Simple randomisation service specification

Sealed Envelope's simple randomisation service has two variants, Simple and Simple +. The features available depend on which variant is chosen, but the following features are common to both:

• Web-based service
• Online set-up - the client may set up the system themselves or ask Sealed Envelope to do it on their behalf (extra costs apply).
• The email address given when setting up the trial is called the administrator email address, and it can be used to change the password, delete the trial, or receive a list of all randomisations performed.
• 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 completing a form to enter a patient identifier and other details which depend on the service chosen.
• The randomisation allocation (treatment group or code) is shown on screen.
• 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.
• There is only one password, and anyone with knowledge of the password can perform a randomisation.
• A request to change the password can 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.
• A list of all randomisations to date can be sent to the administrator email address at any time.
• 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.
• 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.
• 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.
• Further randomisations may be purchased online at any time. Payment is available by card or invoice.

Simple

• Online randomisation is achieved by the user entering a unique patient identifier, their own email address and the randomisation system password only.
• Randomisation is by random permuted blocks to treatment A or B in ratio 1:1.
• The user is shown the treatment group on screen and also in a notification email which is sent to the email address given by the user randomising and the administrator email address.
• The first 50 randomisations are free for non-commercial trials (see terms and conditions for details).

Simple +

• Randomisation lists may be uploaded to the service to enable stratification, unequal treatment allocation, user-defined block sizes and custom treatment names.
• If the randomisation list contains codes, these will be given out rather than the treatment group, making the system suitable for blinded trials.
• Online randomisation is achieved by the user entering a unique patient identifier, their own email address, any stratification factors and the randomisation system password.
• Inclusion and exclusion criteria may optionally be configured. If configured, they must be answered Yes or No as appropriate to allow randomisation to occur.
• Submitting the randomisation form with a valid password allocates the subject to the next available treatment or code in the randomisation list, sequentially within strata.
• The randomisation list cannot be viewed through the system. Note that for lists uploaded with randomisation codes we do not store the treatment group column. Suitable safeguards for maintaining the integrity and confidentiality of the list are the client's responsibility.
• Randomisation by SMS is available. Randomisation is achieved by the user sending a text message containing a trial identifier (SMS ID), patient identifier and stratification information (if applicable). The allocated treatment or code is texted back to the user.
• Instructions for randomising by SMS can be viewed in the administration area.
• The usual randomisation notification is sent to the administrator email address containing details of the randomisation when SMS is used.