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
Project Development Series
Project Activity Series
Data Management Series

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-047 Non-Study-Specific Audit CAPA Form
TF-050 Process Audit Report

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

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

SOP Number – QASOP-007
SOP Title – Research Templates

Associated Documents

TF-001 Research SOP Template
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-036 SAE Form
TF-037 SUSAR Reporting Checklist
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

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-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-021 Risk Assessment Form
TF-023 Chief Investigator Conditions of Sponsorship Agreement

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

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

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

SOP Number – PASOP-005
SOP Title – Informed Consent

Associated Documents

TF-034 Screening and Recruitment Log 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

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

Associated Documents

TF-037 SUSAR Reporting Checklist
TF-038 SUSAR Reporting Form

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

SOP Number – PASOP-012
SOP Title – Amendments

Associated Documents

N/A

SOP Number – PASOP-013
SOP Title – End of Study Procedures

Associated Documents

N/A

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

Data Management Series

SOP Number – DMSOP-001
SOP Title – Data Management

Associated Documents

N/A

SOP Number – DMSOP-002
SOP Title – Case Report Forms

Associated Documents

N/A