Glasgow Clinical Trials Unit

SOPs Guidelines
Title Number Version Release Date
Research Governance Protocol Template 51.001A 3.0 30/05/18
CTIMP Protocol Template 51.001B 3.0 30/05/18
Programme Assessment Review Form 51.003A 2.0 14/07/16
Risk Assessment Tool 51.004A 4.0 24/05/18
Risk Assessment for Research Studies sponsored by NHS GG&C 51.004B 1.0 05/10/22
Hosted Non-Commercial CTIMP Risk Assessment 51.004C 1.0 05/10/22
International Site Questionnaire 51.007A 2.0 14/07/16
NHS GG&C and University of Glasgow Co-Sponsor Letter 51.007B 1.0 20/01/21
NHS GG&C Sponsor Letter 51.007C 1.0 20/01/21
Responsibilities delegated to the Chief Investigator for CTIMP Trials Co-Sponsored by the University of Glasgow and NHS GG&C 51.007D 3.0 20/01/21
Responsibilities delegated to the Chief Investigator for CTIMP Trials Sponsored by NHS GG&C 51.007E 1.0 20/01/21
Protocol Deviation Reporting Form 51.008A 3.0 20/12/18
Protocol Deviation Reporting Form (Part 2) 51.008B 3.0 19/04/22
Protocol Deviation Log 51.008C 2.0 14/06/22
NHS Project Costs for Non-commercial Grants 51.010A 4.0 26/10/22
List of CTU Groups and Support Departments 51.010B 2.0 14/07/16
Feasibility Form 51.010C 4.0 26/10/22
Grant with Potential non CA/CE marked Medical Device - Checklist 51.010D 1.0 18/01/22
Short Letter CTA CI Employer 51.011A 2.0 14/07/16
Proforma for Signing of Non-Commercial Funded Clinical Trial Agreement 51.011C 2.0 14/07/16
Vendor Assessment List 51.015A 3.0 18/11/21
Data Management Vendor Assessment 51.015B 3.0 23/11/21
Laboratory Vendor Assessment 51.015C 3.0 23/11/21
IMP Manufacturer Vendor Assessment Form 51.015D 2.0 14/07/16
NHS GG&C Vendor Assessment Tool For IMP Manufactures 51.015E 2.0 14/07/16
Vendor Assessment Report 51.015F 2.0 23/11/21
Vendor Assessment Reminder/Escalation Letter 51.015G 1.0 18/11/21
Collaborator Assessment Questionnaire 51.015H 1.0 24/11/21
Vendor Exemption Letter 51.015I 1.0 18/11/21
Vendor Assessors and SMEs 51.015J 1.0 18/11/21
Vendor Assessment Outcome 51.015K 1.0 18/11/21
Imaging Facility Vendor Assessment 51.015L 1.0 21/12/21
Trial Master File Index 51.016A 4.0 04/10/21
CI File Index 51.016B 5.0 04/10/21
PI Site File Index 51.016C 2.0 14/07/16
Pharmacovigilance File Index 51.016D 3.0 14/07/16
IMP Management File Index 51.016E 4.0 12/12/18
CTM File Index 51.016F 3.0 11/12/18
Project Management Unit File Index 51.016G 2.0 14/07/16
Sponsor File Index 51.016H 2.0 24/05/18
TMF Quality Control Review 51.016I 1.0 14/07/16
TMF Cover Sheet 51.016J 1.0 14/07/16
Sponsor Oversight Checklist - CTIMPs 51.018A 6.0 02/03/20
NHS GG&C Sponsor/Co-Sponsor RGL 51.020A 3.0 02/03/20
Amendment Type Confirmation Email 51.021A 2.0 14/07/16
Template IDMC Charter 51.023A 2.0 14/07/16
IDMC Recommendation Form 51.023B 2.0 14/07/16
Letter of Invitation to IDMC member GG&C sole Sponsor 51.023C 1.0 25/08/22
Letter of Invitation to IDMC member GG&C/UoG co-sponsor 51.023D 1.0 25/08/22
Essential Documents for Archiving - Archiving Checklist (for CTIMPs) 51.024A 4.0 12/04/18
Agreement on Delegation of Responsibility for Archiving Study Documentation Form 51.024B 2.0 12/04/18
Archiving Certificate 51.024C 2.0 12/04/18
Essential Documents for Archiving - Archiving Checklist 51.024D 3.0 12/04/18
Essential Documents for Archiving - Archiving Checklist (for Non-CTIMPs) 51.025A 2.0 12/04/18
Categorising Laboratory Tests undertaken within CTIMPs Sponsored by NHS GG&C or Co-Sponsored by NHS GG&C and University of Glasgow 51.028A 1.0 24/05/18
Laboratory Manual 51.029A 2.0 02/11/18
Site Sample Log 51.030A 1.0 24/05/18
Sample Transfer Form 51.030B 1.0 24/05/18
Sample Handling Manual 51.030C 2.0 02/11/18
NHS GG&C Research Governance Non-Compliance and CAPA Report 51.031A 1.0 17/12/18
Serious Breach Corrective and Preventative Action Plan Tracker 51.031B 1.0 17/12/18
Corrective and Preventative Action Plan Tracker 51.031C 1.0 17/12/18
Categorising Imaging Tests undertaken within CTIMPS Sponsored by NHS GG&C or Co-Sponsored by NHS GG&C and University of Glasgow 51.033A 1.0 09/03/20
MRI Site Survey Template 51.033B 1.0 09/03/20
CT Site Survey Template 51.033C 1.0 09/03/20
Sponsor Imaging Manual Template 51.034A 1.0 09/03/20
CT/MRI Subject Data Transmittal Form Template 51.034B 1.0 09/03/20
Template MRI/CT Protocol 51.034C 1.0 09/03/20
CT/MRI Imaging Parameters Template 51.034D 1.0 09/03/20
Data Transfer Log 51.034E 1.0 09/03/20
Letter of Invitation to TSC Member GG&C Sole Sponsor 51.036A 1.0 25/08/22
Letter of Invitation to TSC Member GG&C/UoG Co-sponsor 51.036B 1.0 25/08/22