Ask the Experts: Trial Operations Adjustments in a Remote World
Attendees at last week’s WCG FDAnews 15th Annual FDA Inspections Summit peppered compliance experts with a variety of questions related to handling remote operations during the pandemic. Craig Lipset, adviser and founder of Clinical Innovation Partners; Jen Keun, compliance lead at LMC Manna Research; and David Borasky, WCG Clinical’s vice president of IRB compliance, discussed some of the thorniest aspects of operating trials remotely. The following is a summary of the question-and-answer session.
Question: How can a site justify asking a sponsor to reimburse the cost of electronic regulatory applications the site uses?
Keun: Some sponsors have given us pushback, but we tell them this is the way our site is working to improve efficiency and give them access to data for remote monitoring. We do highlight to sponsors how much access they’ll be able to get without actually being on site. It’s really comparable to being on site.
We were already looking at electronic applications before the pandemic. It’s the way that we think that the future is going so we are aligning ourselves and are trying to work with sponsors that will cover the cost. If there is a lot of pushback, we can always go back to paper source. It really depends on the length of the trial and whether it is worth the investment. It’s not something that we’re doing all of our future studies on but on a lot of the lengthier trials, we are trying to push these applications and sponsors are tending to agree.
Lipset: It can be a challenge for sponsors and CROs when there is a better way to operate with a small number of sites; are they able to shift to taking a different strategy with just a select number of sites or do they need to appeal to the lowest common denominator just to have a consistent process on their part, even if it’s not the best process. It’s nice to hear that you are seeing some adoption and flexibility, certainly in 2020 and hopefully going forward.
Q: How do you do source data verification (SDV) in places such as the EU, where the sites and local regulations don’t allow for remote monitoring?
Keun: There is off-site monitoring that they can do, like pre-phone calls and video calls just to discuss the trial in general. I do know that remote SDV is very limited and the sponsors kind of have to fight that and determine to what extent they want to do it. For sponsors that want remote monitoring, sites have to be prepared to provide that information by anonymizing their trial source, things like that, to make sure they are following their regulatory guidances.
Lipset: I’ve heard of instances out there where some have tried to be creative to use video to show medical records to remote monitors, but I think people have to be very careful trying to take those types of creative workarounds. Using an unsecure video or even a secure video doesn’t necessarily absolve you of the local privacy regulations that made it a challenge in the first place.
Borasky: Just because we have the technology doesn’t mean it’s always appropriate in a regulated environment.
Q: What is the IRB perspective on remote monitoring and its role in oversight of the safety and risk assessments within the protocol?
Borasky: We get asked a lot of questions about remote monitoring and it does fall into kind of a gray area. Remote monitoring is very possible in this environment and completely something you can do without having to compromise on compliance. That’s certainly another overarching message from the IRBs. For instance, when we’re advising you how to shift to consent for a remote consenting process, we’re not telling you that you’ve got any wiggle room for complying with the regulations; it’s just that there are ways you can do it in a compliant manner
At least for the IRB world, there will
be a lasting impact on being more open to nontraditional ways of doing things and still being comfortable that you’re being compliant.
Q: With use of these additional remote monitoring tools, are there any specific HiPAA certifications/requirements sponsors need to make sure their vendors have?
Lipset: From a sponsor perspective, if it’s their own monitoring workforce and they are potentially getting access to different types of protected health information shared through these electronic technologies, it’s a fair question to review with privacy officers. It’s probably something more CROs have already thought about and have incorporated perhaps in their procedures.
Keun: Generally, we don’t share source records through the portal. It would only be things to verify the regulatory binders and then a lot of patient-specific stuff would be done via Zoom or an over-the-shoulder type of review just to protect that patient’s information.
Q: How do you verify the facilities you use for remote visits? Are video visits adequate?
Keun: It is kind of awkward, carrying a camera around to show the facility.
But it’s still the same checklist as what you would use in person; it’s just now you have to designate the time for the video hookup. We’ve done them successfully and been able to set up trials during this time.
Q: Sites are using Sharepoint applications to share documents for monitoring review. How does the FDA view this sharing of source data in light of Part 11 compliance?
Keun: We always review all the portals that are suggested by sponsors to make sure they are compliant. The FDA didn’t really outline any limits, as long as appropriate security measures are in place. From a site perspective, we just need to make sure we are checking that before we start using the portal.