Silver Spring, July 2017.  Without much ado, late last month FDA released a draft revision of “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers – Guidance for Industry.”  And the Questions and mostly Answers throughout the draft guidance are, in many ways, just as long and as complex as the document title.

The last time FDA attempted to take on a guidance on these matters was in 2003 – way before we even knew what a mobile app or wearable was.  So with that in mind, FDA clearly had a lot of catching up to do.  One of the continuing themes in the guidance is FDA expects clinical trial sponsors to take a risk-based approach when it comes to validation, audit trails, and record archiving of source data (electronic records) from electronic systems, mobile apps, etc. used to collect and analyse for eventual submission.

The guidance then goes into further details on FDA expectations for such validations – suggesting that there are multiple categories of systems and different levels of validation depending sounding much like the GAMP (Good Automated Manufacturing Practice) guidelines.  Starting with COTS (Commercial Off The Shelf) office utilities including word processing, spreadsheets, etc., then COTS for a clinical purpose including document management systems, and finally for COTS systems integrated with or other developed systems or customised, increasing levels of validations culminating in full validations with an array of documentation may be expected by FDA during inspections.

For those interested in FDA expectations for mobile technology used for collecting data during clinical investigations, as well as cloud-based analysis, there are seven questions ranging from how to validate the use of mHealth apps and wearables, to maintaining security/privacy, to training in the use of the mobile apps.  You can get a complimentary copy of the guidance here.  For more information on how The CRO Group may be of assistance in designing your clinical study using wearable devices with mHealth apps to collect the data supportive of premarket submissions, (and by that we mean hooking you up with the right wearables and apps, writing the procedures for use, planning and executing the validations, and packaging this in a manner suitable for a Presub meeting, go to our contact page, select “Clinical Studies”, and just ask.