Info

You need to be well-versed with HTML to configure consent forms. The HTML files can be created manually or using online editors like this.

In future versions, we plan to give a UI-based editor within OpenSpecimen to create the consent forms.

...

<ec-print-template> <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;">

19. Add Participant’s Information in the Consent document: Below is an example to display/print First Name and Last Name

Expand

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 style="width: 45%; float: left; clear: left;">
          <div class="col-xs-8 os-no-left-padding">
            <div user-input field="ectx.customFields.consentDate" type="date-time">
              <os-date-picker name="consentDate" date="ectx.customFields.consentDate" default-current-date ng-disabled="1 != 0"></os-date-picker>
            </div>
          </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 os-field-error field="econsentForm.consentDate"></div>
      </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 0px;#if(true)display: none;#end">
  <div style="display: block; margin-bottom: 10px;">
    <span>
      <div user-input field="ectx.customFields.iAgree">
        <input type="radio" name="iAgree" value="Yes" ng-model="ectx.customFields.iAgree"
          ng-required="(ectx.statements.C0003=='N' || ectx.statements.C0003==null)">
          <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>
      </div>
    </span>
  </div>
  <div style="display: block;">
    <span>
      <div user-input field="ectx.customFields.iAgree">
        <input type="radio" name="iAgree" value="No" ng-model="ectx.customFields.iAgree"
          ng-required="(ectx.statements.C0003=='N' || ectx.statements.C0003==null)">
          <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>
      </div>
    </span>
  </div>
  <div os-field-error field="econsentForm.iAgree"></div>
</div>

4. Add custom field text-box

Code Block

  <div>
      <label class="control-label">
        <span>Print Name of Biobank Participant</span>
      </label>
    </div>

    <div style="width: 70%; float: left">
      <div user-input field="ectx.customFields.participantName">
        <div>
          <textarea class="form-control" name="participantName" ng-model="ectx.customFields.participantName" rows="1" required></textarea>
        </div>
      </div>
      <div os-field-error field="econsentForm.participantName"> </div>
    </div>

5. Add signature field

Code Block

 <div style="width: 70%; float: left">
      <div>
      <label class="control-label">
        <span>
          <strong>Signature of Biobank Participant</strong>
        </span>
      </label>
      </div>
      <div user-input field="ectx.customFields.signature" type="signature">
        <ec-signature name="signature" image="ectx.customFields.signature" ng-required="(ectx.customFields.signatureAuthRep==null && (ectx.statements.C0003=='N' || ectx.statements.C0003==null))">
        </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 style="float: left; clear: left;">
    <label style="float: left; clear: left;">
        <strong>Today's Date</strong>
    </label>
</div>

  <div class="clearfix">
      <div style="width: 45%; float: left; clear: left;">
          <div class="col-xs-8 os-no-left-padding">
            <div user-input field="ectx.customFields.consentDate" type="date-time">
              <os-date-picker name="consentDate" date="ectx.customFields.consentDate" default-current-date ng-disabled="1 != 0"></os-date-picker>
            </div>
          </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 os-field-error field="econsentForm.consentDate"></div>
      </div>
    </div>

7. Add number custom field

Code Block

language	html

<div style="margin-bottom: 20px;">
          <label style="display: block;">Height (centimetres)</label>
          <div style="width: 250px;" user-input field="ectx.customFields.height_centimetres">
            <input style="padding: 8px; border: 1px solid #ddd; border-radius: 4px; width: 100%" name="height_centimetres" ng-model="ectx.customFields.height_centimetres" required
              ng-pattern="/^[1-9][0-9]*$/">
            <div os-field-error field="econsentForm.height_centimetres"> </div>
          </div>
        </div>

8. Add OpenSpecimen PV-dropdown as a custom field site dropdown

Code Block

language	html

   <div style="margin-bottom: 20px;">
          <label style="display: block;">Collection Center</label>
          <div user-input field="ectx.customFields.preferred_collection_site" type="user">
            <div style="display: inline-block; margin-right: 20px;">
              <os-sites name="preferred_collection_site" ng-model="ectx.customFields.preferred_collection_site" ></os-sites>
            </div>
            <div os-field-error field="econsentForm.preferred_collection_site"> </div>
          </div>
        </div>

