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.
Hi Terri, Thanks for the comment. I think there a different approaches to remote monitoring and does not necessarily mean the site gets more responsibility, etc. It can mean your monitor is better prepared and picks up on things earlier. There are some approaches that have not been well received since the input of the site was not done. That is a big mistake.
remote monitoring does not necessarily mean less monitoring or no onsite compliment. It could decrease the burden of a site.
Hope to see you at the session we are having at the ACRP meeting in Atlanta.
Thank you, SAM
Opinions on remote monitoring vary depending on whether you are a site or a sponsor/CRO. From a sponsor view, the bottom line is about saving money. Here is my opinion as a site from coordinating research for 19 years.
Remote monitoring puts the sites in the position of literally monitoring themselves. I participated in one study that was entirely remote monitoring and it took me hours to prepare the documents the sponsors expected to be faxed in prior to the calls which would take an additional hour. Temperature logs, delegation logs, source documents that required redacting, investigational product dispensing logs, etc.; all had to be pulled and faxed which caused an enormous amount of work on the site’s end without reimbursement for the extra work because it was “the cost of doing business”.
A simple study turned into extraneous work for our site. I am more comfortable having monitors come to our site to make sure an adverse event/serious adverse event/endpoint isn’t missed. Coordinators are human and do miss events and endpoints which is why it’s better to have an independent person physically look at the data.
From a site perspective, remote monitoring significantly reduces the relationship with the sponsor which is essential in the communication and understanding of the protocol and success of the trial. I have empathy for new coordinators and sites starting up without the opportunity to develop a relationship with the sponsor because many initiations are web-based and remote. And how many times are the coordinators and physicians called away during the trainings? The answer is most of the time. Web-based presentations will never have the same effect for a site as an in-person site initiation or monitoring visit.
Terri Campbell RN, CCRC
Pharmaceutical Research Specialist
Genesis Healthcare System