Search
Search
Close
Back
Back
Portfolio
QA - SOPs & Documents
Jump to:
Pre-trial – planning, protocol development, set-up
Title
Ref No.
PDF
CCTU Set up Procedure for CCTU Led non-CTIMP Trials
SOP070
PDF
CCTU Study Managements Groups and Committees
GD026
Word
CCTU Patient Information Sheet & Informed Consent Form for 11 to 15 yrs old
TPL017
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 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 Initial Health Economics Meeting Form
FRM089
Pharmacovigilance
Title
Ref No.
PDF
CCTU Pharmacovigilance Process for Investigator Teams
SOP002
Data management and statistics
Title
Ref No.
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 Determination of Analysis Population
SOP032
Sample management
Title
Ref No.
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 Monitoring Cambridge Sponsored CTIMPs
SOP011
PDF
CCTU Reference Safety Information in CTIMPs
SOP061
PDF
CCTU Version Control of Trial Level Documents
SOP031
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
Closing down a trial – post-study procedures and archiving
Title
Ref No.
PDF
CCTU End of Trial Procedures CCTU Led Non-CTIMPs
SOP077
Word
CCTU Investigator Site File Archiving Checklist
TPL052
