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QA - SOPs & Documents
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Pre-trial – planning, protocol development, set-up
Title
Ref No.
PDF
Delegation of Roles and Responsibilities for Cambridge Sponsored Clinical Trials of Investigational Medicinal Products (CTIMPs)
R&D/SOP001 - Version 8
Word
CCTU Participating Sites Delegation Log
TPL058B - Version 3
PDF
CCTU Identification and feasibility of Identification and Feasibility Assessment of Participating Sites for Cambridge Sponsored CCTU Led Clinical Trials
SOP081 - Version 2
PDF
CCTU Funding and Collaboration Flowchart
INFO14 - Version 3
PDF
Set up and Activation of Participating Sites for Cambridge Sponsored CCTU Led Clinical Trials
SOP039 - Version 5
PDF
CCTU Study Managements Groups and Committees
GD026 - Version 5
Word
CCTU Coordination Centre Delegation of Responsibilities
TPL058A - Version 7
Word
CCTU Participant Information Sheet & Informed Consent Form for 11 to 15 yrs old
TPL017
Word
CCTU Patient Information Sheet & Informed Consent Form
TPL002 - Version 11
Word
CCTU Clinical Trial Protocol Template
TPL001 - Version 11
PDF
CCTU Funding and Collaboration Procedure
SOP054 - Version 4
PDF
CCTU CTIMP Start-up/Set-up Procedures for Trial Teams
SOP047 - Version 10
PDF
CCTU Initiation Meeting for CTIMPs
SOP024 - Version 6
PDF
CCTU Trial Master File and Site File Essential Document Management
SOP015 - Version 7
PDF
CCTU Test of Out of Hours Medical Cover Arrangements
SOP005 - Version 8
Pharmacovigilance
Title
Ref No.
PDF
CCTU DSUR and Annual Progress Reporting
SOP003 - Version 13
PDF
CCTU Urgent safety Measures for CTIMPs
SOP019 - Version 7
PDF
CCTU Pharmacovigilance Process for Investigator Teams
SOP002 - Version 10
Data management and statistics
Title
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PDF
CCTU Paper Case Report Form Design
SOP013 - Version 8
PDF
CCTU Randomisation Using sealed Envelope
SOP058 - Version 7
PDF
CCTU General Principals of Randomisation
SOP036 - Version 9
PDF
CCTU Determination of Analysis Population
SOP032 - Version 2
Sample management
Title
Ref No.
PDF
Guidance for CTUs Assessing the Suitability of Laboratories Processing/Analysing Clinical Trial Samples
GD054 - Version 2
PDF
CCTU Management of Trial Specific Equipment
SOP030 - Version 3
PDF
CCTU Packaging Requirements for the Transport of Biological Samples
SOP016 - Version 4
Word
CCTU Sample Tracking and Processing Template
TPL031 - Version 3
Conduct of a trial
Title
Ref No.
PDF
CCTU Review of SAE Line Listings by Academic Research Leads
SOP068 – Version 3
PDF
CCTU Monitoring Cambridge Sponsored CTIMPs
SOP011 - Version 13
PDF
SmPC, IB and Reference Safety Information Management in CTIMPs
SOP061 - Version 5
PDF
CCTU Version Control of Trial Level Documents
SOP031 - Version 5
PDF
CCTU Handling Protocol or Regulatory Non Compliance
SOP018 - Version 7
PDF
CCTU Amendment Management of CTIMPs by Trial Teams
SOP014 - Version 14
Closing down a trial – post-study procedures and archiving
Title
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