York Teaching Hospital NHS Foundation Trust provides a comprehensive range of acute hospital and specialist healthcare services for approximately 800,000 people living in and around York, North Yorkshire, North East Yorkshire and Ryedale - an area covering 3,400 square miles.
The Research & Development Office strive to increase the opportunities for patients and their families to be informed about, and involved in, our research and research processes.
The information on these pages will be relevant to York Hospital staff NHS Foundation Trust staff who are planning their own research study.
This section contains the Standard Operating Procedures (SOPs) and Guidance documents issued by the R&D Unit.
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SOPs and Guidance
| Title | Number | Version Number | Implementation Date | Related SOP |
|---|---|---|---|---|
| AE/SAE Log | R&D/F46 | 3.0 | 9th February 2021 | R&D/S05 & R&D/S19 |
| Amendment Checklist (Research Teams) | R&D/F18 | 10.0 | 15th August 2022 | R&D/S07 & R&D/S74 |
| Amendment Log | R&D/F118 | 3.0 | 15th August 2022 | R&D/S78 |
| Archive Box Label | R&D/F56 | 9.0 | 8th January 2023 | R&D/S11 |
| Audit Report Form | R&D/F68 | 5.0 | 9th October 2023 | R&D/S71 |
| Checklist for Implementing Service Level Agreements: Non-Trust Sponsored Studies | R&D/F02 | 1.0 | 8th March 2018 | R&D/S63 |
| Confirmation of Capacity & Capability Checklist - PIC Sites | R&D/F80 | 5.0 | 5th November 2020 | R&D/S67 |
| Consent Checklist | R&D/F99 | 4.0 | 9th October 2023 | R&D/S71 |
| Development Safety Update Report (DSUR) Form | R&D/F21 | 6.0 | 21st November 2022 | R&D/S06 |
| Document Version Control Log | R&D/F101 | 3.0 | 6th March 2023 | R&D/S74 |
| Enrolment Log | R&D/F110 | 1.0 | 17th August 2017 | R&D/S09 |
| Feasibility Application Form | R&D/F03 | 8.0 | 13th February 2023 | R&D/S02 |
| File Note Log | R&D/F59 | 2.0 | 17th August 2017 | R&D/S09 |
| Honorary Contract/Researcher Access Application Form | R&D/F75 | 6.0 | 2nd November 2022 | R&D/S20 |
| Initiation Report | R&D/F14 | 6.0 | 13th February 2023 | R&D/S08 |
| Interim Monitoring Report | R&D/F10 | 7.0 | 13th February 2023 | R&D/S08 |
| Investigator Site File Contents List | R&D/F11 | 7.0 | 9th October 2023 | R&D/S09 & R&D/S71 |
| Investigator Site File Remote Monitoring Checklist | R&D/F78 | 1.0 | 5th February 2020 | R&D/S08 |
| Laboratory Checklist | R&D/F60 | 5.0 | 4th January 2016 | |
| Lone Working Visit Log | R&D/F113 | 4.0 | 24th April 2023 | R&D/S98 |
| Lone Worker Profile | R&D/F114 | 4.0 | 24th April 2023 | R&D/S98 |
| Medical Records Checklist | R&D/F98 | 4.0 | 9th October 2023 |
R&D/S71 |
| Monitoring/Audit Action List | R&D/F66 | 7.0 | 13th February 2023 | R&D/S08 |
| Monitoring Checklist (for Trust Sponsored Studies) | R&D/F65 | 7.0 | 13th February 2023 | R&D/S08 |
| Monitoring Summary Report | R&D/F69 | 6.0 | 13th February 2023 | R&D/S08 |
| Monitoring Visit Log | R&D/F17 | 6,0 | 13th February 2023 | R&D/S08 |
