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 Expedited Trust Approval Process R&D/SOP007 21 March, 2016
PDF icon R&D Intellectual Property Management R&D/POL004 20 May, 2015
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 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
PDF icon Set up and Opening of a Participating Site CCTU/SOP039 6 September, 2017
PDF icon Delegation of Roles and Responsibilities for Trust Sponsored Clinical Trials of Investigational Medicinal Products (CTIMPs) R&D/SOP001 6 November, 2017
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
Microsoft Office document icon Protocol Template CCTU/TPL001 14 March, 2017
Microsoft Office document icon Participant Information Sheet and Informed Consent Form CCTU/TPL002 7 August, 2018
PDF icon Trial Specific Training Guidance CCTU/GD010 19 October, 2018
File Participant ID Card CCTU/TPL014 19 October, 2018
File Trial Specific Data Management Plan CCTU/TPL009 14 January, 2019
Microsoft Office document icon International Study Lead Site Initiation Checklist CCTU/TPL075 29 November, 2018
Microsoft Office document icon Country Level TMF Index CCTU/TPL076 29 November, 2018
Microsoft Office document icon International Study TMF Country Level (TMF sub section) CCTU/TPL077 29 November, 2018
Microsoft Office document icon International CTIMP Study Level Feasibility Questionnaire CCTU/TPL078 29 November, 2018
File CCTU Collaboration Request CCTU/FRM083 17 April, 2019
Microsoft Office document icon CTIMP Submission Documents CCTU/GD029 10 April, 2019
Microsoft Office document icon Participating Site Initiation Form CCTU/FRM086 7 May, 2019
File CCTU/FRM089 Initial Health Economics Form CCTU/FRM089 23 March, 2019
PDF icon Funding and Collaboration Flowchart CCTU/INF014 2 October, 2017
PDF icon EudraCT and IRAS Account Creation Process CCTU/GD015 30 October, 2017
PDF icon Trial Specific Training Guidance CCTU/GD010 19 October, 2018
Microsoft Office document icon Patient Information Sheet and Informed Consent Form 11-15 Year Olds CCTU/TPL017 4 February, 2019
PDF icon Initial MHRA Submission Guidance CCTU/GD013 1 July, 2019
File Registration of Interest-Feasibility Template CCTU/TPL065 6 August, 2019
Microsoft Office document icon Delegation of Responsibilities Log CCTU/TPL058 13 May, 2019
PDF icon Selection and Use of Vendors CCTU/SOP045 24 September, 2019
File Participating Site Activation Letter CCTU/TPL028 6 August, 2019
PDF icon Test of Out of Hours Medical Cover Arrangements CCTU/SOP005 29 November, 2018
PDF icon Trial Master File / Site File - Essential Document Management CCTU/SOP015 27 March, 2018
PDF icon Risk Assessment Process for CTIMP's CCTU/SOP040 6 November, 2017
PDF icon Green Light IMP Release Procedure CCTU/SOP041 25 June, 2018
PDF icon Funding and Collaboration Process CCTU/SOP054 1 March, 2019
PDF icon Setting Up International Studies CCTU/SOP064 14 January, 2019
PDF icon Initiation Meeting for CTIMPs CCTU/SOP024 21 November, 2018
PDF icon Start up Procedure for Trials Teams (CTIMPs) CCTU/SOP047 2 December, 2019
File GP Letter Template CCTU/TPL015 18 November, 2019

Trial documentation

Title of documentsort descending Reference number Date ratified
File Statistics Index CCTU/TPL056 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
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 CCTU/TPL079 14 January, 2019
Microsoft Office document icon International Study Lead Site Initiation Checklist CCTU/TPL075 29 November, 2018
Microsoft Office document icon Country Level TMF Index CCTU/TPL076 29 November, 2018
Microsoft Office document icon International Study TMF Country Level (TMF sub section) CCTU/TPL077 29 November, 2018
Microsoft Office document icon International CTIMP Study Level Feasibility Questionnaire CCTU/TPL078 29 November, 2018
Microsoft Office document icon Lab File Index (part of TMF) CCTU/TPL080 10 April, 2019
Microsoft Office document icon Trial Master File Index CCTU/TPL032 10 April, 2019
Microsoft Office document icon Lab File Index for CCTU Trials CCTU/TPL081 10 April, 2019
Microsoft Office document icon Delegation of Responsibilities Log CCTU/TPL058 13 May, 2019
Microsoft Office document icon Monitoring Log CCTU/FRM010 12 June, 2018
Microsoft Office document icon Subject ID Log CCTU/FRM039 20 August, 2018
Microsoft Office document icon Trial Specific Equipment Log CCTU/FRM043 14 February, 2018
Microsoft Office document icon Trial Specific Training Record CCTU/FRM051 6 April, 2018
Microsoft Office document icon Study Contact Sheet CCTU/FRM027 22 November, 2019
File Protocol Non Compliance Log CCTU/FRM042 11 October, 2019

Pharmacovigilance

Title of documentsort descending Reference number Date ratified
File Development Safety Update Report Template CCTU/TPL012 10 April, 2019
PDF icon Source Data Ten Top Tips CCTU/INF013 30 October, 2018
PDF icon Common Monitoring Findings CCTU/INF012 16 September, 2019
PDF icon Pharmacovigilance Process for Investigator Teams CCTU/SOP002 20 September, 2019
Microsoft Office document icon Data Monitoring Committee Charter Template CCTU/TPL010 16 August, 2019
PDF icon DSUR& Annual Progress Reporting CCTU/SOP003 29 November, 2018
PDF icon Urgent Safety Measures for CTIMPs CCTU/SOP019 18 November, 2019

