The Harvard Longwood Medical Area (HLMA) Quality Improvement Program has developed three Electronic Regulatory Binders (eBinders). The eBinders, developed in REDCap and Box.com, facilitate proper study management through electronic storage of study/regulatory documents and study management tools/logs.
Instructions for institution-specific regulatory requirements, best practice recommendations, and GCP/Federal regulations are contained within each regulatory binder section.
The eBinders allows you to:
- Quickly download a custom template or utilize QIP’s template to customize your own binder to fit your study needs
- Maintain regulatory documents for one or multiple studies
- Securely share its contents with local and international study team members
How to access the binders:
- In REDCap from the Project Setup screen select ‘Online Designer’ followed by selecting ‘Download’ new instrument from library on the Data Collection Instruments screen. Click here for additional instructions.
- Type Regulatory Binder in the search bar and select Import into my REDCap project
- Contact Stanley Estime to obtain access to the Box Template or if you have difficulty accessing REDCap’s eBinder