The SOPs are managed by the Keele CTU Quality Assurance Group.  Please email any comments or queries to primarycare.sop@keele.ac.uk

Complete List of Current released Keele CTU and Sponsor SOPs, with master list of all SOP supporting documents and templates.

  • SOP 1: Writing, Revising and Management of SOPs 
  • SOP 2: Document Control 
  • SOP 3: Developing and Submitting Grant Proposals and Contracts Sign Off 
  • SOP 5: Site Initiation
  • SOP 6: Study Master File 
  • SOP 7: Document Design, Development, Quality Control and Sign Off 
  • SOP 8a: Recruitment  
  • SOP 8b: Informed Consent
  • SOP 9: Audit 
  • SOP 10: Study Contracts
  • SOP 11: Regulatory Submission
  • SOP 12: Research Passports & NHS-to-NHS Agreements, Honorary Research Contracts & Letters of Access  
  • SOP 14: Monitoring
  • SOP 15: Study Closure  
  • SOP 16: Analysis
  • SOP 17: Archiving and Destruction   
  • SOP 18: Training Records
  • SOP 19: Investigational Medicinal Product (IMP) Management 
  • SOP 20: Safety Reporting and Pharmacovigilance
  • SOP 21Non-Compliance: Deviations and Serious Breaches of GCP and / or the Trial Protocol  
  • SOP 22: Non-Compliance: Deviations from SOPs
  • SOP 24: Software and Database Development and Maintenance
  • SOP 25: Software Testing
  • SOP 26: Software Release Process
  • SOP 27: Software Versioning
  • SOP 28: Software Modification Request
  • SOP 29: User Account & Password Management
  • SOP 30: Computer System Risk Management
  • SOP 31: System Backup and Disaster Recovery
  • SOP 32: Randomisation
  • SOP 33Trial Steering Committees and Data Monitoring Committees
  • SOP 39: User Acceptance Testing
  • SOP 40: Risk Assessment
  • SOP 41: Vendor Assessment and Oversight
  • SOP 42: Database Locking
  • SOP 43: Data Query Management and Stage 1 Data Clean
  • SOP 44: Stage 2 Data Check and Cleaning
  • SOP 45: Data Coding, Applied Rules and Scoring Methods
  • SOP 46: Data Logging/Tracking (management of processing study responses)
  • SOP 47: Data Collection - study mail-out preparation

Keele University Sponsor Policies and SOPs

  • HSCR-POL-01: Policy for Health and Social Care Research
  • FWK01: CTIMP Management Framework
  • SOSOP01: Applying for Sponsorship (CTIMP)
  • SOSOP02: Sponsor Oversight and Reporting Requirements

Glossary for Keele Health and Social Care SOPs

Glossary