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 pertaining to clinical research implementation and management were created and/or revised by the Assistant Dean for 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 Jferris@utmck.edu 

1.1 Investigator Initiated Research Studies
2.1 Quality Assurance and Monitoring Plan
3.1 Obtaining and Documenting Informed Consent
4.1 Responsibilities of Research Team
5.1 Training, Credentials, and Certification of Research Personnel
6.1 Steps to Conduct a Clinical Research Study
7.1 Accrual, Organization, Revision, and Storage of Essential Documents
8.1 Pre-Screening and Screening of Subjects
9.1 Adverse Event Reporting
10.1A Research Patient Stipends
10.1B Dispensing Patient Stipends
11.1 Reporting Pathways for Clinical Research Support Staff
12.1 Pre-Hiring Pathway for Clinical Research Staff

In addition, to further foster research integrity and safety, the Institutional Review Board (IRB) of the University of Tennessee Graduate School of Medicine (UTGSM), established policies and procedures relating to IRB submissions, communications, and requirements when working with human participants. These policies and procedures (SOPs) will be interpreted and enforced in accordance with the principles outlined in the Belmont Report, Federal and State laws, rules and regulations, general principles of Medical Ethics, and applicable policies and procedures of the University of Tennessee. Please review these SOPs located at on the IRB webpage.

 

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