Simple randomisation service specification

Sealed Envelope’s simple randomisation service has the following features:

  • Web based service with optional randomisation via SMS
  • Online set up - the client may set up the system themselves or ask Sealed Envelope to do it on their behalf (extra costs apply).
  • Randomisation lists may be uploaded to the service to enable stratification. Allocations are provided sequentially within strata. This allows block sizes, unequal treatment allocation and treatment names or codes to be defined.
  • If a randomisation list is not uploaded, randomisation is by random permuted blocks to treatment A or B in ratio 1:1.
  • Inclusion and exclusion criteria may optionally be configured. If configured they must be answered Yes or No as appropriate to allow randomisation to occur.
  • The system is accessed via a secure connection (SSL) over the internet. This connection encrypts data between the user’s internet browser and the server.
  • Online randomisation is achieved by the user entering a patient identifier (text field - must be unique), stratification information (if applicable), confirming eligibility criteria (if applicable), own email address and the randomisation system password. Randomisation by SMS is achieved by the user sending a text message containing a trial identifier, patient identifier and stratification information (if applicable).
  • The patient is randomised to the next treatment or code and the chosen treatment group or code shown or texted to the user.
  • An email notification is generated displaying the chosen treatment group or code and sent to the email address given by the user randomising and the administrator email address. The administrator email address is the one provided when the system is set up (usually a trial coordinator or central trial email address).
  • A list of all randomisations performed to date may be sent to the administrator email address by entering the password.
  • The randomisation list cannot be viewed through the system. Note that for lists uploaded with randomisation codes we do not store the treatment group. Suitable safeguards for maintaining the integrity and confidentiality of the list are the client’s responsibility.
  • There is only one password and anyone with knowledge of the password can perform a randomisation. A request to change the password may be sent to the administrator email address. If the special link contained in that email is visited within 7 days of the request a new password can be set.
  • Data and randomisations held by the randomisation system cannot be changed or edited by users. Sealed Envelope will not edit or delete any data held by the system.
  • A request to delete a trial may be sent to the administrator email address by entering the password. If the special link contained in that email is visited within 7 days of the request and the password entered, the trial and all associated randomisations will be permanently deleted. Sealed Envelope cannot recover this data once it has been deleted.
  • There is no audit trail provided for this system. However, the list of randomisations and email notifications provide a complete account of all actions taken on the system. We recommend the email notifications are retained for this purpose.
  • The system has been tested by Sealed Envelope during software development and we are confident it performs as intended. However, clients are encouraged to test the system first by creating a dummy version of their trial and using a dummy randomisation list (if appropriate). We recommend clients test this system thoroughly and document their findings before setting up the system for actual use in their trial.
Page updated 1 Jul 2016 13:15