Editing randomisations

Randomisation forms may be edited but note the following:

  • The treatment group or code can never be edited.

  • Making changes to fields used to stratify the randomisation with random permuted blocks will have no effect on the blocking. In other words, randomisation is always stratified by the values recorded at the time of randomisation.

  • Making changes to fields used to balance the randomisation with minimisation will be reflected in future randomisations. Randomisation with minimisation always takes into account the current values of balancing factors at the point of each randomisation.

  • Inclusion and exclusion criteria can be changed to show that the subject was not eligible. Validation rules that prevent ineligible subjects being randomised are removed when editing an existing randomisation form.

  • Whether a randomisation was performed manually or not cannot be changed.

Page updated 25 Mar 2016 12:24