Feeling unwell or injured? Make sure you choose the right NHS service
 
 
Leeches to lasers – 250 years of charitable support
 
We are proud to be a no smoking site. You cannot smoke anywhere.
 
Welcome subsidy £1000 and loan package up to £3000 for all UK recruited Nurses, Midwives, ODPs and Radiographers (bands 5&6)

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 Set up and Opening of a Participating Site for Trust Sponsored Clinical Trials CCTU/SOP039 9 March, 2012
PDF icon Test of Out of Hours Medical Cover Arrangements CCTU/SOP005 25 April, 2013
PDF icon Writing a Clinical Research Protocol CCTU/SOP043 11 April, 2013
PDF icon Trial Steering Committee or Study Steering Committee Guidance CCTU/GD018 26 March, 2013
PDF icon Data Monitoring (& Ethics) Committee CCTU/GD017 21 March, 2013
PDF icon R&D Research Passports R&D SOP010 29 October, 2013
PDF icon Study Management Groups and Committees CCTU/GD026 9 December, 2013
File Registration of Interest / Request for Study Protocol CCTU/FRM062 23 June, 2014
File Trial Specific Data Management Plan CCTU/TPL009 25 June, 2014
File Initial Health Economics Form CCTU/FRM089 19 March, 2015
PDF icon Risk Assessment Process for CTIMP's CCTU/SOP040 24 August, 2015
PDF icon Funding and Collaboration Process CCTU/SOP054 7 September, 2015
PDF icon Funding and Collaboration Flowchart CCTU/INF014 7 September, 2015
PDF icon Delegation of Roles and Responsibilities for Trust Sponsored CTIMPs R&D SOP001 13 October, 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 13 May, 2016
PDF icon Initial MHRA Submission Guidance CCTU/GD013 27 March, 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, 2016
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 26 July, 2016
File Case Report Forms Completion Guidelines Template CCTU/TPL050 19 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
PDF icon Initiation Meeting for CTIMPs CCTU/SOP024 30 November, 2016
PDF icon Trial Master File / Site File - Essential Document Management CCTU/SOP015 29 November, 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
Microsoft Office document icon Delegation of Responsibilities Log CCTU/TPL058 30 January, 2017
PDF icon CCTU Operational Manual CCTU/INF010 30 January, 2017
File Study/Trial Steering Committee Charter CCTU/TPL027 4 October, 2016
Microsoft Office document icon Participant Information Sheet and Informed Consent Form CCTU/TPL002 29 November, 2016
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 Use of Vendors CCTU/SOP045 28 March, 2017
PDF icon IRAS Application Guidance and Standard Wording NON CTIMPs ONLY R&D GD002 28 March, 2017
PDF icon RD_SOP005 Management of Research Contracts.pdf R&D SOP005 25 June, 2014

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
File Subject Screening/Enrolment Log CCTU/FRM023 20 August, 2014
Microsoft Office document icon Subject ID Log CCTU/FRM039 20 August, 2014
File Local Pharmacy Site File Index CCTU/TPL038 18 June, 2015
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
PDF icon Study Contact Sheet CCTU/FRM027 21 March, 2016
File GP Letter Template CCTU/TPL015 26 July, 2016
File Local Pharmacy Site File Index CCTU/TPL038 27 September, 2016
Microsoft Office document icon Site Information Index in the TMF CCTU/TPL034 27 September, 2016
Microsoft Office document icon File Note CCTU/FRM038 27 September, 2016
Microsoft Office document icon Delegation of Responsibilities Log CCTU/TPL058 30 January, 2017
File Statistics File Index CCTU/TPL056 30 January, 2017
File Subject Consent Enrolment Log CCTU/TPL059 30 January, 2017
File Potential Subject Approach Log CCTU/TPL060 30 January, 2017
Microsoft Office document icon Trial Master File Index CCTU/TPL032 28 March, 2017
Microsoft Office document icon Investigator Site File Index CCTU/TPL033 28 March, 2017

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 27 March, 2015
PDF icon DSUR & Annual Progress Reporting CCTU/SOP003 27 March, 2015
Microsoft Office document icon Data Monitoring Committee Charter Template CCTU/TPL010 17 March, 2014
PDF icon Pharmacovigilance Process for Investigator Teams CCTU/SOP002 7 March, 2016
PDF icon Pregnancy Reporting Form CCTU/FRM003 14 March, 2016
PDF icon Other important safety issue reporting form CCTU/FRM004 14 March, 2016
PDF icon Urgent safety measures for CTIMPs CCTU/SOP019 31 May, 2016
PDF icon SAE/SAR reporting form CCTU/FRM001 3 December, 2015
PDF icon Common Monitoring Findings CCTU/INF012 3 November, 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

