Q: In what ways can Dosing be recorded on the dashboard?

A: There are various classifications for dosing indicated by different symbols on the dashboard. The classifications are as follows:

DEFINITIONS:

MISSED: the participant did not use the app to confirm dosing within the allowed dosing window.  Please follow up with the participant using the following suggested steps:

1. Remind the participant to use the app for every dose. The app is intended to help the participant follow the protocol and confirm that doses are taken per protocol.
2. Ask whether she/he is having difficulty using the app -see subsequent support sections in this guide to help resolve technical issues
3. If you cannot help the participant remotely please try and have her/him dose in front of you with the app as soon as possible. Review the step(s) that are causing problems so that you can help resolve them or you can describe the issue(s) to AiCure Support.

SELF-REPORTED: the participant did not use the AiCure app as intended; she/he confirmed dosing by using the “self-report” option on the app.  They may have tapped on the “Medication Already Taken?” button or were interrupted while recording their dose and returned later to report it. Please follow steps 1-3 above.

PENDING: Dose(s) will show as pending if no data has been transmitted.  Please note connectivity is NOT required to dose with AiCure, the data will be stored locally on the device. However, connectivity is needed for the data to upload to the dashboard.

• If they are having trouble uploading their doses, inform the subject to restart their device, make sure they have decent 4G or WiFi connection, then open the app for several minutes to allow the stored data to upload.

SITE REPORTED: This indicates the site has evidence of the dose being taken without the app, e.g. by review of medication accountability. Missed doses can be reclassified to this by the site.

IN-CLINIC: This indicates the dose was taken on site without using the AiCure app. Missed doses can be reclassified to this by the site.

PARTIAL DOSE (some medication taken, some self-reported or missed): The app was interrupted during dosing; the participant may have accidentally touched a button, accepted a call or reached the end of the dosing window.  Please instruct the participant not to perform any other actions or hit buttons while using the app during dosing.

YELLOW or RED ALERT: These are viewable on the Sponsor Dashboard. This indicates the participant has misused the app whether intentionally or not.  AiCure will contact you regarding these events and discuss appropriate re-education and retraining.

All doses containing a vertical grey/black line (excluding self-reports) can be reclassified by the site. For further instructions on how to reclassify doses, please refer to the article “How to Reclassify Doses”.