Clinical Research SOP Collaboration Group (CRCG)

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 give procedure, who is responsible for doing it, and when it is to be performed. If instructions on how to performthe 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.

UofU SOPs Contact Us