Regulatory Binder

BU/BMC Clinical Research Study Regulatory Binder Templates

The templates below are provided for use in your Regulatory binder, as necessary per your study requirements. These are designed as “forms” in MS Word so that you may enter some information such as study name, ID and PI in the header before printing out hard copy pages for use in your binder/files so that pages can be easily identified.

Customizing templates: If you decide to modify the templates further than filling in the form blanks, you will have to unprotect the document. In MS Word 2003, click “Tools” in the main menu and then click “unprotect document” (there is no password). In MS Word 2007, click the “Review” tab, then click “protect document,” then click “restrict formatting and edits,” and at the bottom of the screen click “stop protection.”

Study Identification (cover page)
Essential Documents Location Log (cover page)
Communications Log (Tabs 1, 6, 7, 8, 14, 15)
IRB Submission Tracking Log (Tab 1)
Deviation/Exception Submission Log (Tab 1)
DSMP Template (Tab 2)
Screening/Enrollment Log (Tab 5)
Study Participant Withdrawal/Termination Log (Tab 5)
Internal AE/UP Report Tracking Log (Tab 6)
Internal AE/UP Report Tracking Log – MS Excel version
Safety Report Tracking Log (Tab 6)
Safety Report Tracking Log – MS Excel version
Site Visit Log
(Tab 7)
Phone Call Summary Report (Tab 8)
Study-Related SOPs (Tab 9)
Task Delegation/Signature Log (Tab 10)
Staff Member Training Log (Tab 10)
Staff Training Log for Groups (Tab 10)
Staff License/Certification Log (Tab 10)
Stored Biosample Log (Tab 11)
Test Article Accountability (Tab 12)
Test Article Disposition and/or Return to Sponsor (Tab 12)
Test Article Shipping Receipt Log (Tab 12)