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Standard Operating Procedure (SOP) Library

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. If you would like to request an SOP be developed or have one to share, please contact Dharti Patel (dhartibenpatel@uabmc.edu).

Clinical/Operating (CL)

Regulatory/Management (RM) - includes device studies

Fiscal Management (FM)

Logs

Implementing clinical studies requires rigorous attention to organization, including the documentation of myriad details. To help with this effort, we have provided below several templates for logs and checklists. The logs will not only help you track key study information, but also support your team's efforts to meet Good Clinical Practice (GCP) guidelines. The log templates are provided in MS Word so you can modify them to meet your needs. It is recommended that use of these logs be incorporated into your SOPs!

Organization Tools