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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 8.0 18th July 2019 F03,
Application to the Trust for Sponsorship of a Research Study R&D/S82 2.0 15th July 2019 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 3.0 15th July 2019 None
Data Management R&D/S29 4.0 2nd October 2019 None
Data Monitoring Committees for Clinical Trials R&D/S72 4.0 22nd July 2019 T27
Delegation of Tasks for Trust Sponsored Research Studies R&D/S03 8.0 5th August 2019 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 5.0 15th July 2019 F18, F101
Monitoring of Trust Sponsored Research Studies R&D/S08 12.0 9th December 2019 F10, F14, F17, F64, F65, F66, F69, F70, T03
Preparing a Statistical Analysis Plan R&D/S85 4.0 15th July 2019 None
Production of a Randomisation Schedule for Randomised Controlled Trials (RCTs) R&D/S62 4.0 2nd October 2019 F45
Risk Assessment R&D/S18 4.0 5th August 2019 F15
Reporting Requirements During Research Studies R&D/S06 5.0 22nd March 2019 F21, F22
Study Close-Out R&D/S21 4.0 9th December 2019 F19

1st April 2016 to 31st March 2017

York and Scarborough

147 research studies open to recruitment

=

4588 patients recruited into clinical trials