Elements of an Organized Regulatory Binder Training for Investigators and Research Personnel

What is a 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.” https://catalyst.harvard.edu/services/regbinder/

https://hub.ucsf.edu/regulatory-binder-requirements Good to Know… “The Regulatory Binder is often the first document reviewed during audits and inspections. Not all the essential documents are available at the start of the study. Documents can be grouped into those that are generated before study initiation, those that are generated during trial conduct and those that are generated after study completion. Not all documents have to be filed in one single binder. The Regulatory Binder may sometimes consist of several binders that are stored in the same or different locations. It is important to know where all these documents are located to be able to pull them out when needed in a timely manner. The Regulatory Binder is referred to synonymously as the Study Files, Investigator Files or Investigator Binder.” https://hub.ucsf.edu/regulatory-binder-requirements

The Sections in a Regulatory Binder Protocol Original Amendments Informed Consent Forms (ICF) Assent Form Data Collection Forms used on study Blank Case Report Forms, Data Collection Sheets, Questionnaires

The Sections in a Regulatory Binder Institutional Review Board Correspondence Initial Letter Of Approval Letters of Continuing Review All other outcome letters Correspondence from Ancillary Review Committees IBC, RSC, RDBC Letters of Approval Correspondence from research personnel Meeting minutes Principal investigator correspondence Staff correspondence

The Sections in a Regulatory Binder Staff Qualifications Curriculum Vitaes Medical Licenses Human Subject Protection Training (CITI Training) Specialized training (Ex: IATA, Site Initiation Training…) Delegation of Authority (DOA) Log Contact List IRB Roster and FWA number Lab Certifications CAP CLIA Normal lab range references

The Sections in a Regulatory Binder FDA Required Forms 1572 Financial Disclosure Event Reports Note to File Deviations Serious Averse Events IND Reports Data Safety Monitoring Board (DSMB) Reports Monitor Log Queries Reports

The Sections in a Regulatory Binder Audit Report Subject logs Screening log Enrollment log Randomization log Specimen Tracking Logs Receipts Drug or device accountability records dispensing log shipping and receiving records temperature logs

The Sections in a Regulatory Binder Investigator brochure Device manual Packet insert Sponsor correspondence Registration to CT.gov Close out meeting Final study report

The Sections that Should not be in a Regulatory Binder Subject PHI Signed Informed Consent Forms Completed Case Report Forms Financial Information Contracts Clinical Trial Agreements

Summary A regulatory binder is a compilation of all necessary study documents that are maintained during the course of a study. Regulatory binders are necessary for any clinical study that is being conducted. Not all sections discussed are mandatory, and some of your sections may differ according to your study. Regulatory binders should be updated frequently.

Resources Hand out – Regulatory Binder Checklist Complion - A Regulatory Binder: Creating Your First Regulatory Binder (http://resources.complion.com/032014-a-regulatory-binder-creating- your-first-regulatory-binder-thank-you- page?submissionGuid=6f0cc4fd-a0e8-41a5-8c55-0f2cbf2ee9a0) Clinical Research HUB (UCSF) - https://hub.ucsf.edu/regulatory- binder-requirements Harvard Catalyst - https://catalyst.harvard.edu/docs/regulatory_support/Regulatory_Bind er.pdf National Institute of Health - http://www.nidcr.nih.gov/research/toolkit

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