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 (SOPs) 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.
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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. |
Standard Operating Procedure Library
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STANDARD OPERATING PROCEDURE PROCESS
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FDA INSPECTIONS
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PROTOCOL TRAINING FOR INVESTIGATORS AND STUDY STAFF
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INVESTIGATOR RESPONSIBILITIES
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DELEGATION OF AUTHORITY
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STUDY RECORDS MANAGEMENT
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STUDY RECORDS MANAGEMENT SUPPLEMENT A
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DEVIATIONS: DOCUMENTATION AND REPORTING
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OBTAINING WRITTEN INFORMED CONSENT
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CASE REPORT FORM COMPLETION STANDARD
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MONITORING VISITS FOR EXTERNALLY SPONSORED CLINICAL TRIALS
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Investigational New Drug Applications in FDA-Regulated Research
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Investigational Device Exemption Applications in FDA-Regulated Research
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CLINICAL RESEARCH INSTITUTIONAL FEE SCHEDULE
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CLINICAL RESEARCH INSTITUTIONAL FEE SCHEDULE SUPPLEMENT A – COST STRUCTURE RATIONALE
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Clinical Trial Safety Assessment and Reporting