June 08 2022
Written by: Mary Gulzow, CCRP, CommonSpirit Health Research Institute, CORA NCORP
Remote Audit/Monitor. Now what?
For many research sites, study participant and regulatory records have been maintained on paper records. Since medical facilities have electronic records, source documentation from those patient records have routinely been printed from the EMR and filed in paper format. This process continued for auditing preparations. This may be the case for some audits; however, the evolution to remote auditing is now a reality.
Do you really need to print?
Remote auditing took a huge upward climb during the COVID-19 pandemic. Sites found themselves meeting with their information system and compliance departments to implement good clinical practice guidelines and processes to allow required monitoring of research. Documents were to be in digital format and have the capability to be shared securely. The practice of printing and filing, changed to upload and save to a pdf. Some sites did have an option to allow monitor remote electronic medical record access.
Training
The remote monitoring and audit process brought new challenges for staff training. Step by step procedures were not always practical when dealing with electronic systems. Problem-solving and new terminology was required to utilize digital tools. Research sponsors did not collaborate with same software, so research coordinators spent many hours training. Help desks were inundated with electronic issues and user questions. Companies were trying to find the best option for video conferencing, so some sites experienced multiple vendor changes with more education and trial by error training. Not only do they respond to change as technical, but the change in communication style from face-to-face to virtual was stressful during this process.
Lack of Tools
Video conferencing became a necessity, and with that, equipment was not available. Web cams were expensive and hard to acquire. Some facilities had waiting lists.
“Hey, this scanning, redacting and labeling for a remote audit is taking me too much time! We are not getting paid enough for this! – And, I do not have a title for that!”
Time and effort did not account for remote auditing. Not only were records, source documentation and regulatory document to be scanned and uploaded to a shared system, the monitor was sending emails with lists of items to check to make sure you have paper documentation on site.
Are We Back to Normal? What is Normal?
Why go back? Why print? Why not move forward. You have now implemented electronic documentation. You have acquired on the job training with electronic world problem solving. You have implemented secure networks with appropriate access. Can this new form of document storage become cost effective and provide easy accessibility to records and improve research integrity?
Many research facilities are multiple locations with satellite sites. With the correct electronic system, subject documentation can help maintain the requirements of good clinical practice and reduce deviations. Electronic records are incorporating capabilities for pharmacy safeguards including medication interactions. Clinical trial management systems are incorporating protocol builds in order to minimize human error by providing safeguards and medical use requirements.
What About DHHS and FDA?
Guidance was issued by governmental regulations for emergency use during the COVID-19 pandemic. It was intended to remain in effect for the duration of the emergency. The exact timeline is unknown; however, a request for remote interactive evaluation from FDA should be viewed with the utmost importance. A request of facility’s ability to participate with teleconference, livestream video, screen sharing, remote communication and activities to transfer records would be confirmed and organized. Declining FDA’s request for remote evaluation could delay applications.
Site Needs and Capabilities
Each research center needs to review their own current practices and feasibility. The ability to move to a complete electronic system may not be feasible. Hybrid records and storage are commonly reported.
If your facility can move forward with providing electronic based systems, it could decrease the cost of operations in the long term. As research compliance and regulations move to this manner, overall government funded research auditing expenses should decrease and thus allow more funds in their budgets. The community based and underserved populated area could see more opportunities for research. If each research base decreased their on-site monitoring, the affect could bring about more site awareness to manipulate or upgrade their systems and records for remote capabilities. In turn, changes such as these could change the vision and allow for less waste.
Sources:
“Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities during the COVID-19 Public Health Emergency” Guidance for Industry – April 2021 US Dept of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Veterinary Medicine
https://www.fda.gov/media/147582/download