| SOP Reference Number | SOP Title |
| S-1002 | Sponsorship Review and Approval
|
| S-1003 | UHL Sponsor risk assessment and management |
| S-1004 | SOP for development safety update report for CTIMPS |
| S-1005 | SOP for management of contracts |
| S-1006 | SOP for informed consent |
| S-1007 | UHL Monitoring |
| S-1008 | UHL Training for Staff Engaged in Research |
| S-1009 | UHL SAEs_SUSARS |
| S-1010 | UHL Chief Investigator Responsibilities |
| S-1011 | SOP for site initiation of CTIMP research |
| S-1012 | UHL CAPA |
| S-1013 | UHL Serious Breaches |
| S-1014 | UHL Sponsor Green Light Process for research sponsored by UHL |
| S-1015 | UHL Essential Documents |
| S-1016 | UHL Procedure in event of non-compliance |
| S-1017 | UHL Green Light Process for Amendments |
| S-1019 | Procedure for the management of suspected fraud and misconduct |
| S-1020 | Process of assessing site feasibility |
| S-1021 | Process of writing study protocols |
| S-1022 | Process of submission of annual progress reports |
| S-1023 | Investigators brochure (IB)/summary of product characteristics (SPC) preparation, review, approval and amendment |
| S-1024 | Study close down |
| S-1025 | Convening a data safety monitoring committee |
| S-1026 | Urgent safety measures |
| S-1027 | Creating a statistical analysis plan (SAP) |
| S-1028 | Managing amendments to contracts |
| S-1029 | Archiving of paper hybrid TMF Essential Documents |
| S-1030 | End of study reporting requirements |
| S-1031 | Data management process |
| S-1032 | Vendor Selection |
| S-1033 | Randomisation and blinding |
| S-1034 | Obtaining finance approval |
| S-1035 | Case report form production |
| S-1036 | UHL Audit |
| S-1037 | Management of healthy volunteers in research studies of the bioequivalence, pharmacokinetics (PK) or pharmacodynamics of investigational medicinal products |
| S-1039 | Sample management for research studies sponsored by UHL |
| S-1040 | UHL Safety Reporting NON CE Marked Devices |
| S-1041 | UHL Safety Reporting for CE Marked Devices |
| S-1043 | Transparency for Research Sponsored by UHL |
| S-1045 | End of Sponsor Green Light |
| S-1047 | Re-Opening Process During Pandemic for Sponsored Studies |
| SOP Reference Number & Title | Appendix Title |
| S-1002: SOP Sponsorship Review and Approval | Appendix 1 - Sponsorship Review and Approval Peer Review Form
Appendix 2 - Sponsorship Review and Approval Overview
|
| S-1003: SOP UHL Sponsor risk assessment and management | Appendix 1 - Risk Matrix Score Tables Appendix 2 – UHL 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 Appendix 7 - UHL Multi-centre 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 Appendix 2 - UHL Multi-centre Checklist |
| 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 |
| SOP 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-1024: UHL Study Closedown | Appendix 1 - UHL Site Close Down Report Template
Appendix 1a - Report Non CE Marked Medical Devices Studies Template
Appendix 2 - Visit Log
Appendix 3 - Checklist for Non CTIMP Studies
Appendix 3a - Checklist for CE Marked Device Studies |
| S-1023: Investigators brochure (IB)/summary of product characteristics (SPC) preparation, review, approval and amendment | 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 paper hybrid TMF Essential Documents | Appendix 1 – Archiving Facility Checklist
Appendix 2 – Pre-Archiving Checklist
Appendix 3 – Archiving Process Flowchart
Appendix 4 – Retrieval Process Flowchart
Appendix 5 – Archiving Guidance Timetable
Appendix 6 – Sponsor Expiry of Archiving Period Notification
Appendix 7 – Sponsor Archiving Period Notification
Appendix A
Appendix B
Appendix C
Appendix D
Retention Schedules |
| S-1030: SOP UHL End of Study | Appendix 1 - 1 Month Pre Due Date Reminder
Appendix 2 - Due Date Email Reminder
Appendix 3 - 1 Month Post Due Date Email Reminder
Appendix 4 - EoS Report Acknowledgement
|
| S-1031: SOP for Data Management | Appendix 1 – Blank DoA Signature Log Appendix 2 - Data Management Flow Chart |
| 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-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 |
| SOP S-1045 – End of Sponsor Green Light | Appendix 1A - Checklist CI site Appendix 1B - Checklist
Appendix 2 – 6 Month Email Reminder
Appendix 3 – 9 Month Email Reminder
Appendix 4 – 10 Month Email Reminder
Appendix 5 – 11 Month Email Reminder
Appendix 6 – Receipt of Completed Sponsor Green Light Checklist
Appendix 7 - Completion Request (Multi-Centre)
Appendix 8 - Reminder 1 Month (Single Site)
Appendix 9 - Reminder 1 Month (Multi-Site)
Appendix 10 - Reminder 2 Months (Single Site)
Appendix 11 - Reminder 2 Months (Multi-Site)
Appendix 12 - Request for Further Information
Appendix 13 - Acknowledgement of Completed Sponsor Green Light Checklist |
| SOP S-1047 – Re-Opening Process During Pandemic for Sponsored Studies | Appendix 1 – UHL Pandemic Response |
