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titleExamples to add the different types of custom fields in the consent document
  1. 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
languagehtml
<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
languagehtml
 <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
languagehtml
 <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
languagehtml
 <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 print printed on the next page.

Code Block
languagehtml
 <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
languagehtml
<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
nameParticipant English 11 Nov - v1.0 (1).html

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

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

15. 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
languagehtml
<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>

Adding the Consent Form to a CP

Once the HTML is ready, you can upload it for a CP using the below steps.

Expand
titleAdding a consent document to the CP
  1. From the navigation menu, go to the Collection Protocols list page > CP Overview > Consents tab

    Image Removed

  2. The user is redirected to the list page of the CP level consents. Click on “Add”.

    Image Removed

  3. Enter the name of the consent document in the “Title” field and the version in the “Revision” field, and upload the HTML file in the “Document File” field. All three fields are mandatory. Click on “Add”.

    Image Removed

  4. 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.

From v9.1, OpenSpecimen will not allow updating the consent document if that is used with any patient.

Expand
titleSteps to edit eConsent document
  1. Go to the CP Overview > Consents

  2. Click on the “Edit” icon beside the consent document

    Image Removed

  3. If you want to update the title and version, just update the fields and click update. No need to re-upload the document.

  4. In case an updated document is to be uploaded, leave the other fields unchanged. Upload the document and click “Update”.

Consent Revision (Versioning)

A consent document can have multiple versions. When 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.

Expand
titleSteps to add a new version of the document
  1. From the consents list page, click on the “+” icon across the document.

    Image Removed

  2. Enter the version of the consent document. Upload the document and click “Add”.

    Image Removed

Archiving Consent Form

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Upload Consent Document in OpenSpecimen

Users can upload the consent documents Consent tab and can access those in the collection protocol. From v9.0, OpenSpecimen will allow using the same consent form in different CPs. User who has. the access to the Consent can be uploaded or updated consent document in OpenSpecimen.

Expand
titleUpload Consent Document in OpenSpecimen
  1. Login to the OpenSpecimen → Click on Consent Card

  2. Click on View Documents

    Image Added

  3. Click on Add and provide the Title and Revision details and upload the HTML consent form you created

    Image Added

Adding the Consent Form to a CP

Once the HTML is ready, you can upload it for a CP using the below steps.

Expand
titleAdding a consent document to the CP
  1. From the navigation menu, go to the Collection Protocols list page > CP Overview > Consents tab

    Image Added

  2. The user is redirected to the list page of the CP level consents. Click on “Add”.

    Image Added

  3. Select the Consent Document from the list and click on Add

    Image Added

  4. 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.

From v9.1, OpenSpecimen will not allow updating the consent document if that is used with any patient.

Expand
titleSteps to edit eConsent document
  1. Navigates to the Home page → Click on Consent Card → View Documents

  2. Click on the “Update” icon beside the consent document(As highlighted below)

    Image Added
  3. If you want to update the title and version, just update the fields and click update. No need to re-upload the document.

  4. In case an updated document is to be uploaded, leave the other fields unchanged. Upload the document and click “Update”.

Consent Revision (Versioning)

A consent document can have multiple versions. When 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.

Expand
titleSteps to add a new version of the document
  1. Navigate to the Home → Consents → View Documents → Click on "+” icon

    Image Added

  2. Enter the version of the consent document. Upload the document and click “Add”.

    Image Added

Archiving Consent Form

In case a version of a 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, editing, and reporting.

From v9.0, OpenSpecimen allows archiving the document at the system level and CP level. If the document is archived at the system level, the user won't be able to add that in new collection protocols, but if that document is already used in other CP will work without affecting anything.

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

  1. System Level Archive Option:

    1. Navigates to Home → Consent → View Documents

    2. Click on the Archive option

      Image Added

  2. 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.

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  1. Navigate to Home → Consent Card → View Documents → Click on the Download button below

    Image Added

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.

...

Image Removed
Expand
titleClick here to see the screenshot

Navigate to Home Page → Consent Card → View Documents –> Click on Audit Trail button

Image Added

Image Modified

Consents Digests

You can add multiple users to get the daily digest email about eConsents. The digest email has the information of the patient who consented on that day or who updated the consent document on that day for that patient along with the date. Also, you can configure when to send the digest email, like Hourly, Monthy, Daily, On Demand etc.

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