Clinical Governance SOP

The purpose of the Clinical Governance Quality System (CG-QMS) is to document the processes in the form of Standard Operating Procedures (SOPs) for the governance of clinical research to ensure that all University of Lincoln researchers* and Lincoln Clinical Trial Unit (LinCTU) staff understand the necessary requirements and procedures covered by the standards set by ICH-GCP and any regulatory bodies.

SOPs are mandatory for all research (including student research, CTIMP and Device studies)

  1. CG-QMS SOP CG01 Training Final 2.0 15 Apr 2024
  2. CG-QMS SOP CG02 Sponsorship Final v2.0 15 Apr 2024
  3. CG-QMS SOP CG03 Risk Assessment Final v2.0 15 Apr 2024
  4. CG-QMS SOP CG04 Protocol Development Final v1.0 01 May 2021
  5. CG-QMS SOP CG05 Ethics Applications Final v1.0 01 May 2021
  6. CG-QMS SOP CG06 Regulatory Applications Final v1.0 01 May 2021
  7. CG-QMS SOP CG07 Trial Master _ Site File Final v1.0 01 May 2021
  8. CG-QMS SOP CG08 Trial Initiation Final v1.0 01 May 2021
  9. CG-QMS SOP CG09 Recruitment and Consent Final v1.0 01 May 2021
  10. CG-QMS SOP CG10 Adverse Events and Safety Reporting Final v1.0 01 May 2021
  11. CG-QMS SOP CG11 Serious Breach Final v1.0 01 May 2021
  12. CG-QMS SOP CG12 Amendment Final v1.0 01 May 2021
  13. CG-QMS SOP CG13 Monitoring and Audit Final 01 May2 021
  14. CG-QMS SOP CG14 Trial Closure Final v1.0 01 May 2021
  15. CG-QMS SOP CG15 Archiving (Clinical data) Final v1.0 01 May 2021
  16. CG-QMS SOP CGD1 Data Protection and Confidentiality Final v1.0 01 May 2021
  17. CG-QMS SOP CGD2 Data Management Final v1.0 01 May 2021
  18. CG-QMS SOP CGD3 Data Storage, Security and Backup Final v1.0 01 May 2021
  19. CG-QMS SOP CGD4 Database Design Final v1.0 01 May 2021
  20. CG-QMS SOP CGD5 Case Report Form Final v1.0 01 May 2021
  21. CG-QMS SOP CGD6 Randomisation Final v1.0 01 May 2021
  22. CG-QMS SOP CGI1 ICT Purchasing Final v1.0 01 May 2021
  23. CG-QMS SOP CGS1 Statistical Principles Final v1.0 01 May 2021
  24. CG-QMS SOP CGS2 Statistical analysis plan Final v1.0 01 May 2021
  25. CG-QMS SOP CGS3 Sample Size Calculations Final v1.0 01 May 2021
  26. CG-QMS SOP CGS4 Health Economic Analysis Plan Final v1.0 01 May 2021
  27. CG-QMS Data Monitoring Committee Final v1.0 01 May 2021
  28. CG-QMS Trial Management Group Final v1.0 01 May 20211
  29. CG-QMS Trial Steering Committee Final v1.0 01 May 2021
  30. CG-QMS CGQM Clinical Governance – Quality Manual Final v1.0 01May2021.docx

researchers as defined in the University of Lincoln Code of Practice for Research: Refers to any person who conducts research, including but not limited to as an employee; an independent contractor or consultant; a research student; a visiting or emeritus member of staff; or a member of staff on a joint clinical or honorary contract