Template Language and General Guidance

Study Closure Submission Process Guidance

VUMC Template Language for Sponsor Consents

HRPP Guidance Eligibility Assessment Prior to Consent

Screening/Tracking Patients for EHR-based Research Recruitment  & Guidance for Initial Patient Contact  tip sheet is available on StarBRITE

We recommend using the extensive database of template language published by The National Comprehensive Cancer Network (NCCN) for developing your consent form language.

Access the Database

Research Study Compliance Assessment Tool

This compliance assessment tool is a self-assessment tool to assist principal investigators and their study teams with conducting a self-audit of their study, along with preparing for a directed audit and/or post-approval monitoring review.  This document is intended as a tool for the research community for the purpose of reviewing their study.  This compliance assessment tool will not be reviewed by the IRB unless the study team chooses to submit with continuing review.

Documentation of Informed Consent Process Tool

This tool was developed to assist study teams to meet the requirements for IRB Policy IV.B. which includes a process for documentation of informed consent process that is outside of the signing of the consent document. This tool is available for use with any study and can be printed for your study document/regulatory binder or kept electronically.