SMART-TRIAL has a standard medication module that cannot be modified. The medication module suits most studies but in case you do need to collect specific information that is not included in the medication module, you can consider creating your own medication form, as a regular form.
To use the medication module, you have to enable it as an add-on in the study builder. You can get access to this view when creating a study or by clicking on "Edit study" in the study overview.
To add a medication entry:
- Go to the subject's profile by clicking on either the subject ID or subject name in the site overview.
- In the second tab "medication", click +Add medication button. A dialog for a new medication entry will appear here.
- Select a registration type. A new dialog box appears and the required medication details have to be filled out.
Click Add medication entry. The medication will be visible in the medication overview as illustrated in the image below.
Use filters to show all, only concomitant or IMP medication entries, as well as all or only ongoing medication.
- The 'status' column in the medication overview can be used to verify medication entries, either fully or partially.
When registering a new IMP or concomitant you are required to fill out all information on the registration form, except for start/stop date and route, these being optional. The start and stop date are especially useful for crossover studies, to register precisely when a subject began and stopped taking a given medication.
To edit a medication entry
- Go to the subject's profile.
- In the second tab "Medication", find a medication entry you want to edit.
- Click ✎Edit icon at the end of the row and make changes to the form.
- Click Update medication. All changes will be saved.
SMART-TRIAL logs every change made to a medication entry and stores information such as when, by who, and a reason why the change was made. This information is tracked both in the change log and in the audit log. The change log tracks medication changes for a specific medication entry, whereas the audit log tracks all medication changes across the study.
- Access a change log by clicking on the Change log button, , when in the "Medication" tab.
- The Change log tracks when a change was made, the person performing the change, the reason for change, and what is changed including the old and new values.