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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 Use of Vendors
SOP045
CCTU-SOP045 Use of Vendors.pdf
PDF
CCTU Study Managements Groups and Committees
GD026
CCTUGD026 study managements groups and committees_1.pdf
Word
CCTU Delegation of Responsibilities
TPL058
CCTU_TPL058 Delegation_of_Responsibilities_4.doc
Word
CCTU Patient Information Sheet & Informed Consent Form for 11 to 15 yrs old
TPL017
CCTU_TPL017_PIS ICF 11 to 15 yrs old_0.doc
Word
CCTU Patient Information Sheet & Informed Consent Form
TPL002
CCTU_TPL002_PIS & ICF_5.doc
Word
CCTU Clinical Trial Protocol Template
TPL001
CCTU_TPL001_Clinical Trial Protocol Template_1.doc
PDF
CCTU Funding and Collaboration Procedure
SOP054
CCTU_SOP054 CCTU Funding and Collaboration Procedure.pdf
PDF
CCTU CTIMP Set up Procedure For Trial Teams
SOP047
CCTU_SOP047 CTIMP Set up Procedure For Trial Teams_0.pdf
PDF
CCTU Risk Assessment Procedure for CTIMPs
SOP040
CCTU_SOP040 Risk Assessment Procedure for CTIMPs_0.pdf
PDF
CCTU Set Up and Opening of a Participating Site
SOP039
CCTU_SOP039_Set Up and Opening of a Participating Site.pdf
PDF
CCTU Initiation Meeting for CTIMPs
SOP024
CCTU_SOP024 Initiation Meeting for CTIMPs.pdf
PDF
CCTU Trial Master File / Site File Essential Document Management
SOP015
CCTU_SOP015 TMF and Site File Essential Document Management.pdf
PDF
CCTU Test of Out of Hours Medical Cover Arrangements
SOP005
CCTU_SOP005 Test of Out of Hours Medical Cover Arrangements.pdf
PDF
CCTU Funding and Collaboration Flowchart
INF014
CCTU_INF014 CCTU Funding and Collaboration Flowchart.pdf
Word
CCTU CTIMP Submission Checklist
GD029
CCTU_GD029CTIMP Submission Checklist_0.doc
PDF
CCTU Initial MHRA Submission Guidance
GD013
CCTU_GD013 Initial MHRA Submission Guidance_3.pdf
Word
CCTU Initial Health Economics Meeting Form
FRM089
CCTU_FRM089 Initial Health Economics Meeting form_0.docx
Word
CCTU Collaboration Request Form
FRM083
CCTU_FRM083 Collaboration Request Form_1 (1).docx

Pharmacovigilance

Title
Ref No.
PDF
CCTU DSUR and Annual Progress Reporting
SOP003
CCTU-SOP003 DSUR and Annual Progress Reporting.pdf
PDF
CCTU Urgent safety Measures for CTIMPs
SOP019
CCTU_SOP019 Urgent safety Measures for CTIMPs.pdf
PDF
CCTU Pharmacovigilance Process for Investigator Teams
SOP002
CCTU_SOP002 Pharmacovigilance Process for Investigator Teams.pdf
PDF
CCTU Source Data Top Tips
INF013
CCTU_INF013 Source data top tips_0.pdf
PDF
CCTU Common Monitoring Findings
INF012
CCTU_INF012_Common_monitoring_findings_3.pdf

Data management and statistics

Title
Ref No.
PDF
CCTU Blinded Randomisation
SOP046
CCTU_SOP046 Blinded Randomisation_0.pdf
PDF
CCTU Randomisation Using sealed Envelope
SOP058
CCTU-SOP058 Randomisation Using sealed Envelope.pdf
PDF
CCTU Providing a Dataset from a Clinical Trial Database
SOP057
CCTU_SOP057 Providing a Dataset from a Clinical Trial Database.pdf
PDF
CCTU Validation and Verification of Software Systems
SOP056
CCTU_SOP056 Validation and Verification of Software Systems_0.pdf
PDF
CCTU Open Label Randomisation
SOP036
CCTU_SOP036 Open Label Randomisation.pdf
PDF
CCTU Database Locking
SOP033
CCTU_SOP033 Database Locking.pdf
PDF
CCTU Statistical Anaysis Plan
SOP023
CCTU_SOP023 Statistical Anaysis Plan.pdf
PDF
CCTU Statistical Principals
SOP022
CCTU_SOP022 Statistical Principals.pdf
PDF
CCTU Paper Based Randomisation
SOP053
CCTU-SOP053 Paper Based Randomisation.pdf
PDF
CCTU Determination of Analysis Population
SOP032
CCTU_SOP032 Determination of Analysis population.pdf
PDF
CCTU Case Report Form Design
SOP013
CCTU_SOP013 Case Report Form Design_2.pdf

Sample management

Title
Ref No.
PDF
CCTU Research Sample Management
SOP044
CCTU_SOP044 Research Sample Management_3.pdf
PDF
CCTU Management of Trial Specific Equipment
SOP030
CCTU_SOP030 Management of Trial Specific Equipment.pdf
PDF
CCTU Packaging Requirements for the Transport of Biological Samples
SOP016
CCTU_SOP016- Packaging Requirements for the Transport of Biological Samples.pdf
Word
CCTU Sample Tracking and Processing Template
TPL031
CCTU_TPL031_ Sample_ Tracking_ and_ Processing_ Template_0.doc

Conduct of a trial

Title
Ref No.
PDF
CCTU Use of Vendors
SOP045
CCTU-SOP045 Use of Vendors_0.pdf
PDF
CCTU Monitoring Cambridge Sponsored CTIMPs
SOP011
CCTU-SOP011 Monitoring Cambridge Sponsored CTIMPs_0.pdf
PDF
CCTU Reference Safety Information in CTIMPs
SOP061
CCTU_SOP061 SmPC,IB and Reference Safety Information Management in CTIMPs.pdf
PDF
CCTU Version Control of Trial Level Documents
SOP031
CCTU_SOP031 Version Control of Clinical Research Project Documents.pdf
PDF
CCTU Data Transfer
SOP029
CCTU_SOP029 Data Transfer.pdf
PDF
CCTU Handling Protocol or Regulatory Non Compliance
SOP018
CCTU_SOP018 Handling Protocol or Regulatory Non Compliance.pdf
PDF
CCTU TMF and Site File Essential Document Management
SOP015
CCTU_SOP015 TMF and Site File Essential Document Management.pdf
PDF
CCTU Amendment Management of CTIMPs by Trial Teams
SOP014
CCTU_SOP014 Amendment Management of CTIMPs by Trial Teams_0.pdf
Word
CCTU File Note
FRM038
CCTU_FRM038_File Note_1.doc
Word
CCTU Non Compliance Report Form
FRM013
CCTU_FRM013 Non Compliance Report Form_2.docx
Word
CCTU SmPC Review Form
FRM105
CCTU_FRM 105 SmPC Review Form_1.doc

Closing down a trial – post-study procedures and archiving

Title
Ref No.
PDF
CCTU End of Trial Procedures
SOP004
CCTU_SOP004 End of Trial Procedures.pdf
PDF
CCTU Archiving Process
SOP006
CCTU_SOP006 The CCTU Archiving Process_1.pdf
Word
CCTU End of Trial Report
TPL037
CCTU_TPL037 END OF TRIAL REPORT_0.docx
Word
CCTU Archiving Record
FRM17
CCTU_FRM17_Archiving_ Record_1.doc
Word
CCTU Investigator Site File Archiving Checklist
TPL052
CCTU_TPL052_Investigator_Site_ File_ archiving Checklist_1.doc