Research Standard Operating Procedures
What are Standard Operating Procedures (SOP)?
“Detailed, written instructions to achieve uniformity of the performance of a specific function.” (ICH GCP 1.55)
In simple terms an SOP is a written process and a way for the clinical site to perform a task the same way each time it is completed.
SOPs are used to:
- Identify the responsible person for each task;
- Describe what is to be completed;
- Train staff; and
- Monitor site performance.
What are the benefits of using SOPs?
- SOPs ensure that sites follow Federal Regulations, International Conference on Harmonization Good Clinical Practice Guidelines, and UH Institutional Policies to protect the rights and welfare of human study participants.
- They improve quality of data collected and improves research,
- Provide a reference and guideline for conducting research, and
- Act as a training tool for new employees and/or trainees.
Developed by the Clinical Research Center Clinical Research SOP Committee
Tips for writing SOPs
- Determine a single task to focus on.
- List all the steps currently used to complete that task.
- Take each step in the task and make it more efficient and easier to follow.
- Following the template, fill in each step.
- Use clear, concise language.
- Use the active voice when writing.
- Avoid names; use job functions instead.
Things to Remember
- The Principal Investigator should approve all SOPs and designate an effective date.
- SOPs should be reviewed on a regular basis (usually annually) to ensure policy based regulations are up-to-date.
- Previous versions of SOPs should be retained.
- All staff should have SOP training (document this training)
- SOPs should be accessible to staff
- SOPs are an integral part of good research practice!