Depending on your trial's configuration, there may be more than one way to register a participant: either as a Patient Connect app user or a Two-Way Texting user.

• Patient Connect app users complete their scheduled dosing and questionnaires through the Patient Connect mobile app. If you would like to register the participant with this option, please refer to the following KB Article: How to Register a Patient Connect App Participant on the Site Coordinator Dashboard

• Two-Way Texting users receive and respond to SMS text messages to confirm dosing and complete other tasks.

For most trials, Patient Connect is the default, and often the only, available method for participant registration.

If you're unsure whether Two-Way Texting is available for your trial, please contact your sponsor team for confirmation.

However, if you do not see a "Patient Type" selection when clicking Add Participant in the dashboard, Two-Way Texting is not enabled for your study and you should refer to the above article to register your participant.

Q: How do I register my participant as a Two-Way Texting user?

A: Registration of a Two-Way Texting user is a 2-Part Process: adding the participant to the dashboard, and activating them on their device. Follow the steps below to complete their registration. Please note that, as AiCure is customized to the different specifications and needs of each trial, some steps may vary.

Part 1: Adding the Participant to the Dashboard

1. Log into the AiCure portal (login.aicure.com) and select your study
2. Click "Add Participant" at the top of the page
3. Enter the Participant ID and select the text message language
4. In the Patient Type section, select "SMS Text" then click NEXT
5. Enter the participants' mobile phone number. All SMS text messages will be sent to this number throughout the study so ensure the phone number is correct.
6. Select the participant's time zone or the capital city within their time zone
7. Select a treatment regimen for the study period (if applicable to your study)
8. Confirm the start and end dates of the study period
9. Set the participants' dosing reminder time
10. Select the visit time (if applicable to your study)
11. Review the registration summary and make any final edits using the pencil icon. Once you have confirmed the participant registration information is correct, click “Complete Activation"
    • TIP: Information selected during the registration period such as dosing reminder time and visit time can be updated after registration. You can find step-by-step instructions on the AiCure Help Center (support.aicure.com).
12. An activation SMS text message will then be sent to the participant's phone number you provided.

Part 2: On the Participant's Device

1. The participant will receive a text message with the following message once registration is complete on the dashboard:

Welcome to the <trial name> study! Privacy Policy https://aicure.com/privacy-policy. Reply Agree or A to consent to receiving messages for this study. Reply Disagree or D to opt-out. Msg&Data rates may apply.

2. To consent to receiving any further text messages for the trial and complete their activation, please instruct the participant to reply "A" or "Agree" (or the translation equivalent displayed in the text).
   • Important: If the participant does not consent, they will not be able to complete dosing using the AiCure Two-Way texting feature.
3. If done correctly, the participant will receive the following text message in response:

<trial name> Thank you. Your response has been captured. Your next medication is scheduled for <dosing window> on <next dose date>.

4. If done incorrectly, the participant will receive the following text message and should send the appropriate response:

Invalid Response. Your response was not captured. Please reply with Agree or A

Once their activation is complete, they will start receiving regular SMS text messages to complete dosing and other activities going forward.

Q: What text message would the participant receive once it's time to complete their activities?

A: The participant will receive the following text prompting them to begin:

It is time for your study medication. Reply Y or YES to confirm you took your medication today.

And if they reply correctly, they will receive the following response:

Thank you. Your response has been captured. Your next medication is scheduled for <dosing window> on <next dose date>.

If they reply incorrectly, they will receive the following response:

Invalid Response. Your response was not captured. Please reply with Y or Yes

Q: What text message would the participant receive if I place them on a dose hold?

A: Once you place them on a Dose Hold on the dashboard (by clicking "Dose Hold" on the Participant Settings tab), they will receive the following text message and should not continue dosing or reply.

You have been placed on a dose hold. No study medication should be taken until further notice. Reach out to your site if you have any questions.

When they are taken off Dose Hold (by clicking "Dose Un-Hold" on the Participant Settings tab), the participant will receive the following text message:

Welcome back. Your dosing for the Optional Continuation Portion of the <trial name> study has been re-activated. Please take your medication based on the instructions from your site.

Q: Can my participant unsubscribe to the Two-Way Texting messages?

A: Yes, the participant can unsubscribe from receiving these messages at any time. Please note however, they will no longer be able to log their activities in AiCure until they are re-subscribed. And they will still remain active on the dashboard until they are deactivated by the site.

Replying "Stop" at any time unsubscribes them from receiving any future messages. If they do so, they will receive the following response:

You have successfully been unsubscribed. You will not receive any more messages from this number. Reply START to resubscribe.

Replying "Start" any time after re-subscribes them so they will resume receiving text messages. If they do so, they will receive the following response:

You have successfully been re-subscribed to messages from this number. Reply HELP for help. Reply STOP to unsubscribe. Msg&Data Rates May Apply.

Q: My participant isn't receiving any text messages. How do I resolve this?

A: This could possibly be due to the phone number being blocked on their device.

To unblock a number on an iPhone, go to Settings > Phone > Blocked Contacts. Find the number you want to unblock, swipe left on it, and then tap Unblock. You can also do this from Settings > Messages > Blocked Contacts

To unblock a number on an Android phone, open the Phone app, tap the three dots (More options) in the top-right corner, and go to Settings. Then, select Blocked numbers, find the number you want to unblock, and tap the X or Unblock button next to it.