| SOP Reference Number & Title | Appendix Title |
| S-1002: SOP UHL Documentation review process | Appendix 1 – Sponsor Request Form
Appendix 2 – Peer Review |
|
S-1003: SOP UHL Sponsor risk assessment and management
| Appendix 1 – Risk Matrix Score Tables
Appendix 2 – Risk Assessment Form
Appendix 4 – Risk Assessment Flow Chart
Appendix 5 – UHL Sponsor Review Risk Assessed Studies Checklist
Appendix 6 – Sponsor Review Non-Risk Assessed Checklist |
|
S-1004: SOP for development safety update report for CTIMPS
| Appendix 1 – DSUR Template
Appendix 2 – DSUR Reporting Timeframe Working Illustration
Appendix 3 – DSUR Reporting Timeframe Working Instructions |
|
S-1005: SOP for management of contracts
|
Appendix 1 – UHL Contracts Review and Approval Process
|
|
S-1006: SOP for informed consent
| Appendix 1 – Blank DoA Signature Log
Appendix 2 – Assent Signature Log
Appendix 3 – Assent Consent Log
Appendix 4 – Witness Consent Form Template
Appendix 5 Consent Witness Statement
Appendix 6 – Pre-Consent activity proforma
Appendix 7 – eSignature Log |
|
SOP S-1007 UHL Monitoring
|
Appendix 1 – Monitoring Plan
Template
Appendix 1a – Monitoring Plan
Template Medical Devices
Appendix 2 – Monitoring
Strategy Table
Appendix 3 – Contact
Monitoring Log
Appendix 4 – Trial Monitoring
Visit Log
Appendix 5 – UHL Template
Schedule Source Data
Appendix 6 – CTIMP Monitoring
Visit Report Appendix 6a – Monitoring
Visit Report Non CE Marked Medical Devices
Appendix 7 – Pharmacy visit
report
Appendix 8 – Non-CTIMP Interim Site Audit checklist
& Response
Appendix 8a – CE Marked
Medical device Interim Site Audit checklist & Response Doc
|
|
SOP S-1008 UHL Training for Staff Engaged in Research
| Appendix 1 – SOPs Read Log for UHL Sponsored Studies
Appendix 2 – Protocol Training Log
Appendix 3 – CTIMP SOP generic list
Appendix 4 – Non-CTIMP SOP generic list |
|
SOP S-1009 UHL SAEs_SUSARS
| Appendix 1 – Pregnancy Reporting Form
Appendix 2 – Multicentre line listing
Appendix 3 – SAE Tracking Log
Appendix 4 – UHL SAE Process Flowchart
Appendix 5 – Template Sponsor SAE Email
Appendix 6 – Multicentre line listing CTIMP Appendix 7 – eSUSAR Guidance
Appendix 8 – UHL SUSAR Process Flowchart
Appendix 9 – UHL Expedited Safety Report Notification Email
Appendix 10 – UHL Suspected SUSAR Unblinding Process Flowchart
UHL SAE Form A Completion Guidance Document CTIMP
UHL SAE Form B Completion Guidance Document Non-CTIMP
UHL SAE Reporting Form A CTIMP
UHL SAE Reporting Form B Non CTIMP
|
|
SOP S-1010 UHL Chief Investigator Responsibilities
| Appendix 1 – Roles and Responsibilities of CI Agreement |
|
S-1011: SOP for site initiation of CTIMP research
| Appendix 1a – Site Initiation Checklist & Outstanding Issues Report
Appendix 2 – Pharmacy Site Initiation Visit Checklist
Appendix 3 – SOP Read Log for UHL Sponsored Studies
Appendix 4 – Subject Screening Log
Appendix 5 – Subject Enrolment Log
Appendix 6 – Site Initiation Checklist & Outstanding Issues Report Non-CTIMP
Appendix 6a – UHL Site Initiation Checklist & Outstanding Issues Report – CE Marked Medical Device Studies
Appendix 7 – Site Initiation Checklist Guidance Non-CTIMP
Appendix 7a – Site Initiation Checklist Guidance – CE Marked Medical Device Studies
Appendix 8 – Investigational Medical Device Accountability Log |
|
SOP S-1012 UHL CAPA
| Appendix 1 – CAPA Form |
|
SOP S-1013 UHL Serious Breaches
| Appendix 1 – Serious Breach Notification form
Appendix 2 – Template file note
Appendix 3 – Protocol Deviation Tracking Log |
|
SOP S-1014 UHL Sponsor Green Light Process for research
sponsored by UHL
| Appendix 1 – Green Light Process First Site
Appendix 2 – Multi Centre Site Sponsor Green Light
Appendix 3 – Contracts Agreements Listing |
|
SOP S-1015 UHL Essential Documents
| Appendix 1 – TMF ISF Contents CTIMP
Appendix 1a TMF Non CE Marked Medical Device Studies
Appendix 2 – TMF ISF Contents non CTIMP
Appendix 2a – TMF ISF Contents Index for CE Marked and Proof of Concept Studies
Appendix 3 – Version Control Doc
