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Ranges from single to multi-centre, national to international, phase II to phase IV drug trials, as well as other randomised control trials and well designed studies.

COVID-19 Clinical Trials

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QA - SOPs & Documents

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Pre-trial – planning, protocol development, set-up

Title
Ref No.
PDF
CCTU Funding and Collaboration Flowchart
INFO14 - Version 2
CCTU_INF014 CCTU Funding and Collaboration Flowchart.pdf
PDF
Set up and Activation of Participating Sites for Cambridge Sponsored CCTU Led Clinical Trials
SOP039 - Version 4
CCTU-SOP039 Activating a PS for Cambridge Sponsored CCTU led trials.pdf
PDF
CCTU Use of Vendors
SOP045 - Version 3
CCTU-SOP045 Use of Vendors.pdf
PDF
CCTU Study Managements Groups and Committees
GD026 - Version 3
CCTUGD026 study managements groups and committees.pdf
Word
CCTU Delegation of Responsibilities
TPL058 - Version 4
CCTU_TPL058 Delegation_of_Responsibilities_4.doc
Word
CCTU Patient Information Sheet & Informed Consent Form for 11 to 15 yrs old
TPL017 - Version 2
CCTU_TPL017_PIS ICF 11 to 15 yrs old_0.doc
Word
CCTU Patient Information Sheet & Informed Consent Form
TPL002 - Version 8
CCTU_TPL002_PIS & ICF_5.doc
Word
CCTU Clinical Trial Protocol Template
TPL001 - Version 8
CCTU_TPL001_Clinical Trial Protocol Template_1.doc
PDF
CCTU Funding and Collaboration Procedure
SOP054 - Version 3
CCTU_SOP054 CCTU Funding and Collaboration Procedure.pdf
PDF
CCTU CTIMP Set up Procedure For Trial Teams
SOP047 - Version 6
CCTU_SOP047 CTIMP Set up Procedure For Trial Teams.pdf
PDF
CCTU Initiation Meeting for CTIMPs
SOP024 - Version 2
CCTU_SOP024 Initiation Meeting for CTIMPs.pdf
PDF
CCTU Trial Master File / Site File Essential Document Management
SOP015 - Version 6
CCTU_SOP015 TMF and Site File Essential Document Management.pdf
PDF
CCTU Test of Out of Hours Medical Cover Arrangements
SOP005 - Version 6
CCTU_SOP005 Test of Out of Hours Medical Cover Arrangements.pdf
PDF
CCTU Funding and Collaboration Flowchart
INF014 - Version 1
CCTU_INF014 CCTU Funding and Collaboration Flowchart.pdf
Word
CCTU CTIMP Submission Checklist
GD029 - Version 3
CCTU_GD029CTIMP Submission Checklist.doc
Word
CCTU Collaboration Request Form
FRM083 - Version 6
CCTU_FRM083 Collaboration Request Form.docx

Pharmacovigilance

Title
Ref No.
PDF
CCTU DSUR and Annual Progress Reporting
SOP003 - Version 10
CCTU-SOP003 DSUR and Annual Progress Reporting.pdf
PDF
CCTU Urgent safety Measures for CTIMPs
SOP019 - Version 5
CCTU_SOP019 Urgent safety Measures for CTIMPs.pdf
PDF
CCTU Pharmacovigilance Process for Investigator Teams
SOP002 - Version 8
CCTU_SOP002 Pharmacovigilance Process for Investigator Teams.pdf

Data management and statistics

Title
Ref No.
PDF
CCTU Case Report Form Design
SOP013 - Version 6
CCTU_SOP013 Case Report Form Design_2.pdf
PDF
CCTU Blinded Randomisation
SOP046 - Version 4
CCTU_SOP046 Blinded Randomisation.pdf
PDF
CCTU Randomisation Using sealed Envelope
SOP058 - Version 5
CCTU-SOP058 Randomisation Using sealed Envelope.pdf
PDF
CCTU Open Label Randomisation
SOP036 - Version 8
CCTU_SOP036 Open Label Randomisation.pdf
PDF
CCTU Database Locking
SOP033 - Version 7
CCTU_SOP033 Database Locking.pdf
PDF
CCTU Statistical Anaysis Plan
SOP023 - Version 7
CCTU_SOP023 Statistical Anaysis Plan.pdf
PDF
CCTU Statistical Principles
SOP022 - Version 7
CCTU_SOP022 Statistical Principles.pdf
PDF
CCTU Paper Based Randomisation
SOP053 - Version 3
CCTU-SOP053 Paper Based Randomisation.pdf
PDF
CCTU Determination of Analysis Population
SOP032 - Version 2
CCTU_SOP032 Determination of Analysis population.pdf

Sample management

Title
Ref No.
PDF
CCTU Research Sample Management
SOP044 - Version 5
CCTU_SOP044 Research Sample Management.pdf
PDF
CCTU Management of Trial Specific Equipment
SOP030 - Version 2
CCTU_SOP030 Management of Trial Specific Equipment.pdf
PDF
CCTU Packaging Requirements for the Transport of Biological Samples
SOP016 - Version 4
CCTU_SOP016- Packaging Requirements for the Transport of Biological Samples.pdf
Word
CCTU Sample Tracking and Processing Template
TPL031 - Version 3
CCTU_TPL031_ Sample_ Tracking_ and_ Processing_ Template.doc

Conduct of a trial

Title
Ref No.
PDF
CCTU Monitoring Cambridge Sponsored CTIMPs
SOP011 - Version 8
CCTU-SOP011 Monitoring Cambridge Sponsored CTIMPs_0.pdf
PDF
CCTU Reference Safety Information in CTIMPs
SOP061 - Version 5
CCTU_SOP061 SmPC,IB and Reference Safety Information Management in CTIMPs.pdf
PDF
CCTU Version Control of Trial Level Documents
SOP031 - Version 3
CCTU_SOP031 Version Control of Clinical Research Project Documents.pdf
PDF
CCTU Data Transfer
SOP029 - Version 4
CCTU_SOP029 Data Transfer.pdf
PDF
CCTU Handling Protocol or Regulatory Non Compliance
SOP018 - Version 6
CCTU_SOP018 Handling Protocol or Regulatory Non Compliance.pdf
PDF
CCTU Amendment Management of CTIMPs by Trial Teams
SOP014 - Version 10
CCTU-SOP014 Amendment Management of CTIMPs by Trial Teams.pdf
Word
CCTU File Note
FRM038 - Version 5
CCTU_FRM038_File Note_1.doc
Word
CCTU Non Compliance Report Form
FRM013 - Version 6
CCTU_FRM013 Non Compliance Report Form_2.docx

Closing down a trial – post-study procedures and archiving

Title
Ref No.
PDF
CCTU End of Trial Procedures
SOP004 - Version 10
CCTU_SOP004 End of Trial Procedures.pdf
PDF
CCTU Archiving Process
SOP006 - Version 6
CCTU_SOP006 The CCTU Archiving Process.pdf
Word
CCTU End of Trial Report
TPL037 - Version 1
CCTU_TPL037 END OF TRIAL REPORT_0.docx
Word
CCTU Archiving Records
FRM017 - Version 6
CCTU_FRM17_Archiving_ Record.doc