Glasgow Clinical Trials Unit

SOPs Guidelines
Title Number Version Release Date
Reporting of Fraud in Clinical Trials of an Investigational Medicinal Product not identified as a Serious Breach of GCP 53.002A 1.0 05/07/22
Monitoring Plan for a Clinical Trial of an Investigational Medicinal Product 53.004A 5.0 26/11/20
NHS GG&C Research Governance Monitoring Risk Assessment 53.004B 5.0 26/11/20
Monitoring Costing Plan 53.004D 2.0 15/07/16
Monitoring Telephone Contact Form 53.004E 2.0 15/07/16
Monitoring Visit Agenda Template 53.004F 2.0 15/07/16
Monitoring Visit Log 53.004G 2.0 15/07/16
Preliminary Follow Up Letter / Follow Up Letter 54.004H 3.0 18/01/22
Site Compliance Visit Report 53.004I 2.0 15/07/16
Pharmacy Visit Report 53.004K 2.0 15/07/16
Site Close Out Report 53.004L 2.0 15/07/16
Monitoring Escalation Report 53.004M 2.0 15/07/16
End of Trial Monitoring Document Reconciliation 53.004O 2.0 15/07/16
Research Audit Plan 53.005A 5.0 18/02/22
Research Study Site File Index 53.005C 3.0 15/07/16
Responsibilities Log 53.005D 3.0 15/07/16
Screening/Recruitment/Withdrawal Log 53.005E 2.0 15/07/16
Patient Identification Log 53.005F 3.0 15/07/16
Key Study Contacts 53.005G 2.0 15/07/16
Site Tracker/Protocol/Amendment Distribution Log 53.005H 2.0 15/07/16
Training Log 53.005I 2.0 15/07/16
File Note Template 53.005J 3.0 15/07/16
Archiving Log 53.005K 3.0 15/07/16
Participating Site File Index 53.005N 2.0 15/07/16
Internal Audit Schedule 53.005P 1.0 18/02/22
Audit Start Up Communication Letter 53.005Q 1.0 18/02/22
Remote Trial Health Check Generator 53.005R 1.0 18/02/22
Remote Audit Start Up Communication Letter 53.005S 1.0 18/02/22
Internal Audit - Approved Auditors 53.005T 1.0 18/02/22
Audit Finding Reminder 53.005U 1.0 18/02/22
Audit Reminder 53.005V 1.0 18/02/22
Perceived Risk Feedback 53.005W 1.0 18/02/22
Audit Report Template 53.005X 1.0 18/02/22
Research & Innovation Monitoring Handover Checklist 53.006A 2.0 25/08/22
Accompanied Visit Checklist 53.008A 2.0 08/02/23
Protocol Deviation Log 53.009A 1.0 11/12/18