SOPs for Clinical Research
IGHID Clinical Research SOP Template Overview
The SOP templates offered on this site are geared towards outpatient clinical research. They can be used by any research site around the world but their focus is on sites who are part of the Institute for Global Health and Infectious Diseases at UNC. Developing SOPs and procedures is a time-consuming process that requires years of experience and dedicated administrative time. These templates are a resource designed to expedite the process of site readiness. They are easily adapted with highlighted areas geared to stimulate discussion at the site on how make a process work for your local context.
The SOP categories are divided into Administrative, Principal Investigator (PI) oversight, Clinical Management and Participant Safety, and Data Management. The Tools for Research folder provides quick access to well-developed and commonly used tools in research.
IGHID Regulatory has a set of SOPs focused on IRB submissions and maintenance of essential documents. Please email the IGHID Regulatory Director, Tania Hossain at email@example.com to request access. Pharmacy and laboratory SOPs are not included. For laboratory processes, please contact the UNC Global CTU Laboratory Manager, Amy James at firstname.lastname@example.org
The SOPs are adapted from experienced IGHID research projects and encopmas studies that undergo regular site monitoring from DAIDS and Industry sponsors along with sponsor audits. The SOPs and workflows described have been refined over the years and have produced clear staff roles, a focus on continuous quality improvement, participant safety, and high-quality data.