Consent forms are configured at a CP level in HTML and contain the following:

HTML text
Consent Statements
Custom fields

Prerequisites

'Allowed File Types' setting

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title	Steps to include html in the allowed file types:

Go to Menu > Settings
Search “Allowed File Types”
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Check if ‘HTML’ is included in the setting. If not, click on the setting
Copy all the original allowed file types from the “Existing Value”. Paste it in “New Value”, put a comma, and include ‘HTML’ along with it. Click “Update” once done.
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Consent Statements

The consent statements are defined at a global level so that they can be reused across CPs. Go to Menu->Consents to define new consent statements. Refer to Coded Consents for more details.

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Expand

title	Steps to set the consent response concept codes

Go to Extras > Dropdown Manager > Consent Response dropdown
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Click on the consent response value “Yes” and click “Edit”
Enter the concept code as “Y” and click “Update”
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Similarly, edit the concept codes of all the responses. Here are the default concept codes that you can use:

Consent Response	Concept Code
Yes	Y
No	N
Not Specified	NS
Withdrawn	W
None	NN

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There are three sections in the consent form:

Formatted text
Consent statements
Custom fields

Formatted HTML text

This section contains the consent text. For example:

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title	Examples to add the different types of custom fields in the consent document

The ‘Consent Date’ should display the default value as the current date and time. Ensure that the control type in the consent custom fields form is updated to ‘Date and Time’.

In the consent HTML, the code for the ‘Consent Date’ field needs to be updated as below:

Code Block

language	html

<div class="clearfix">
    <div class="col-xs-8 os-no-left-padding">
      <os-date-picker name="consentDate" date="ectx.customFields.consentDate" default-current-date></os-date-picker>
    </div>
    <div class="col-xs-4 os-no-left-padding">
		  <timepicker class="os-time-no-wheels" ng-model="ectx.customFields.consentDate" show-meridian="false"></timepicker>
		</div>
    </div>

The ‘os-date-picker’ sets the value to the current date and the time picker allows the display of the current timestamp.

2. Add consent statement with the default value set and hidden on the overview page

Code Block
<div consent-question="C0003"> <input type="hidden" ng-model="ectx.statements.C0003" ng-init="ectx.statements.C0003 = ectx.statements.C0003 \|\| 'Y'"> </div>

3. Add custom field radio button "I Agree/I do not agree"

Code Block

<div class="clearfix" style="padding: 8px 8px 8px 0px;">
	<label class="radio-inline">
		<input type="radio" name="iAgree" value="Yes" ng-model="ectx.customFields.iAgree" required>
			<span>
				<strong>I agree</strong> that you may contact me if there are results from the genetic research that may be relevant to my health.
			</span>
		</label>
		<p></p>
		<label class="radio-inline">
			<input type="radio" name="iAgree" value="No" ng-model="ectx.customFields.iAgree" required>
				<span>
					<strong>I do not agree</strong> that you may contact me if there are results from the genetic research that may be relevant to my health.
				</span>
			</label>
			<div os-field-error field="econsentForm.iAgree"></div>
		</div>

4. Add custom field text-box

Code Block

  <div class="clearfix">
		  <div style="width: 70%;">
		  	<label class="control-label">
			  <span>Print Name of Biobank Participant</span>
			</label>
		    <textarea class="form-control" ng-model="ectx.customFields.participantName" rows="1" required></textarea>
		  </div>
  </div>

5. Add signature field

Code Block

 <div class="clearfix" style="padding: 8px 8px 8px 0px;">
	  	  <label class="control-label">
			  <span><strong>e-signature Biobank Participant(Mandatory)</strong></span>
		  </label>
		  <div>
			  <ec-signature name="signature" image="ectx.customFields.signature" required></ec-signature>
		  </div>
		  <div os-field-error field="econsentForm.signature"></div>
	  </div>

6. Add date as a custom field with default current date and non-editable

Code Block

 <div class="clearfix">
	    <div style="width: 45%;">
		  <label class="control-label">
		    <span>Date</span>
		  </label>
		  <div class="clearfix">
		    <div class="col-xs-8 os-no-left-padding">
			  <os-date-picker name="consentDate" date="ectx.customFields.consentDate" default-current-date ng-disabled="1 != 0"></os-date-picker>
			</div>
			<div class="col-xs-4 os-no-left-padding">
			  <timepicker class="os-time-no-wheels" ng-model="ectx.customFields.consentDate" show-meridian="false" readonly-input="true"></timepicker>
			</div>
		  </div>
		  <div os-field-error field="econsentForm.consentDate"></div>
		</div>
	  </div>

7. Add number custom field

Code Block

language	html

 <div class="clearfix" style="padding: 8px 8px 8px 0px;">
  <div style="width: 10%; float: left">
  <label class="control-label">
    <span>Patient Age</span>
  </label>
  <ec-number name="age"
    ng-model="ectx.customFields.participantAgeWhenConsented"></ec-number>
  </div>
</div>

