Standard operating procedures help standardise key clinical trial operations. As a Coordinating Principal Investigator, you are responsible (in consultation with your Sponsor and organisation) for implementing standard operating procedures (SOPs) to ensure that trials are conducted and data is generated, documented and reported in compliance with the protocol, Good Clinical Practice principles 2.13 and 4.2.6, and other regulatory requirements.

SOPs help sites meet two essential requirements of GCP:

  • to protect the rights, safety, and wellbeing of participants; and
  • to ensure the reliability and credibility of trial data.


Supporting Documentation


Files for Essential Trial Documents