The building steps for all SMART-TRIAL products are mostly the same but the occurring differences and extra features that are worth remembering when building a Suite study are explained in this article.
- When creating a study, select Suite as your product. If you need to register a patient's medication in your study, you will have to enable the "medication" module in the add-ons menu. The adverse event module, study notifications, randomization module, file vault, white labeling, and the translation module might also be relevant for your study, and in such case, these add-ons can be enabled according to your study need in the study builder.
- When selecting subject attributes for your study, remember to select at least E-mail and/or mobile number in order to be able to send out questionnaires through these media.
- When creating the process, "Subject Event", "Information Event" and "Visit event" will be the available types of data event you can select between.
- When creating a subject event, you can select whether you want to send the questionnaires via E-mail or E-mail and SMS or not to send them out at all. In case you select "Do not send" the subjects will be able to fill the questionnaires out on-site when visiting the sites. Read more about the on-site fill-out option in the article "On-Site Subject Fill Out".
- In the process, you will have the option of enabling unscheduled events and randomization if needed for your Suite study.
- You can also enable Public Registration in case you want to allow subjects to access your questionnaires via a unique link that is created for each site in your study. To read more about signing up through a shared link you can read the Public Registration and Re-enrollment article. You can also enable Public Re-Enrollment in the process if needed in your study.
- There are also some advanced settings available, such as a reminder function and an expire setting. These settings are also setup when creating the process and a more detailed description of these can be found via this link.
- When the study is created, everything is setup, and data collection is initiated, the clinical staff can enroll new subjects, fill out forms, or review form answers through the site overview.