Standard Operating Procedures (SOPs) 

York Trials Unit (YTU) runs studies/trials according to a set of Standard Operating Procedures (SOPs) which have been developed to ensure our trials are run and managed to a high standard.

Please note that these documents are accessible by YTU staff and investigators only. If you would like access to any of our SOPs, please contact Jude Watson (jude.watson@york.ac.uk).

YTU Procedures

  • YT01 Preparation, Review and Approval of SOPs
  • YT02 Complaints Procedure SOP
  • YT03 Storage and Archiving SOP
  • YT04 Training Authorisation Process SOP
  • YT06 Trial Supplies SOP

Trial Procedures

  • T01 Trial Master File 
  • T02 Trial Management SOP
  • T03 Trial Steering Committees SOP
  • T04 Data Monitoring Committees SOP
  • T05 University Public Liability Insurance 
  • T06 Ethics & Health Research Authority Approvals
  • T07 Amendments to ethically approved documents
  • TO8 Deparment of Health Sciences Research Governance Committee Approval
  • T09 Sponsership, Contracts & Agreements
  • T10 Site Set up and Initiation
  • T11 Informed consent SOP
  • T12 Duty of Care SOP
  • T13 Reporting Adverse Incidents due to Medical Devices
  • T14 Adverse Event and Serious Adverse Event Reporting (non-CTMPs and CTIMPs) SOP
  • T20 Trial Reports
  • T21 Trial and Trial Site Closure SOP
  • T22 Lone Working SOP

Data Management

  • DM01 CRF Design
  • DM02 Data Scanning and Verifying
  • DM03 Manual Entry of Data
  • DM04 Data Dowloading
  • DM05 Second Checking of Data
  • DM06 Data Validation
  • DM07 Locking Databases
  • DM08 Exporting Data
  • DM09 Electronic Data Auditing

Data Systems

  • DS01 Directory Structure
  • DS02 Randomisation
  • DS03 System Development
  • DS08 Business Continuity Disaster Recovery

Statistics and Health Economics

  • HE01 Health Economics SOP
  • S01 Statistical Considerations SOP