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Table of Contents

Recording consent response

The consent responses can be recorded from during or after participant registration. Consents can be collected in any of the below screensmodes:

  1. Register participant page

  2. Participant overview page > Consents tab

There are 2 modes in which consent response can be added:

  1. Patient Mode: This logs out the lab person from OpenSpecimen. The tab can then be given to the participant in the patient mode so that s/he can take her/his time to read and submit the responses.
    In patient mode, the patient only sees the respective questions on the screen and cannot view any other data of OpenSpecimen.

  2. Consent Collector mode: This allows the person who is collecting consents to stay logged in and enter the responses himself.

ExpandtitleSteps to add consent from the register participant page

  1. Survey Mode

  2. Consent Collector Mode

  3. Via Email

Privileges

A user having the below necessary privileges will be able to collect consent data from patients:

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From v7.0, a “Consent Collector” role is also present by default which has the above privileges required to collect consent.

Clinical Coordinator Mode

This mode is used when an OpenSpecimen user is collecting the consent.

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  1. Go to CP overview> Participants > Add

  2. Enter the participant details

  3. At the end of the page, click on “Proceed to Consents”

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Click on “Add” for adding the consent in consent collector mode. Click on “Patient Mode” for handing it to the patient.

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Choose the consent that you want to enter from the dropdown

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Enter the consent responses and click “Save”. In case it is in the “Patient Mode” a message will be displayed.

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Here are the steps to collect consent from the Participant overview > Consents tab:

Expand
titleSteps to collect consent from the participant consent tab

  1. Go to CP > Participant list > Participant > Consents tab

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  2. Follow the steps from “Steps to add consent from register participant page” step 4 onwards to collect the consent.

Editing the consent response

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  2. If the ‘Surveys’ have been configured in the CP settings and the participant conditions match the survey conditions, you will be redirected directly to the appropriate form. Refer ‘Surveys ’ for more information

  3. If no surveys are configured or the survey conditions don’t match the participant registration, you will be redirected to the below page

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    Add- Allows you to enter the responses in consent collector mode. This is used when co-ordinator is filling in the survey responses along with the participant
    Survey Mode- Allows you to enter responses in the Survey mode. This is used when participant is asked to fill in the survey responses

  4. Choose the consent that you want to enter from the dropdown

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Survey Mode

This is used when you want to hand over a tablet or a desktop to the participant. The survey can be filled in two different modes:

  • as a signed-in user- The user is not logged out of the system while filling responses

  • as a participant- The user is logged out of the system while filling the responses

For details on how to create surveys and use them, refer ‘Surveys ’ wiki

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Expand
titleSteps to edit the consent responsecollect the responses in Survey mode

  1. Go to

the Participant >

  1. ‘Participant Overview > Consents

tab

  1. > Survey Mode’

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    A list of surveys is displayed in the dropdown

  2. Click on

the “Edit” icon beside the consent document for which response is to be edited
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  • Alternatively, click on the title of the consent form. This will lead you to the filled consent document.

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  • Click on “Edit” from the top

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  • Change the details in the document and click on “Save”

    • Print/Save PDF of the consent

    1. the title of the survey. A pop-up appears with the 2 survey modes:

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    2. Choose the ‘as signed-in user’ if you want to remain signed in and fill in the responses. Select the ‘as participant’ to log out of the system and fill in the responses. Click on ‘Proceed’

    3. You will be redirected to the start of the survey

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    4. Fill in the responses.

    5. Once the responses are filled, click on ‘Sign In’ to go back to the OpenSpecimen. If you had used the ‘as signed-in user’ mode, you will not be asked for credentials again while logging in.

    Print/Save PDF

    The filled-up consent document can be printed or downloaded as PDF as below:

    Expand
    titlePrint the consent document

    1. Go to Participant > Overview > Consents tab

    2. Click on the consent document title which is to be printed

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    2. Click on “Print” at the top of the consent document.

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    2. In case a printer is not attached, the document can be saved as a PDF document.

    Email Consent Forms

    The consent form can also be emailed to

    ...

    It is possible to send the consent form to a participant via email. Thus, a participant need not visit the lab and will be able to remotely fill in the consent.

    This can be done using the “Survey Links” option. Refer <Wiki> for more information.the participants so that they can enter the consent details from home. A unique URL is generated per participant and is valid for a configured number of days.

    Expand
    titleSteps to email consent form to participants

    1. Go to the Participant list page of a CP.

    2. Select the participants to whom you want to email the consent. Click on “Email Survey” at the top.

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    3. Participants and their email addresses appear on the next screen. Click on “Next”.

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    4. Select the survey to be emailed from the dropdown. Click “Submit” once done.

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    5. A success message appears that survey links have been sent to the participants. User redirected to the participant list page

    6. You can email consent to more participants by going to Participant List Page > More > Survey Invitations > Email Survey. Follow steps 3 and 4 after clicking “Email Survey”

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    Refer to Email Forms to Participants for more information on prerequisites, configuring the email template, and the number of days the link remains active.

    Delete collected Survey/eConsent form

    Sometimes users collect the consent incorrectly, or patients want to revoke the consent. In that case, user can delete that collected consent from the OpenSpecimen v9.1 version using the below step.

    1. Go to the Participant Overview page.

    2. Click on the Consents tab.

    3. Click on the Delete button highlighted in the below screenshot

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