Leeches to lasers – 250 years of charitable support
 
£1000 welcome subsidy for all UK recruited nurses, midwives, ODPs and radiographers. See latest vacancies ...
 
 
We are proud to be a no smoking site. You cannot smoke anywhere.
 
Feeling unwell or injured? Make sure you choose the right NHS service

CCTU standard operating procedures (SOPs)

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

Title of documentsort descending Reference number Date ratified
Microsoft Office document icon Participating Site Archiving Arrangements CCTU/FRM030 10 February, 2012
PDF icon Set up and Opening of a Participating Site for Trust Sponsored Clinical Trials CCTU/SOP039 9 March, 2012
PDF icon IRAS Application Form Guidance R&D GD002 2 July, 2012
PDF icon Electronic SUSAR Reporting Registration Form CCTU/FRM028 11 April, 2013
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 Use of Vendors CCTU/SOP045 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 Initial MHRA Submission Guidance CCTU/GD013 27 March, 2015
PDF icon Management of Contracts for Research Projects R&D SOP005 25 June, 2014
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 Data Transfer CCTU SOP029 8 June, 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, 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
PDF icon Initial Research Ethics Committee Submission Guidance CCTU/GD012 30 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

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
PDF icon Emergency Unbinding Request Form CCTU FRM055 21 March, 2016
File GP Letter Template CCTU/TPL015 26 July, 2016
Microsoft Office document icon Trial Master File Index CCTU/TPL032 12 October, 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 Site File Index CCTU/TPL033 30 November, 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

Pharmacovigilance

Title of documentsort descending Reference number Date ratified
PDF icon Electronic SUSAR Reporting Registration Form CCTU/FRM028 11 April, 2013
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
File Development Safety Update Report Template CCTU TPL012 14 April, 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

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 Case report form design CCTU SOP013 15 June, 2016
PDF icon Open Label Randomisation CCTU SOP036 31 May, 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 Building a MACRO database CCTU/GD005 8 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

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
PDF icon Confirmation of Consent process CCTU/TPL018 12 February, 2013
PDF icon Use of Vendors CCTU/SOP045 11 April, 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
File Non-Compliance Report Form CCTU/FRM013 3 March, 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
PDF icon Monitoring Trust sponsored CTIMPs CCTU SOP011 26 July, 2016
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

Closing down a trial – post-study procedures and archiving

Title of documentsort descending Reference number Date ratified
Microsoft Office document icon Participating Site Archiving Arrangements CCTU/FRM030 10 February, 2012
File End of Trial Report CCTU/TPL037 14 April, 2015
PDF icon End of Trial Procedures (CTIMPs) CCTU/SOP004 21 March, 2016
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 Record Form CCTU/FRM017 30 November, 2016
Microsoft Office document icon Archiving Box Label CCTU/FRM015 29 November, 2016

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