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      Getting Started with a Clario Handheld
      • 31 Jan 2025
      • 6 Minutes to read
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      Contents

      Getting Started with a Clario Handheld

      • Updated on 31 Jan 2025
      • 6 Minutes to read
      • Print
      • Dark
        Light
      • PDF
      Article summary

      Empowering patients to participate in trials from anywhere using a smartphone.

      eCOA Handhelds enable patients and clinicians to complete instruments on a provisioned or personal smartphone that sends data to a central system for web review of data by site and sponsor staff.

      1

      Access to the Clario Portal

      Created an online account and joined a study.

      2

      Full battery

      Charged the Handheld prior to the first visit.

      3

      Access to the Clario App

      Powered on the Handheld and located the Clario App.

      4

      Test connection

      Verified network connection with a test transmission.

      5

      Connect Wi-Fi

      Connected mobile or Wi-Fi network.

      6

      Create subject

      Created a new subject in eCOA Web Tablet.

      7

      Assign Handheld (site user)

      QR Code scanned and initial settings configured.

      8

      Assign Handheld (subject)

      The subject established login credentials.

      Online Account Requirements

      Before moving forward, please ensure that you can successfully access these online systems:

      Clario Global Account

      Site staff should ensure they can log in with their credentials or create a new account.

      Study Account

      Site staff should ensure their request to join a study was approved by their sponsor or CRO teams.

      Learn how to create a Clario Global Account.

      Learn how to join an eCOA study.

      Preparing the Handheld for Use

      Follow the instructions below to set up your Clario-provisioned smartphone.

      1. Charge the Handheld: Plug the charging cord into the charging port then connect to a wall outlet. Use any included charging adaptors if needed.

      2. Turn on the Handheld: Press and hold the power button.

      3. Unlock the Screen: Swipe your finger across the screen.

      4. Start the Application: Tap the Clario icon.

      Remember to charge the Handheld prior to your patient’s scheduled visit. We recommend having the Handheld fully charged prior to the first site visit so that the device has enough power for the participant assignment and any required activities for the rest of the day.

      Set up the Clario App on your personal smartphone. Click here for instructions.

      Testing the In-Built Cellular Connection

      Your Handheld automatically connects to a cellular network when one is available. You don't need to configure this connection; you simply need to test it by following these steps:

      1. Check the network signal strength: Look to the upper right corner of the Handheld screen. If the network signal strength is two bars or less and a Wi-Fi connection is available, please connect the device to Wi-Fi to prevent transmission errors.

      2. Open the Clario App: Press the Clario App icon.

      3. Press Here to Check Connection: When you first turn on an unassigned device, test the network connection by tapping this button.

      4. Connected. Press to check again: If the test is successful, the button will turn green.

      5. Not Connected. Press to check again: If the test is unsuccessful, the button will turn red. So, you may need to move to a location with a stronger network signal or connect to Wi-Fi.

      A successful test only applies to your location at that time. If you move to an area with a poor signal, you may not be able to transmit data.

      Connecting the Handheld to Wi-Fi

      Your Clario Handheld automatically sends stored data when connected.

      Check the network signal in the upper right corner of the screen. If it's two bars or less and Wi-Fi is available, connect to Wi-Fi to avoid transmission errors by following these steps:

      1. Access Settings: From the home screen, tap the drop-down arrow in the top right corner. Then, tap the gear icon.

      2. Select Wi-Fi: In the settings menu, choose Wi-Fi.

      3. Turn on Wi-Fi: Slide the toggle next to Wi-Fi to the right. It will turn green when on.

      4. Smart Network: Check the Smart Network Switch box.

      5. Connect to a Network: Select your desired network and enter the password if prompted. The Handheld will indicate it is connected.

      6. Return to Home: Tap the back button to return to the main page.

      Ensure data is transmitted before the participant leaves with the Clario Handheld. If you can't connect to a cellular network or Wi-Fi, contact Clario Customer Care for help.

