Remote monitoring is here to stay, says Sandra SAM Sather, MS, BSN, CCRC, CCRA, vice president at Clinical Pathways, LLC. That said, she wonders if it increases the burden on research sites to de-identify subjects’ medical records.
She notes that, in many cases today, it does increase that burden and often blocks access remotely to subjects’ records. That’s the bad news. The good news? According to Sather, it doesn’t have to be that way. The key is to have the right agreements and processes in place.
“We can address the barriers and burden for clinical research associates and research sites to support monitors’ access to subjects’ source documents without de-identification before the review,” Sather says. “Many think the Health Insurance Portability and Accountability Act restricts research sites from disclosing patient records for monitoring review (even remotely), but that’s a myth.” De-identification can also waste a lot of time and resources, she adds.
Sather and colleagues Kelly Cairns, MA, BASc, APMR, CCRA, leader for clinical trial operations with Boehringer Ingelheim (Canada), and Dr. Gil Price, CEO and owner of MaGil IRB & Drug Safety Solution, will present Remote Monitoring and Access to Electronic Medical Records at the ACRP 2016 Meeting & Expo, April 16-19, in Atlanta, Ga.