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QA - SOPs & Documents

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

Title
Ref No.
PDF
CCTU Funding and Collaboration Flowchart
INFO14 - Version 2
PDF
Set up and Activation of Participating Sites for Cambridge Sponsored CCTU Led Clinical Trials
SOP039 - Version 4
PDF
CCTU Use of Vendors
SOP045 - Version 3
PDF
CCTU Study Managements Groups and Committees
GD026 - Version 3
Word
CCTU Delegation of Responsibilities
TPL058 - Version 4
Word
CCTU Patient Information Sheet & Informed Consent Form for 11 to 15 yrs old
TPL017 - Version 2
Word
CCTU Patient Information Sheet & Informed Consent Form
TPL002 - Version 8
Word
CCTU Clinical Trial Protocol Template
TPL001 - Version 8
PDF
CCTU Funding and Collaboration Procedure
SOP054 - Version 3
PDF
CCTU CTIMP Set up Procedure For Trial Teams
SOP047 - Version 6
PDF
CCTU Initiation Meeting for CTIMPs
SOP024 - Version 2
PDF
CCTU Trial Master File / Site File Essential Document Management
SOP015 - Version 6
PDF
CCTU Test of Out of Hours Medical Cover Arrangements
SOP005 - Version 6
PDF
CCTU Funding and Collaboration Flowchart
INF014 - Version 1
Word
CCTU CTIMP Submission Checklist
GD029 - Version 3
Word
CCTU Collaboration Request Form
FRM083 - Version 6

Pharmacovigilance

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

Data management and statistics

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

Sample management

Title
Ref No.
PDF
CCTU Research Sample Management
SOP044 - Version 5
PDF
CCTU Management of Trial Specific Equipment
SOP030 - Version 2
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 Monitoring Cambridge Sponsored CTIMPs
SOP011 - Version 8
PDF
CCTU Reference Safety Information in CTIMPs
SOP061 - Version 5
PDF
CCTU Version Control of Trial Level Documents
SOP031 - Version 3
PDF
CCTU Data Transfer
SOP029 - Version 4
PDF
CCTU Handling Protocol or Regulatory Non Compliance
SOP018 - Version 6
PDF
CCTU Amendment Management of CTIMPs by Trial Teams
SOP014 - Version 10
Word
CCTU File Note
FRM038 - Version 5
Word
CCTU Non Compliance Report Form
FRM013 - Version 6

Closing down a trial – post-study procedures and archiving

Title
Ref No.
PDF
CCTU End of Trial Procedures
SOP004 - Version 10
PDF
CCTU Archiving Process
SOP006 - Version 6
Word
CCTU End of Trial Report
TPL037 - Version 1
Word
CCTU Archiving Records
FRM017 - Version 6