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CCTU standard operating procedures (SOPs)

Before a trial can start – planning, protocol development, set-up phase

Title of documentsort descending Reference number Date ratified
File Initial Health Economics Form CCTU/FRM089 19 March, 2015
PDF icon Funding and Collaboration Flowchart CCTU/INF014 7 September, 2015
PDF icon EudraCT and IRAS Account Creation Process CCTU/GD015 14 October, 2015
PDF icon Expedited Trust Approval Process R&D/SOP007 21 March, 2016
PDF icon R&D Intellectual Property Management R&D/POL004 20 May, 2015
Microsoft Office document icon CTIMP Submission Documents CCTU/GD029 26 July, 2016
File GP Letter Template CCTU/TPL015 26 July, 2016
Microsoft Office document icon Participating Site Initiation Form CCTU/FRM086 4 October, 2016
PDF icon Trial Specific Training Guidance CCTU/GD010 27 September, 2016
Microsoft Office document icon Patient Information Sheet and Informed Consent Form 11-15 Year Olds CCTU/TPL017 30 November, 2016
PDF icon Start up Procedure for Trials Teams (CTIMP) CCTU/SOP047 30 November, 2016
PDF icon CCTU Operational Manual CCTU/INF010 30 January, 2017
PDF icon Initial Research Ethics Committee Submission Guidance CCTU/GD012 14 March, 2017
PDF icon Management of Contracts for Research Projects R&D/SOP005 28 March, 2017
PDF icon Use of Vendors CCTU/SOP045 28 March, 2017
PDF icon Initial MHRA Submission Guidance CCTU/GD013 25 May, 2017
File Registration of Interest-Feasibility Template CCTU/TPL065 27 July, 2017
PDF icon Research Passport, Honorary Research Contracts and Letters of Access R&D/SOP010 28 July, 2017
File Study/Trial Steering Committee Charter CCTU/TPL027 27 July, 2017
File Participating Site Activation Letter CCTU/TPL028 27 July, 2017
PDF icon Set up and Opening of a Participating Site CCTU/SOP039 6 September, 2017
PDF icon Initiation Meeting for CTIMPs CCTU/SOP024 30 November, 2016
PDF icon Funding and Collaboration Process CCTU/SOP054 6 November, 2017
PDF icon Risk Assessment Process for CTIMP's CCTU/SOP040 6 November, 2017
PDF icon Delegation of Roles and Responsibilities for Trust Sponsored Clinical Trials of Investigational Medicinal Products (CTIMPs) R&D/SOP001 6 November, 2017
PDF icon Trial Master File / Site File - Essential Document Management CCTU/SOP015 27 March, 2018
Microsoft Office document icon Case Report Forms Completion Guidelines Template CCTU/TPL050 27 March, 2018
PDF icon Study Management Groups and Committees CCTU/GD026 14 May, 2018
PDF icon Green Light IMP Release Procedure CCTU/SOP041 25 June, 2018
Microsoft Office document icon Protocol Template CCTU/TPL001 14 March, 2017
File CCTU Collaboration Request CCTU/FRM083 21 August, 2018
Microsoft Office document icon Participant Information Sheet and Informed Consent Form CCTU/TPL002 7 August, 2018
Microsoft Office document icon Delegation of Responsibilities Log CCTU/TPL058 15 September, 2018
PDF icon Trial Specific Training Guidance CCTU/GD010 19 October, 2018
File Participant ID Card CCTU/TPL014 19 October, 2018
PDF icon Test of Out of Hours Medical Cover Arrangements CCTU/SOP005 29 November, 2018
File Trial Specific Data Management Plan CCTU/TPL009 14 January, 2019
PDF icon Setting Up International Studies 14 January, 2019
Microsoft Office document icon International Study Lead Site Initiation Checklist 29 November, 2018
Microsoft Office document icon Country Level TMF Index 29 November, 2018
Microsoft Office document icon International Study TMF Country Level (TMF sub section) 29 November, 2018
Microsoft Office document icon International CTIMP Study Level Feasibility Questionnaire 29 November, 2018

