About the Clinical Research SOP Library
The Clinical Research Standard Operating Procedures (SOPs) provide a unified framework to support high‑quality, compliant research across the University of Utah. These campus‑wide SOPs promote consistency, strengthen regulatory alignment, and enhance the safety and integrity of clinical research activities.
The University of Utah Clinical Research SOP Collaboration Group (CRCG) has created these Standard Operating Procedures to be used by all individuals participating in clinical research at the University of Utah.
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STANDARD OPERATING PROCEDURE PROCESS
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FDA INSPECTIONS
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FDA INSPECTIONS SUPPLEMENT A
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FDA INSPECTIONS SUPPLEMENT B
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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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DEVIATIONS: DOCUMENTATION AND REPORTING – SUPPLEMENT A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) PLANS
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OBTAINING WRITTEN INFORMED CONSENT
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OBTAINING WRITTEN INFORMED CONSENT SUPPLEMENT A - REMOTE 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
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internal monitoring of university of utah clinical studies
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FORM FDA 1572
These SOPs 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.
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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.
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Standard Operating Procedure Library
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STANDARD OPERATING PROCEDURE PROCESS
-
FDA INSPECTIONS
-
FDA INSPECTIONS SUPPLEMENT A
-
FDA INSPECTIONS SUPPLEMENT B
-
PROTOCOL TRAINING FOR INVESTIGATORS AND STUDY STAFF
-
INVESTIGATOR RESPONSIBILITIES
-
DELEGATION OF AUTHORITY
-
STUDY RECORDS MANAGEMENT
-
STUDY RECORDS MANAGEMENT SUPPLEMENT A
-
DEVIATIONS: DOCUMENTATION AND REPORTING
-
DEVIATIONS: DOCUMENTATION AND REPORTING – SUPPLEMENT A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) PLANS
-
OBTAINING WRITTEN INFORMED CONSENT
-
OBTAINING WRITTEN INFORMED CONSENT SUPPLEMENT A - REMOTE CONSENT
-
CASE REPORT FORM COMPLETION STANDARD
-
MONITORING VISITS FOR EXTERNALLY SPONSORED CLINICAL TRIALS
-
Investigational New Drug Applications in FDA-Regulated Research
-
Investigational Device Exemption Applications in FDA-Regulated Research
-
CLINICAL RESEARCH INSTITUTIONAL FEE SCHEDULE
-
CLINICAL RESEARCH INSTITUTIONAL FEE SCHEDULE SUPPLEMENT A – COST STRUCTURE RATIONALE
-
Clinical Trial Safety Assessment and Reporting
-
internal monitoring of university of utah clinical studies
-
FORM FDA 1572
This library of Standard Operating Procedures is a resource for anyone conducting clinical research at the University of Utah as applicable to the research being done.
As a research institution, the University of Utah must comply with laws, policies and regulations established by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), the International Conference on Harmonization guidelines (ICH), and the State of Utah.
Our University clinical research SOPs define processes in-line with the laws, policies and regulations governing human subject research and should be utilized by all personnel conducting such research at the University of Utah.
In an effort to standardize all clinical research efforts at the University, and to align with the 1U initiative, the Office of Quality Compliance highly promotes the utilization of these SOPs. However, if additional details or processes specific to individual departments/divisions need to be followed, Working Guidelines should be developed as a supplement to the SOPs in this library.
Departmental leadership or their delegates should develop these Working Guidelines for use by the individual departments/divisions. Any department/divisional Working Guidelines should not conflict with the SOPs in this library and should follow the same basic principles and standards.
Any SOPs that are of the same topic and similar process should be retired and the University SOP should be implemented. Each group is encouraged to create supplemental working guidelines as needed to further direct their department/study processes.
Every effort should be made to adhere to the processes outlined in these SOPs. If an exception to an SOP is needed, the department should clearly document, in writing, what part of the SOP cannot be adhered to and an alternative process that will be followed.
An SOP is the chief document to describe what is to be done for a given procedure, who is responsible for doing it, and when it is to be performed. If instructions on how to perform the procedure are relatively simple, they may be included in the SOP.
However, if the steps are especially detailed or change depending on department practices then a separate, department-specific Guidance Document/WPD should be created to describe the full details.
A Guidance or Work Practice Document is a supportive document that describes in detail how a specific procedure is to be performed or suggest direction on operational processes and workflows. Refer to UU SOP-01, Sections “Definitions and Acronyms”, 1.1. and 2.2.
You can continue to utilize your other SOPs as long as they do not contain contradicting processes to the SOPs in this library.
Training and documentation of training should be carried out by the individual departments as part of their current training plan.
Optional Resources
- If you need an example of a general training log, please see this link.
- A certificate to document review of each SOP can be obtained here.
The Office of Quality Compliance may conduct periodic audits to identify areas where researchers may need additional training, or to alert the office of any SOPs that should be created or amended.
Please submit any questions or comments and someone from the SOP Collaboration Team will contact you within 2-3 business days.
Clinical Research SOP Development Process
1 SOP needs are identified by the following methods:
• Request from University employee (either by email to crcg@utah.edu or through the CRCG web form)
• Multiple Google searches for specific content (identified through Google analytics
report)
• Need identified and suggested by CRCG member(s)
2 CRCG is the Clinical Research SOP Collaboration Group.
3 CRCG approval is performed by voting members, according to bylaws.
4 CRC is the Clinical Research Committee, chaired by the School of Medicine Associate Dean of Clinical Research.
5 VPR is the Vice President for Research