DOUBLE-BLINDED TRIALS

Overview

In a double-blinded trial, neither the researchers nor the subjects know which treatment the subjects are receiving. Randomize.net can be configured to assign the subject a Kit ID number during the randomization process.

For example, consider the following block: ABBA

Example Kit ID Number List:

The first subject is randomized to treatment A, and the first available kit containing that treatment, KIT001, is assigned to the subject.

The second subject is randomized to treatment B, and the first available kit containing that treatment, KIT003, is assigned to the subject.

The third subject is randomized to treatment B, and the first available kit containing that treatment, KIT004, is assigned to the subject.

The fourth subject is randomized to treatment A, and the first available kit containing that treatment, KIT002, is assigned to the subject.

Kit Management

Randomize.net allows Kit Administrators (unblinded administrators) to have full control over the kits for a trial. This includes:

• Uploading new kit ID numbers
• Assigning kits to clinical sites
• Setting email warnings for low kits
• Viewing which kits have been assigned

Kit Replacement

If configured, Randomize.net allows the Clinical Site to request a kit replacement. Randomize.net will select a kit belonging to the same treatment arm that the subject was randomized to, and mark that kit as used.

Emergency Unblinding

If configured, Randomize.net allows emergency unblinding through the Clinical Site accounts. When that happens, an emergency unblinding email notification is sent. Each emergency unblinding is recorded and shown in the reports.