The Office for Health and Medical Research (OHMR) have developed a suite of clinical trial (Site) standard operating procedures (SOPs) for use in NSW Public Health Organisations. The SOPs were developed to assist sites to conduct trial activities in accordance with Good Clinical Practice (GCP) and any relevant local and national requirements.
These SOPs have been written at a high level so that they can be implemented across all NSW sites. It is recommended, therefore, that any local detail is added in the form of work instructions.
The review period is 6 months. After that, the SOPs will be revised to take into account the feedback received and thereafter, will be reviewed periodically to ensure currency and completeness.
ALL USERS ARE ENCOURAGED TO PROVIDE FEEDBACK DURING THE 6 MONTH REVIEW PERIOD.
PLEASE PROVIDE FEEDBACK ON RELEVANT SOPS BELOW
2. SOP-QA-01 Clinical Trial Training Qualification
3. SOP-QA-02 Hosting an Audit or Regulatory Inspection
4. SOP-QA-03 Sub-Contracting External Vendors
5. SOP-TC-01 Trial Feasibility & Start-Up
6. SOP-TC-02 Delegation of Duties by the Principle Investigator
7. SOP-TC-03 Informed Consent
8. SOP-TC-04 Managing and Reporting Safety Events
9. SOP-TC-05 Reporting Non-Compliance and Suspected Breaches of GCP or the Protocol
10. SOP-TC-06 Investigational Medicinal Product Management and Emergency Unblinding
11. SOP-TC-07 Source Data and Case Report Form Completion
12. SOP-TC-08 Handling and Transporting Biological Specimens
13. SOP-TC-09 Investigator Site File & Essential Documents
14. SOP-TC-10 Close-Out at a Trial Site
15. SOP-TC-11 Clinical Trial Archiving
ALL USERS ARE ENCOURAGED TO MAKE SUGGESTIONS FOR IMPROVEMENT AND SUGGESTIONS FOR ADDITIONAL SOPS DURING THE 6 MONTH REVIEW PERIOD.
If you like to discuss how these SOPs can be further adapted to your local setting, please contact the clinicaltrialsNSW unit at the Office for Health and Medical Research via email: clinicaltrialsNSW@health.nsw.gov.au