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Clinical Research
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Standard Operating Procedures
Standard Operating Procedures
Below are the standard operating procedures of UNMC's clinical research program. They are categorized into four sections, study management, clinical operations, administrative, and emergency preparedness. Feel free to 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 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
Clinical Operations
- 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
Administrative
Privacy & Information Security
Privacy deals with protected health information, how we use it and disclose it, and patients' rights. You must report all suspected privacy and information security violations to the contacts below.
Deb Bishop
Privacy Officer
402-559-5136
Lisa Bazis
Information Security Officer
402-559-2882
Policies & Procedures
Find a complete catalog of UNMC and Nebraska Medicine policies.