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:
If you wish to provide feedback or contact the team at the NSW Regional Health Partners Clinical Trials Roadmap please email ctroadmap@hmri.org.au
New South Wales Regional Health Partners respectfully acknowledge Aboriginal people as the past, present and future traditional custodians of the land and recognise their continued connection to land, waters and culture. We aim to partner with the Elders, community members and community controlled health services to improve health outcomes for Aboriginal people.