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 an eCRF study are explained in this article.
- When creating a study, select eCRF 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, and file vault 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.
- The verification tool that SMART-TRIAL offers might be useful for some eCRF studies. It is used to mark data as verified and it can be given any meaning desired by the study. Read more about different ways to use this tool in the "Verification" article.
- When creating the process, "Visit event" will be the only available type of data event you can select.
- In the process, you will have the option of enabling unscheduled events and randomization if needed for your eCRF study.
- When the study is created, everything is setup, and data collection is initiated, the clinical staff can enroll new subjects and get access to and fill out forms through the site overview.