Standard operating procedures

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

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If you would like access to any of the standard operating procedures, contact the QA team at ctruqa@sheffield.ac.uk.


General

  • 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

Prospect

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 ctru-dm-group@sheffield.ac.uk.


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

Statistics

  • 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 Managing Participation Changes and Discontinuation
  • 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

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