Standard Operating Procedures
The Sheffield Clinical Trials Research Unit runs studies/trials according to the Standard Operating Procedures below.
If you would like access to any of the Standard Operating Procedures please contact Richard Eyre, Quality Assurance Officer.
Data Management
Shef/CTRU/DM001 Data Protection
Shef/CTRU/DM002 Archiving
Shef/CTRU/DM003 Case Report Form Development
Shef/CTRU/DM004 Study Database Development
Shef/CTRU/DM005 Central Data Validation
Shef/CTRU/DM006 Study Database: Data Entry
Shef/CTRU/DM007 Study Files & Filing
Shef/CTRU/DM009 Data Management & Monitoring Protocol
Shef/CTRU/DM011 End of Trial Reporting
General
Shef/CTRU/GEN002 SOP Management
Shef/CTRU/GEN003 Training Records and Staff Training
Project Management
Shef/CTRU/PM003 Writing a Protocol
Shef/CTRU/PM004 Adverse Events & Serious Adverse Events
Shef/CTRU/PM005 Investigational Medicinal Product Management
Shef/CTRU/PM008 Periodic Safety Reporting
Shef/CTRU/PM009 Urgent Safety Measures
Shef/CTRU/PM010 Delegation of Duties for Researchers
Shef/CTRU/PM011 Protocol Violations and Deviations
Regulatory Authority Approval
Shef/CTRU/RAA001 Obtaining Ethical Approval
Shef/CTRU/RAA002 Regulatory Approvals
Statistics
Shef/CTRU/ST001 The Statistical Analysis Plan
Shef/CTRU/ST003 Data Evaluability
Shef/CTRU/ST004 Interim Data Analysis
Shef/CTRU/ST005 Randomisation and Blinding
Study Governance
Shef/CTRU/GOV001 Trial Management Group
Shef/CTRU/GOV002 Trial Steering Committee
Shef/CTRU/GOV003 Data Monitoring & Ethics Committee
Study Set-up
Shef/CTRU/SSU001 Informed Consent Procedures for Adults
Shef/CTRU/SSU002 Trial Initiation and Site Set-up
Quality Assurance
Shef/CTRU/QU001 Trial Monitoring
Shef/CTRU/QA004 Clinical Trial Risk Assessment
Information Services
Shef/CTRU/IS002 Information Services Security
Shef/CTRU/IS003 Information Services Disaster Mitigation & Recovery
Reference
Shef/CTRU/RD001 Reference Document for SOPs