A regulatory binder is a set of essential regulatory documents that must be maintained throughout a clinical trial and several years after completion. The study binder is often the first item reviewed by the clinical trial monitors, auditors, and FDA inspectors. For decades, the use of paper-based regulatory binders has been the norm. However, with an increasingly mobile workforce, this norm is rapidly changing. The reasons for this go beyond COVID-related remote work, and change that was overdue well before the pandemic forced us all to rethink how we work.
In a 2019 industrial survey, 71% of CROs reported problems tracking and reporting paper documents. Misfiling or misplacing documents was an issue for 59% of the respondents, while 48% of the participants described they had trouble with manual document transfers. The enormous volume of required regulatory documents, increased risk of errors, and the additional time needed to maintain paper documents have resulted in the clinical research industry seeking alternative solutions. Given the size of the issue for respondents, one can imagine how many salary hours are wasted chasing down documents.
eReg is the new standard
An Electronic Regulatory system, or eReg, is a digital platform used to store and track regulatory documents in the form of electronic regulatory binders throughout the life cycle of a clinical trial. eReg binders provide a way to efficiently manage a large number of documents while maintaining regulatory compliance. A recent conversation with a regulatory staff member drove the point home about the impact an eReg system had on her day to day life when she mentioned she used to spend almost an entire day each week filing documents across 50+ studies.
According to one survey, in 2014, three out of every ten clinical trial sites used eReg binders. These numbers are snowballing, and the transition to eRegulatory is becoming more and more common throughout the industry.
Going beyond the essentials
All the documents stored in an eReg binder can be electronically signed while fulfilling the requirements of electronic signatures, as defined by the FDA. This eliminates the tedious task of tracking down an investigator or other site staff for a signature on a regulatory document. Similarly, electronic logs, such as screening or enrollment logs, subject visit tracking logs, and adverse event tracking logs, are an essential component of an eReg binder. These logs help organize the events of a clinical trial, making it easier to track down deviations and ensure quality and protocol adherence.
However, the advantages of eReg binders go far beyond this. Here’s a glance at some of the additional benefits that the electronic management of regulatory documents has to offer:
• Reduced study startup time: The pre-defined study binders with electronic logs and automated workflows to manage and complete documents are essential features of the eRegulatory system of data management and significantly reduce the study startup times. These features also help decrease the time required for the trial site staff to prepare, store, and handle paper documents, leading to a more time-efficient and smooth running of a clinical trial.
• Remote monitoring: Remote access and monitoring allow investigators, clinical research staff, monitors, and consultants to view and manage data, even if they are located miles away from the physical trial site. The access can be limited based on the sites’ requirements, and the activity is tracked and audited. This feature is particularly important for conducting virtual, patient-centric, decentralized trials, which are becoming increasingly popular.
• Decreased risk of errors: eRegulatory software can help reduce or eliminate compliance risks associated with data management. Essential documents and timelines are automatically tracked, and the study staff is alerted of any missing data, discrepancies, and expiring documents. Thus, the trial site staff spend less time on time-consuming and repetitive regulatory tasks and instead focus on providing improved patient care. If you or one of your staff has ever had to chase down missing IRB rosters, CVs or delegation log signatures, then you’ll know how critical this point is.
• Real-time measurement of study progress: eReg binders allow the investigators and sponsors to analyze trial progress in real-time. Study bottlenecks can be identified promptly, and potential delays are mitigated before they arise. The real-time assessment of data is also of tremendous benefit to adaptive clinical trials, which are trials that are flexible and allow modifications to the study design after initiation, based on the data collected from the study.
In summary, data integration, storage, and transfer are important components of any clinical trial. eReg binders are redefining the process of data management by providing a way to manage documents in a simplified fashion, resulting in reduced workload, improved compliance, and decreased time consumption. With the ever-increasing use of technology in the clinical research industry, eRegulatory software is unquestionably the future of data management in clinical trials.
Clinical.ly Research Suite can help your site transition!
Clinical.ly’s eRegBinder allows clinical research sites to transition from paper-based documents to an eRegulatory system. Some of the features that make eRegBinder an ideal choice for most research sites are 21 CFR Part 11-compliant electronic signatures, intuitive electronic logs, advanced permission controls to support remote monitoring, and real-time insight into the performance of the trials.
Contact us today to see how we can help you make the leap from paper to electronic!