The document describes a Functional Profile that identifies critical capabilities for the conduct of regulated clinical research utilizing EHR systems. Further to conforming to the EuroRec Repository Profiling Tools, this Profile identifies additional functionalities toward facilitating ease of use for those involved in clinical research.

The submission was finalized in October 2009 and formally approved by EuroRec on November 2009...

The document describes a Functional Profile that identifies critical capabilities for the conduct of regulated clinical research utilizing EHR systems. Further to conforming to the EuroRec Repository Profiling Tools, this Profile identifies additional functionalities toward facilitating ease of use for those involved in clinical research.

The submission was finalized in October 2009 and formally approved by EuroRec on November 2009...

As the healthcare and pharmaceutical technology spheres move closer together at the clinical research interface, the eClinical paradigm needs to be revisited in order to leverage emerging political, cultural, procedural and technological opportunities. Understanding investigational site experiences with today’s clinical trial technologies and their perspectives on future requirements is critical to delivery of improved eClinical solutions. The eClinical Forum has recently conducted an in depth, global survey of investigational site experiences with clinical trial technologies and their future expectations. The 2009 survey allows a comparison with results from a survey performed in 2001 with 840 investigational sites. This comparison provides us with a unique opportunity to extrapolate future trends...

This document is intended as a practical guide to assist clinical research site personnel in:

• Understanding and anticipating expectations when participating in clinical research (regardless of whether they are using an EHR system)
• Selecting or upgrading an EHR system to hold data which could potentially become source data to support regulated research work for drug or medical device clinical trials or development activities
• Identifying best practices in implementing and maintaining an EHR system, especially if it may hold data that could become source for clinical trials

A checklist is provided to identify site activities in selecting and implementing EHR software suitable for use in clinical research. While this document presents one approach a site may use to meet the expectations of the research regulations (e.g., Part 11), it should be understood that any technical and procedural solutions should be implemented in the context of a risk assessment...

This is an Addendum to the document ‘Requirements for EHR Systems Providing Source for Clinical Research Release 1’ published by the EHRCR Working Group in February 2008. Since the release of that document, the User Requirements have been clarified, and some redundancies have been removed. In addition, the User Requirements have been mapped to regulations and guidance documents, and to the final approved HL7 normative version of the EHRCR Functional Profile (which has undergone extensive stakeholder scrutiny), and to the EuroRec EHRCR profile...