Trial documentation

Title of documentsort descending Reference number Date ratified
PDF icon Confirmation of Consent process CCTU/TPL018 12 February, 2013
Microsoft Office document icon Monitoring Log CCTU/FRM010 12 June, 2014
Microsoft Office document icon Subject ID Log CCTU/FRM039 20 August, 2014
Microsoft Office document icon Trial Specific Equipment Log CCTU/FRM043 7 March, 2016
PDF icon Trial Specific Training Record CCTU/FRM051 21 March, 2016
File GP Letter Template CCTU/TPL015 26 July, 2016
File Subject Consent Enrolment Log CCTU/TPL059 30 January, 2017
File Potential Subject Approach Log CCTU/TPL060 30 January, 2017
File Protocol Non Compliance Log CCTU/FRM042 27 July, 2017
File Participating Site Activation Letter CCTU/TPL028 27 July, 2017
File Statistics Index CCTU/TPL056 27 March, 2018
Microsoft Office document icon Study Contact Sheet CCTU/FRM027 27 March, 2018
Microsoft Office document icon Site Information Index in the TMF CCTU/TPL034 27 March, 2018
Microsoft Office document icon Investigator Site File Index CCTU/TPL033 21 June, 2018
Microsoft Office document icon File Note Log CCTU/FRM050 22 February, 2018
Microsoft Office document icon Delegation of Responsibilities Log CCTU/TPL058 15 September, 2018
Microsoft Office document icon Trial Master File Index CCTU/TPL032 15 September, 2018
File Local Pharmacy Site File Index CCTU/TPL038 29 November, 2018
File GP Letter Pregnant Partner CCTU/TPL070 14 January, 2019
Microsoft Office document icon Pregnant Partner PIS and ICF Template 14 January, 2019
Microsoft Office document icon International Study Lead Site Initiation Checklist 29 November, 2018
Microsoft Office document icon Country Level TMF Index 29 November, 2018
Microsoft Office document icon International Study TMF Country Level (TMF sub section) 29 November, 2018
Microsoft Office document icon International CTIMP Study Level Feasibility Questionnaire 29 November, 2018

Pharmacovigilance

Title of documentsort descending Reference number Date ratified
PDF icon Commercial Involvement in DSUR Generation/Submission CCTU/GD016 21 March, 2013
PDF icon Urgent safety measures for CTIMPs CCTU/SOP019 31 May, 2016
PDF icon Source Data Ten Top Tips CCTU/INF013 3 November, 2016
File Development Safety Update Report Template CCTU/TPL012 23 March, 2017
PDF icon Common Monitoring Findings CCTU/INF012 7 September, 2017
PDF icon SAE/SAR Reporting Form CCTU/FRM001 6 November, 2017
PDF icon Pregnancy Reporting Form CCTU/FRM003 6 November, 2017
Microsoft Office document icon Data Monitoring Committee Charter Template CCTU/TPL010 27 July, 2017
PDF icon Pharmacovigilance Process for Investigator Teams CCTU/SOP002 25 January, 2018
PDF icon Other important safety issue reporting form CCTU/FRM004 28 March, 2018
PDF icon DSUR& Annual Progress Reporting CCTU/SOP003 29 November, 2018

Data management and statistics

Title of documentsort descending Reference number Date ratified
File Visit Schedule CCTU/FRM077 16 December, 2013
Microsoft Office document icon Study Parameters CCTU/FRM032 19 March, 2014
PDF icon Determination of analysis population CCTU/SOP032 18 March, 2014
Microsoft Office document icon Tenalea Study Specific User Manual CCTU/TPL036 18 June, 2015
PDF icon Determination of Analysis Populations CCTU/SOP032 18 March, 2014
PDF icon Emergency Unbinding Request Form CCTU/FRM055 21 March, 2016
PDF icon Validation and Verification of Software Systems CCTU/SOP056 8 June, 2016
File Data Export Checklist CCTU/FRM093 3 October, 2016
File Permission to Unlock a Hard Locked Database CCTU/FRM072 12 October, 2016
PDF icon Paper Based Randomisation CCTU/SOP053 30 November, 2016
File Unblinding Log CCTU/FRM104 14 March, 2017
File Data Management Index CCTU/TPL063 28 March, 2017
Microsoft Office document icon Query Management Log CCTU/TPL064 29 March, 2017
PDF icon Back Up Emergency Unblinding Using Tenalea CCTU/GD009 29 November, 2016
Microsoft Office document icon Data Monitoring Comittee Charter (DMC) CCTU/TPL010 27 July, 2017
File Study/Trial Steering Committee Charter CCTU/TPL027 27 July, 2017
PDF icon Providing a Dataset from a Clinical Trial Database CCTU/SOP057 27 July, 2017
PDF icon Case Report Form Design CCTU/SOP013 15 August, 2017
PDF icon Blinded Randomisation CCTU/SOP046 30 November, 2016
PDF icon Un blinding in an Emergency Situation R&D/SOP008 28 March, 2017
Microsoft Office document icon Statistical Analysis Plan Template CCTU/TLP007 24 January, 2018
PDF icon Statistical Analysis Plan CCTU/SOP023 24 January, 2018
PDF icon Statistical Principles CCTU/SOP22 25 January, 2018
File Statistics Index CCTU/TPL056 27 March, 2018
File Randomisation File Index CCTU/TPL053 27 March, 2018
PDF icon Open Label Randomisation CCTU/SOP036 27 March, 2018
PDF icon Study Management Groups and Committees CCTU/GD026 14 May, 2018
Microsoft Office document icon Analysis of Population Database Approval Form CCTU/FRM029 14 May, 2018
PDF icon Database Locking CCTU/SOP033 25 June, 2018
File Completion of Data Cleaning Confirmation CCTU/FRM096 25 June, 2018
File Trial Data Capture Implementation Approval Form CCTU/FRM076 25 June, 2018
PDF icon Randomisation using Sealed Envelope CCTU/SOP058 26 June, 2018
File Trial Data Design Approval Form CCTU/FRM074 2 August, 2018
File Hard Lock Completion Confirmation CCTU/FRM097 19 October, 2018
File Interim Data Request CCTU/FRM095 19 October, 2018
File Database Lock Request and Data Extract Authorisation CCTU/FRM094 19 October, 2018
File Sealed Envelope Trial Registration Form CCTU/FRM098 30 November, 2018
File Trial Specific Data Management Plan CCTU/TPL009 14 January, 2019
File Variable List CCTU/TPL048 14 January, 2019
PDF icon Overview of Data Management Tools and Procedures CCTU/SOP049 23 January, 2019

