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SOPs and Guidance

Management of Trust Sponsored Studies

Title Number Version Implementation Date Related Documents
Application to the Trust for Sponsorship of a CTIMP R&D/S02 9.0 13th February 2023 F03
Application to the Trust for Sponsorship of a Research Study R&D/S82 3.0 13th February 2023 S02, S14, S74, S83, G05, G06
Application for Sponsorship of a Non-CE Marked Medical Device Study R&D/S83 2.0 15th July 2019 None
Case Report Form (CRF) Design and Completion R&D/S81 4.0 14th December 2022 None
Data Management R&D/S29 4.0 2nd October 2019 None
Data Monitoring Committees for Clinical Trials R&D/S72 5.0 7th December 2022 T27
Delegation of Tasks for Trust Sponsored Research Studies R&D/S03 9.0 6th December 2022 F16, T62
End of Study Reports and Publications R&D/S27 4.0 15th July 2019 T24
Making Amendments to Trust Sponsored Research Studies R&D/S74 6.0 27th February 2023 F18, F101
Monitoring of Trust Sponsored Research Studies R&D/S08 13.0 17th April 2023 F10, F14, F17, F64, F65, F66, F69, F70, F78, T03
Preparing a Statistical Analysis Plan R&D/S85 5.0 7th December 2022 None
Production of a Randomisation Schedule for Randomised Controlled Trials (RCTs) R&D/S62 5.0 24th April 2023 F45
Risk Assessment R&D/S18 5.0 13th February 2023 F15
Reporting Requirements During Research Studies R&D/S06 6.0 21st November 2022 F21, F22
Study Close-Out R&D/S21 5.0 21st November 2022 F19
REDCap Database Access R&D/S65 1.0 15th May 2024 None

1st April 2023 – 31st March 2024

York & Scarborough

50 research studies open to recruitment


3246 patients recruited into clinical trials