| Notification of Urgent Safety Measure Form | R&D/F20 | 5.0 | 4th February 2021 | R&D/S68 |
| Pharmacy Audit Checklist | R&D/F100 | 4.0 | 9th October 2023 | R&D/S71 |
| PI Declaration of Responsibilities (Form) | R&D/F76 | 1.0 | 1st March 2023 | R&D/S14 |
| PIC Site File: Template Contents List | R&D/F120 | 2.0 | 5th November 2020 | R&D/S67 |
| Pregnancy Notification Form | R&D/F121 | 3.0 | 3rd January 2024 | R&D/S05 & R&D/S19 |
| Protocol/GCP Deviations Log | R&D/F119 | 2.0 | 18th April 2023 | R&D/S04 |
| Quarterly Study Review Form for Trust Sponsored Studies | R&D/F22 | 6.0 | 14th February 2023 | R&D/S06 |
| Refund of Research Participant Travel Costs - Cashiers Office | R&D/F122 | 2.0 | 24th June 2021 | R&D/S31 |
| Refund of Research Participant Travel Costs - Cheque | R&D/F123 | 2.0 | 24th June 2021 | R&D/S31 |
| Refund of Research Participant Travel Costs - Direct Bank Transfer | R&D/F124 | 2.0 | 24th June 2021 | R&D/S31 |
| Research Related SAE/SUSAR Initial Report Form | R&D/F07 | 7.0 | 3rd January 2024 | R&D/S05 & R&D/S19 |
| Research Related SAE/SUSAR Follow-Up Report Form | R&D/F08 | 5.0 | 9th February 2021 | R&D/S05 & R&D/S19 |
| Risk Assessment Form | R&D/F15 | 5.0 | 13th February 2023 | R&D/S18 |
| SUSAR Unblinding Record | R&D/F09 | 5.0 | 9th February 2021 | R&D/S13 & R&D/S05 |
| SAE/SUSAR R&D Unit Checklist | R&D/F49 | 2.0 | 17th August 2017 | R&D/S13 |
| Screening Log | R&D/F71 | 2.0 | 17th August 2017 | R&D/S09 |
| Serious Breach Notification Form - to MHRA and REC (CTIMPs only) | R&D/F06 | 8.0 | 19th September 2018 | R&D/S04 |
| Serious Breach Notification Form - to the REC (non-CTIMPs only) | R&D/F81 | 5.0 | 18th April 2023 | R&D/S04 |
| Set Up Checklist for New Studies (Research Teams) | R&D/F103 | 2.0 | 18th April 2023 | R&D/S37 |
| Site Initiation Attendance Log | R&D/F70 | 6.0 | 13th February 2023 | R&D/S08 |
| Source Data Location List | R&D/F58 | 3.0 | 11th October 2023 | R&D/S09 |
| Source Data Verification (SDV) Form | R&D/F64 | 6.0 | 13th February 2023 | R&D/S08 |
| Sponsor Details of Randomisation (For Sponsor Use Only) | R&D/F45 | 4.0 | 2nd October 2019 | R&D/S62 |
| Study Audit Checklist (for Hosted Studies) | R&D/F67 | 4.0 | 9th October 2023 | R&D/S71 |
| Study Close Out Report | R&D/F19 | 5.0 | 21st November 2022 | R&D/S21 |
| Study Delegation and Signature Log | R&D/F16 | 8.0 | 6th December 2022 | R&D/S03 |
| Sub-Contracting Services for Research Activities: Checklist for Assessing Potential Establishments | R&D/F01 | 2.0 | 12th June 2019 | R&D/S63 |
| SUSAR Data Collection Form | R&D/F47 | 3.0 | 9th February 2021 | R&D/S13 & R&D/S05 |
| Suspected Serious Breach Notification to Sponsor Form (all studies) | R&D/F05 | 7.0 | 18th April 2023 | R&D/S04 |
| Training Log | R&D/F55 | 5.0 | 4th October 2023 | R&D/S25 |
| Trial Master File Contents List | R&D/F95 | 2.0 | 17th August 2017 | R&D/S09 & R&D/S08 |
| Training/Meeting Register | R&D/F54 | 1.0 | 9th October 2018 | |
