1.2 Signature and Delegation of Duties Documents to be filed in this Section include: Log • Signature and Delegation of Duties Log – Completed and signed by all site staff assigned/involved with the study and signed and dated by the site Principal Investigator. [...] 9.2 Site Initiation Follow Up Letter Documents to be filed in this Section include: • Site Initiation Follow-Up Letter to Site 9.3 Site Activation Documentation/Letter Documents to be filed in this Section include: • Official Notification of Site Activation Letter Page 7 of 15 MCTC011 Investigator Site File (ISF) Essential Document Filing Guidance V 2.0 Published 10.0 Site Training 1. [...] 15.4 Monitoring Visit Correspondence Documents to be filed in this Section include: including feedback to site including • Monitoring Visit Confirmation Letters Correspondence • Monitoring Visit Follow Up Letters 15.5 Trial Close-Out Documents to be filed in this Section include: - Including Correspondence • Trial Close-Out Report, if applicable • Trial Close-Out Letter • Investigator Agreement to. [...] 16.7 Related Correspondence Documents to be filed in this Section include: • All significant correspondence relating to the storage of Biospecimen Research aspects of the study, from the site to the Sponsor. [...] Note: In the Comments column of the ISF Table of Contents write “All IMP related activities have been delegated by Sponsor to Central Pharmacy or Site Pharmacy – documents located within the Central or Site Pharmacy folder.” 22.6 Related Correspondence Documents to be filed in this Section include: • All significant correspondence relating to the Investigational Product/s, to and from the Sponsor.
Authors
- Pages
- 15
- Published in
- Australia
