FDA Draft Guidance “Electronic Source Data in Clinical Investigations”

The revised FDA draft guidance document  “Electronic Source Data in Clinical Investigations” provides guidance to clinical trial sponsors, CROs, data managers, clinical investigators and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The original January 2011 draft guidance has been updated to clarify a number of points made to the FDA by commentators in the industry and the new draft guidance is published to collect additional public comments.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No doubt a number of the recommendations contained in the draft guidance document will be of concern to software vendor's whose systems do not currently meet the technical recommendations provided.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 This is something we have provided feedback on and we would encourage everybody in the industry to review the new draft guidance and provide comments.

You can view a copy of the new draft guidance at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM328691.pdf and comment through the usual FDA process at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

The use of Unique Device Identifiers in Healthcare

Monday 12th and Thursday 13th September saw a very interesting public meeting organized by the US FDA, entitled "Unique Device Identification (UDI) for Postmarket Surveillance and Compliance".

Rather than looking at details of the rule currently being developed for the unique identification for medical devices (details of which can be found at http://www.fda.gov/udi) the meeting looked at how UDIs would be used in the real world.

Whereas Pharmaceuticals is looking to reduce or prevent counterfeiting by the use of serialization (see our recent webcasts on serialization - "Strategic Management of Product Serial Identifiers" and "Serialized Labelling: Impacts on the Business Model"), in the medical devices sector there is a global drive to be able to uniquely identify medical devices at all point in the supply chain, at point of initial use and throughout the life of the device. Whereas pharmaceutical products are clearly identified (e.g. via the National Drug Code [NDC] in the US), this is not the case for medical devices.

At the moment medical devices are identified inconsistently my manufacturer, model, product name, hospital allocated item number, SKU# etc. As the public meeting heard, the ability to uniquely identify what a medical device is has significant benefits in terms of:

• More accurate device registries (e.g. of implantable devices)
• Faster and more focused product recalls
• Fewer patient/device errors (ensuring the right patient receives the right device)
• Better post marketing surveillance and adverse events reporting

Key to this will be not only the use of the UDI, but the development of data standards which will allow the significant therapeutic attributes of devices to the standardized. This will allow data to be analyzed by specific device model and attributes(e.g. drug coated stents versus polymer coated stents) and different models from different manufacturers to be compared in terms of patient outcome.

The tracking of devices via the Electronic Health Record (EHR) or Personal Health Record (PHR) is one of the most significant steps to enable all of this - where the EHR records the Unique Device Identifier to be recorded, and thereby linked to model number and manufacturer, to the batch/lot or serial number where required, and a host of other associated device data available from a manufacturers database.


This is part of a global initiative to uniquely identify medical devices via a Global Medical Device Nomenclature - which is important when you consider how important it is for a German cardiac specialist to know exactly what sort of heart pacemaker is implanted in the Australian tourist who has just been rushed in the emergency room!

Although we're most likely a year away from finalizing the FDA rule on UDI, and two years away for initial requirements for Class III devices, the use of UDI heralds the possibility of a new era in reduced hospital errors, better device safety, faster recalls, improved safety signal detection and the abilty to use real evidence - and not marketing hype - to know what the best device is for any given patient.


Details of the public meeting program and presentations can be found on the US FDA website at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm263947.htm