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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
PDF icon Data Monitoring (& Ethics) Committee CCTU/GD017 21 March, 2013
File Trial Specific Data Management Plan CCTU/TPL009 25 June, 2014
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 Green Light IMP Release Procedure CCTU/SOP041 7 March, 2016
File CCTU Collaboration Request CCTU/FRM083 31 May, 2016
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
File Collaboration Enquiry Form CCTU/FRM090 2 August, 2016
Microsoft Office document icon Participating Site Initiation Form CCTU/FRM086 4 October, 2016
File Participant ID Card CCTU/TPL014 3 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
File Electronic Susar Reporting Registration Form CCTU/FRM028 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
Microsoft Office document icon Participant Information Sheet and Informed Consent Form CCTU/TPL002 6 September, 2017
Microsoft Office document icon Delegation of Responsibilities Log CCTU/TPL058 27 July, 2017
PDF icon Initiation Meeting for CTIMPs CCTU/SOP024 30 November, 2016
Microsoft Office document icon Protocol Template CCTU/TPL001 14 March, 2017
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 Test of Out of Hours Medical Cover Arrangements CCTU/SOP005 1 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 Study Management Groups and Committees CCTU/GD026 25 January, 2018
PDF icon Trial Master File / Site File - Essential Document Management CCTU/SOP015 27 March, 2018
PDF icon Trial Steering Committee or Study Steering Committee Guidance CCTU/GD018 27 March, 2018
Microsoft Office document icon Case Report Forms Completion Guidelines Template CCTU/TPL050 27 March, 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
PDF icon File Note Log CCTU/FRM050 7 March, 2016
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 Local Pharmacy Site File Index CCTU/TPL038 27 September, 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
Microsoft Office document icon Delegation of Responsibilities Log CCTU/TPL058 27 July, 2017
File Statistics Index CCTU/TPL056 27 March, 2018
Microsoft Office document icon Trial Master File Index CCTU/TPL032 27 March, 2018
Microsoft Office document icon Study Contact Sheet CCTU/FRM027 27 March, 2018
Microsoft Office document icon Investigator Site File Index CCTU/TPL033 27 March, 2018
Microsoft Office document icon Site Information Index in the TMF CCTU/TPL034 27 March, 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 Electronic Susar Reporting Registration Form CCTU/FRM028 14 March, 2017
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 DSUR& Annual Progress Reporting CCTU/SOP003 25 January, 2018
PDF icon Other important safety issue reporting form CCTU/FRM004 28 March, 2018

Data management and statistics

Title of documentsort descending Reference number Date ratified
PDF icon Data Management Using MACRO CCTU/SOP027 27 June, 2013
File Visit Schedule CCTU/FRM077 16 December, 2013
Microsoft Office document icon Analysis of population database approval form CCTU/FRM029 18 March, 2014
Microsoft Office document icon Study Parameters CCTU/FRM032 19 March, 2014
PDF icon Determination of analysis population CCTU/SOP032 18 March, 2014
File Trial Specific Data Management Plan CCTU/TPL009 25 June, 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 30 June, 2016
PDF icon Overview of Data Management Tools and procedures CCTU/SOP049 26 July, 2016
File Variable List CCTU/TPL048 26 July, 2016
File Soft Lock CompletionConfirmation CCTU/FRM096 4 October, 2016
File Interim Data Request CCTU/FRM095 4 October, 2016
File Data Export Checklist CCTU/FRM093 3 October, 2016
PDF icon Database Locking CCTU/SOP033 12 October, 2016
File Permission to Unlock a Hard Locked Database CCTU/FRM072 12 October, 2016
File Hard Lock Completion Confirmation CCTU/FRM097 4 October, 2016
File Database Lock Request and Data Extract Authorisation CCTU/FRM094 4 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 Building a MACRO database CCTU/GD005 28 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
PDF icon Randomisation using Sealed Envelope CCTU/SOP058 25 January, 2018
PDF icon Study Management Groups and Committees CCTU/GD026 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

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
Microsoft Office document icon Adverse Event Log CCTU/FRM006 1 October, 2014
PDF icon R&D Research Misconduct Procedure R&D/POL002 27 January, 2016
PDF icon Green Light IMP Release Procedure CCTU/SOP041 7 March, 2016
PDF icon Data Transfer CCTU/SOP029 8 June, 2016
PDF icon Version Control of Trial Level Documents CCTU/SOP031 14 October, 2015
File Interim Data Request CCTU/FRM095 4 October, 2016
PDF icon Back up Emergency Unblinding using TENALEA CCTU/GD009 29 November, 2016
PDF icon Monitoring Activities Guidance Document CCTU/GD008 29 November, 2016
PDF icon EPIC Training Record R&D/FRM005 7 February, 2017
PDF icon Monitoring Trust Sponsored CTIMPs CCTU/SOP011 9 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
PDF icon Management of CTIMP Amendments by Trial Teams CCTU/SOP014 27 March, 2018

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 5 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