Part 11 of the Code of Federal Regulations (CFR) contains the Food & Drug Administration’s (FDA) rules and regulations pertaining to electronic records and electronic signatures. 21 CFR Part 11 defines the criteria for which systems and processes are trustworthy, secure, and reliable for electronic records and signatures. Below you will find WashU resources on […]
Compliance Trainings Below are the major compliance trainings required for the research community. Most mandatory trainings are assigned in Learn@Work based on HR data or by the completion of the Compliance Profile. All members of the research community are encouraged to complete the compliance profile at the start of a new position or when job […]
Includes secure content requiring login to view.
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 Templates Monitoring/Auditing […]
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 […]
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 […]
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: DocuSign: See the HRPO Research Guide for more guidance on the use of e-consent.
The Human Research Protection Office (HRPO) offers Guidance for human studies research, including policies and guidance materials. These resource include HRPO’s 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 […]
E-Consent Discussion Forum
DocuSign Resources & Support