Download the PHS 398 Checklist.
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, […]
Download the Study Visit Source Document (DOC).
Download the Phone Screen Checklist (DOC).
Download the Follow-up Phone Call Documentation (DOC)
Download the First Dose Documentation (DOC).
Download the End of Study/Early Termination Visit Source Document (DOC).
Download the Specimen Collection Log (DOC).
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 […]
There are many ways to document the informed consent process. Below are several examples that can be modified to apply to your consent process, study population, and any optional items included in your consent document. Documentation of Informed Consent (DOC) Documentation of Informed consent 2 (DOC) Documentation of Informed Consent verbal and written (DOC) Documentation […]