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 | Implementation Date | Related Documents |
| Set Up and Management of Research Studies | R&D/S09 | 5.0 | 15th August 2022 | R&D/F11, R&D/F58, R&D/F59, R&D/F71, R&D/F95, R&D/F110,R&D/T20 |
| Breaches of GCP or the Study Protocol | R&D/S04 | 8.0 | 18th April 2023 | R&D/F05, R&D/F81, R&D/F119 |
| Urgent Safety Measures or Safety Concerns requiring a temporary or permanent halt to a study | R&D/S68 | 2.0 | 4th February 2021 | R&D/F20 |
| Research Misconduct and Fraud | R&D/S16 | 5.0 | 11th July 2023 | None |
| Intellectual Property | R&D/S93 | 2.0 | 20th April 2022 | None |
| Claiming Research Participant Travel Costs | R&D/S31 | 2.0 | 24th June 2021 | R&D/F122,R&D/F123, R&D/F124 |
| Lone Working | R&D/S98 | 4.0 | 24th April 2023 | R&D/F113, R&D/F114 |
| Preparation, Review and Approval of Study-Specific Standard Operating Procedures for Research | R&D/S26 | 6.0 | 11th August 2020 | R&D/T08 |
| Providing and Documenting Training for Researchers | R&D/S25 | 6.0 | 4th October 2023 | R&D/F55 |
| Quality Assurance | R&D/S28 | 5.0 | 13th February 2023 | None |
| Receiving Informed Consent in Research Studies | R&D/S10 | 6.0 | 4th October 2023 | None |
| Research Related Adverse Event Reporting for Non-CTIMP Studies | R&D/S19 | 3.0 | 3rd January 2024 | R&D/F07, R&D/F08, R&D/F46, R&D/F121,R&D/T02 |
| Research Related Adverse Event Reporting for Trust Sponsored Studies (including reporting of a pregnancy) | R&D/S05 | 9.0 | 3rd January 2024 | R&D/F07, R&D/F08, R&D/F46, R&D/F121, T02 |
| Access to Clinical Trials Protocols and RSI (Reference Safety Information) | R&D/S30 | 2.0 | 27th August 2020 | None |
| Auditing of Research Studies and Processes | R&D/S71 | 5.0 | 27th February 2023 | R&D/F57, R&D/F67, R&D/F68,R&D/F98, R&D/F99, R&D/F100 |
| Identification of Potential Research Participants | R&D/S77 | 6.0 | 13th April 2022 | R&D/T29 |
| Identifying Research Participants in the Medical Records and on CPD | R&D/S24 | 6.0 | 3rd January 2024 | R&D/T26, R&D/T47, R&D/T48 |
| Implementing Amendments for Research Studies NOT Sponsored by the Trust | R&D/S07 | 7.0 | 15th August 2022 | R&D/F18, R&D/F118 |
| Processing Laboratory Research Samples | R&D/S94 | 4.0 | 16th September 2021 | R&F/T60 |
| Delivery Team Requirements in the event of an IMP Recall | R&D/S69 | 1.0 | 16th August 2022 | None |
| Research Related Adverse Incident Reporting | R&D/S112 | 1.0 | 14th February 2023 | None |
| External Monitoring Visits | R&D/S66 | 1.0 | 16th August 2023 | None |
| Source Data | R&D/S109 | 1.0 | 14th February 2024 | None |
1st April 2023 – 31st March 2024
York & Scarborough
50 research studies open to recruitment
3246 patients recruited into clinical trials
