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Covers:

- CRF design

- Clinical database – testing, documentation, GCP requirements

- DMP – what needs to be included, validation checks

- Data cleaning – consistency checking

- Data entry – data cleaning

- Running queries

- Lab section – half hour covering lab agreements. Reconciling lab results against CRF

- Coding – MedDRA dictionary

- SAE reconciliation

- Exercises in data review, data analysis – what a Statistician would be looking for

- Database locking – criteria for locking a database

 

This course is now fully booked. Please email octrutrialshub@ndorms.ox.ac.uk if you would like to be added to the waiting list if spaces become available.