Subgrouping: Source Documents

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 […]

Documentation of Informed Consent

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 […]

Action Form

This type of form is often used to document an event that requires an action (unscheduled visit, lab re-draw, appointment scheduling, etc.) Download the Action Form (PDF).

Receipt Log

Download the study drug/device shipment receipt log.