Page 496 - 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
• Contacts
Not Applicable
Not Applicable
Sponsor contact information,
CRO Contact information,
Site (Third Party) Contact List,
Other_____________________________
________
________
• Site Monitor Visit Log Not Applicable
Not Applicable
Confirmation of Visit Letter
Monitor Reports
________
________
• Subject Information Not Applicable
Not Applicable
Subject Screening Log
Subject Enrollment Log
Immediately Reportable Adverse Event Log
or Equivalent
Blank subject ID or safety card
Other_____________________________
________
________
• IRB Documents
Not Applicable
Not Applicable
Consents
o English o Spanish o other
HIPAA
o English
o Spanish
o other
Approved subject study materials and
information sheets o English
o Spanish
o other
Advertisements
Confidential Disclosure Form
Protocol
o Protocol/Amendment Signature Page
o Protocols
o Protocol Deviations o Protocol Violations
Other_____________________________
________
________
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