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SOPs and Guidance

Conducting Research Studies at York Trust Hospitals - SOPS and related Forms and Templates

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 2022 to 31st March 2023

York and Scarborough

125 research studies open to recruitment

=

3882 patients recruited into clinical trials