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Category: Forms and Templates
PHS 398 Checklist
Download the PHS 398 Checklist.
Running Note
Investigators and coordinators have found a running note to be an effective way to document interactions with participants. This document should be an ongoing record that is signed and dated as each entry is made. Items noted on this type of document are phone call conversations, items to watch for during the next study visit, […]
Study Visit Source Document
Download the Study Visit Source Document (DOC).
Phone Screen Checklist
Download the Phone Screen Checklist (DOC).
Follow-up Phone Call
Download the Follow-up Phone Call Documentation (DOC)
First Dose Documentation
Download the First Dose Documentation (DOC).
End of Study/Early Termination Visit Source Document
Download the End of Study/Early Termination Visit Source Document (DOC).
Specimen Collection Log
Download the Specimen Collection Log (DOC).
Department Signature Sheet
This type of document is typically used to capture all faculty, staff, and students who are engaged in research. This document should be signed as part of the onboarding process. Typically, this document is filed at the departmental level and referenced in a Note to File in each regulatory binder. Download the Department Signature Sheet […]