Sampling

Title of documentsort descending Reference number Date ratified
PDF icon Packaging Requirements for the Transport of Biological Samples CCTU/SOP016 27 September, 2016
Microsoft Office document icon Sample Tracking and Processing Template CCTU/TPL031 6 November, 2017
PDF icon Research Sample Management CCTU/SOP044 6 November, 2017

Conduct of a trial

Title of documentsort descending Reference number Date ratified
PDF icon Confirmation of Consent process CCTU/TPL018 12 February, 2013
PDF icon R&D Research Misconduct Procedure R&D/POL002 27 January, 2016
PDF icon Data Transfer CCTU/SOP029 8 June, 2016
PDF icon Version Control of Trial Level Documents CCTU/SOP031 14 October, 2015
PDF icon Back up Emergency Unblinding using TENALEA CCTU/GD009 29 November, 2016
PDF icon EPIC Training Record R&D/FRM005 7 February, 2017
File Data Management Index CCTU/TPL063 28 March, 2017
Microsoft Office document icon SmPC/IB Review Form CCTU/FRM105 27 March, 2017
PDF icon Use of Vendors CCTU/SOP045 28 March, 2017
PDF icon Reference Safety Information in CTIMPs CCTU/SOP061 3 May, 2017
PDF icon Handling of Protocol or Regulatory Non Compliance CCTU/SOP018 27 July, 2017
File Protocol Non Compliance Log CCTU/FRM042 27 July, 2017
File Non-Compliance Report Form CCTU/FRM013 19 February, 2018
PDF icon R&D Facilitating Monitoring Visits for Clinical Trials at CUH R&D/SOP012 18 December, 2017
Microsoft Office document icon File Note Log CCTU/FRM050 22 February, 2018
Microsoft Office document icon File Note CCTU/FRM038 22 February, 2018
PDF icon Trial Master File / Site File - Essential Document Management CCTU/SOP015 27 March, 2018
Microsoft Office document icon File Note Log CCTU/FRM050 22 February, 2018
PDF icon Green Light IMP Release Procedure CCTU/SOP041 25 June, 2018
PDF icon Monitoring Activities Guidance Document CCTU/GD008 6 July, 2018
PDF icon Monitoring Trust Sponsored CTIMPs CCTU/SOP011 6 July, 2018
PDF icon Amendment Management by Trial Teams CCTU/SOP014 24 September, 2018
File Interim Data Request CCTU/FRM095 19 October, 2018
File GP Letter Pregnant Partner CCTU/TPL070 14 January, 2019
Microsoft Office document icon Pregnant Partner PIS and ICF Template 14 January, 2019

Closing down a trial – post-study procedures and archiving

Title of documentsort descending Reference number Date ratified
File End of Trial Report CCTU/TPL037 14 April, 2015
PDF icon Archiving CTIMPs CCTU/SOP006 29 November, 2016
PDF icon Archiving Record Form CCTU/FRM017 14 March, 2017
File Participating Site Archiving Arrangements CCTU/FRM030 15 March, 2017
Microsoft Office document icon Site Information in the TMF Archiving Checklist CCTU/TPL055 5 October, 2017
Microsoft Office document icon Investigator Site File Archiving Checklist CCTU/TPL052 5 October, 2017
Microsoft Office document icon Trial Master File Archiving Checklist CCTU/TPL051 9 October, 2017
Microsoft Office document icon Archiving Box Label CCTU/FRM015 5 October, 2017
PDF icon End of Trial Procedures (CTIMPs) CCTU/SOP004 27 March, 2018

Please note: new SOPS are currently in development and will appear here when available.

For Word versions of the templates found below please email cctu@addenbrookes.nhs.uk