Appendix 4 – File retention recommendations |
|
SOP S-1017 UHL Green Light Process for Amendments
| Appendix 1 – Amendments requiring MHRA authorisation only
Appendix 2 – Amendments requiring MHRA & REC authorisation
Appendix 3 – Amendments requiring REC favourable opinion
Appendix 4 – Amendments not normally requiring notification
|
|
S-1019: Procedure for the management of suspected fraud and
misconduct
| Appendix 1 – Suspected Fraud or Misconduct Initial Investigation Template
Appendix 2 – Suspected Fraud or Misconduct Interview Template
Appendix 3 – Evidence Listing Template |
|
S-1020: Process of assessing site feasibility
| Appendix 1 – Site Feasibility Assessment
Appendix 2 – Site Feasibility |
|
S-1021: Process of writing study protocols
| Appendix 3 – Protocol Training Log |
|
S-1023: Investigators brochure (IB)/summary of product
characteristics (SPC) preparation, review, approval and amendment
| Appendix 1 – Investigators Brochure Contents Template
Appendix 2 – Investigators Brochure Review template |
| S-1024: Study close down | Appendix 1 – Site Close Down Report Template
Appendix 1a – Site Close Down Report Non CE Marked Medical Device Studies Template
Appendix 2 – Site Close Down Visit Log
Appendix 3 – UHL Site Close Down Checklist for UHL Sponsored Non CTIMP Studies
Appendix 3a – UHL Site Close Down Checklist for UHL Sponsored CE Marked Device Studies |
| S-1025: Convening a data safety monitoring committee | Appendix 1 – Data Safety Monitoring Committee Charter Template |
| S-1026: Urgent safety measures | Appendix 1 – Urgent Safety Measures Template |
| S-1029: SOP for archiving of essential documents | Appendix 1 – Archiving Facility Checklist
Appendix 2 – Archiving Electronic Aspects of TMF
Appendix 3 – Pre-Archiving Checklist
Appendix 4 – Archiving process flowchart
Appendix 5 – Retrieval process flowchart
Appendix 6 – Archiving-Guidance-Timetable
Form A
Form B
Form C
Form D |
| S-1035: SOP for case report form production | Appendix 1 – Case Report Form Template
Appendix 2 – A guide to designing a case report form |
| S-1037: SOP for management of healthy volunteers in research studies of the bioequivalence, pharmacokinetics (PK) or pharmacodynamics of investigational medicinal products | Appendix 1 – TOPS Consent Form Template |
|
SOP S-1038 SOP Processing and Reporting SAEs, SADEs and
USADEs for Medical Device Studies
|
Appendix 1 – Event
Categorisation Flow Chart
Appendix 2 – Adverse event
Adverse Effect record
Appendix 3 – Serious Adverse
Event Report Form C
Appendix 4 – Multicentre line
listing
Appendix 5 – MHRA reporting
timelines table
Appendix 6 – UHL Medical
Device Process Flowchart
Appendix 7 – Template SAE
SADE Follow Up Information Request Email
|
| SOP S-1039 Sample management for research studies sponsored by UHL | Appendix 1a – FRIDGE Temperature Log
Appendix 1b – FREEZER Temperature Log
Appendix 1c – NITROGEN Log
Appendix 2 – Sample Tracking Log
Appendix 3 – Sample End of Study Sponsor Form
Appendix 4 – Shipping Instructions for Biological Samples
Appendix 5 – Human Tissue Disposal Form |
SOP S-1040 UHL Safety Reporting NON CE Marked Devices
| Appendix 1 – Event Categorisation Flow Chart
Appendix 2 – Adverse Event Adverse Effect Record
Appendix 3 – SAE Report Form C
Appendix 4 – SAE Form C Completion Guidance Document
Appendix 5 – Medical Device Sponsor Process Flowchart
Appendix 6 – Template SAE SADE Follow Up Information Request Email
Appendix 7 – Device Deficiency Form |
| SOP S-1041 Medical Device Studies Safety Reporting (NOT requiring MHRA approval) | Appendix 1 – Event Categorisation Flow Chart
Appendix 2 – Adverse Event Adverse Effect Record
Appendix 3 – SAE Report Form C
Appendix 4 – SAE Form C Completion Guidance Document
Appendix 5 – Multicentre Line Listing
Appendix 6 – Medical Device Sponsor Process Flowchart
Appendix 7 – Template SAE SADE Follow Up Information Request
Appendix 8 – Device Deficiency Form |
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