The University of Tennessee Graduate School of Medicine, Knoxville

Standard Operating Procedures for Clinical Research

Standard Operating Procedures (SOPs) outline research practices in ways that ensure compliance with institutional, state, and federal regulations. SOPs are meant to promote Good Clinical Practice in the performance of research activities that involve human participants, or the use of their data. They provide a unified approach to common research practices.

The following SOPs were created and/or revised by the Assistant Director of Research, Director of Research, GSM Dean. These SOPs are compliant with local Institutional Review Board SOPs and will ensure that GSM research endeavors produce high quality data and ensure that the rights and welfare of our patients are protected. If you are currently conducting, or plan to conduct, clinical research involving human participants, please read these SOPs, which serve as guidance for the appropriate performance of clinical research.

For outstanding questions pertaining to SOPs, please contact 

101.1 Preparation, Review, Revision, and Maintenance of Standard Operating Procedures
102.1A Investigator Initiated Research Studies
102.1B Quality Assurance amd Monitoring Plan
103.1 Obtaining and Documenting Informed Consent
104.1 Responsibilities of Research Team
105.1 Training, Credentials, and Certification of Research Personnel
106.1 Steps to Conduct a Clinical Research Study
107.1 Accrual, Organization, Revision, and Storage of Essential Documents and Supplies for Investigator Initiated Research Studies
108.1 Pre-Screening and Screening of Subjects



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