Clinical Research SOPs
- SOP 1: Preparation, Maintenance, Revision and Training
- SOP 2: Research Team Responsibilities
- SOP 3: Regulatory Binder and Study File Maintenance
- SOP 4: Interactions with IRB
- SOP 5: Case Report Form Query Resolution
- SOP 6: Source Documentation
- SOP 7: Maintenance of Equipment
- SOP 8: Specimen Collection and Handling
- SOP 9: Reporting Events
- SOP 10: Sponsor Monitoring Visits
- SOP 11: Drug and Device Accountability
- SOP 12: Subject Recruitment
- SOP 13: Informed Consent
- SOP 14: FDA Audit
- SOP 15: Training
- SOP 16: Florence e-Consent
- SOP 17: Protocol Registration and Results System
- SOP 18: Long-Term Storage
- SOP 19: Subject Screening and Enrollment
- SOP 20: Use of Florence for Electronic Records and Electronic Signatures
- SOP 21: Onboarding and Training 3rd Party Individuals
- SOP 22: Cosmos Access
- SOP 23: OnCore (Coming Soon)
- SOP 24: Electronic Regulatory Records
- SOP 25: Epic Research Billing Review
Guidance Documents
- Clinical Research
- GW COVID-19 Specimen
- HIPAA Waiver
- Identification Code List
- Pre-Site Selection
- Study Start-up and Close-out
- Florence e-Consent
- Florence Monitor
- EPIC Onsite Research Monitoring
- Subject Injury Language
- GWU/MFA Internal Monitoring Manual
- Document an IRB Review
- Adding a Consent to an IRB Review