Standard Operating Procedures and Template Documents

This section contains UHB’s approved Standard Operating Procedures (SOPs) for research.

Please refer to this page often as the most up-to-date version of each SOP will appear on this page. If you have any questions, please contact Deborah Popoola.

Policies

All UHB’s approved research policies published on UHB’s intranet, which is only available to staff.

Standard Operating Procedures

Reference Number Document title Version  
RDS001

Creation and Control of R&D SOPs, Templates and Guidance Documents

3

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RDS002

Safety Reporting including Adverse Events in Research

6

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RDS003

Reporting of Serious Breaches in Clinical Research

3

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RDS004 R&D Progress Reports 3

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RDS005 R&D Study Audits and Inspections 3

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RDS009 Record Keeping, Document and Data Control in Research 3

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RDS010 Contracts and Agreements 2

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RDS011

Study Monitoring of Trust Sponsored Studies

2

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RDS012

Approvals Process

3

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RDS013

R&D Office Procedure for Reviewing Study Amendments

2

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RDS014

Research Related Archiving

1

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RDS015

External Reporting on Clinical Research Studies

3

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RDS016

Consent in Research

2

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RDS017a

Project Management:
From Study Set Up to Closeout for UHB NFT sponsored

1

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RDS017b Project Management:
From Study Set-Up to Closeout for studies hosted by UHB
1

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Template Documents

Reference Number Document title Version  
RDT004

Protocol Signature Page

1

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RDT007

Protocol Deviations Log

1

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RDT008

Delegation of Duties

1

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RDT010 UHB Trial Master File Checklist 3

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RDT010.1 Investigator Study Site File Index Checklist 3

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RDT011 Handover Plan 2

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RDT012 R&D Protocol Template for Clinical Research Studies 2

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RDT020 File Note 2

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RDT021 Training Log 1

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RDT024 Pregnancy Report Form 1

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RDT025 Archive Plan 1

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RDT026 Archive Inventory List 1

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RDT027 Subject Screening Log 1

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RDT028 Research Archive Label 1

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RDT029 Study Archived Notification 1

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RDT031 Formal Notification of Closure Letter – External Sponsor 1

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RDT032 Formal Notification of Closure Letter – UHB Sponsor 2

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RDT039 External Monitor Training Certificate for EPR 10

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RDT040 Post Monitoring Visit Checklist 2 Click here to view

 

Guidance Documents

RDG001 Guidance on the Content of a
Study File
3

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RDG003 Site Initiation 1

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RDG008 Guidance for Delegating and
Receiving Informed Consent in Research
1

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