Page 497 - eBook Version 8 Book 1 of 2 JUL 2022

Study Binder Template
Divider Section
Definition
Located in Storage Binder Number
Located in Storage Box Number
• IRB
Not Applicable
Not Applicable
Initial Approval Letter
Federal Wide Assurance Letter
CR
MODs
COC
Reportable Events
Radiation Safety approval letter
Certificate of Confidentiality
Other_____________________________
________
________
• Study Personnel
Not Applicable
Not Applicable
1572
1571
Delegation Log
Trainings
CVs
Licenses
Financial Disclosure
Other_____________________________
________
________
• Pharmacy
Not Applicable
Not Applicable
CV of Pharmacist
License
Temp Logs
Not Applicable
Investigator’s Brochure
o Investigator Brochure Signature Page
o Investigator Brochure
o Other________________________
Package Inserts
Other_____________________________

• Laboratory
Not Applicable
Not Applicable
Central Laboratory Information
Repository Information
Certificates/ Accreditation
CV of Lab director
License
Laboratory Manual
Reference Ranges
Temperature Logs
Shipping Logs
Blank CMC Requisition Forms
Other_____________________________
________
________
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