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

Forms and Templates

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

 

FORMS 

Title Number Version number Implementation date
AE/SAE Log R&D/F46 2.0 15th August 2017
Amendment Checklist (Research Teams) R&D/F18 7.0 15th August 2017
Archive Box Label R&D/F56 5.0 15th August 2017
Audit Assessment Tool R&D/F57 6.0 18th September 2017
Audit Report Form R&D/F68 3.0 21st September 2015
Audit Report Form R&D/F68 4.0 18th September 2017
Consent Checklist R&D/F99 3.0 18th September 2017
Development Safety Update Report (DSUR) Form R&D/F21 4.0 15th August 2017
Feasibility Application Form R&D/F03 6.0 14th August 2017
Feasibility Checklist R&D/F04 6.0 14th August 2017
File Note Log R&D/F59 2.0 17th August 2017
Honorary Contract/Researcher Access Application Form R&D/F75 4.0 21st August 2017
Initiation Report R&D/F14 4.0 15th April 2013
Interim Monitoring Report R&D/F10 5.0 17th August 2017
Investigator Site File Contents (Hosted Studies) R&D/F11 5.0 5th June 2017
Laboratory Checklist R&D/F60 5.0 4th January 2016
Medical Records Checklist R&D/F98 3.0 18th September 2017
Monitoring/Audit Action List R&D/F66 5.0 17th August 2017
Monitoring Checklist (for Trust Sponsored Studies) R&D/F65 5.0 12th August 2014
Monitoring Summary Report R&D/F69 4.0 17th August 2017
Monitoring Visit Log R&D/F17 4.0 17th August 2017
Confirmation of Capacity & Capability Checklist - PIC Sites R&D/F80 3.0 24th August 2017
Confirmation of Capacity and Capability Checklist R&D/F12 6.0 21st August 2017
Notification of Urgent Safety Measure Form R&D/F20 4.0 24th August 2017
Quarterly Progress Report Form R&D/F22 3.0 15th August 2017
Pharmacy Audit Checklist R&D/F100 2.0 21st September 2015
Pharmacy Audit Checklist R&D/F100 3.0 18th December 2017
Research Related SAE/SUSAR Initial Report Form R&D/F07 4.0 15th August 2017
Research Related SAE/SUSAR Follow-Up Report Form R&D/F08 4.0 15th August 2017
SUSAR Unblinding Record R&D/F09 4.0 17th August 2017
Risk Assessment Form R&D/F15 3.0 22nd August 2017
SAE/SUSAR R&D Unit Checklist R&D/F49 2.0 17th August 2017
Screening Log R&D/F71 2.0 17th August 2017
Serious Breach Notification Form - to MHRA and REC (CIMPTs only) R&D/F06 7.0 14th August 2017
Serious Breach Notification Form - to the REC (non-CTIMPs only) R&D/F81 4.0 14th August 2017
Site Initiation Attendance Log R&D/F70 4.0 17th August 2017
Source Data Location List R&D/F58 2.0 17th August 2017
Source Data Verification (SDV) Form R&D/F64 4.0 17th August 2017
Sponsor Details of Randomisation (For Sponsor Use Only) R&D/F45 3.0 15th June 2017
Study Close Out Report R&D/F19 3.0 21st August 2017
Study Delegation and Signature Log R&D/F16 6.0 14th August 2017
Sub-contracting Services for Research Activities: Checklist for Assessing Potential Establishments R&D/F01 1.0 13th December 2017
SUSAR Data Collection Form R&D/F47 2.0 17th August 2017
Suspected Serious Breach Notification to Sponsor Form (All studies) R&D/F05 6.0 14th August 2017
Training Log R&D/F55 3.0 5th June 2017
Trial Master File Contents List R&D/F95 2.0 17th August 2017
Version Control Document Tracking Checklist R&D/F101 1.0 17th November 2014
Document Version Control Log R&D/F101 2.0 18th December 2017
Lone Working Visit Log R&D/F113 2.0 24th August 2017
Lone Worker Profile R&D/F114 2.0 24th August 2017
Amendment Log R&D/F118 2.0 15th August 2017
Protocol/GCP Deviations Log R&D/F119 1.0 14th August 2017
Pregnancy Notification Form R&D/F121 1.0 15th August 2017
Enrolment Log R&D/F110 1.0 17th August 2017
PIC Site File: Template Contents List R&D/F120 1.0 24th August 2017

 

Honorary Contract Checklist

 

TEMPLATES 

Title Number Version number Implementation date
Template Case Note Labels 1 - 'safety reporting required' R&D/T26 3.0 21st August 2017
Data Monitoring Committee Terms of Reference R&D/T27 3.0 24th August 2017
End of Study Template R&D/T24 3.0 22nd August 2017
File Note Template R&D/T20 2.0 17th August 2017
File Note Identification of Research Participants R&D/T29 3.0 24th August 2017
Monitoring Plan Template R&D/T03 5.0 17th August 2017
NHS to NHS Proforma R&D/T34 3.0 9th March 2015
NHS to NHS Proforma R&D/T43 4.0 21st August 2017
Research Related Adverse Event (AE) Recording Template R&D/T02 4.0 15th August 2017
SOP Template R&D/T01 8.0 15th June 2017
Study-Specific SOP Template R&D/T08 4.0 15th June 2017
Template Case Note Labels 2 - 'observational/safety reporting NOT required' R&D/T47 2.0 21st August 2017
Wallet Cards Template R&D/T48 2.0 21st August 2017