      Creating a Subject

      Creating a subject includes three major activities and a corresponding shortlist of instructions. We'll be creating subjects in Clario's online portal using the eCOA Web Tablet solution. Although you'll use a Handheld device for data capture, we'll first guide you through the virtual tablet setup.

      • Locating your Startup Unlock Code: This solution requires a unique security code specific to your site, called the 'Startup Unlock Code'. We'll show you how to apply this code during initialization.

      • Initializing eCOA Web Tablet: Follow four quick steps to access the subject creation feature.

      • Creating a Subject: Once the virtual tablet is initialized, you can add your subject to Clario's clinical trial database.

      Locating Your Startup Unlock Code

      1. Log into the Clario Portal: Enter your user credentials at: Clario Portal login.

      2. Access your study: Press Select Study or Organization and select your study from the list. Or click the desired 'Project Name' from the Recently Accessed list.

      3. Accessing the report: Tap Reports and select the 'Tablet Unlock Codes' report.

      4. Retain the unlock code: Leave the report open so that you can enter the Startup Unlock Code when necessary.

      Learn more about using the unlock codes.

      Initializing eCOA Web Tablet

      Begin by logging into the Clario Portal and opening your study. Follow the prompts on the screen, clicking Next to finish the setup.

      1. Start the application: Press Web eCOA Tablet to launch the application in a new tab.

      2. Configure the application: Select your site and preferred language. Then enter the Startup Unlock Code.

      3. Review license agreement: The conditions of the End User License must be accepted in order to proceed with tablet use.

      4. Add first user: Complete all form fields including re-entering the Startup Unlock Code to set up the Site Administrator.

      5. Log in: Enter your user credentials including selecting your user role and press Log in.

      Creating a Subject

      1. Add Patient: Press Add Patient to start the web form.

      2. Subject Demographics: Enter the subject's demographics and assign a temporary password. Press Next.

      3. Subject Language: Select your subject's preferred language and press Next.

      4. Set Time Zone: Choose your site's time zone from the drop-down menu and press Next.

      5. Sign Affidavit: Enter your Web eCOA Tablet password to sign the affidavit and press Next.

      6. Subject List: Tap the target subject shown in the subject list. Once selected, a QR Code icon will appear in the side bar menu.

      7. QR Code: The QR Code will appear. Press the QR Code icon to generate the subject-specific code. A new message screen will appear displaying a large QR Code that refers to your target subject.

      The process for adding subjects varies across studies and eCOA solutions. Consult your study's Clario Learn curriculum for details.

      Assigning a Subject to the Handheld (Site User Procedures)

      You're almost done activating the Handheld! After scanning the QR Code, follow the prompts on the device. When instructed, hand the Handheld to the subject to complete the process.

      1. Open Clario App: Press the Clario App icon.

      2. Activate Camera: Press the QR Code icon to activate the device's camera.

      3. Scan QR Code: Aim the camera at the QR Code displayed in eCOA Web Tablet.

        The subject will be automatically enrolled when the QR Code scan was successful.

        Enter the Study URL and Setup Code into the device if the QR Code scan failed.

      4. Respond to Prompts: Review and respond to each message screen, pressing Next to proceed.

      5. Complete Setup: Give the device to the subject to finish the setup process.

      Completing Handheld Assignment (Subject Procedures)

      The final step to prepare the eCOA at Home app for the subject is to assign them to the app. The following steps guide you through this process:

      1. Review Privacy Statement: The subject must read the entire privacy statement and press I understand to accept the terms.

      2. Create Password: The subject must create and confirm a numeric-only password (4-32 digits). Passwords with letters or special characters will be rejected.

      3. Select Security Question: The subject must set up security questions and answers for the 'Reset Password' process.

      4. Installation: No action required from the subject at this time.

      5. Welcome: The eCOA at Home app is now assigned to the subject. They can start using the app according to the study protocol.

      Some studies may use a PIN ('Personal Identification Number') rather than a password.

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