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Spot checks to validate data transfer from the CRFs to the electronic database will be completed by the Good Clinical Practice Unit.
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"There will be further work required to load these into a searchable database, which will be completed by mid-June".
A Therapist database on the CTU MACRO system will be completed by the therapists.
All analyses will be described in a detailed statistical analysis plan which will be completed before unblinding and database lock.
All core laboratory readings and adjudications will be completed and entered into the computer database before the study is unblinded.
Initially a workforce profile will be established from workforce databases and a comprehensive survey of the Nurse Consultant workforce will be completed.
All primary and secondary outcome data will be completed online and thus will be automatically entered into a database.
Data collection process: Data extraction will be completed by one reviewer using a pre-designed standardised form and entered into Microsoft Excel database (Microsoft, Redmond, Washington, USA).
Phase 3 will be completed in 2018.
The barrier will be completed in 1982.
Prototypes will be completed.
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