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QA - SOPs & Documents

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

Title
Ref No.
PDF
CCTU Use of Vendors
SOP045
PDF
CCTU Study Managements Groups and Committees
GD026
Word
CCTU Delegation of Responsibilities
TPL058
Word
CCTU Patient Information Sheet & Informed Consent Form for 11 to 15 yrs old
TPL017
Word
CCTU Patient Information Sheet & Informed Consent Form
TPL002
Word
CCTU Clinical Trial Protocol Template
TPL001
PDF
CCTU Funding and Collaboration Procedure
SOP054
PDF
CCTU CTIMP Set up Procedure For Trial Teams
SOP047
PDF
CCTU Risk Assessment Procedure for CTIMPs
SOP040
PDF
CCTU Set Up and Opening of a Participating Site
SOP039
PDF
CCTU Initiation Meeting for CTIMPs
SOP024
PDF
CCTU Trial Master File / Site File Essential Document Management
SOP015
PDF
CCTU Test of Out of Hours Medical Cover Arrangements
SOP005
PDF
CCTU Funding and Collaboration Flowchart
INF014
Word
CCTU CTIMP Submission Checklist
GD029
PDF
CCTU Initial MHRA Submission Guidance
GD013
Word
CCTU Initial Health Economics Meeting Form
FRM089
Word
CCTU Collaboration Request Form
FRM083

Pharmacovigilance

Title
Ref No.
PDF
CCTU DSUR and Annual Progress Reporting
SOP003
PDF
CCTU Urgent safety Measures for CTIMPs
SOP019
PDF
CCTU Pharmacovigilance Process for Investigator Teams
SOP002
PDF
CCTU Source Data Top Tips
INF013
PDF
CCTU Common Monitoring Findings
INF012

Data management and statistics

Title
Ref No.
PDF
CCTU Blinded Randomisation
SOP046
PDF
CCTU Randomisation Using sealed Envelope
SOP058
PDF
CCTU Providing a Dataset from a Clinical Trial Database
SOP057
PDF
CCTU Validation and Verification of Software Systems
SOP056
PDF
CCTU Open Label Randomisation
SOP036
PDF
CCTU Database Locking
SOP033
PDF
CCTU Statistical Anaysis Plan
SOP023
PDF
CCTU Statistical Principals
SOP022
PDF
CCTU Paper Based Randomisation
SOP053
PDF
CCTU Determination of Analysis Population
SOP032
PDF
CCTU Case Report Form Design
SOP013

Sample management

Title
Ref No.
PDF
CCTU Research Sample Management
SOP044
PDF
CCTU Management of Trial Specific Equipment
SOP030
PDF
CCTU Packaging Requirements for the Transport of Biological Samples
SOP016
Word
CCTU Sample Tracking and Processing Template
TPL031

Conduct of a trial

Title
Ref No.
PDF
CCTU Use of Vendors
SOP045
PDF
CCTU Monitoring Cambridge Sponsored CTIMPs
SOP011
PDF
CCTU Reference Safety Information in CTIMPs
SOP061
PDF
CCTU Version Control of Trial Level Documents
SOP031
PDF
CCTU Data Transfer
SOP029
PDF
CCTU Handling Protocol or Regulatory Non Compliance
SOP018
PDF
CCTU TMF and Site File Essential Document Management
SOP015
PDF
CCTU Amendment Management of CTIMPs by Trial Teams
SOP014
Word
CCTU File Note
FRM038
Word
CCTU Non Compliance Report Form
FRM013
Word
CCTU SmPC Review Form
FRM105

Closing down a trial – post-study procedures and archiving

Title
Ref No.
PDF
CCTU End of Trial Procedures
SOP004
PDF
CCTU Archiving Process
SOP006
Word
CCTU End of Trial Report
TPL037
Word
CCTU Archiving Record
FRM17
Word
CCTU Investigator Site File Archiving Checklist
TPL052