Saturday 25th November 2017

York Foundation Trust R&D Unit

NHS

Contact us

For general enquiries please
contact:

PostYork Foundation Trust R&D Unit,
Learning and Research Centre,
York Hospital,
Wigginton Road,
York YO31 8HE


Telephone iconTelephone: 01904 726996


Fax iconFax: 01904 725700


Email iconEmail: research.governance
@york.nhs.uk

Standard Operating Procedures

SEE 'IMPORTANT SOP NEWS' ON THE 'SOPs AND GUIDANCE' PAGE

 

SOPs

Title Number Version number Implementation date
Application Process for an Honorary Contract, Letter of Access or Research Passport R&D/S20 4.0 21st August 2017
Application to the Trust for Sponsor of a CTIMP R&D/S02 7.0 14th August 2017
Auditing of Research Studies and Processes R&D/S71 4.0 2nd May 2017
Archiving of Research Study Documents R&D/S11 5.0 15th August 2017
Case Report Form (CRF) Design and Completion R&D/S81 2.0 24th August 2017
Contractnig with Laboratories to undertake Research R&D/S63 4.0 4th January 2016
Sub-contracting Services for Research Activities R&D/S63 5.0 13th December 2017
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 6.0 14th August 2017
End of Study Reports and Publications R&D/S27 3.0 22nd August 2017
Local New Study Set Up: Capacity and Capability Assessment R&D/S14 6.0 21st August 2017
Identification of Potential Research Participants R&D/S77 4.0 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 5.0 15th August 2017
Information Governance R&D/S17 3.0 17th August 2017
Laboratory Procedures for Research Studies R&D/S94 2.0 8th February 2016
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 3.0 24th August 2017
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 6.0 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 3.0 1st September 2014
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 4.0 26th September 2016
R&D SAE/SUSAR Handling and Assessment Procedure R&D/S13 5.0 17th August 2017
EDGE Database Management R&D/S15 6.0 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
Risk Assessment R&D/S18 3.0 21st August 2017
Reporting Requirements During Research Studies R&D/S06 4.0 15th August 2017
Breaches of GCP or the Study Protocol R&D/S04 7.0 14th August 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
Study Close-Out: CTIMPs and other research studies R&D/S21 3.0 21st August 2017
Transfer of Research Participant Case Notes Between NHS and Non-NHS Premises R&D/S65 4.0 24th August 2017
Lone Working R&D/S98 2.0 24th August 2017
Self-directed training in York Foundation Trust R&D Unit Standard Operating Procedures on Q-Pulse R&D/S22 2.0 15th June 2017
Access to Clinical Trials Protocols and RSI (Reference Safety Information) R&D/S30 1.0 21st August 2017
Research Related Adverse Event Reporting for Non-CTIMP Studies R&D/S19 1.0 22nd 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
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
Intellectual Property R&D/S93 1.0 12th October 2017