Investigator Site File (ISF) Sample Note-to-File
Go Back to DonnaBellas Clinical Research Consulting Home Page
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 | |
| Memo - Location of Confidentiality Disclosure Agreement (CDA) | Word | |
| Memo - Location of electronic CRFs & Queries | Word | |
| Memo - Location of paper CRFs & Queries | Word | |
| Memo - Location of Final Study Report | Word | |
| Memo - Location of Investigation Product (IP) Documents | Word | |
| Memo - Location of Misc Study Manual | Word | |
| Memo - Location of Screening & Enrollment Log | Word | |
| Memo - Location of Subject Identification Log | Word | |
| Memo - Location of Subject Signed Informed Consent Form (ICF) Documents | Word | |
| Memo - Missing Medical License | Word | |
| Memo - Non-Signature on Study Staff Delegation Log | Word | |
| Memo - Template | Word |
This site was created by Donnabellas and is part of LattoArts © DonnaBellas 2005. For questions or more information, please contact info@donnabellas.com with your request.
Learn about DonnaBellas non-profit www.DonnaBellasAngels.org
"Medicine Heals the Body, Art Heals the Soul".