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SOPs and Guidance

Forms and Templates

FORMS 

Title Number   Version Number Implementation Date Related SOP
AE/SAE Log R&D/F46 2.0 15th August 2017 R&D/S05 & R&D/S19
Amendment Checklist (Research Teams) R&D/F18 9.0 21st November 2018 R&D/S07 & R&D/S74
Amendment Log R&D/F118 2.0 15th August 2017 R&D/S78
Archive Box Label R&D/F56 7.0 17th December 2018 R&D/S11
Audit Assessment Tool R&D/F57 6.0 18th September 2017 R&D/S71
Audit Report Form R&D/F68 4.0 18th September 2017 R&D/S71
Checklist for Implementing Service Level Agreements: Non-Trust Sponsored Studies R&D/F02 1.0 8th March 2018 R&D/S63
Confirmation of Capacity and Capability Checklist R&D/F12 7.0 30th November 2018 R&D/S14
Confirmation of Capacity & Capability Checklist - PIC Sites R&D/F80 4.0 6th March 2019 R&D/S67
Consent Checklist R&D/F99 3.0 18th September 2017 R&D/S71
Development Safety Update Report (DSUR) Form R&D/F21 5.0 20th March 2019 R&D/S06
Document Version Control Log R&D/F101 2.0 18th December 2017 R&D/S74
Enrolment Log R&D/F110 1.0 17th August 2017 R&D/S09
Feasibility Application Form R&D/F03 7.0 18th July 2019 R&D/S02
File Note Log R&D/F59 2.0 17th August 2017 R&D/S09
Honorary Contract/Researcher Access Application Form R&D/F75 5.0 28th February 2019 R&D/S20
Initiation Report R&D/F14 4.0 15th April 2013 R&D/S08
Interim Monitoring Report R&D/F10 5.0 17th August 2017 R&D/S08
Investigator Site File Contents List R&D/F11 6.0 10th May 2018 R&D/S09 & R&D/S71
Laboratory Checklist R&D/F60 5.0 4th January 2016
Lone Working Visit Log R&D/F113 2.0 24th August 2017 R&D/S98
Lone Worker Profile R&D/F114 2.0 24th August 2017 R&D/S98
Medical Records Checklist R&D/F98 3.0 18th September 2017

R&D/S71

Monitoring/Audit Action List R&D/F66 5.0 17th August 2017 R&D/S08
Monitoring Checklist (for Trust Sponsored Studies) R&D/F65 5.0 12th August 2014 R&D/S08
Monitoring Summary Report R&D/F69 4.0 17th August 2017 R&D/S08
Monitoring Visit Log R&D/F17 4.0 17th August 2017 R&D/S08
Notification of Urgent Safety Measure Form R&D/F20 4.0 24th August 2017 R&D/S68
Pharmacy Audit Checklist R&D/F100 3.0 18th December 2017 R&D/S71
PIC Site File: Template Contents List R&D/F120 1.0 24th August 2017 R&D/S67
Pregnancy Notification Form R&D/F121 1.0 15th August 2017 R&D/S05 & R&D/S19
Protocol/GCP Deviations Log R&D/F119 1.0 14th August 2018 R&D/S04
Quarterly Study Review Form for Trust Sponsored Studies R&D/F22 5.0 11th April 2019 R&D/S06
Refund of Research Participant Travel Costs - Cashiers Office R&D/F122 1.0 24th September 2018 R&D/S31
Refund of Research Participant Travel Costs - Cheque R&D/F123 1.0 24th September 2018 R&D/S31
Refund of Research Participant Travel Costs - Direct Bank Transfer R&D/F124 24th September 2018 R&D/S31
Research Records Archive Storage Checklist for Investigator Site Self-archiving R&D/F106 1.0 18th October 2018
Research Related SAE/SUSAR Initial Report Form R&D/F07 5.0 20th August 2018 R&D/S05 & R&D/S19
Research Related SAE/SUSAR Follow-Up Report Form R&D/F08 4.0 15th August 2017 R&D/S05 & R&D/S19
Risk Assessment Form R&D/F15 4.0 5th August 2019 R&D/S18
SUSAR Unblinding Record R&D/F09 4.0 17th August 2017 R&D/S13
SAE/SUSAR R&D Unit Checklist R&D/F49 2.0 17th August 2017 R&D/S13
Screening Log R&D/F71 2.0 17th August 2017 R&D/S09
Serious Breach Notification Form - to MHRA and REC (CTIMPs only) R&D/F06 8.0 19th September 2018 R&D/S04
Serious Breach Notification Form - to the REC (non-CTIMPs only) R&D/F81 4.0 14th August 2017 R&D/S04
Set Up Checklist for New Studies (Research Teams) R&D/F103 1.0 15th April 2019 R&D/S37
Site Initiation Attendance Log R&D/F70 4.0 17th August 2017 R&D/S08
Source Data Location List R&D/F58 2.0 17th August 2017 R&D/S09
Source Data Verification (SDV) Form R&D/F64 4.0 17th August 2017 R&D/S08
Sponsor Details of Randomisation (For Sponsor Use Only) R&D/F45 3.0 15th June 2017 R&D/S62
Sponsor Details of Randomisation (For Sponsor Use Only) R&D/F45 4.0 2nd October 2019 R&D/S62
Study Audit Checklist (for Hosted Studies) R&D/F67 3.0 21st September 2015 R&D/S71
Study Close Out Report R&D/F19 3.0 21st August 2017 R&D/S21
Study Delegation and Signature Log R&D/F16 7.0 5th August 2019 R&D/S03
Sub-Contracting Services for Research Activities: Checklist for Assessing Potential Establishments R&D/F01 2.0 12th June 2019 R&D/S63
SUSAR Data Collection Form R&D/F47 2.0 17th August 2017 R&D/S13
Suspected Serious Breach Notification to Sponsor Form (All studies) R&D/F05 6.0 14th August 2017 R&D/S04
Training Log R&D/F55 4.0 6th August 2019 R&D/S25
Trial Master File Contents List R&D/F95 2.0 17th August 2017 R&D/S09 & R&D/S08
Training/Meeting Register R&D/F54 1.0 9th October 2018

