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SOPs and Guidance

Standard Operating Procedures

SOPs

Title Number Version Number Implementation Date
Access to Clinical Trials Protocols and RSI (Reference Safety Information) R&D/S30 1.0 21st August 2017
Application Process for an Honorary Contract, Letter of Access or Research Passport R&D/S20 5.0 28th February 2019
Application to the Trust for Sponsor of a CTIMP R&D/S02 7.0 14th August 2017
Application to the Trust for Sponsorship of a Research Study R&D/S82 1.0 24th August 2017
Application for Sponsorship of a Non-CE Marked Medical Device Study R&D/S83 1.0 24th August 2017
Archiving of Research Study Documents R&D/S11 6.0 2nd May 2019
Auditing of Research Studies and Processes R&D/S71 4.0 14th August 2017
Breaches of GCP or the Study Protocol R&D/S04 7.0 14th August 2017
Case Report Form (CRF) Design and Completion R&D/S81 2.0 24th August 2017
Claiming Research Participant Travel Costs R&D/S31 1.0 24th September 2018
Contracts for Clinical Trials of Investigational Medicinal Products R&D/S23 3.0 10th November 2014
Data Management R&D/S29 3.0 22nd August 2017
Data Monitoring Committees for Clinical Trials R&D/S72 3.0 24th August 2017
Delegation of Tasks for Trust Sponsored Research Studies R&D/S03 7.0 20th June 2018
EDGE Database Management R&D/S15 8.0 8th April 2019
End of Study Reports and Publications R&D/S27 3.0 22nd August 2017
Completing an Expression of Interest (EOI) and Preparing for a Site Selection Visit (Research Teams) R&D/S36 3.0 15th April 2019
Identification of Potential Research Participants R&D/S77 5.0 24th August 2017
Identifying Research Participants in the Medical Records and on CPD R&D/S24 3.0 21st August 2017
Implementing Amendments for Research Studies NOT Sponsored by the Trust R&D/S07 6.0 21st November 2018
Information Governance R&D/S17 3.0 17th August 2017
Intellectual Property R&D/S93 1.0 12th October 2017
Issuing Confirmation of Capacity and Capability R&D/S14 7.0 30th November 2018
Lone Working R&D/S98 2.0 24th August 2017
Making Amendments to Trust Sponsored Research Studies R&D/S74 4.0 24th August 2017
Managing MHRA Inspections (Clinical Trials of Investigational Medicinal Products) R&D/S53 3.0 22nd August 2017
Monitoring of Trust Sponsored Research Studies R&D/S08 11.0 17th August 2017
Participant Identification Centres: Setup & Management R&D/S67 4.0 6th March 2019
Preparation, Review & Approval of SOPs for Research R&D/S01 10.0 15th June 2017
Preparation, Review and Approval of Study-Specific Standard Operating Procedures for Research R&D/S26 5.0 15th June 2017
Preparing a Statistical Analysis Plan R&D/S85 3.0 15th June 2017
Production of a Randomisation Schedule for Randomised Controlled Trials (RCTs) R&D/S62 3.0 15th June 2017
Providing and Documenting Training for Researchers R&D/S25 4.0 5th June 2017
Quality Assurance R&D/S28 4.0 22nd August 2017
Receiving Informed Consent in Research Studies R&D/S10 4.0 16th January 2018
Receiving and Acknowledging Safety Notifications to the R&D Unit R&D/S12  4.0  15th August 2017
R&D Processing of Amendments R&D/S75 6.0 6th May 2019
R&D Unit procedure for archiving clinical research documents - Role of the Named Archivist R&D/S52 1.0 4th April 2019
R&D SAE/SUSAR Handling and Assessment Procedure R&D/S13 5.0 17th August 2017
Research Misconduct and Fraud R&D/S16 4.0 17th August 2017
Research Related Adverse Event Reporting Procedure for CTIMP Studies (including reporting a pregnancy) R&D/S05 7.0 15th August 2017
Research Related Adverse Event Reporting for Non-CTIMP Studies R&D/S19 1.0 22nd August 2017
Risk Assessment R&D/S18 3.0 21st August 2017
Reporting Requirements During Research Studies R&D/S06 5.0 20th March 2019
Self-directed training in York Foundation Trust R&D Unit Standard Operating Procedures on Q-Pulse R&D/S22 2.0 15th June 2017
Set Up and Management of Research Studies R&D/S09 4.0 17th August 2017
Setting-up Research Studies Involving Imaging (including studies using Ionising Radiation) R&D/S64 2.0 30th April 2012
Setting up new studies with your Research Delivery Facilitator (RDF) and their Research Administrative Co-ordinator (RACo) (Research Teams) R&D/S37 1.0 15th April 2019
Study Close-Out: CTIMPs and other research studies R&D/S21 3.0 21st August 2017
Sub-contracting Services for Research Activities R&D/S63 5.0 13th December 2017
Sub-Contracting Services for Research Activities R&D/S63 6.0 12th June 2019
Transfer of Research Participant Case Notes Between NHS and Non-NHS Premises R&D/S65 4.0 24th August 2017
Urgent Safety Measures or Safety Concerns requiring a temporary or permanent halt to a study R&D/S68 1.0 24th August 2017

1st April 2016 to 31st March 2017

York and Scarborough

147 research studies open to recruitment

=

4588 patients recruited into clinical trials