The SOPs are managed by the Research Integrity Office with support from Keele Clinical Trials Unit.  Please email any comments or queries to primarycare.sop@keele.ac.uk

 

The Health and Social Care Research SOP Training matrix outlines the relevant SOPs by job role guiding users to SOPs applicable to their role.

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

  • SOSOP01: Applying for Sponsorship (CTIMP)
  • SOSOP02: Sponsor Oversight and Reporting Requirements
  • HSCR-POL-01: Policy for Health and Social Care Research
  • FWK01: CTIMP Management Framework
  • HSCR SOP01‌: Writing, Revising and Managing SOPs and Associated Documents
  • 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: CTU 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

Glossary for Keele Health and Social Care SOPs