Standard Operating Procedures (SOPs)

The Clinical Trials Unit provides a set of Standard Operating Procedures (SOPs) to guide the conduct of clinical research in the department. All clinical trials whose PI has a primary appointment in the Dept. of Internal Medicine must follow these SOPs for study procedures.

The SOPs cover a variety of topics in the following categories:

• Clinical Trial Operations (e.g., Consent, Record Keeping, Internal Auditing)
• Finance (e.g., Industry Trial Costs)
• Regulatory (e.g., FDA Inspections)

Many of the SOPs are also accompanied by supporting Work Practice Documents (describing how specific procedures should be performed) and example forms.

All Internal Medicine SOPS and supporting documents/logs are filed by topic in the Clinical Research Training Program (CRTP) under the SOPs Module. You can also find University of Utah wide SOPs on the Office of Quality Compliance website under Standard Operating Procedures page.

Investigator-Initiated Trials Guidance Documents and Forms

In addition to the SOPs, a set of guidance documents has been developed to outline the process and requirements for the start up of Investigator-Initiated Trials. We encourage all investigators and clinical research coordinators to reference these forms when planning a new study. These documents are filed under the Investigator Initiated Trial Start-up Process heading on the CRTP SOPs Module.