Clinical Research Center Standard Operating Procedures
Below are the Standard Operating Procedures of the Clinical Research Center. They are categorized into 4 sections, Study Management, Clinical Operations, Administrative, and Emergency Preparedness. You may edit and adapt for your department.
Study Management
- 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 Combinded
- 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
Clinical Operations
- CO01- Staff Competencies
- CO02- CRC Laboratory Orientation
- CO03- Laboratory Orientation
- CO04- Performing an ECG
- CO05- Monoclonal Antibody Admisitration
- 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
Administrative
- 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