Randomisation Schedule Sign Off Checklist
Please use this form to document the sign off of all stages of the randomisation schedule selection.
Study title/Acronym:
Sponsor code:
1
2
3
4
5
6
7
8
9
Sign off by
Database
Developer
Signature
Date
Database Developer generates 10 randomisation
schedules (randomisation number/treatment
allocation code)
All 10 schedules are received by Statistician to check Statistician
they meet protocol criteria for randomisation
All 10 schedules are verified (signed and dated) by
Statistician
Statistician
Database Developer randomly selects and
Database
documents on the chosen schedule which of the 10
Developer
schedules is the Master Randomisation Schedule to
be used for the study
Database Developer generates Code break
Database
document which is password-protected detailing
Developer
treatment allocation
Database Developer generates Code break secure
Database
password document (listing the above password)
Developer
All documents provided to TM/SC for inclusion in the Database
SMF (EXCEPT if a blinded trial, all documents are sent Developer
in separate emails to the Quality Assurance Office
[email protected] , ONLY the 10
signed schedules are supplied to the TM/SC.
For blinded trials with a 3rd party manufacturer, the
Quality
Quality Office send all documents separately to the
Office
manufacturing facility
Database developer links Master Randomisation
Database
Schedule to the study database before ‘go live’ date
Developer
Checklist complete (TM/SC signature):……………………………………………………Date:………………………………..
CHL14 Document114-Feb-2017