Newcastle Clinical Trials Unit

Standard Operating Procedures (SOP)

Standard Operating Procedures

Standard Operating Procedures (SOPs) are written documentation of processes that require a standard of quality and consistency.

SOPs are an essential element for the control of clinical research from planning through to study closure, and for all the activities which support the clinical research process (eg sample processing, PT Registration and study budgets).

The advantages of a SOP system are to provide:

  • standardised approach
  • structure for systems development and continuous improvement
  • best practice and processes in line with current legislation
  • integration and training platform for individuals
  • transparency in approach
  • audit trail

Most importantly, SOPs must be maintained and be available to all; for this reason we provide the SOP Library.