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Introduction
Consent documents are to be uploaded as HTML documents at forms are configured at a CP level. These documents can contain a detailed explanation and answers of general questions, followed by at least one consent statement and the details of the consenting participant.
Create eConsent document
Prerequisites
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The consent form is configured in HTML and can contain the following:
Formatted text
Consent Statements
Custom fields
Prerequisites
Consent Statements
Consent statement should be defined in the “Consents”
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module. The consent statements are defined at a global level so that they can reused across CPs.
Refer to Coded Consentsfor more details.
Custom Fields
The consent form could have fields like consent witness, consent date, eSignatures etc. These fields are to be added in a “Consent Custom Fields” form attached at “Consent Document Custom Fields” level.
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Few pointers to keep in mind:
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A single form is maintained for consent custom fields across the system to avoid duplicating fields across CP and making it easy for reporting.
Refer to Create and Edit Formfor details on how to create a new form.
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Refrain from adding duplicate fields. For example, ‘participant name’ is the same as the ‘patient name’ |
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A single form is maintained for consent custom fields across the system. The relevant fields that are to be used in the consent document are to be defined in the consent HTML. Detailed steps are explained below, under this.
Designing the document
This can be done in 3 steps:
Descriptive text
Consent statements
Participant information and other details
Descriptive text:
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Here’s a demo HTML file for reference. This is an example of an assent form for a minor.
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Designing the Consent Form
Consent form is designed in HTML HTML gives us the flexibility to easily format the consent form. E.g. bullet points, bold, underline, embed videos/photos, etc.
There are three sections in the Consent Form:
Formatted text
Consent statements
Custom fields
Formatted text
This section applies to any informative text that has to be included in the consent form. For example, see below.
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You can use online HTML editors like this to create this section. |
Consent Statements
Consent statement(s) are to can be added after the descriptive text. You can add them in the form of anywhere in the consent form. They can be a dropdown, radio-button, checkbox. All these can be defined in the HTML.
Here’s how it would look in the document:
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Below is the code for defining the above consent statements in the consent document:
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<div style="padding: 8px 8px 8px 0px; border-top: 5px solid #ddd;">
<div class="clearfix" consent-question="C0001" style="padding: 8px 8px 8px 0px; border-bottom: 1px solid #ddd;">
<label class="control-label">
<span>Do you consent to participate in biobank activities?</span>
</label>
<div>
<label class="radio-inline">
<input type="radio" name="C0001" value="Y" ng-model="ectx.statements.C0001" required>
<span>Yes</span>
</label>
<label class="radio-inline">
<input type="radio" name="C0001" value="N" ng-model="ectx.statements.C0001" required>
<span>No</span>
</label>
</div>
<div os-field-error field="econsentForm.C0001"></div>
</div>
<div class="clearfix" consent-question="C0002" style="padding: 8px 8px 8px 0px; border-bottom: 1px solid #ddd;">
<label class="control-label">
<input name="C0002" type="checkbox" ng-model="ectx.statements.C0002" ng-true-value="'Y'" ng-false-value="'N'">
<span>I consent to store my specimens in long term storage for future research.</span>
</label>
</div>
<div class="clearfix" consent-question="C104" style="padding: 8px 8px 8px 0px; border-bottom: 1px solid #ddd;">
<label class="control-label">
<span>I consent to distribute my specimens to external institutes for future research.</span>
</label>
<div style="width: 10%">
<select name="C104" class="form-control" ng-model="ectx.statements.C104" required>
<option value="Y">Yes</option>
<option value="N">No</option>
</select>
</div>
<div os-field-error field="econsentForm.C104"></div>
</div> |
Participant information and other details
or checkbox.
For example:
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Custom Fields
Details such as signature, date of signature etc. that were defined in the custom form (step 2 in the “Prerequisites”) appear can be displayed as below in the consent documentform.
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<div class="clearfix" style="padding: 8px 8px 8px 0px;">
<div style="width: 33%; float: left">
<label class="control-label">
<span>Consent Date</span>
</label>
<div>
<os-date-picker name="consentDate" date="ectx.customFields.consentDate"></os-date-picker>
</div>
<div os-field-error field="econsentForm.consentDate"></div>
</div>
<div style="width: 33%; float: left; padding-left: 16px;">
<label class="control-label">
<span>Consent Witness</span>
</label>
<div>
<os-users ng-model="ectx.customFields.witness" select-prop="id"></os-users>
</div>
</div>
<div style="width: 33%; float: left; padding-left: 16px;">
<label class="control-label">
<span>Signed Form</span>
</label>
<div>
<ec-file-uploader file="ectx.customFields.signedConsentFile"></ec-file-uploader>
</div>
</div>
</div>
<div>
<div>
<div class="clearfix" style="padding: 8px 8px 8px 0px;">
<div style="float: left">
<label class="control-label">
<span>Signature</span>
</label>
<div>
<ec-signature name="signature" image="ectx.customFields.signature" required></ec-signature>
</div>
<div os-field-error field="econsentForm.signature"></div>
</div>
</div>
</div>
</div>
<div class="clearfix" style="padding: 8px 8px 8px 0px;">
<div style="width: 100%; float: left">
<label class="control-label">
<span>Comments</span>
</label>
<div>
<textarea class="form-control" ng-model="ectx.customFields.comments" rows="2"></textarea>
</div>
</div>
</div> |
Once this HTML is created, this is ready to be uploaded to the system.
Adding the consent document to the CP
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Example Consent Form
<include the complete HTML here>
Adding the Consent From to a CP
Once the HTML is ready, you can upload it for a CP as the consent form using the below steps.
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Updating a Consent Form
The title, version and the document all HTML content can be updated. It can be done by clicking the “Edit” icon from the consents list page.
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Consent Versioning
A consent document can have different multiple versions. The detailed information can be changed, questions can be modified in the newer version. You can add the revision of the document and upload the respective documentWhen a new version is added, the new version is available for old and new participants. The data collected for older version remains in the database and is available for querying.
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Archiving Consent Form
In case a version of consent form is not needed anymore, it can be archived. Once archived, the form is not available anymore. However, if consent is already collected for that version, then it is available for viewing, edit and reporting.
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Download Consent
Consent The consent form’s HTML file can be downloaded from the CP consents tab. This can be and used to update the text, statements, and details and re-upload as a new consent fileediting the form or uploading it another instance or another CP. This saves the re-work of designing the document from scratch.
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Sort Consents
The order of consent documents can be changed using the “Sort” option. T It This is mandatory to put a sort order in front of each documentsort the consent forms in a specific order. If no order is specified, the system will displayed in the order the forms are uploaded.
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