Observation and investigation (including, but not limited to clinical and social/behavioral research) using human participants is subject to a variety of regulation and policies. Several offices at Washington University have oversight in the human research area. Other offices offer services and assistance in the performance of this research. All human research is subject to review and approval by the Institutional Review Board, which works closely with the Human Research Protection Office.
Human Subjects Research
Policies, Procedures and Guidelines
- Certificates of Confidentiality (CoCs)
- Clinical Trials Registration and Informed Consent Posting Guideline
- Clinicaltrials.gov Registration and Results Disclosure Policy
- Electronic Storage of Human Research Study Documents
- External Audits, Inquiries, Inspections & Unannounced Visits
- FDA Part 11 Certification
- Good Clinical Practice Policy
- Guidance for Disposal of Drugs Used in Clinical Research
- HRPO Policies, Procedures, & Guidance
- Human Subjects Education Policy
- ICH-GCP E6(R2) Guidelines
- Individual Participant Data (IPD) Sharing Statement
- Institutional Review Board Membership Letter
- Institutional Statement of Commitment to the Protection of Human Participants in Research
- Investigational Drug/Device Accountability Policy
- Monitoring Guidance and FAQs
- OnCore Standard Operating Procedures
- Part 11 Compliance – Electronic Records & Signatures
- Reporting Results on Clinicaltrials.gov
- Use of Legally Authorized Representatives
Procedures
Washington University School of Medicine Policies
How-Tos
- Bookmark and Password Protect Scanned Informed Consent Documents
- Create a REDCap E-Consent
- Determine if Your Trial Needs to Be Registered on Clinicaltrials.gov
- Donate a Body
- Include Informed Consent Document Language for Registered Clinical Trials
- Participate in Research Studies
- Prepare for an Audit
- Register a Trial on Clinicaltrials.gov
Systems and Tools
Forms and Templates
- Certification of Review of Electronic Files Research Consent Documents
- Certification of Review of Electronic Files Research Study Documents
- E-Consent Resources
- FDA Audit Checklist
- NIH Toolkit for Clinical Researchers
- Protocol Templates for Clinical Trials (NIH Templates for both biomedical and behavioral & social sciences research involving human subjects)
- Self-Audit Toolkit
COVID-19
- Consenting Hospitalized Patients by Phone or Video Conference
- COVID-19 Note to File
- COVID-19 Protocol Deviation Note to File
- Documentation of Verbal Consent with LAR-PG
- Documentation of Informed Consent with COVID-19 Patients – Impartial Witness
- Documentation of Verbal Consent
- Documentation of Written Informed Consent
- Protocol Deviation Log
Source Documents
- Documentation of Informed Consent
- Documentation of Study Visit Interventions/Observations
- Essential Regulatory Documentation
Standard Operating Procedure (SOP) Templates
- Calibration and Maintenance of Site Equipment
- Curriculum Vitae
- Informed Consent Process and Documentation
- IRB Approval
- Management of Source Documents and Case Report Forms
- Patient Recruitment
- Preparation and Handling of Laboratory Samples
- Reporting Unanticipated Problems, SAEs, and Adverse Drug/Device Events
- Sponsor CRO Audit
- Study Termination Visit
- Training
Training Documentation
Offices and Committees
Education and Training
- Accelerating Clinical Coordinator Excellence (ACCE) Program
- CITI Program- Human Subjects and GCP Training
- Clinical Research Coordinator Orientation Manual
- DocuSign Resources & Support
- E-Consent Discussion Forum
- Good Clinical Practice (GCP) Certification
- HRPO Education
- Human Subjects Education and GCP Training Requirements Diagram
- ICTS Clinical Research Training Center
- Necessary Elements in the Fundamentals of Human Subjects Research
- OnCore Training
- REDCap Workshops
- Research Coordinator Brown Bag Series
- Trainings for Researchers