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 […]
Author: Danica
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 […]
NIH – Requirements for Disclosure of Other Support, Foreign Components and Conflicts of Interest
NIH – Requirements for Disclosure of Other Support, Foreign Components and Conflicts of Interest
NIH – Pre-award and Post-award Disclosures Table Relating to the Biographical Sketch and Other Support (PDF)
NIH: Pre-award and Post-award Disclosures Relating to the Biographical Sketch and Other Support
NIH – Other Support and Foreign Components FAQs
NIH: Other Support and Foreign Components – FAQs
NSF – Frequently Asked Questions: Current and Pending (Other) Support
February 2023
NSF – Pre- and Post-award Disclosures Relating to the Biographical Sketch and Current and Pending (Other) Support
NSPM-33 Implementation Guidance
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: DocuSign: See the HRPO Research Guide for more guidance on the use of e-consent.
HRPO Policies, Procedures, & Guidance
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 WashU 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 […]