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 CGQM Clinical Governance – Quality Manual
2. CG-QMS SOP CG01 Research Training Portfolio
3. CG-QMS SOP CG02 Sponsorship
4. CG-QMS SOP CG03 Clinical Research Risk Assessment
5. CG-QMS SOP CG04 Protocol Development
6. CG-QMS SOP CG05 Ethics Applications
7. CG-QMS SOP CG06 Applying for Clinical Trial Authorisation (CTA)
8. CG-QMS SOP CG07 Trial Master / Investigator Site File
9. CG-QMS SOP CG08 Study Initiation
10. CG-QMS SOP CG09 Recruitment and Consent
11. CG-QMS SOP CG10 Adverse Events and Safety Reporting
12. CG-QMS SOP CG11 Serious Breach Reporting
13. CG-QMS SOP CG12 Amendments to Research Projects
14. CG-QMS SOP CG13 Monitoring and Audit
15. CG-QMS SOP CG14 Trial/Study Closure
16. CG-QMS SOP CG15 Archiving Clinical Data
17. CG-QMS SOP CGD1 Data Protection and Confidentiality
18. CG-QMS SOP CGD2 Data Management
19. CG-QMS SOP CGD3 Data Storage, Security and Backup
20. CG-QMS SOP CGD4 Database Design
21. CG-QMS SOP CGD5 Case Report Forms
22. CG-QMS SOP CGD6 Randomisation
23. CG-QMS SOP CGl1 ICT Purchasing 
24. CG-QMS SOP CGS1 Statistical Principles
25. CG-QMS SOP CGS2 Statistical analysis plan
26. CG-QMS SOP CGS3 Sample Size Calculations 
27. CG-QMS SOP CGS4 Health Economic Analysis Plan
28. CG-QMS Data Monitoring Committee
29. CG-QMS Trial Management Group
30. CG-QMS Trial Steering Committee

* 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