| Delegation and signature Log - Delegation of tasks to a named person for CTAs | R&D/F125 | 2.0 | 27th September 2021 | R&D/S107 |
| Notice to End of Honorary Contract/Letter of Access | R&D/F06 | 1.0 | 24th December 2024 | R&D/S113 |
| Notice of End of Sub-Contracted Service Agreement | R&D/F86 | 1.0 | 24th December 2024 | R&D/S113 |
| Notification of Study Closure to Treatment or Continuous Care Site | R&D/F97 | 1.0 | 24th December 2024 | R&D/S113 |
| Confirmation of R&I Closeout | R&D/F104 | 1.0 | 24th December 2024 | R&D/S113 |
TEMPLATES
| Title | Number | Version Number | Implementation Date | Related SOP |
|---|---|---|---|---|
| Closedown Checklist | R&D/T46 | 1.0 | 10th October 2023 | R&D/S11 |
| Co-sponsorship Agreement | R&D/T11 | 4.0 | 22nd November 2023 | R&D/S23 |
| Database Amendment Log | R&D/T41 | 1.0 | 11th July 2023 | R&D/S40 |
| Data Monitoring Committee Terms of Reference | R&D/T27 | 5.0 | 7th December 2022 | R&D/S72 |
| Delegation of Duties and Signature Log for the Trial Management of Trust Sponsored Studies | R&D/T62 | 2.0 | 5th August 2019 | R&D/S03 & R&D/S09 |
| End of Study Template | R&D/T24 | 4.0 | 15th July 2019 | R&D/S27 |
| File Note Template | R&D/T20 | 2.0 | 17th August 2017 | R&D/S09 |
| File Note Identification of Research Participants | R&D/T29 | 5.0 | 13th April 2022 | R&D/S77 |
| Material Transfer Agreement (MTA) Template | R&D/T31 | 3.0 | 6th March 2023 | |
| Monitoring Plan Template | R&D/T03 | 7.0 | 13th February 2023 | R&D/S08 |
| mNCA Responsibility Schedule - Trust modifications | R&D/T17 | 4.0 | 22nd November 2023 | R&D/S23 |
| NHS to NHS Proforma | R&D/T34 | 6.0 | 2nd November 2022 | R&D/S20 |
| PI Oversight: Meeting/Teleconference Record Template | R&D/T45 | 1.0 | 1st August 2018 | |
| QA Check of Research Database | R&D/T25 | 1.0 | 11th July 2023 | R&D/S40 |
| Remote Source Data Verification (SDV) Agreement | R&D/T50 | 1.0 | 27th February 2023 | |
| Research Related Adverse Event (AE) Recording Template | R&D/T02 | 6.0 | 18th October 2021 | R&D/S05 & R&D/S19 |
| SOP Template | R&D/T01 | 11.0 | 16th January 2023 | R&D/S01 |
| Study-Specific SOP Template | R&D/T08 | 5.0 | 11th August 2020 | R&D/S26 |
| Sub-contract Agreement | R&D/T12 | 4.0 | 22nd November 2023 | R&D/S23 |
| Template Case Note Labels 1 - 'safety reporting required' | R&D/T26 | 5.0 | 18th January 2022 | R&D/S24 |
| Template Case Note Labels 2 - 'observational/safety reporting' | R&D/T47 | 4.0 | 18th January 2022 | R&D/S24 |
| Wallet Cards Template | R&D/T48 | 3.0 | 9th March 2022 | R&D/S24 |
| PI Agreement | R&D/T44 | 1.0 | 18th September 2023 | R&D/S110 |
| CI Declaration of Responsibilities | R&D/T61 | 1.0 | 15th October 2024 | R&D/S02, R&D/S82, R&D/S83 |
| Feasibility Review Result Template Letter/Email | R&D/T21 | 7.0 | 13th February 2023 | R&D/S02 |
1st April 2023 – 31st March 2024
York & Scarborough
50 research studies open to recruitment
3246 patients recruited into clinical trials
