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Research Standard Operating Procedures and Quality Assurance System

If you require one of the Standard Operating Procedures (SOPs) or referenced Template Forms (TFs) listed in the SOP Library, please contact [email protected]

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Quality Assurance Series


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
  • TF-003 Research Sponsorship Quality Management System Reading Log


SOP Number – QASOP-002
SOP Title – GCP Audits

Associated Documents

  • TF-004 Confidential Audit Findings
  • TF-005 ISF Audit Self-Assessment Checklist
  • 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 Vendor Audit Report
  • TF-048 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 – Document Version Control

Associated Documents

  • TF-013 Document 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 Document Version Control Log
  • TF-014 ISF Delegation Log
  • TF-015 TMF Delegation Log
  • TF-016 Training Log
  • 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-041 Protocol Deviation Tracking Log
  • TF-042 Notification of Protocol Violation Form
  • 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


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

Project Development Series


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


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 – Vendor Selection, Management and Contracts

Associated Documents

  • TF-025 Vendor Assessment Form
  • TF-026 Vendor 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

Project Activity Series


SOP Number – PASOP-001
SOP Title – Annual Update of Investigators Brochure

Associated Documents

  • TF-024 Delegation of Sponsor Duties Agreement


SOP Number – PASOP-002
SOP Title – Site 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 Documents TMF & 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 & 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 & 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 – Amendments

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 & Capability from R&D to deliver

Associated Documents

N/A

Data Management Series


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