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 […]

HRPO Policies, Procedures, & Guidance

HRPO’s Research Toolkit is a central page to access their Research Guide and Washington University IRB Policies, and additional resources. The HRPO Digital Commons hosts educational resources such as publications, presentations, and podcasts related to human subjects research and human research protections. The HRPO Help Services page provides information on contacting HRPO using the SWAT! […]

Office of Information Security

The Office of Information Security works with researchers, offering tools, services, and guidance to protect research, meet regulatory requirements, and ensure the confidentiality, integrity, and availability of data.