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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 4.0 17th August 2017 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 7.0 14th August 2017 R&D/F05, R&D/F06, R&D/F81, R&D/F119
Urgent Safety Measures or Safety Concerns requiring a temporary or permanent halt to a study R&D/S68 1.0 24th August 2017 R&D/F20
Research Misconduct and Fraud R&D/S16 4.0 17th August 2017 None
Intellectual Property R&D/S93 1.0 12th October 2017 None
Claiming Research Participant Travel Costs R&D/S31 1.0 24th September 2018 R&D/F122,R&D/F123, R&D/F124
Lone Working R&D/S98 2.0 24th August 2017 R&D/F113, R&D/F114
Preparation, Review and Approval of Study-Specific Standard Operating Procedures for Research R&D/S26 5.0 15th June 2017 R&D/T08
Providing and Documenting Training for Researchers R&D/S25 5.0 6th August 2019 R&D/F55
Quality Assurance R&D/S28 4.0 15th June 2017 None
Receiving Informed Consent in Research Studies R&D/S10 4.0 16th January 2018 None
Research Related Adverse Event Reporting for Non-CTIMP Studies R&D/S19 1.0 22nd August 2017 R&D/F07, R&D/F08, R&D/F46, R&D/F121,R&D/T02
Research Related Adverse Event Reporting Procedure for CTIMP Studies (including reporting a pregnancy) R&D/S05 7.0 15th August 2017 R&D/F07, R&D/F08, R&D/F46, R&D/F121, T02
Transfer of Research Participant Case Notes Between NHS and Non-NHS Premises R&D/S65 4.0 24th August 2017 None
Access to Clinical Trials Protocols and RSI (Reference Safety Information) R&D/S30 1.0 21st August 2017 None
Auditing of Research Studies and Processes R&D/S71 4.0 2nd May 2017 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 5.0 24th August 2017 R&D/T29
Identifying Research Participants in the Medical Records and on CPD R&D/S24 3.0 21st August 2017 R&D/T26, R&D/T47, R&D/T48
Implementing Amendments for Research Studies NOT Sponsored by the Trust R&D/S07 6.0 21st November 2018 R&D/F18, R&D/F118
Information Governance R&D/S17 3.0 17th August 2017 None

1st April 2016 to 31st March 2017

York and Scarborough

147 research studies open to recruitment

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4588 patients recruited into clinical trials