Viewing and downloading randomisations

1. Documentation
2. Red Pill and Randomisation
3. Version 9
4. Randomisation
5. Viewing and downloading randomisations

Viewing

For trials set-up for internet randomisation only, clicking the Randomisations link in the left-hand sidebar 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 Patients link in the left-hand sidebar will display a list of patients. Randomised patients 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 patients in the list displays more detail for that record. A link will be displayed to mark as randomised in error if the patient 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 left-hand sidebar 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
• Parent patient. Foreign key: patient table.id. In Red Pill applications this is the id of the patient that the randomisation belongs to
• Patient identifier: unique patient 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 & time of randomisation
• Randomisation code: this will be the treatment group for unblinded trials
• Unblinded?: has the patient been unblinded? 0=no, 1=yes
• Reason for unblinding: the reason entered when the randomisation was unblinded
• Date unblinded
• Manual randomisation?: was this a manual randomisation?
• Randomised in error?: was the patient randomised in error? 0=no, 1=yes
• Reason marked in error
• Date marked error: the date the randomisation was marked as in error
• Timestamp for row creation
• Date & time of last update to row
• 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 entered study
• 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.