Viewing and downloading randomisations

1. Documentation
2. Red Pill and Randomisation
3. Version 11
4. Randomisation
5. Viewing and downloading randomisations

Viewing

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.