US regulators have released a new draft guidance document aimed at providing industry with insight on the use of electronic source data in clinical investigations.
The guidance, set to be published on 20 November 2012 and summarized in a 19 November Federal Register posting, specifically relates to those involved in the capture, review and archive of electronic source data in FDA-regulated clinical trials.
Explains FDA: "The revised draft guidance promotes capturing source data in electronic form, and is intended to assist in ensuring the reliability, quality, integrity and traceability of electronic source data." In addition to industry sponsors of trials, the guidance will also be of use-and apply-to clinical research organizations, data management centers and clinical investigators, explained FDA.
A Simple Premise
The premise of the guidance is simple: It's better for all parties involved to capture clinical data in electronic form. Why? FDA notes that 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, 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The draft guidance is the second version of one first released on 7 January 2011. Regulators say the number of comments received-42 in all-caused them to reconsider the guidance and make a number of changes.
"The revised draft guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of electronic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 Register posting.
Industry Weighs In
A review of those comments by some industry leaders found much to like, but lots of language in need of clarification and additional-or sometimes less--specificity.
In a response to the 7 January draft guidance, CRO Quintiles said it generally applauded the guidance for attempting to provide clarity to an otherwise murky area. But it also had some minor complaints: a lack of discussion regarding the required characteristics of the electronic data systems used to collect data, the transfer of data through the eCRF being slightly misleading, data security issues and the use of data by regulators, among others.
Industry trade group PhRMA's comments primarily focused on the guidance's lack of specificity regarding the use of electronic systems in general. New innovations would either leave FDA's guidance behind, or the guidance would stifle new innovation, wrote PhRMA.
"Regulated industry and its traditional service providers, as well as providers and users of these new innovations, will benefit from additional FDA guidance on the applications of traditional validation and electronic records and electronic signature (ER/ES) to ensure that these innovative solutions retain the credibility and authenticity required by the agency in replacing historical paper counterparts."
Continued PhRMA: "It is also PhRMA's assertion that the draft eSource guidance does not adequately clarify these innovative uses of computerized systems to capture source data in electronic form, nor does it clarify how traditional biopharmaceutical electronic data capture systems (EDC) can better serve as eSource systems." Instead, PhRMA asserted that FDA's guidance document, as it existed before, would transfer too much authority to clinical investigators and implement Health Level 7's (HL7) data exchange standards at too early a stage for operational readiness.
While it remains to be seen if FDA's changes satisfy industry's comments, FDA indicated some of the changes would "clarify a number of points made by industry," including those related to the source of data originators, auditable trails of data, the use of the eCRF and the responsibilities of clinical investigators.
For now, FDA said it will continue to collect public comment on the revised draft guidance until 19 January 2013 (60 days after publication in the federal register).