Standard operating procedures

The Clinical Trials Research Unit runs studies and trials according to the standard operating procedures listed below.


If you would like access to any of the standard operating procedures, contact the QA team at


  • Shef/CTRU/GEN001 SOP requirements for non-CTRU statisticians, health economists and modellers
  • Shef/CTRU/GEN002 SOP Management
  • Shef/CTRU/GEN003 Training Records and Staff Training
  • Shef/CTRU/GEN004 Quality Checking of Study Outputs

Data management

  • Shef/CTRU/DM001 Data Protection
  • Shef/CTRU/DM003 Case Report Form Development
  • Shef/CTRU/DM004 Study Database Development
  • Shef/CTRU/DM005 Central Data Validation
  • Shef/CTRU/DM006 Data Entry and Import
  • Shef/CTRU/DM009 Data Management Plan
  • Shef/CTRU/DM012 Study Database Lock and Retention
  • Shef/CTRU/DM015 Data Sharing


We can provide expertise in data management and database design. Using Prospect, our in-house web-based electronic data capture system, we will work with you to design a bespoke database to allow you to meet your data collection and management needs.

Prospect is designed specifically to support remote data input for clinical studies.  It provides user-friendly data collection with validation features to promote high-quality data and allows for comprehensive privilege management, enabling custom access control on a per-user basis.  The system also incorporates a user activity log and a data audit trail.

For more information, email us at

Project management

  • Shef/CTRU/PM003 Developing and Using a Protocol
  • 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
  • Sheff/CTRU/PM011 Non-Compliances and Serious Breaches
  • Shef/CTRU/PM012 Archiving
  • Shef/CTRU/PM013 Document Control
  • Shef/CTRU/PM014 End of Trial Reporting
  • Shef/CTRU/PM015 Study Files and Filing
  • Shef/CTRU/PM016 Adverse Events and Serious Adverse Events for CTIMPs
  • Shef/CTRU/PM017 Adverse Events and Serious Adverse Events for non-CTIMPs

Regulatory authority approval

  • Shef/CTRU/RA003 Obtaining Ethical and Regulatory Approvals


  • Shef/CTRU/ST001 The Statistical Analysis Plan
  • Shef/CTRU/ST003 Data Evaluation
  • Shef/CTRU/ST004 Interim Data Analysis
  • Shef/CTRU/ST006 Undertaking a Statistical Analysis
  • Shef/CTRU/ST007 Randomisation using the CTRU randomisation system
  • Shef/CTRU/ST008 Sample Size
  • Shef/CTRU/ST009 Blinding

Study governance

  • Shef/CTRU/GOV001 Trial Management Group
  • Shef/CTRU/GOV002 Trial Steering Committee
  • Shef/CTRU/GOV003 Data Monitoring and Ethics Committee

Study set-up

  • Shef/CTRU/SSU001 Informed Consent Procedures
  • Shef/CTRU/SSU003 Participant Discontinuation and Withdrawal of Consent
  • Shef/CTRU/SSU004 Assessment of Investigator Sites
  • Shef/CTRU/SSU005 Proposal Development
  • Shef/CTRU/SSU006 Contracting

Quality assurance

  • Shef/CTRU/QA001 Site Monitoring
  • Shef/CTRU/QA002 Audits
  • Shef/CTRU/QA004 Risk Assessment
  • Shef/CTRU/QA005 Site Initiation

Information services

  • Shef/CTRU/IS001 Computer System Validation
  • Shef/CTRU/IS002 Computer System Security and Continuity

Centres of excellence

The University's cross-faculty research centres harness our interdisciplinary expertise to solve the world's most pressing challenges.