Submission of comments to the FDA on their Draft Guidance on Standardized Study Data

eCF Submission to EMA on their Reflection Paper on the Use of IRT (Interactive Voice/Web response Systems in Clinical Trials)

Practical Considerations for Clinical Trial Sites using Electronic Health Records (EHRs) certified for Clinical Research

eCF comments on FDA Draft Guidance: Electronic Source Doc in Clinical Investigations

The EHRCR Functional Profile Working Group is comprised of dedicated individuals from the United States and the European Union in the following industries: pharmaceutical, biotechnology, clinical research technology vendor, healthcare technology vendor, and federal regulator.

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

2009: EHRCR User Requirements Addendum, Draft 2, 16 April 2009

2009: HL7 EHR Clinical Research Functional Profile, Release 1

Considerations for Implementation of Electronic Patient Reported Outcomes (ePRO) in Clinical Studies 

A Guide to the Options, Issues, Best Practices and Learning Experiences

Please download to review these comments.

Please download to review this document.

Please download to review this position paper.