If you would like a copy of one the Standard Operating Procedures (SOPs) or Template Forms (TFs) listed below, please contact research@cntw.nhs.uk.

SOP Number – QASOP-001
SOP Title – Development and Maintenance of CNTW Research SOPs
Associated Documents:

  • TF-001 Research SOP Template
  • TF-002 Quality Management System Database

SOP Number – QASOP-002
SOP Title – GCP Audits
Associated Documents:

  • TF-004 Confidential Audit Findings
  • TF-006 TMF Audit Self-Assessment Checklist
  • TF-007 Corrective and Preventative Action Form
  • TF-008 Audit Pro Forma
  • TF-009 Pre-Audit Pro Forma
  • TF-010 Annual Audit Plan
  • TF-011 Risk-Graded Assessment of Hosted Studies
  • TF-012 First Participant Audit Pro Forma
  • TF-029 Systems Audit Report
  • TF-030 Service Provider Audit Report
  • TF-047 Non-Study-Specific Audit CAPA Form
  • TF-050 Process Audit Report
  • TF-057 GCP Audit Certificate

SOP Number – QASOP-003
SOP Title – Corrective and Preventative Action
Associated Documents:

  • TF-007 Corrective and Preventative Action Form

SOP Number – QASOP-004
SOP Title – Research Records Version Control
Associated Documents:

  • TF-013 Research Records Version Control Log

SOP Number – QASOP-005
SOP Title – Training of Research Staff
Associated Documents:

  • TF-014 ISF Delegation Log
  • TF-015 TMF Delegation Log
  • TF-016 Training Log

SOP Number – QASOP-006
SOP Title – Archiving
Associated Documents

  • WI-007 Archiving
  • TF-017 Archiving Box Label
  • TF-018 Archiving Chain of Custody Form
  • TF-019 TMF Archiving Checklist
  • TF-020 ISF Archiving Checklist
  • TF-049 Archive Inventory
  • TF-064 Pre-Archiving Pro Forma

SOP Number – QASOP-007
SOP Title – Research Templates
Associated Documents:

  • TF-001 Research SOP Template
  • TF-007 Corrective and Preventative Action Log
  • TF-013 Research Records Version Control Log
  • TF-014 ISF Delegation Log
  • TF-015 TMF Delegation Log
  • TF-016 Training Log
  • TF-025 Service Provider Assessment Form
  • TF-026 Service Provider Selection Form
  • TF-031 Regulatory Green Light Checklist
  • TF-032 ISF Index
  • TF-033 TMF Index
  • TF-034 Screening and Recruitment Log Template
  • TF-035 Internal Monitoring Form
  • TF-036 SAE Form
  • TF-038 SUSAR Reporting Form
  • TF-039 Out of Office Hours Test Sheet
  • TF-041 Protocol Deviation Tracking Log
  • TF-042 Notification of Protocol Violation Form
  • TF-043 Declaration by Principal Investigator
  • TF-044 Research Study Protocol Template (CTIMPs)
  • TF-045 Participant Information Sheet Template
  • TF-046 Informed Consent Form Template
  • TF-048 Research Project Proposal Template
  • TF-056 Study Procedures Log
  • TF-058 File Note Template
  • TF-059 Non-CTIMP SAE Form
  • TF-061 Trial-wide Deviation Log
  • TF-062 Final Study Report
  • TF-067 In Office Hours Test Sheet

SOP Number – QASOP-008
SOP Title – Sponsor Oversight Communication
Associated Documents: N/A

SOP Number – QASOP-009
SOP Title – Publications
Associated Documents: N/A

SOP Number – QASOP-010
SOP Title – Electronic Health Records
Associated Documents: N/A

SOP Number – QASOP-011
SOP Title – Out of Office Hours Cover
Associated Documents:

  • TF-039 Out of Office Hours Test Sheet

SOP Number – PDSOP-001
SOP Title – Research Funding Applications
Associated Documents:

  • TF-027 Pre-Award Meeting Agenda
  • TF-028 Post-Award Meeting Agenda

SOP Number – PDSOP-002
SOP Title – Sponsorship (Interventional Research)
Associated Documents:

  • TF-021 Risk Assessment Form
  • TF-023 Chief Investigator Conditions of Sponsorship Agreement
  • TF-024 Delegation of Sponsor Duties Agreement
  • TF-028 Post-Award Meeting Agenda
  • TF-066 Sponsorship Review Log

SOP Number – PDSOP-003
SOP Title – Sponsorship (Non-Interventional Research)
Associated Documents:

  • TF-023 Chief Investigator Conditions of Sponsorship Agreement
  • TF-054 Confirmation of Sponsorship Letter

