Problem Statement
The majority of clinical trials require documentation of essential documents (e.g., delegation log, staff qualifications (CV), IRB correspondence) in what is referred to as a Regulatory Binder. With the trend toward electronic data storage, clinical sites want to document and store essential documents electronically. Quality Improvement (QI) Program onsite auditing experience indicates electronic storage is inconsistently exercised during study and/or documents are generated in hard copy, scanned, and then saved to a file.
Solution
A QI Program at a healthcare system and with Enterprise Research Infrastructure & Services (ERIS) developed the Electronic Regulatory Binder (eReg Binder) template within Research Electronic Data Capture (REDCap) using features inherent to a university application and plug-ins developed by the healthcare's ERIS team. The eReg Binder assists sites with the electronic development and maintenance of regulatory documents for IRB approved protocols. This project is unique in that it contains:
- Data collection instruments that electronically capture required regulatory information similar to what is generally captured in the
- Regulatory Binder for all studies
- Branching logic that identifies and collects study specific regulatory information, such as laboratory certifications and FDA forms
- Report builder for developing site specific reports including delegation of responsibility log, protocol amendment tracking log, and consent version tracking log
- Calendar for keeping track of due-dates for regulatory documents
- User rights application for the principal investigator to grant different levels of viewing/editing rights for study staff
The eReg Binder was piloted in November 2014 to the healthcare system research community and has received positive feedback from sites who are interested in using the eReg Binder as the “official binder” for their study. The project has also garnered the attention of coordinating centers responsible for large multi-site studies. This healthcare system’s QI Program intends to make the eReg binder available to the REDCap consortium in 2015.
Future Directions and Implications for Other Institutions
This tool accomplishes the goal of creating and storing all research related data electronically: it allows sites to enter study management related information (e.g., study staff information, protocol and consent form version information) into the REDCap project, thus no longer needing to generate hard copies. REDCap is available to members of the REDCap Consortium. Additional features within REDCap allow study sites to link the eReg Binder with REDCap subject data collection projects. With the user rights application, institutional Quality Assurance/QI Programs can audit regulatory documentation remotely.