For some trials maintenance therapy may be given to subjects after randomisation, for instance every three months until the therapy period is finished. Where the trial is double blind it is therefore necessary to generate further codes that match the treatment allocation of the original randomisation code.
To generate a maintenance code for a randomisation the appropriate record should be viewed in the randomisation list and the ‘Get maintenance code’ link clicked on. The user will then be presented with the randomisation details and asked to enter a reason the code is needed and their password to confirm the need for a maintenance code.
After entering a reason and the correct password and clicking the ‘Get maintenance code’ button the user will be shown the next maintenance code on-screen, provided a suitable code is available for the site in the code list. In addition an email containing the maintenance code will be automatically sent out to all trial administrators and all investigators associated with the site that the randomisation originates from, as long as they have notifications enabled. All maintenance codes that have been allocated to a subject can be viewed in the randomisation details. Each code and the date and time of allocation are shown at the bottom of the randomisation details.
Replacement codes are a special type of maintenance code. For trials that don’t require maintenance codes, the option to generate a replacement code may be presented. This works in exactly the same way as maintenance codes, and is useful in case a drug kit is damaged or lost after randomisation.
Some double blind trials have rescue medication - usually a lower dose of the active treatment to be used for subjects showing signs of intolerance.
To generate a rescue code for a randomisation the appropriate record should be viewed in the randomisation list and the ‘Get rescue code’ link clicked on. The user will then be presented with the randomisation details and asked to enter their password to confirm the need for a rescue code. Following confirmation the user will be shown the rescue code on-screen (e.g. ‘R2001’), provided a suitable code is available for the site in the rescue code list. In addition an email containing the rescue code will be automatically sent out to all trial administrators and all investigators associated with the site that the randomisation originates from, as long as they have notifications enabled.
Some trials may allow multiple rescue codes to be generated for the same subject. In this case the additional rescue codes will be appended to existing codes (e.g. ‘R2001, R2003’).