8. Add OpenSpecimen PV-dropdown as a custom field biohazard, race

Code Block

language	html

 <div style="width: 33%">
  <label class="control-label">
    <span>Disease</span>
  </label>
  <ec-select name="biohazard" ng-model="ectx.customFields.biohazard" multiple>
    <custom-field>consentCustomFields.biohazard</custom-field>
  </ec-select>
</div>

<div style="width: 33%">
  <label class="control-label">
    <span>Race</span>
  </label>
  <ec-select name="race"
    ng-model="ectx.customFields.race">
    <pv>race</pv>
  </ec-select>
</div>

9. Add custom field dropdown value with options

Code Block

language	html

 <div style="width: 25%">
<select name="consentedAt" class="form-control" ng-model="ectx.customFields.consentedAt" >
<option value="Home">Home</option>
<option value="Work place">Work place</option>
<option value="Doctor's clinic">Doctor's clinic</option>
</select>
</div>

10. Add print break in the consent document PDF: <ec-print-page-break></ec-print-page-break> is used to add the print break in the downloaded PDF.

In the below example, the 'We may contact you….' line will be printed on the next page.

Code Block

language	html

 <ol>
	<li>
		<u>You will be asked to donate a blood sample (approximately 3 tablespoons) and urine sample.</u> If these samples are not collected today, they may be collected at a future time when you have a blood draw ordered by your doctor or a separate appointment that is convenient for you. In some cases, we may ask you for a saliva (spit) or buccal (cheek swab) sample. We may also use blood, urine, or tissue samples collected as part of your clinical care now or in the future that would otherwise be thrown away.
	</li>
	<li>
		<u>We will request information about you and your health.  We will collect your name, address and other contact information.</u> We will use your electronic health records now and, in the future, to update your health information. We will store some of your health information, including your name, contact information, and medical history, in the Columbia Biobank database.  Biobank staff will make a note that you are a participant in the biobank in your electronic health record.
	</li>
	<ec-print-page-break></ec-print-page-break>
	<li>
		<u>We may contact you in the future.</u> We may ask you to complete additional questionnaires about your health or contact you to get additional information and ask if you are interested in joining other research studies. We may also contact you for another biological sample. We may ask for additional samples in order to study changes in your sample over time, or because we used up the first sample you provided. If we ask you for another sample, you may always say no.
	</li>
	<li>
		<u>Your coded samples, health information, and the research results may be shared with the scientific research community.</u> A science and ethics committee will review each request for data access. We will not give researchers outside of Columbia University Irving Medical Center-NewYork Presbyterian your name or any other information that could directly identify you.
	</li>
</ol>

11. Show/hide field/section based on the other field selection

Syntax: Needs to add the 'ng-show' tag to implement the show/hide logic

Code Block

language	html

<div ng-show="ectx.statements.C0003=='N'" >
 <p> .... </p>
 <label class="radio-inline">
  ......
 </label>
</div>

Example: When a user clicks on the “I agree to participate" option, the below section highlighted in red is enabled.

Example HTML for the above example:

View file

name	Participant English 11 Nov - v1.0 (1).html

12. Mark consent statement non-editable with default selected.

Code Block

language	html

<div class="clearfix" consent-question="M001">
          <label class="control-label"> 
          		<input name="M001" type="checkbox" ng-true-value="'Y'" ng-false-value="'N'"  ng-disabled="1 != 0"  ng-model="ectx.statements.M001" ng-init="ectx.statements.M001 =  'Y'"> </label> 
            <span>I consented for cancer study</span>
</div>

13. Default custom value with non-editable

Code Block

language	html

<input type="radio" name="health_info_described_in" value="both" ng-model="ectx.customFields.health_info_described_in" 
ng-init="ectx.customFields.health_info_described_in =  'both'" ng-disabled="1 != 0">

14. Make field mandatory based on other field value

Eg:1 - Make Guardian name custom field mandatory for Male patients.

Code Block

language	html

<div>
 <textarea class="form-control" ng-model="ectx.customFields.parentGuardianName" rows="1" ng-required="cpr.participant.gender == 'Male'"> </textarea>
</div>

Eg:2 - Make Guardian name custom field mandatory when site='Stanford Hospital'

Code Block

language	html

<div>
 <textarea class="form-control" ng-model="ectx.customFields.parentGuardianName" rows="1" ng-required="cpr.registrationSite == 'Stanford Hospital''"> </textarea>
</div>

Eg:3 - Make Participant Signature(signature) mandatory if Gurgdian signature(signatureAuthRep) is not entered

Code Block

language	html

<div>
    <ec-signature name="signature" image="ectx.customFields.signature" ng-required="ectx.customFields.signatureAuthRep==null"></ec-signature>
  </div>

15. Add File Type Control

Code Block

language	html

  <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>

16. Conditional field mandatory (File Type Field)

Eg, The consent form has the participant’s signature, parent’s signature, and paper consent file (File type). Out of three fields, one of them needs to fill.

