STANDARD OPERATING PROCEDURES

---

Purpose of the SOPs

All clinical research investigators and research team members must abide by the policies of LSU Health New Orleans, the Food and Drug Administration (FDA), Department of Health and Human Services (DHHS), and any other applicable regulatory bodies when conducting clinical research. The investigators and research team members are subject to review of their research practices by regulatory authorities and sponsors, as appropriate. SOPs provide detailed, written instructions that create consistency in the conduct of clinical research at each investigational site.

Information about the SOPs

The current document contains SOPs for clinical research investigators and research team members working with an LSU Health New Orleans Clinical Trials Office (CTO). The Health Sciences Center (HSC) CTO is a centralized administrative infrastructure for the pre-award management of clinical research conducted by LSU Health investigators on the LSUHSC Campus and/or non-LSUHSC clinics and hospitals. The Healthcare Network (HN) CTO is a centralized administrative infrastructure for the management of industry-sponsored clinical research conducted by LSU Health investigators in a Healthcare Network Clinic(s). The Stanley S. Scott Cancer Center (SSSCC) offers a centralized administrative infrastructure for the management of cancer-related clinical research conducted by LSU Health investigators. The CTO SOPs are standardized across the three central offices and are written with a focus on Good Clinical Research Practices.

While the SOPs provide comprehensive guidelines for the conduct of sponsored and FDA-regulated research, they can guide or inform processes for other types of clinical research studies (i.e., Investigator-Initiated). Additional SOPs or addendums at the department level are encouraged to further detail specific procedures. Any department-level SOPs will be subject to review by the CTOs or the IRB.

When working with a non-LSU Health New Orleans clinic or hospital, please refer to the site-specific SOPs for conducting research.