- A set of binder tabs to organize and maintain research study documentation
- A checklist/guideline for what records to keep
- Helps study sites achieve and maintain regulatory compliance
|A template for maintaining regulatory documentation in human subjects research.||Regulatory Binder|
The Regulatory Binder is a template and guidance document for tracking documentation associated with studies involving human subjects. It is designed to help study sites achieve and maintain regulatory compliance and adhere to high standards of practice in the conduct of research involving human subjects.
The binder is divided into several sections, each of which outlines regulatory documentation requirements, general guidance for organization and record keeping, and, when applicable, references to federal regulations and Good Clinical Practice guidelines.
Each Harvard Catalyst-affiliated institution may have additional regulatory requirements or guidance not covered by the materials in the binder. Investigators are encouraged to contact their institutional Quality Assurance/Quality Improvement (QA/QI) office for details.
The eReg Binder is a REDCap project developed by the Partners Human Research Quality Improvement (QI) Program and Enterprise Research Infrastructure & Services (ERIS). The eReg Binder assists sites with the electronic storage and maintenance of regulatory documents for IRB-approved protocols. The eReg Binder is available through the REDCap consortium.