed to "eliminate the recommendations for retention of redundant paper records or certified copies."

AdvaMed, the device industry trade group, also praised the guidance, saying it was heartened by FDA's insistence that sponsors have access to an investigational site's electronic health records (EHR) data for a study. "Controlled access to the original e-records is critical to our ability to properly monitor data quality and we find there is still some reluctance for sponsors to be granted access to EHRs," it said.

Other companies, including Sanofi, AstraZeneca, Boehringer Ingelheim, Teva, Johnson & Johnson and GlaxoSmithKline, also weighed in on the guidance.

FDA Changes

In an 18 September 2013 Federal Register posting, FDA announced the release of the final version of the November 2012 guidance, saying it had reviewed comments made by industry groups and made clarifications to all sections within the guidance.

A comparison of the 2012 draft guidance and the 2013 final guidance illustrates a number of those changes, the most extensive of which appear to have been made to the electronic data capture sections. To PhRMA's comments, FDA has now clarified that paper-based documents should only be retained if they are used in the original data reporting process, and should be kept for the purposes of FDA inspection. FDA clarified that some documents (e.g. CT scans) will not need to be kept, though the clinical interpretation of the image would need to be.

Another section calls for "Adequate controls… to ensure confidence in the reliability, quality and integrity of the electronic source data." FDA has recently cited several manufacturers in India for falsifying source data for nonclinical testing, and the agency seems keenly aware of how changes could be made without adequate protections to monitor or guard against such changes. "Only a clinical investigator or delegated clinical study staff should perform modifications or corrections to eCRF data," FDA added.

The majority of other changes appear to be more minor in scope, with words added to either clarify the intent of a phrase or to add information that must be included.

Guidance for Industry: Electronic Source Data in Clinical Investigations

Federal Register


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