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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 3.0 9th February 2021 R&D/S05 & R&D/S19
Amendment Checklist (Research Teams) R&D/F18 10.0 15th August 2022 R&D/S07 & R&D/S74
Amendment Log R&D/F118 3.0 15th August 2022 R&D/S78
Archive Box Label R&D/F56 9.0 8th January 2023 R&D/S11
Audit Report Form R&D/F68 5.0 9th October 2023 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 & Capability Checklist - PIC Sites R&D/F80 5.0 5th November 2020 R&D/S67
Consent Checklist R&D/F99 4.0 9th October 2023 R&D/S71
Development Safety Update Report (DSUR) Form R&D/F21 6.0 21st November 2022 R&D/S06
Document Version Control Log R&D/F101 3.0 6th March 2023 R&D/S74
Enrolment Log R&D/F110 1.0 17th August 2017 R&D/S09
Feasibility Application Form R&D/F03 8.0 13th February 2023 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 6.0 2nd November 2022 R&D/S20
Initiation Report R&D/F14 6.0 13th February 2023 R&D/S08
Interim Monitoring Report R&D/F10 7.0 13th February 2023 R&D/S08
Investigator Site File Contents List R&D/F11 7.0 9th October 2023 R&D/S09 & R&D/S71
Investigator Site File Remote Monitoring Checklist R&D/F78 1.0 5th February 2020 R&D/S08
Laboratory Checklist R&D/F60 5.0 4th January 2016
Lone Working Visit Log R&D/F113 4.0 24th April 2023 R&D/S98
Lone Worker Profile R&D/F114 4.0 24th April 2023 R&D/S98
Medical Records Checklist R&D/F98 4.0 9th October 2023

R&D/S71

Monitoring/Audit Action List R&D/F66 7.0 13th February 2023 R&D/S08
Monitoring Checklist (for Trust Sponsored Studies) R&D/F65 7.0 13th February 2023 R&D/S08
Monitoring Summary Report R&D/F69 6.0 13th February 2023 R&D/S08
Monitoring Visit Log R&D/F17 6,0 13th February 2023 R&D/S08
Notification of Urgent Safety Measure Form R&D/F20 5.0 4th February 2021 R&D/S68
Pharmacy Audit Checklist R&D/F100 4.0 9th October 2023 R&D/S71
PI Declaration of Responsibilities (Form) R&D/F76 1.0 1st March 2023 R&D/S14
PIC Site File: Template Contents List R&D/F120 2.0 5th November 2020 R&D/S67
Pregnancy Notification Form R&D/F121 3.0 3rd January 2024 R&D/S05 & R&D/S19
Protocol/GCP Deviations Log R&D/F119 2.0 18th April 2023 R&D/S04
Quarterly Study Review Form for Trust Sponsored Studies R&D/F22 6.0 14th February 2023 R&D/S06
Refund of Research Participant Travel Costs - Cashiers Office R&D/F122 2.0 24th June 2021 R&D/S31
Refund of Research Participant Travel Costs - Cheque R&D/F123 2.0 24th June 2021 R&D/S31
Refund of Research Participant Travel Costs - Direct Bank Transfer R&D/F124 2.0 24th June 2021 R&D/S31
Research Related SAE/SUSAR Initial Report Form R&D/F07 7.0 3rd January 2024 R&D/S05 & R&D/S19
Research Related SAE/SUSAR Follow-Up Report Form R&D/F08 5.0 9th February 2021 R&D/S05 & R&D/S19
Risk Assessment Form R&D/F15 5.0 13th February 2023 R&D/S18
SUSAR Unblinding Record R&D/F09 5.0 9th February 2021 R&D/S13 & R&D/S05
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 5.0 18th April 2023 R&D/S04
Set Up Checklist for New Studies (Research Teams) R&D/F103 2.0 18th April 2023 R&D/S37
Site Initiation Attendance Log R&D/F70 6.0 13th February 2023 R&D/S08
Source Data Location List R&D/F58 3.0 11th October 2023 R&D/S09
Source Data Verification (SDV) Form R&D/F64 6.0 13th February 2023 R&D/S08
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 4.0 9th October 2023 R&D/S71
Study Close Out Report R&D/F19 5.0 21st November 2022 R&D/S21
Study Delegation and Signature Log R&D/F16 8.0 6th December 2022 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 3.0 9th February 2021 R&D/S13 & R&D/S05
Suspected Serious Breach Notification to Sponsor Form (all studies) R&D/F05 7.0 18th April 2023 R&D/S04
Training Log R&D/F55 5.0 4th October 2023 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
Delegation and signature Log - Delegation of tasks to a named person for CTAs R&D/F125 2.0 27th September 2021 R&D/S107

 Honorary Contract Checklist

TEMPLATES 

Title Number   Version Number Implementation Date Related SOP
Closedown Checklist R&D/T46 1.0 10th October 2023 R&D/S11
Co-sponsorship Agreement R&D/T11 4.0 22nd November 2023 R&D/S23
Database Amendment Log R&D/T41 1.0 11th July 2023 R&D/S40
Data Monitoring Committee Terms of Reference R&D/T27 5.0 7th December 2022 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 5.0 13th April 2022 R&D/S77
Material Transfer Agreement (MTA) Template R&D/T31 3.0 6th March 2023
Monitoring Plan Template R&D/T03 7.0 13th February 2023 R&D/S08
mNCA Responsibility Schedule - Trust modifications R&D/T17 4.0 22nd November 2023 R&D/S23
NHS to NHS Proforma R&D/T34 6.0 2nd November 2022 R&D/S20
PI Oversight: Meeting/Teleconference Record Template R&D/T45 1.0 1st August 2018
QA Check of Research Database R&D/T25 1.0 11th July 2023 R&D/S40
Remote Source Data Verification (SDV) Agreement R&D/T50 1.0 27th February 2023
Research Related Adverse Event (AE) Recording Template R&D/T02 6.0 18th October 2021 R&D/S05 & R&D/S19
SOP Template R&D/T01 11.0 16th January 2023 R&D/S01
Study-Specific SOP Template R&D/T08 5.0 11th August 2020 R&D/S26
Sub-contract Agreement R&D/T12 4.0 22nd November 2023 R&D/S23
Template Case Note Labels 1 - 'safety reporting required' R&D/T26 5.0 18th January 2022 R&D/S24
Template Case Note Labels 2 - 'observational/safety reporting' R&D/T47 4.0 18th January 2022 R&D/S24
Wallet Cards Template R&D/T48 3.0 9th March 2022 R&D/S24
PI Agreement R&D/T44 1.0 18th September 2023 R&D/S110

1st April 2022 to 31st March 2023

York and Scarborough

125 research studies open to recruitment

=

3882 patients recruited into clinical trials