Essential Regulatory Documentation

Purpose Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of Good Clinical Practice and all applicable regulatory requirements. Best Practice Considerations Review ICH […]

Documentation of Study Visit Interventions/Observations

Purpose The purpose of source documentation is to reconstruct the research study as it happened. It should allow for data to be confirmed, validated, and support the fundamental principle of protecting the participant’s rights, safety and well-being. These templates are intended to assist in documenting study procedures, interventions, observations, etc. Below are several examples that […]

Documentation of Informed Consent

Purpose These templates are intended to assist in documenting the consent discussion and process with potential participants. There are many ways to document the informed consent process. Below are several examples that can be customized to meet your specific study needs/requirements (study populations, optional items etc.). Best Practice Considerations Documentation of the consent/assent process should […]

E-Consent Resources

There are e-consent tools available at WUSTL. Before implementing an e-consent process, it must be approved by the IRB for use in your study. REDCap: REDCap E-Consent Template REDCap Workshop Recordings E-Consent Discussion Forum DocuSign: DocuSign DocuSign (21 CFR Part 11-Compliant) DocuSign Resources & Support See the HRPO Research Guide for more guidance on the […]

Protocol Deviation Log

The Protocol Deviation Log (DOC) is intended to capture deviations across participants, allowing researchers to form a summary of overall Protocol Deviations caused by COVID-19.

COVID-19 Protocol Deviation Note to File

The COVID-19 Protocol Deviation Note to File (DOC) is intended to be participant-specific, outlining the deviations that occurred for an individual participant due to COVID-19. A separate Protocol Deviation Note to File should be kept for each affected participant.

COVID-19 Note to File

The COVID-19 Note to File (DOC) is intended to be a global Note to File, kept in a study’s regulatory binder, explaining COVID-19’s impact on the study overall.

Consenting Hospitalized Patients by Phone or Video Conference

Guidance for Consenting Hospitalized Patients by Phone or Video Conference (DOC) Please note this process should only be used for studies requiring written consent for hospitalized patients by phone or video conference for clinical trials while on isolation for confirmed or suspected COVID-19. This modified consent process must be reviewed and approved by the IRB prior to […]

Documentation of Written Informed Consent

For studies requiring written consent, the COVID-19 Documentation of Written Informed Consent (DOC) includes processes for when direct communications with participants is not feasible or safe due to COVID-19.