Code Block

<div style="width: 45%; float: left;">
  <label class="control-label">
   <span>Upload Paper Consent</span></label>
 <div>
   <ec-file-uploader file="ectx.customFields.signedConsentFile" name="signedConsentFile" ng-required="(ectx.customFields.signature==null && ectx.customFields.signatureAuthRep ==null)"></ec-file-uploader>
 </div>
    <div os-field-error field="econsentForm.signedConsentFile"></div>
</div>

17. Configure headers and footer for the consent document print file: To configure this, you need to set the print template in OpenSpecimen settings as below. You can set the logo, stamp on headers, and footer, including page numbers.

Example: PDF

Example HTML code for the above document:

Code Block

language	html

<div>
  <ec-page-header>
    <div class="clearfix" style="border-bottom: 1px solid #ddd; position:relative;height: 70px; background: "#fff"; display: inline-block; width: 100%; padding: 8px 8px;">
	  <div style="float: left;">
        <img style="position: absolute; z-index: 1000; height: 60px; width: 450px;" src="https://test.openspecimen.org/logo/RS2133_RS460_Columbia_CUIMC_H_B_RGB_A.png">
	  </div>
	</div>
  </ec-page-header>

  <ec-page-footer>
    <div class="clearfix" style="border-top: 1px solid #ddd; position:relative;height: 70px; display: inline-block; width: 100%; padding: 8px 8px;">
	  <div style="float: left;">
        <img style="position: absolute; z-index: 1000; height: 60px; width: 300px;" src="https://test.openspecimen.org/logo/cumc_stamp.png">
	  </div>
	  <div style="float: right; color: #666;">
	    <span>- {{currentPage}} of {{totalPages}} - </span>
	  </div>
	</div>
  </ec-page-footer>
</div>

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Expand

title	Upload Consent Document in OpenSpecimen

Login to the OpenSpecimen → Click on Consent Card
Click on View Documents
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Click on Add and provide the Title and Revision details and upload the HTML consent form you created
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Adding the Consent Form to a CP

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title	Adding a consent document to the CP

From the navigation menu, go to the Collection Protocols list page > CP Overview > Consents tab
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The user is redirected to the list page of the CP level consents. Click on “Add”.
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Select the Consent Document from the list and click on Add
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It will be visible at the end of the consent statements in the list view.

Updating a Consent Form

The title, version, and HTML content can be updated. It can be done by clicking the “Edit” icon from the consents list page.

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Expand

title	Steps to edit eConsent document

Navigates to the Home page → Click on Consent Card → View Documents
Click on the “Update” icon beside the consent document(As highlighted below)
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If you want to update the title and version, just update the fields and click update. No need to re-upload the document.
In case an updated document is to be uploaded, leave the other fields unchanged. Upload the document and click “Update”.

Consent Revision (Versioning)

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title	Steps to add a new version of the document

Navigate to the Home → Consents → View Documents → Click on the "+” icon
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Enter the version of the consent document. Upload the document and click “Add”.
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Archiving Consent Form

If a version of a consent form is not needed, it can be archived. Once archived, the consent document is not available anymore for consent response collection. However, if consent is already collected for that version, then it is available for viewing, editing, and reporting.

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Users also allow to Archive the document in the collection protocol, and users won't be able to collect any responses for new patients.

System Level Archive Option:
1. Navigates to Home → Consent → View Documents
2. Click on the Archive option
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CP Level Archive Option:
1. Go to the Collection Protocol Overview Page → Consents tab

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Download Consent

The consent form’s HTML file can be downloaded and used to edit the form or upload it to another instance or another CP. This saves the re-work of designing the document from scratch.

Navigate to Home → Consent Card → View Documents → Click on the Download button below
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Sort Consents

The order of consent documents can be changed using the “Sort” option. If no order is specified, the consent documents will appear in the order that they were added.

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title	Steps to re-order the consent documents

Go to CP Overview > Consents > Sort
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Enter the sort order starting from 1. Click “Update”.
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While choosing to add the consents for a participant, these documents appear in the same order as specified.
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Audit Trails for consent document

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title	Click here to see screenshots...

Digests Settings:

Digests Email Example:

Digest email configuration: The user user should have the super admin privilege to change the digest job settings as below.

Go to Home--> Jobs
Search For “Consent response" as below
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. Click on three dots and edit
Setup the job based on your requirement like daily, Hourly, etc
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Version	Old Version 49	New Version 50
Changes made by	Tushar Tajane	Tushar Tajane
Saved on	Oct 04, 2022	Nov 07, 2022

Versions Compared

Key

Prerequisites

'Allowed File Types' setting

Consent Statements

Formatted HTML text

Adding the Consent Form to a CP

Updating a Consent Form

Consent Revision (Versioning)

Archiving Consent Form

Download Consent

Sort Consents

Audit Trails for consent document

Page Comparison

Versions Compared

Key

Prerequisites

'Allowed File Types' setting

Consent Statements

Formatted HTML text

Adding the Consent Form to a CP

Updating a Consent Form

Consent Revision (Versioning)

Archiving Consent Form

Download Consent

Sort Consents

Audit Trails for consent document