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      Getting Started with a Subject's Handheld
      • 31 Jan 2025
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      Getting Started with a Subject's Handheld

      • 更新日 31 Jan 2025
      • 6 読む分
      • 印刷する
      • 闇
        光
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      The content is currently unavailable in Ja - 日本語. You are viewing the default English version.
      記事の要約

      Using a BYOD approach integrates seamlessly into subjects' daily lives, offering flexibility and convenience.

      Bring-your-own-device (BYOD) offers trial subjects a choice and, rather than giving them an additional device, BYOD makes use of subjects' familiarity with their own mobile phone.

      1

      Online requirements

      Site staff accessed study on Clario's portal, and the subject accessed to app stores.

      2

      Smartphone requirements

      OS or iOS, and screen size, meet requirements.

      3

      Full battery

      Verified subject's phone has sufficient charge.

      4

      Accessed the Clario App

      The subject downloaded and installed eCOA at Home.

      5

      Test connection

      Verified subject's phone connects to a 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 both the site staff and the participant can successfully access these online systems:

      Clario Global Account

      Site staff should ensure they can log in with your 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.

      Google Play Store

      The subject needs a Google Play Store account that is accessible on their Android phone.

      App Store

      The subject needs an Apple App Store account that is accessible on their iPhone.

      Smartphone Requirements

      Most modern smartphones meet these requirements.

      Android OS 10.0 and above

      Apple iOS 12.0 and above

      Minimum Screen Size: 5.4" (13.7 cm)

      Minimum Resolution: 720x1600

      Learn how to create a Clario Global Account.

      Learn how to join an eCOA study.

      Battery and Network Connection

      Full battery

      Subjects should be advised to charge the device regularly to ensure it remains powered throughout the day.

      Network connection

      A network connection is necessary to successfully transmit data during the study.

      Check the network signal strength, which can usually be found in the upper right corner of any smartphone 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.

      Charging the Handheld

      Downloading and Installing the Clario App

      1. Open the app store: Ask the subject to unlock their device and open the app store.

      2. Locate the app: Refer to your study-specific training to find the app name. Then, provide this app name to the subject so they can search for it on their smartphone.

      3. Install the app: Ask the subject to authorize installation of the app and follow any prompts to complete the download.

      4. Start the app: Close the store, go to your installed apps, and select the study app. Ensure the subject knows where to find it.

      5. Ready to assign: When you open the eCOA at Home app, a QR Code screen will appear, indicating the app is ready for subject assignment.

      Updates and permissions

      When using eCOA at Home for the first time, the app asks for certain permissions to access Bluetooth, notifications, and the camera. Subjects must allow these permissions in order for the app to work properly on their phones.

      During the course of the study the software may be updated to reflect changes in the protocol or for other technical reasons. Subjects should know to allow the software to update to the most recent version when prompted to do so. If the software is not upgraded it may become unusable.

      Using an iPhone

      Using an Android phone

      Testing the In-Built Cellular Connection

      1. Check the network signal strength: Look to the upper right corner of your smartphone. 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 app, 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.

      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 in to 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 eCOA at Home (Site User Procedures)

      You're almost done activating the eCOA at Home app! After scanning the QR code, follow the prompts on the device.

      These tasks are typically done by clinical site staff on a provisioned phone, but the subject might prefer to use their own phone. Discuss with the subject who will complete these tasks. As the site user, you can guide the subject while they perform the actions.

      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 eCOA at Home 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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