Internal Medicine Research Administration provides a set of Standard Operating Procedures to guide the conduct of clinical research in the department.
The SOPs cover a variety of topics in the following categories:
- Clinical Trial Operations (e.g., Informed Consent, Screening, 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 SOPs and supporting documents are filed by topic on the Internal Medicine Research Admin Pulse 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 Pulse page.
For questions or training on these SOPs, please contact:
Scott J. Low, MBA, CCRP
Associate Director, Clinical Research Compliance
University of Utah, Department of Internal Medicine
801-585-1380
scott.low@hsc.utah.edu