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

Survey Mode
Consent Collector Mode
Via Email

Privileges

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

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.

Go to CP overview> Participants > Add Enter the participant details At the end of the page, click on “Proceed to Consents” 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 ‘ ’ 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 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

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 ‘Introduction to Surveys ’ wiki

Go to ‘Participant Overview > Consents > Survey Mode’ 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: 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 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-out consent document can be printed or downloaded as a PDF as below:

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

Go to the Participant list page of a CP. Select the participants to whom you want to email the consent. Click on “Email Survey” at the top. Participants and their email addresses appear on the next screen. Click on “Next”. Select the survey to be emailed from the dropdown. Click “Submit” once done. A success message appears that survey links have been sent to the participants. User redirected to the participant list page 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”

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

Delete/Send incomplete survey

Sometimes users may collect the consent incorrectly, a patient may decide to revoke their consent, or the consent may be only partially completed. In such cases, users can delete the survey, send a partially completed survey, or complete the consent themselves from the page below.

1. Go to the Participant Overview page.
2. Click the Consents tab.
3. Available actions:
  - - Delete – Deletes the collected survey/consent form.
    - Survey Mode – Opens the survey so the user can complete it if it is incomplete.
    - Send Survey – Sends the incomplete survey to the participant so they can complete it.
    - Lock – Locks the collected survey so other users cannot edit or delete it unless they have permission to unlock it.
    - History – Shows who last updated the survey and when it was updated.