Investigator Site File (ISF) Sample Note-to-File

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The following table contains sample memos for your regulatory binder to help ensure compliance with Good Clinical Practices (GCPs). These memos are meant as reference only. To ensure compliance, please verify whether they will be acceptable per the study Sponsor.

The memos are available in Word (so you can customize) and Adobe PDF (immediate print and use.)

Memo - Location of Clinical Study Agreement (CSA) Word PDF
Memo - Location of Confidentiality Disclosure Agreement (CDA) Word PDF
Memo - Location of electronic CRFs & Queries Word PDF
Memo - Location of paper CRFs & Queries Word PDF
Memo - Location of Final Study Report Word PDF
Memo - Location of Investigation Product (IP) Documents Word PDF
Memo - Location of Misc Study Manual Word PDF
Memo - Location of Screening & Enrollment Log Word PDF
Memo - Location of Subject Identification Log Word PDF
Memo - Location of Subject Signed Informed Consent Form (ICF) Documents Word PDF
Memo - Missing Medical License Word PDF
Memo - Non-Signature on Study Staff Delegation Log Word PDF
Memo - Template Word PDF
     

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