 Honorary Contract Checklist

TEMPLATES 

Title Number   Version Number Implementation Date Related SOP
Co-sponsorship Agreement R&D/T11 3.0 10th November 2014 R&D/S23
Data Monitoring Committee Terms of Reference R&D/T27 4.0 22nd July 2019 R&D/S72
Delegation of Duties and Signature Log for the Trial Management of Trust Sponsored Studies R&D/T62 2.0 5th August 2019 R&D/S03 & R&D/S09
End of Study Template R&D/T24 4.0 15th July 2019 R&D/S27
File Note Template R&D/T20 2.0 17th August 2017 R&D/S09
File Note Identification of Research Participants R&D/T29 3.0 24th August 2017 R&D/S77
Material Transfer Agreement (MTA) Template R&D/T31 2.0 6th June 2019
Monitoring Plan Template R&D/T03 5.0 17th August 2017 R&D/S08
mNCA Responsibility Schedule - Trust modifications R&D/T17 3.0 10th November 2014 R&D/S23
NHS to NHS Proforma R&D/T34 5.0 28th February 2019 R&D/S20
PI Oversight: Actions and Decisions Log Template (Single Study) R&D/T41 1.0 1st August 2018
PI Oversight: Actions and Decisions Log Template (Multiple Studies) R&D/T44 1.0 1st August 2018
PI Oversight: Meeting/Teleconference Record Template R&D/T45 1.0 1st August 2018
Radiology Research Participant Labels R&D/T61 1.0 24th January 2018 R&D/S64
Research Related Adverse Event (AE) Recording Template R&D/T02 4.0 15th August 2017 R&D/S05 & R&D/S19
SOP Template R&D/T01 9.0 18th July 2019 R&D/S01
Source Data/CRF Audit Tool R&D/T46 1.0 1st August 2018
Study-Specific SOP Template R&D/T08 4.0 15th June 2017 R&D/S26
Sub-contract Agreement R&D/T12 3.0 10th November 2014 R&D/S23
Template Case Note Labels 1 - 'safety reporting required' R&D/T26 4.0 2nd October 2019 R&D/S24
Template Case Note Labels 2 - 'observational/safety reporting NOT required' R&D/T47 3.0 2nd October 2019 R&D/S24
Wallet Cards Template R&D/T48 2.0 21st August 2017 R&D/S24

1st April 2016 to 31st March 2017

York and Scarborough

147 research studies open to recruitment

=

4588 patients recruited into clinical trials