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Forms
53 NHS GG&C Sponsor Governance
SOPs
Forms
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
Follow Up letter
53.004H
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
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