Data management and statistics

Title of documentsort descending Reference number Date ratified
PDF icon Data Management Using MACRO CCTU/SOP027 27 June, 2013
PDF icon Study Management Groups and Committees CCTU/GD026 9 December, 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
Microsoft Office document icon DMC Charter CCTU/TPL010 19 March, 2014
PDF icon Determination of analysis population CCTU/SOP032 19 March, 2014
File Trial Specific Data Management Plan CCTU/TPL009 25 June, 2014
PDF icon Back Up Emergency Unblinding CCTU/GD009 3 March, 2015
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 Case report form design CCTU/SOP013 15 June, 2016
PDF icon Paper Based Randomisation CCTU/SOP053 31 May, 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
PDF icon Providing a Dataset from a Clinical Trial Database CCTU/SOP057 12 October, 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
Microsoft Office document icon Statistical Analysis Plan Template CCTU/TLP007 11 October, 2016
File Permission to Unlock a Hard Locked Database CCTU/FRM072 12 October, 2016
File Hard Lock Completion Confirmation CCTU/FRM097 17 November, 2016
File Database Lock Request and Data Extract Authorisation CCTU/FRM094 17 November, 2016
PDF icon Paper Based Randomisation CCTU/SOP053 30 November, 2016
PDF icon Blinded Randomisation CCTU/SOP046 30 November, 2016
PDF icon Statistical Analysis Plan CCTU/SOP023 29 November, 2016
PDF icon Statistical Principles CCTU/SOP22 29 November, 2016
File Randomisation File Index CCTU/TPL053 30 January, 2017
File Study/Trial Steering Committee Charter CCTU/TPL027 4 October, 2016
File Statistics File Index CCTU/TPL056 30 January, 2017
PDF icon Open Label Randomisation CCTU/SOP036 14 March, 2017
PDF icon Randomisation using Sealed Envelope CCTU/SOP058 14 March, 2017
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

Sampling

Title of documentsort descending Reference number Date ratified
Microsoft Office document icon Sample tracking and processing template CCTU/TPL031 1 July, 2014
PDF icon Packaging Requirements for the Transport of Biological Samples CCTU/SOP016 27 September, 2016
PDF icon Research Sample Management CCTU/SOP044 27 September, 2016

Conduct of a trial

Title of documentsort descending Reference number Date ratified
10 April, 2017
PDF icon Confirmation of Consent process CCTU/TPL018 12 February, 2013
PDF icon Handling of protocol or regulatory non compliance CCTU/SOP018 12 June, 2014
Microsoft Office document icon Protocol Non Compliance Log CCTU/FRM042 20 August, 2014
Microsoft Office document icon Adverse Event Log CCTU/FRM006 1 October, 2014
PDF icon Maintenance of Study Files CCTU/GD006 19 February, 2015
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 Management of CTIMP Amendments by Trial Teams CCTU/SOP014 29 November, 2016
PDF icon Trial Master File / Site File - Essential Document Management CCTU/SOP015 29 November, 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 R&D EPIC Training Record R&D/FRM005 30 January, 2017
PDF icon R&D Facilitating Monitoring Visits for Clinical Trials at CUH R&D/SOP012 30 January, 2017
PDF icon FRM005 EPIC Training Record SOP012 and FRM005 7 February, 2017
PDF icon SOP012 Facilitating Monitoring Visits for Clinical Trials at CUH SOP012 and FRM005 7 February, 2017
PDF icon Monitoring Trust Sponsored CTIMPs CCTU/SOP011 9 February, 2017
File Data Management Index CCTU/TPL063 28 March, 2017
PDF icon Use of Vendors CCTU/SOP045 28 March, 2017
PDF icon Reference Safety Information in CTIMPs CCTU/SOP061 23 March, 2017
Microsoft Office document icon SmPC/IB Review Form CCTU/FRM105 23 March, 2017
File Non-Compliance Report Form CCTU/FRM013 3 March, 2015

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
Microsoft Office document icon Archiving Checklist for Site Information in the TMF CCTU/TPL055 30 November, 2016
Microsoft Office document icon Investigator Site File Archiving Checklist CCTU/TPL052 30 November, 2016
Microsoft Office document icon Trial Master File Archiving Checklist CCTU/TPL051 30 November, 2016
PDF icon Archiving CTIMPs CCTU/SOP006 29 November, 2016
Microsoft Office document icon Archiving Box Label CCTU/FRM015 29 November, 2016
PDF icon Archiving Record Form CCTU/FRM017 14 March, 2017
PDF icon End of Trial Procedures (CTIMPs) CCTU/SOP004 14 March, 2017
File Participating Site Archiving Arrangements CCTU/FRM030 15 March, 2012

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