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Pragmatic Clinical Trials Unit
  1. Pragmatic Clinical Trials Unit
  2. For Investigators
  3. PCTU SOPs

PCTU SOPs

A standard operating procedure is a set of step-by-step instructions to help those working on a study to carry out the procedures needed to conduct the study efficiently, to a high standard, and in compliance with relevant regulations.

The PCTU has developed standard operating procedures (SOPs) to support all those working on studies to carry out study procedures consistently and to a high standard. The SOPs are designed primarily for trials but many also apply to other studies in which participants are recruited. 

If you have any queries about training or require information on any SOPs listed below, please contact our Quality Assurance team.

In addition, all those working on PCTU linked studies are expected to undertake Data Security and Protection training (previously Information Governance training). For more information on this, please see the Data Security and Protection. 

In the set up phase

  • SOP TP_01 Protocol Development
  • SOP TP_02 Statistician Involvement
  • SOP TP_03 Randomisation and Blinding
  • SOP TP_04 Risk Assessment
  • SOP TP_05 The Approval Process
  • SOP TM_09 Site Initiation
  • SOP DM_02 CRF [Case Report Form] Design
  • SOP DM_06 eCRF Database Application Design and Development
  • SOP DM_07_Database Validation
  • SOP QA_01 Pragmatic CTU SOPs
  • SOP QA_02 QA & QC systems
  • SOP QA_03 Document Control
  • SOP QA_04 Trial Monitoring
  • SOP QA_06 Staff Training

During recruitment and follow-up

  • SOP TM_01 TMF and ISF [Trial Master File and Investigator Site File] Maintenance
  • SOP TM_02 External Trial Oversight Committees
  • SOP TM_03 IMP [Investigational Medicinal Product] Management and Labelling
  • SOP TM_04 Informed consent
  • SOP TM_05 CTIMP Adverse Event Reporting
  • SOP TM_06 Non-CTIMP Adverse Event Reporting
  • SOP TM_07 Document Completion Transport and Storage
  • SOP TM_08 Reporting of Amendments and Deviations
  • SOP TM_10 Handling trial correspondence
  • SOP TM_11 Effective Trial Management
  • SOP TM_12 Progress, Safety and End of Trial Reports
  • SOP SP_01 Statistical Analysis
  • SOP HE_01 Health Economic Analysis
  • SOP QA_05 Statistics and Health Economics QC
  • SOP DM_04_Data Entry Quality Control Data Extraction and Database Lock
  • SOP DM_05_Electronic Data Security
  • SOP DM 08 Database Application Versioning and Change Control
  • SOP DM_09_Business Continuity – Back up and Disaster Recovery
  • SOP DM_11_Data Transfer
  • SOP IT_01 Clinical Trials System Access

Data Analysis 

  • PCTU_SOP_SP 01_Statistical Analysis
  • PCTU_SOP_HE 01_Health Economic Analysis
  • SOP QA_05 Statistical and HE analysis QC

During trial closure

  • SOP TC_01 Trial Close Out
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