Page 498 - 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
• DSMB
Not Applicable
Not Applicable
Approval Letter
Reports
Other_____________________________
________
________
• Manuals
Not Applicable
Not Applicable
Manual of Procedures/Manual of
Operations
IVRS system information manuals
Electronic Database information manuals
Other_____________________________
________
________
• Study Documents
Not Applicable
Not Applicable
Blank Source
Blank CRFs
Blank Questionnaires
Other_____________________________
________
________
• Correspondence
Not Applicable
Not Applicable
Newsletters
Memo
Note to File
E-mails
Other_____________________________
________
________
• Safety
Not Applicable
Not Applicable
Blank Serious Adverse Event Forms
Safety Logs
o SafetyReports
o MedWatch
Other_____________________________
________
________
• Finance/Budget
Not Applicable
Not Applicable
Clinical Trial Agreement
Office of Sponsored Programs
Communication
Performance Site Approval (PSA)
Contract
Grant
Sub-Agreement
Agreement Renewals
Other_____________________________
________
________
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