Standard Operating Procedures

• SM01- Assessing Protocol Feasibility
• SM02- Site Qualification Visit
• SM03- Study Intake Process
• SM11- Regulatory Binder
• SM12- Management of Regulatory Documents- eReg
• SM13- Management of Regulatory Documents
• SM14- IRB Approval
• SM15- Staff Protocol Training
• SM16- DOA Log Combined
• SM17- Site Initiation Visit
• SM31- Recruitment of Subjects
• SM34- Informed Consent

• SM35- General Correspondence
• SM36- Protocol Amendments
• SM37- Release of Information - Monitoring
• SM38- Audits and Inspections
• SM39- Case Report Forms
• SM40- Redacting Source Documents
• SM41- Certified Copies of EMR
• SM42- Adverse Events
• SM44- Review of Laboratory Results
• SM45- Home Health
• SM51- Closeout (Termination) Visit
• SM52- Insufficient Accrual
• SM53- Determining Medication Costs in Clinical Studies

• CO01- Staff Competencies
• CO02- CRC Laboratory Orientation
• CO03- Laboratory Orientation
• CO04- Performing an ECG
• CO05- Monoclonal Antibody Administration
• CO06- Investigational Product Handling
• CO21- Equipment Calibration and Maintenance
• CO22- Eyewash Maintenance
• CO31- Using CRC Space
• CO32- High Containment Space Utilization

• CO33- Scheduling Visits
• CO34- Offsite Work Activities
• CO41- Kit Destruction
• CO42- Allergy Hypersensitivity Management
• CO43- Medication Storage
• CO50- Infection Control
• CO51- Removing Paper Consent from COVID+ Room
• CO52- COVID Equipment Removal

• AD01- Staff Orientation and Training
• AD02- Dress Code
• AD03- Attendance and Leave Requests
• AD05- Key Control
• AD06- Guidelines for Effective Remote Working

• AD07- Travel
• AD08- Professional Development
• AD21- Development and Review of Policies and SOP's
• AD22- Educational Grants from Sponsors
• AD23- Clinical Research Support Fund

• EP01- Medical Emergency (Code Blue)
• EP02- Hazardous Materials
• EP03- Power Outage
• EP04- Essential Staffing

• EP05- External Disaster
• EP06- Fire
• EP07- Severe Weather