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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.

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!