Standard Operating Procedure (SOPs)

Standard operating procedures are uniformly written instructions that are used to record performance of routine operations, processes, and practices across studies at an individual site.

SOPs ensure that procedural deviations are avoided and research tasks are being executed in accordance with institutional, state, and federal guidelines.

The SOP should contain the objective, definition of significant terms and acronyms, and details outlining the procedures. It should be detailed enough to clearly guide staff through a particular task and should be able to be followed by a broad audience.

Existing SOPs should be reviewed and updated regularly. The Administrator or Director should sign the SOPs to signify approval and alignment with internal policies.

Examples of commonly used standard operating procedures in clinical research include:

  • GCP Training.
  • Subject screening and recruitment.
  • Eligibility confirmation.
  • Informed consent process and documentation.

Source: Standard Operating Procedures. (n.d.). UCSF Clinical Research Resource HUB. Retrieved January 9, 2022, from