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

The SOPs in this library define clinical research as:

Clinical Trial
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.
Clinical Research
 
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.
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.
 
Please check with your group regarding supplemental working guidelines and/or additional SOPs which may be established for your department/study processes. 

FAQS

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.

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.

UofU SOPs Contact Us

Last Updated: 11/19/20