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 (IRB) Policies
- 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
- 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
- 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 (Participant Files)
- 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
- Action Form
- Adverse Event Example Template
- Adverse Event Tracking Log
- Audit Monitoring – Site Information Audit Prep Checklist
- Audit Monitoring Review Sheet
- Census Data Demographics CRF
- Concurrent Medications CRF
- Concurrent Medications Sheet Examples
- Correspondence (Research Team/Participant)
- Daily Temperature Log
- Delegation of Authority Log
- Demographics CRF
- Department Signature Sheet
- Deviation Log
- Device Dispensing Log
- Documentation of Informed Consent
- Drug Dispensing Log
- Eligibility Checklist (Inclusion/Exclusion Criteria)
- End of Study Checklist
- End of Study/Early Termination Visit Source Document
- First Dose Documentation
- Follow-up Phone Call
- IND Annual Report Template
- Internal Budget Template
- IRB-FDA Tracking
- LAR (Legally Authorized Representative) Consent Note to File
- Medical History
- Meeting Communication Record
- Monitoring Visits
- Note to File Examples
- On-Site Monitoring Visit Agenda Checklist
- Phone Screen Checklist
- Physical Exam Form Examples
- PI Delegation Log
- Post-Monitoring Visit Letter Attachment
- Protocol Deviation Form
- Protocol Feasibility Checklist
- Protocol Outline (General)
- Receipt Log
- Regulatory Binder Templates
- Regulatory Document Tracker
- Regulatory Document Tracking Form
- Regulatory File Checklist
- Running Note
- Screening, Enrollment, and Master Log
- Site Closure
- Site Preparation Checklist (Pre-Study Visit)
- Site Staff Roles & Responsibilities
- Specimen Collection Log
- Specimen Shipping Log
- Stage of Study Log
- Study Budget Example
- Study Device Accountability Log
- Study Drug Accountability Log
- Study Personnel Log
- Study Team Contact Log
- Study Visit Source Document
- Subject Contact Information
- Subject Participation Tracking
- Telephone Call Log
- Telephone Communication Record
- Trial Initiation Meeting Agenda
- Trial Initiation Report
- Urine Pregnancy Test Record
- Vital Signs CRF Examples
- Vital Signs Height/Weight
- Weekly Protocol Meeting Notes
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