Accessing the system
The Access application is the gateway for Red Pill and randomisation systems. The web address will be contained in automated emails sent out when a new user account is created.
Users are requested to authenticate themselves by providing their log-in credentials. See the Access help for more information.
If you will be randomising or entering CRF data on participants, an administrator for your trial will create your user account. Administrators are usually staff at the trial coordinating centre. The login details will be sent to your email address. This user account will normally be associated with your site, and you will be able to view and add data for participants at this site. Depending on a trial-wide setting controlled by administrators, you may also be able to edit data.
When you log in, you will normally first arrive at a summary page showing the trials you have access to. You can also manage your account details and change your password here. You can get to the summary page at any time using the Home link.
Once you access a trial, you will be able to see enrolled participants at your site and enter data yourself. For randomisation-only systems, you will be able to see previous randomisations at your site and perform randomisations yourself.
When a Red Pill or randomisation system is set up, the first administrator account is created by Sealed Envelope, and the login details are sent to that person's email address. The administrator should log in and create the trial sites, unless the sites have been pre-coded by Sealed Envelope.
You do not need to add all your sites at once - you can come back later and add more sites as needed.
Next you should add some investigator accounts for each site so that randomisation and data entry can be performed by staff at the sites. You do this through the Access application. Check the settings page and make any adjustments to suit your trial.
If your trial has a code list, you should update the list to reflect the availability of treatment kits at each site. Randomisation cannot occur if there are no codes available at a site.
Finally check the specification page and case report forms, and report any discrepancies or errors to Sealed Envelope.