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Clinical Research

Good procedures and work instructions provide a way to communicate and apply consistent standards and practices within your organization. SOPs are the mechanism to document those procedures and instructions. SOPs help maintain routine procedures, provide a means for quality control, help manage performance and in the end, lead to growth and better research. SOPs are becoming more and more valuable to research offices as industry and federally funded studies move to risk based monitoring. Building and managing a research office that has high standards that are documented in their SOPs serves a site well.

In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc...) standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, state and federal guidances. SOPs should contain enough detail to guide research staff through a particular procedure and thereby establish uniformity in the everyday functions of the department. The SOP should have a specific aim but be written in a general format to allow for easy implementation across a broad set of venues and circumstances. The SOP however, should contain specifically defined procedures that can be followed without deviation. A UAB SOP Workgroup developed template SOPs that are available for your use. These are drafts and should be tailored to your area. This is not a complete list and new SOPs will be added over time. 

Clinical/Operating (CL)

Regulatory/Management (RM) - includes device studies

Fiscal Management (FM)


Meredith Fitz-Gerald, MSN, RN
Director, Clinical Research Support Program