eRegulatory Binder at Penn State
“Regulatory binders” are used to organize and maintain research study documentation. Although study teams at Penn State have the CATS IRB system to track their IRB protocols and documentation related to human subjects research, CATS IRB is not intended to store all regulatory documentation. Regulatory binders are intended to store all regulatory documentation, such as FDA regulations and documentation guidelines for good clinical practice (GCP). Having a regulatory binder can help any researcher meet regulatory requirements and establish a high standard of record-keeping for human subjects research.
A binder can help basic science and clinical researchers
- Create a longitudinal archive of the study
- Maintain regulatory compliance
- Promote transparency
- Promote accountability
- Document safety monitoring
Penn State offers both a single-site and multi-site Electronic Regulatory (eReg) Binder template for investigators. The eReg Binder is a RedCap project that can be customized to meet the researcher’s needs.
Both eReg Binders include
- Data collection instruments that capture required regulatory information similar to what is generally captured in paper binders
- Branching logic that identifies and collects study specific regulatory information
- A report builder for developing site-specific reports
- 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
Accessing the eReg Binder
To download the eReg Binder files below, you must have a Penn State WebAccess account. Researchers at the College of Medicine should email eReg@phs.psu.edu for access to the files.
You must also have access to RedCap. Go to https://redcap.ctsi.psu.edu/ to learn about obtaining a RedCap account.
With WebAccess and RedCap accounts, you can download either the single-site or multi-site eReg Binder XML file below, create a new project in RedCap, upload the XML file as the template for the project, and customize the template to fit your study needs.
Download the Single-Site eReg Binder XML file
Download the Multi-Site eReg Binder XML file
eReg Binder Support
At the College of Medicine, the Public Health Sciences Data Management Unit and the Research Quality Assurance program provide support for the eReg Binder. Contact them at eReg@phs.psu.edu for questions or to request the eReg Binder manual.
At the other colleges and campuses, the Office for Research Protections Quality Management Program and the Survey Research Center provide support for the eReg Binder. Contact us at orp-qm@psu.edu for questions and download the eReg Binder manual below.