REGULATORY BINDER CHECKLIST
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Regulatory Binder Checklist
Protocol and Amendments (all versions)
Investigator Brochure (all versions)
Case Report Forms (all versions; typically a blank set of CRFs that can be duplicated)
Completed and signed FDA 1572 Forms for each investigator
Curricula Vitaes (CVs) and documentation of professional licensure of all investigators and research team members where appropriate
Completed Financial Disclosure Forms for research team members

IRB approval documentation for:

The protocol
Protocol amendments
Original informed consent form
Revised informed consent forms
Other written (educational) materials provided to the patients
Amended versions of the consent form
Continuation of the study (based on annual or periodic reviews)
Advertising for study recruitment

IRB Correspondence

Notification of new safety information and the IRB's recommendations pertaining to this information
IRB roster and credentials of IRB members

Informed Consent

Original copies of versions approved by the IRB.

NOTE: Original signed patient informed consents are usually kept in the patient's medical records or research records and not in the Regulatory Binder.
Correspondence with the CTSU and Cooperative Group
Serious Adverse Events and IND Safety Reports
Signature Log (Site Personnel Signature Sheet)

NOTE: This is a list of the signatures and initials of all persons authorized to make entries and/or corrections on CRFs.
Patient Identification List

NOTE: This is a confidential list of the names of all patients with their study Group assigned identification number. It is maintained only at the site and allows the investigator or institution to quickly identify study patients in the case of an emergency.
Patient Screening Log/Registration Log

NOTE: This documents the chronological screening and enrollment of subjects, as well as the reasons for screen-failures.

Clinical Laboratory Certification through the Clinical Laboratory Improvement Amendments (CLIA)
Study Drug Documentation
Drug Shipment and Receipt Records/Forms
Accountability Logs
NCI Drug Accountability Record Forms (DARFs)

NOTE: Study drug documentation may be kept, depending on the drug or agent and how it is dispensed, in the pharmacy binder and a copy in the Regulatory Binder.
Randomization Code from Cooperative Group and sent by CTSU.
Study Closeout Information, when applicable.
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