Data management and statistics

Title of documentsort descending Reference number Date ratified
Microsoft Office document icon Query Management Log CCTU/TPL064 29 March, 2017
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 Case Report Form Design CCTU/SOP013 15 August, 2017
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
File Statistics Index CCTU/TPL056 27 March, 2018
File Randomisation File Index CCTU/TPL053 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
File Completion of Data Cleaning Confirmation CCTU/FRM096 25 June, 2018
File Trial Data Capture Implementation Approval Form CCTU/FRM076 25 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
PDF icon Overview of Data Management Tools and Procedures CCTU/SOP049 22 February, 2019
File Data Management Index CCTU/TPL063 15 May, 2019
File Visit Schedule CCTU/FRM077 25 January, 2018
Microsoft Office document icon Study Parameters CCTU/FRM032 17 April, 2018
PDF icon Determination of Analysis Populations CCTU/SOP032 10 April, 2018
File Emergency Unbinding Request Form CCTU/FRM055 28 February, 2018
File Data Export Checklist CCTU/FRM093 10 October, 2018
File Permission to Unlock a Hard Locked Database CCTU/FRM072 27 June, 2019
Microsoft Office document icon Tenalea Study Specific User Manual CCTU/TPL036 19 June, 2019
File Unblinding Log CCTU/FRM104 21 February, 2019
PDF icon Back Up Emergency Unblinding Using Tenalea CCTU/GD009 7 November, 2018
PDF icon Paper Based Randomisation CCTU/SOP053 7 November, 2018
PDF icon Determination of Analysis Population CCTU/SOP032 10 April, 2018
PDF icon Statistical Principles CCTU/SOP022 25 January, 2018
PDF icon Statistical Analysis Plan CCTU/SOP023 24 January, 2018
PDF icon Database Locking CCTU/SOP033 25 June, 2018
PDF icon Open Label Randomisation CCTU/SOP036 27 March, 2018
PDF icon Validation and Verification of Software Systems CCTU/SOP056 8 August, 2019
PDF icon Providing a Dataset from a Clinical Trial Database CCTU/SOP057 10 April, 2019
PDF icon Randomisation using Sealed Envelope CCTU/SOP058 26 June, 2018
PDF icon Blinded Randomisation CCTU/SOP046 7 November, 2018
File Variable List CCTU/TPL048 14 January, 2019

Sampling

Title of documentsort descending Reference number Date ratified
Microsoft Office document icon Sample Tracking and Processing Template CCTU/TPL031 6 November, 2017
Microsoft Office document icon Lab File Index (part of TMF) CCTU/TPL080 10 April, 2019
Microsoft Office document icon Lab File Index for CCTU Trials CCTU/TPL081 10 April, 2019
PDF icon Packaging Requirements for the Transport of Biological Samples CCTU/SOP016 26 September, 2018
PDF icon Management of Trial Specific Equipment CCTU/SOP030 10 May, 2018
PDF icon Research Sample Management CCTU/SOP044 16 October, 2019

Conduct of a trial

Title of documentsort descending Reference number Date ratified
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 EPIC Training Record R&D/FRM005 7 February, 2017
Microsoft Office document icon File Note Log CCTU/FRM050 22 February, 2018
PDF icon Monitoring Activities Guidance Document CCTU/GD008 6 July, 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 CCTU/TPL079 14 January, 2019
File Data Management Index CCTU/TPL063 15 May, 2019
PDF icon Selection and Use of Vendors CCTU/SOP045 24 September, 2019
PDF icon R&D Facilitating Monitoring Visits for Clinical Trials at CUH R&D/SOP012 23 September, 2019
PDF icon Back up Emergency Unblinding using TENALEA CCTU/GD009 7 November, 2018
Microsoft Office document icon SmPC/IB Review Form CCTU/FRM105 20 September, 2019
PDF icon Reference Safety Information in CTIMPs CCTU/SOP061 20 September, 2019
PDF icon Trial Master File / Site File - Essential Document Management CCTU/SOP015 27 March, 2018
PDF icon Handling of Protocol or Regulatory Non Compliance CCTU/SOP018 11 October, 2019
PDF icon Green Light IMP Release Procedure CCTU/SOP041 25 June, 2018
PDF icon Monitoring Cambridge Sponsored CTIMPs CCTU/SOP011 6 July, 2018
PDF icon Amendment Management by Trial Teams CCTU/SOP014 24 September, 2018
Microsoft Office document icon File Note CCTU/FRM038 22 November, 2019
File Protocol Non Compliance Log CCTU/FRM042 11 October, 2019
File Non-Compliance Report Form CCTU/FRM013 11 October, 2019

Closing down a trial – post-study procedures and archiving

Title of documentsort descending Reference number Date ratified
Microsoft Office document icon Archiving Box Label CCTU/FRM015 22 February, 2019
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 Record Form Location CCTU/FRM017 2 July, 2019
File End of Trial Report CCTU/TPL037 3 July, 2019
PDF icon The CCTU Archiving Process CCTU/SOP006 11 October, 2019
PDF icon End of Trial Procedures (CTIMPs) CCTU/SOP004 18 November, 2019

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