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.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
