The Electronic Regulatory Binder is a project within REDCap that was developed by Partners Human Research Quality Improvement (QI) Program and Enterprise Research Infrastructure & Services (ERIS). The Electronic Regulatory Binder can assist sites with the electronic storage and maintenance of regulatory documents for Partners IRB approved protocols. This project is unique in that it contains:
• Data collection instruments that capture required regulatory information similar to what is generally captured in the QI Regulatory Binder for all studies.
• Branching logic that identifies and collects study specific regulatory information, such as laboratory certifications, and FDA forms.
• A report builder for developing site specific reports including delegation of responsibility log, protocol amendment tracking log, and consent version tracking log.
• A calendar for keeping track of due-dates for regulatory documents.
• Ability for the PI to grant different levels of viewing/editing rights for study staff.
To request a copy of the project for an IRB approved protocol: log into REDCap with your Partners username and password, click the tab titled “Request New Project” and complete the fields for requesting the Electronic Regulatory Binder template. General instructions for using the project to enter and store regulatory information can be found on the project’s homepage. For additional questions and comments related to this project, contact QA/QI Analyst, Michele Gomez, at mgomez6@partners.org.