Remote Monitoring Won’t Require Post-Pandemic “Re-Monitoring,” FDA Says
The FDA considers risk-based remote monitoring conducted during the COVID-19 crisis to be sufficient and will not ask sponsors to re-monitor all data after the pandemic passes, but sponsors themselves may choose to do so, two agency officials say.
Jean Mulinde of the FDA’s Division of Clinical Compliance Evaluation reiterated the agency’s support of risk-based monitoring — remote or not — at a Drug Information Association webinar last week, but advised sites and CROs to discuss the possibility of a follow-up source data verification (SDV) effort with their sponsors.
Mulinde recommended sites, CROs and sponsors work together to determine whether redacted source documents used for remote monitoring during the pandemic will eventually require re-monitoring with certified documentation once on-site monitoring resumes.
Alyson Karesh, director of the FDA’s Division of Clinical Trial Quality, Office of Medical Policy, advised webinar attendees to keep the big picture in mind. “Part of the whole reason to do a risk-based approach is to prioritize,” Karesh said. “SDV or SDR (source data review) may or may not be a good thing to do depending upon the situation. It isn’t necessarily prioritized and it’s not necessarily risk-based.”
But Mulinde, citing previous experience from a compliance perspective, warned that under a 100 percent SDV model, “monitors will then miss really important things because they’re overly focused on transcription checking.”
Speaking from the sponsor point of view, Jackie Gough, director for centralized monitoring and data surveillance at Astellas Pharma, agreed that SDV is not as effective as focusing monitoring efforts on priority issues. “We simply don’t feel that transcription checking is getting us enough value.”
Astellas has no predefined requirement for follow-up monitoring, Gough said, “But if a site monitor discovered something at the site that would indicate to them that the site doesn’t know how to complete the CRFs [case report forms] correctly [or] doesn’t know how to do that transcribing appropriately, nothing prevents (the monitor) from going and doing a spot check of that activity.”