Practical Considerations for Clinical Trial Sites using Electronic Health Records Certified for Clinical Research
The EHRCR Project released a paper to address regulatory considerations regarding clinical trial sites using electronic health records. This is the first paper of its kind, speaking directly to clinical research investigative sites regarding the use of electronic health record systems. It is based on clinical research regulations and guidances and includes a checklist for sites to assess how their systems (whether certified or not), and their processes comply.
The EHRCR Project is comprised of members from pharmaceutical sponsors, CROs, software vendors (both CR and EHR), and has included regulatory review. They have produced an EHRCR Functional Profile which is now an ANSI/HL7 standard, approved by EuroRec, and is currently under consideration to become a CEN/ISO standard. The profile (a) is founded on current clinical research regulations / guidances, (b) translates requirements into measurable criteria to assess suitability of a system for clinical research, and (c) was used as a input for the recently released CCHIT Certified® 2011 Clinical Research certification option for Ambulatory EHRs. For more information on the EHRCR Project: www.ehrcr.org.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
