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Frequently asked questions
Account creation, modification or access

If you have lost your password, you can get a new password by clicking on the “I forgot my password” button on the login page. You will receive an email to reset your password. If you do not receive the email after several minutes, please check your email’s junk/spam folder.
Note the following password rules:

  • The password should not have been modified within the last 12 hours
  • It should not be identical to a previous one
  • It should not contain the user ID
  • An error message will appear when the password is rejected by the system if the criteria are not met.

If you need more information, please refer to the user guide provided when you received your device.

The authentication may fail for different reasons that will appear  in red when you try to connect on the login page:

  • If you forgot your password, please refer to the previous question 
  • If the error message explains that your account has expired, that it is disabled, or that it has been blocked because of too many attempts, please contact the Helpdesk

If you need more information, please refer to the user guide provided when you received your device.

If the study participant, patient or caregiver has forgotten their PIN code, they can recover their pincode by clicking on the “I FORGOT MY PIN CODE” button on their own login page, whatever their collection mode (app on their own smartphone, on the device that you provide them, or on the Web App).
But they will need their “recovery code” to reset a PIN code. If they don’t have it anymore, you can recover it on your own site tablet: you just need to log in  as “site team”, select the patient and press “SHOW RECOVERY CODE” in the Accounts Tab.
If you are in the Clin’form webPortal on your computer, select the subject in the dashboard, go to the PROFILE tab, click on the gear icon near the account you want to display the recovery code and then select “Display recovery code”.

If you need more information, please refer to the user guide provided when you received your device.

If you are a site staff member, you can’t manage your account on your own, please contact your monitor/CRA. 

If you are a monitor, CRA or country manager:

  • For all requests about your own account: please contact your Kayentis Project Manager, always putting on copy the Country manager/Sponsor team in charge of eCOA part.
  • If you are using the Kayentis internal tracker:
    • Request for more than 3 accounts: please fill out the standard tracker and send the document to the Kayentis project manager, always putting on copy the Country manager/Sponsor team in charge of eCOA part.
    • Request for less than 3 accounts: please contact the Helpdesk, always putting on copy the Country manager/Sponsor team in charge of eCOA part.
  • If you are using the sponsor tool, follow your internal process for the management of this request.

If you need more information, please refer to the user guide provided when you received your device.

When the Kayentis team create your account, you will automatically receive an initialization email, with a link to access your account and initiate your password.

Please note that:

  • Chrome is the preferred browser to use for access
  • The address sender is: “Studyname-noReply@kayentis.com” where “Studyname” is the name of your study
  • This email may arrive in your spam box
  • The link must be used within 30 days, otherwise it will expire

 

Don’t forget your login and password. You will need it every time you connect to Clin’form App on the Device or to Clin’form WebPortal on your computer.

If you need more information, please refer to the user guide provided when you received your device.

Connectivity issues

When you receive your device(s), you need to connect to Wi-Fi.

To connect your device, you need to:

  1. Turn on your device.
  2. Go to the setting part of your device by clicking on the gear button at the top right of the screen.
  3. Activate the Wi-Fi and wait for automatic scanning detection to choose your local Wi-Fi network.
  4. You will then have to enter your network id and password to connect.

 

Note that: Connectivity is important for device functioning. If you do not have a Wi-Fi or 4G connection, you can still use the device offline (if device is already setup), and data will be synchronized once a connection becomes available. But the main risk of working offline is to lose data if the device is lost/stolen/down.

If you don’t setup the Wi-Fi, the device will automatically connect via 4G.

You can check your Wi-Fi connectivity at the top right of the screen:

If the Wi-Fi icon is not displayed, the 4G/5G icon must be displayed.

In case of connectivity issues  (no Wi-Fi, 4G/5G icons), follow the instructions below:

  • If no Wi-Fi network available on site and mobile data icon doesn’t show 4G/5G, try to change the location to get better connectivity.
  • If a Wi-Fi network is available on site, go to “Device Connectivity: Setup the Wi-Fi” to activate the Wi-Fi.
  • If your device already is connected to a Wi-Fi network but connectivity is low, deactivate the Wi-Fi in settings using the gear button just bellow the Wi-Fi icon at the top right of the screen.
  •  

If the issue persists, please contact the Kayentis Helpdesk.

Data management

As a site staff member, you can submit a data change request. You will need to create a query in the Clin’form WebPortal.

From the queries tab, select “Create Query” to open a new query. You will need to select the topic that most closely matches what the data change request is about:

  • Subject: for requests related to updating the subject identification code, or subject language
  • Visit: if questionnaires were completed under the wrong visit or wrong subject number
  • Questionnaire: if you are requesting a data change related to one specific questionnaire or value entered

Once all the mandatory fields are selected, please describe your request in as much detail as possible in the “Text” field with the Description of the issue, Requested action, Correction details, and Reason for change

Note: please avoid using symbols. Updates to date and/or time of assessments collected, as well  patient questionnaire responses, are usually not permitted.

  • Queries should only be marked as “urgent” if the data change needs to be completed within one business day
  • Select “Save & Send”

 

If you need more information, please refer to the user guide provided when you received your device.

As a site staff member, you will have to answer queries.

  1. Before answering to a query, please verify that the device is connected to the internet and is not pending any data transfer.
  2. To see queries, login to the study’s Clin’form WebPortal. On the homepage, the number of open queries assigned to you is displayed in “Queries” section.
  3. From the queries list, you can view the open and closed queries for the site. Scrolling to the right, you will see who the query is currently assigned to: if the query is open and you are the current owner, you can respond to the query.

 

To answer an open query assigned to you, click on the query number from the list, and then:

  1. Select the “Answer” tab and write the response in the “Your Message” field.
    • If the query is related to a confirmed missed visit or questionnaire, please confirm that the data is missing and the reason why it is missing
    • If the site/patient has completed the same visit/questionnaire more than once under the same visit name, please indicate which session should be kept under the current visit and specify where the other session should be transferred to.
    • If there is more than one date collected for questionnaires under the same visit name, please confirm on which date the actual visit was performed. For the questionnaires completed outside of the actual visit date, please clarify the reason data was collected on this date.
    • If the site has completed a questionnaire/visit out of chronological order, or the date/time of collection does not match the study reported visit date please clarify why there is a date/time mismatch and specify whether any of the questionnaires need to be transferred to another visit or excluded.
    • If the patient number does match site or study records, please respond to the query with the correct patient number.
    • Note: Symbols (i.e., # % & *) cannot be used in the query response
  1. Reassign the query to the Kayentis Data Manager (if not reassigned, the Data Manager will not be notified that a response was provided).
  2. Then click “Send”.

 

The Kayentis Data Manager will review the response to the query and either close the query if you have completely answered the query,  or reassign you the query back and request further clarification.

If you need more information, please refer to the user guide provided when you received your device.

Management of provisioned devices

The site staff can contact the Kayentis Project Manager responsible for their study, and cc the Clinical Research Associate/Monitor.

The Project Manager will inform them of the procedure to follow and will organize the return.

Site staff should immediately report the incident to the Kayentis Project Manager overseeing the study, as well as to the Clinical Research Associate/Monitor.

They will provide guidance on the procedure to follow and will organize a replacement if necessary.

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