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The Standard Operating Procedures (SOPs) in this library have been established to ensure consistency and compliance with Federal & State regulations, institutional policies, and Good Clinical Practice guidelines that are common to clinical research of all types. By standardizing these SOPs, we are aligning our clinical research activities across campus with the 1U4U vision.

The University of Utah Clinical Research SOP Collaboration Group (CRCG) has created the following Standard Operating Procedures to be used by all individuals participating in clinical research at the University of Utah.
These should be utilized to enhance research quality, efficiency, data reliability and patient safety. Although diversity in trial design, study sponsor, therapeutic area, investigator and coordinator experience, etc. may require unique approaches to specific clinical studies, the establishment and adherence to SOPs helps to ensure compliance with the applicable regulations, policies, and Good Clinical Practice guidelines that are common to clinical research of all types. Please check with your group regarding supplemental working guidelines and/or additional SOPs that may be established for your department/study processes.
In accordance with the CRCG Bylaws, group membership is comprised of qualified and experienced clinical research professionals working in compliance-related roles at the University of Utah. Members are appointed by the Director of the Office of Quality Compliance. Please refer to the links above to review CRCG membership, elected officers, and group bylaws.
 

The SOPs in this library define clinical research and clinical trial as:

 
CLINICAL RESEARCH (CR): Clinical research includes all research involving human participants. It does not include secondary studies using existing biological specimens or data collected without identifiers or data that are publicly available.
  CLINICAL TRIAL (CT): Clinical trials are clinical research studies involving human participants assigned to an intervention in which the study is designed to evaluate the effect(s) of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome.
Please note, clinical research that does not fall under the definition of a clinical trial may choose to follow these SOPs as a way to ensure protocol compliance, data quality and meet good clinical practice.

 

 

Standard Operating Procedure Library 


  1. STANDARD OPERATING PROCEDURE PROCESS
  2. FDA INSPECTIONS
  3. PROTOCOL TRAINING FOR INVESTIGATORS AND STUDY STAFF
  4. INVESTIGATOR RESPONSIBILITIES
  5. DELEGATION OF AUTHORITY
  6. STUDY RECORDS MANAGEMENT
  7. STUDY RECORDS MANAGEMENT SUPPLEMENT A
  8. DEVIATIONS: DOCUMENTATION AND REPORTING
  9. OBTAINING WRITTEN INFORMED CONSENT
  10. CASE REPORT FORM COMPLETION STANDARD
  11. MONITORING VISITS FOR EXTERNALLY SPONSORED CLINICAL TRIALS
  12. Investigational New Drug Applications in FDA-Regulated Research
  13. Investigational Device Exemption Applications in FDA-Regulated Research
  14. CLINICAL RESEARCH INSTITUTIONAL FEE SCHEDULE
  15. CLINICAL RESEARCH INSTITUTIONAL FEE SCHEDULE SUPPLEMENT A – COST STRUCTURE RATIONALE
  16. Clinical Trial Safety Assessment and Reporting
Last Updated: 1/16/24