FDA Urges Sponsors to Ensure Data is ‘Interoperable or Integrated’

Medical product sponsors and researchers should work with electronic health record keepers to help improve clinical trial accuracy and efficiency, the FDA said in a new guidance.

In a final guidance, the FDA encourages sponsors and investigators to use approved EHR or electronic capture data capture (EDC) systems to exchange key information, noting that doing so can dramatically speed up information sharing and precision.

Sponsors and investigators should use EHR systems endorsed by the Office of the National Coordinator for Health Information Technology (ONC). If they lack access to ONC-certified systems, they should make sure security measures are in place to protect study data, the agency said.

Study monitors should have easy access to “all relevant information” detailed in signed consent forms, including how long identifying records will be kept.

Records relating to medical devices must be retained for at least two years after an investigation wraps up or the date that the records are no longer required to support a premarket approval application or a notice of completion, whichever is later.

Read the FDA’s July 18 guidance here: www.fdanews.com/07-18-18-HealthRecordData.pdf. — Bill Myers