SOP Number – PDSOP-004
SOP Title – Research Service Providers –  Selection, Management and Contracts
Associated Documents:

  • TF-025 Service Provider Assessment Form
  • TF-026 Service Provider Selection Form

SOP Number – PDSOP-005
SOP Title – Management of Contracts and Agreements
Associated Documents: N/A

SOP Number – PDSOP-006
SOP Title – Risk Assessment (Interventional Research)
Associated Documents:

  • TF-021 Risk Assessment Form
  • TF-022 Risk Assessment Tool
  • TF-063 Sponsor Risk Assessment

SOP Number – PDSOP-007
SOP Title – Risk Assessment (Non-Interventional Research)
Associated Documents:

  • TF-021 Risk Assessment Form
  • TF-022 Risk Assessment Tool
     

SOP Number – PASOP-001
SOP Title – Annual Update of Investigators Brochure/SmPC
Associated Documents:

  • TF-024 Delegation of Sponsor Duties Agreement

SOP Number – PASOP-002
SOP Title – Research Location Selection and Site Initiation
Associated Documents:

  • TF-014 ISF Delegation Log
  • TF-055 Delegation of Sponsor Duties Schedule

SOP Number – PASOP-003
SOP Title – Regulatory Green Light Process
Associated Documents:

  • TF-031 Regulatory Green Light Checklist
  • TF-043 Declaration by Principal Investigator

SOP Number – PASOP-004
SOP Title – Essential Records TMF and ISF
Associated Documents:

  • TF-032 ISF Index
  • TF-033 TMF Index
  • TF-058 File Note Template

SOP Number – PASOP-005
SOP Title – Informed Consent
Associated Documents:

  • TF-014 ISF Delegation Log
  • TF-015 TMF Delegation Log
  • TF-034 Screening and Recruitment Log Template
  • TF-045 Participant Information Sheet Template
  • TF-046 Informed Consent Form Template

SOP Number – PASOP-006
SOP Title – Randomisation and Unblinding
Associated Documents: N/A

SOP Number – PASOP-007
SOP Title – Monitoring
Associated Documents:

  • TF-021 Risk Assessment Form
  • TF-035 Internal Monitoring Form

SOP Number – PASOP-008
SOP Title – Safety Reporting (AE and SAE)
Associated Documents:

  • TF-024 Delegation of Sponsor Duties Agreement
  • TF-036 SAE Form
  • TF-037 SUSAR Reporting Checklist
  • TF-038 SUSAR Reporting Form
  • TF-059 Non-CTIMP SAE Form
  • TF-060 SAE and SUSAR Log

SOP Number – PASOP-009
SOP Title – Safety Reporting (SUSARs)
Associated Documents:

  • TF-037 SUSAR Reporting Checklist
  • TF-038 SUSAR Reporting Form
  • TF-060 SAE and SUSAR Log

SOP Number – PASOP-010
SOP Title – Serious Breaches of Protocol or GCP
Associated Documents:

  • TF-040 Suspected Serious Breach Form

SOP Number – PASOP-011
SOP Title – Protocol Deviations, Violations, and Urgent Safety Measures
Associated Documents:

  • TF-041 Protocol Deviation Tracking Log
  • TF-042 Notification of Protocol Violation Form
  • TF-061 Trial-wide Deviation Log

SOP Number – PASOP-012
SOP Title – Modifications
Associated Documents: N/A

SOP Number – PASOP-013
SOP Title – End of Study Procedures
Associated Documents:

  • TF-062 Final Study Report

SOP Number – PASOP-014
SOP Title – Urgent Public Health Crisis Research Operations
Associated Documents:

  • TF-051 Public Health Crisis Research Operations Plan
  • TF-053 Public Health Crisis Related Deviations to SOPs

SOP Number – PASOP-015
SOP Title – Confirmation of Capacity and Capability from the Research and Development Team to deliver portfolio adopted research
Associated Documents:

  • CNTW CandC
  • Locality CBU Research Approval Template

SOP Number – PASOP-016
SOP Title – Confirming Modifications to Hosted Portfolio-Adopted Research.
Associated Documents:

  • Modification to Research Capacity and Capability Form

SOP Number – PASOP-017
SOP Title – Safety Reporting for Investigations of Medical Devices
Associated Documents:

  • TF-059 Non-CTIMP SAE Form
  • TF-060 SAE and SUSAR Log
  • TF-070 Medical Device SAE Summary Report
     

SOP Number – DMSOP-001
SOP Title – Data Management
Associated Documents:

  • TF-041 Protocol Deviation Tracking Log

SOP Number – DMSOP-002
SOP Title – Case Report Forms
Associated Documents:

  • TF-041 Protocol Deviation Tracking Log