For trials set-up for internet randomisation only, clicking the
Randomisations link in the top menu will display a
list of randomisations. Administrators will see all randomisations, including
manual randomisations and those subsequently marked as randomised in error, but
Investigators can only see randomisations carried out at their site.
For trials with a randomisation form in the CRF, clicking the Subjects
link in the top menu will display a list of subjects. Randomised
subjects can be identified from the Date randomised column.
The list can be restricted by typing in search terms and ordered by
clicking on the row headers.
Clicking one of the randomisations or subjects in the list displays more detail for that
record. A link will be displayed to
mark as randomised in error if the subject has been randomised.
Some trials may also have a link to unblind the randomisation.
The unblinded treatment group will never be given out by the
randomisation system for double-blind trials, except for when the
unblinding procedure is followed.
Downloading
The full randomisation list can be downloaded in either CSV or Stata fixed format by clicking on the
Downloads link in the top menu and choosing the randomisation form from the list of forms. See the downloads documentation for more information.
The data will vary by trial, but all trials will contain the following standard fields:
id: primary key, unique id
Subject id. In Red Pill applications this is the id of the subject that the randomisation belongs to
Subject identifier: unique subject identifier, may be user entered or generated
User who created row: the name and user id of the randomiser
User who last updated row: the name and user id of the person who last edited the randomisation
Date of study entry in the site’s timezone. yyyy-mm-dd format
Date & time of randomisation (UTC)
Randomisation code: this will be the treatment group for unblinded trials
Manual randomisation?: was this a manual randomisation?
Date of manual randomisation
Time of manual randomisation
Timezone for date and time of manual randomisation
Randomised in error?: was the subject randomised in error? 0=no, 1=yes
Reason marked in error
Date marked error (UTC): the date the randomisation was marked as in error
Timestamp for row creation (UTC)
Date & time of last update to row (UTC)
Reason for editing row
Notes
Justifications for overriding validation: reasons for overriding validation errors
Validation status: forms may be marked as ‘Not validated’, ‘Validated’, or ‘Data unusable’
Validation notes: notes recorded when changing the form validation status
Date of study entry in the site’s timezone. yyyy-mm-dd format
Date withdrew
Site: name of site
Country
Visit: the visit that the form is associated with
For blinded trials the data will not contain the treatment group, even if the randomisation has been unblinded.