Essential Documents Binder

UF Regulatory Binder Template

Section 1: IRB Correspondence

This section should contain your IRB correspondence and approvals for the study. To be sure your file is complete, you may want to check it against the IRB file to assure completeness.

1. IRB Submission Tracking Log

This log can be used to track submissions to the IRB, including the document name, dated submitted, date of IRB action, and necessary follow-up activity.

1. IRB Membership List
2. IRB Correspondence and Notifications

Maintain IRB correspondence and notifications in reverse chronological, with the most recent approvals on top.

Section 2: Study Protocol

This section should contain all versions of the complete protocol (with appendices) that have been submitted and approved by the Study Sponsor, IRB, etc. All revised versions of the study protocol should have a version number or revision date to identify the most recent version of the protocol.

Place all currently used/revised and approved forms in the binder

Section 4: Investigator Brochure

If Applicable.

Section 5: Consent Forms/ Information for Patients/Recruitment Materials

Place the currently approved consent form in the front of this section. Place dividers between this and older, out-dated consent form versions (only put old versions which were actually used to enroll patients).

Place any IRB-approved brochures, checklists, recruitment materials or other information given to subjects in this section. Be sure that all of this information has been APPROVED BY YOUR IRB.

Section 6: Subject Log

Maintain the Cumulative Adverse Event Table, SAEs with IRB notification and response, and Safety reports with IRB Notification and Response in this section.

Section 8: Site-Sponsor Correspondence

File any letters/memos/correspondence sent to the Sponsor from the Site or vice-versa.

Section 9: Other Correspondence/Notes-to-File

File correspondence from other sources and notes to file that have been generated to clarify study related deviations or occurrences in this section.

Notes-to-file can be generated to address general study-related or subject-specific issues. Subject specific notes can be maintained in the individual research file.

Section 10: Telephone/Communications Log

E-mail correspondence or phone log interactions should be documented and maintained with study documentation.

Section 11: Delegation of Study Responsibilities

Formal Delegation of Study Responsibilities should be documented and signed by the Principal Investigator for the study and maintained with study specific documentation.

For each person on your study team, you should maintain copies of current licenses, curriculum vitae or resume, Mandatory Training certificates (e.g. certificate of completion of mandatory NIH training for the Protection of Human Subjects). Be sure to include any study specific training required by the Study Sponsor, including site initiation visits etc.

Section 12: Investigational Product Accountability

If Applicable. Documentation may indicate that this information is maintained by the Investigational Drug Pharmacy if applicable.

Section 13: Laboratory Certifications

If Applicable. Include Lab Certifications (CLIA/CLEP and Lab Normals that are pertinent to your study assessments.