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

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1. Survey Mode

2. Consent Collector Mode

3. Via Email

Privileges

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Consent Collector Mode

This mode is used when an OpenSpecimen user (like Clinic Coordinator) is collecting the consents. In this mode, the user can register the participant and collect consents.

Patient Mode

This is used when the Clinic Coordinator wants to hand over a tablet (for example, iPad) or the desktop to the participant. When switcing over to the patient mode, the system logs out the user and ensures that the patient only sees the consent form on the screen and cannot view any other data of OpenSpecimen.

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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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Go to CP overview> Participants > Add Enter the participant details At the end of the page, click on “Proceed to Consents” Image Removed Click on “Add” for adding the consent in consent collector mode. Click on “Patient Mode” for handing it to the patient. Image Removed Image Added 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 If no surveys are configured or the survey conditions don’t match the participant registration, you will be redirected to the below page Image Added 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 Choose the consent that you want to enter from the dropdown Image Added Image Removed Enter the consent responses and click “Save”. In case it is in the “Patient Mode” a message will be displayed. Image Removed

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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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title Steps to collect consent from the participant consent tabthe responses in Survey mode
Go to CP > Participant list > Participant > Consents tab Image Removed Follow the steps from “Steps to add consent from register participant page” step 4 onwards to collect the consent ‘Participant Overview > Consents > Survey Mode’ Image Added A list of surveys is displayed in the dropdown Click on the title of the survey. A pop-up appears with the 2 survey modes: Image Added 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’ You will be redirected to the start of the survey Image Added Fill in the responses. 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.:

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title Print the consent document
Go to Participant > Overview > Consents tab Click on the consent document title which is to be printed Image Removed Image Added Click on “Print” at the top of the consent document. Image Removed Image Added 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 the patientsparticipants 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.

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

   Image Added