Setup Consent For Visit

Introduction

From version v9.1, OpenSpecimen allows users to collect the Consent Responses at the visit level. This enhancement is helpful when different consent is collected based on each Visit.

E.g., For Baseline visits, the patient consented to a blood specimen. For Follow-up-15, patients will consent for Urine/Tissue or any other type of specimen.

How to set up consent for Visit?

It's all similar to the participant; just a difference is for brand new collection protocols; you can see two options while setting up the content document below.

1. Create a Collection Protocol where you want to set up the consent documents

2. Go to the CP overview Page → Consents

3. Click on + Add Document

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4. The user has to select one of the Options for Participant or Visit. Once you choose an option, all the future consent documents will be set up at the selected level, and the user won't be able to change that, as noted in the above Limitations.

How to add the new Consent document?

Form v9.1, the user needs to add the new consent document at the system level, and those documents are shared across all the Collection protocols. You can refer to this wiki page for the same.

How to add the Consent Validation Rule?

It's similar to participant consent validation; once you add the validation, OpenSpecimen checks the validation and allows the user to collect the specimen based on the validation rule.

How do collect the Consent Responses at the visit level?

Once you add the consent document at the visit level, you can follow the below steps and collect the consent response.

Setup Consent Digests

You can add multiple users to get the daily digest email about eConsents. The digest email

The digest email has the information of the patient and visits in which the patient has consented on that day or who updated the consent document on that day.