9. Add custom field dropdown value with options

Code Block

language	html

    <div style="margin-bottom: 20px;">
          <label style="display: block;">Visit Center</label>
          <div user-input field="ectx.customFields.visit_center">
            <div style="display: inline-block; margin-right: 20px;">
              <ec-select ng-model="ectx.customFields.visit_center" required>
                <custom-field>consent_custom_fields.visit_center</custom-field>
              </ec-select>
            </div>
            <div os-field-error field="econsentForm.visit_center"> </div>
          </div>
        </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-editableMark consent statement editable with default selected.

Code Block

language	html

<input type="radio" name="health_info_described_in" value="both" ng-model="ectx.customFields.health_info_described_in" 
<div class="clearfix" consent-question="M001">
          <label class="control-label"> 
          		<input name="M001" type="checkbox" ng-true-value="'Y'" ng-false-value="'N'" ng-model="ectx.statements.M001" ng-init="ectx.customFields.health_info_described_instatements.M001 = ectx.statements.M001 || 'bothY'" ng-disabled="1 != 0">

14. Make field mandatory based on other field value

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

>
            <span>I consented for cancer study</span>
</div>

14. Default custom value with non-editable

Code Block

language	html

<div><input  <textarea class="form-controltype="radio" name="health_info_described_in" value="both" ng-model="ectx.customFields.parentGuardianNamehealth_info_described_in" rows="1"
ng-requiredinit="cprectx.participant.gendercustomFields.health_info_described_in ==  'Maleboth'"> </textarea>
</div>
 ng-disabled="1 != 0">

15. Make field mandatory based on other field value

Eg:2 1 - Make Guardian name custom field mandatory when site='Stanford Hospital'for Male patients.

Code Block

language	html

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

Eg:3 2 - Make Participant Signature(signature) mandatory if Guardian signature(signatureAuthRep) is not entered Guardian name custom field mandatory when site='Stanford Hospital'

Code Block

language	html

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

Eg:3 - Make Participant Signature(signature) mandatory if Guardian 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>

1516. Add File Type Control

Code Block

language	html

    <div style="margin-bottom: 20px;">
          <label style="display: block;">Photo Identity</label>
          <div user-input field="ectx.customFields.photo_identity" type="file">
            <div style="display: inline-block; margin-right: 20px;">
              <ec-file-uploader name="photo_identity" file="ectx.customFields.photo_identity" required></ec-file-uploader>
            </div>
            <div os-field-error field="econsentForm.photo_identity"> </div>
          </div>
        </div>

1617. 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 user-input field="ectx.customFields.signedConsentFile" type="file">
     <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>
    <div os-field-error field="econsentForm.signedConsentFile"></div>
</div>

1718. Change the caption for the Next and Previous button

Code Block
<ec-page-nav-buttons> <next>Siguiente</next> <previous>Página Anterior</previous> <save>Guardar</save> <cancel>Cancelar</cancel> </ec-page-nav-buttons>

18. 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.

Image Removed

Example: PDF

Image Removed

Example HTML code for the above document:

Code Block

language	html

Code Block

language	html

<div style="position:relative; white-space: nowrap; padding: 20px 0px 0px 0px;">
           <!-- #if (1 == 0) --> // This section will display the information in UI
            <img<table style="positionwidth: absolute80%; z-indexborder: 1000;2px height:solid 60pxblack; widthmargin-left: 450pxauto;" src="https://bb.cuimc.columbia.edu/os-test/logo/RS2133_RS460_Columbia_CUIMC_H_B_RGB_A.png">>
        </div>     </div>  <tr>
</ec-page-header>    <ec-page-footer>        <table style="border-top: 2px solid #ddd; position:relative;height: 70px; display: inline-block; width: 100%; padding: 8px 8px;"> <td>
             <tbody>        <strong>Last <tr>
Name:</strong> {{cpr.participant.lastName}}
         <td style="text-align: left;">       </td>
     <img style="height: 70px; width: 300px;"  src="https://bb.cuimc.columbia.edu/os-test/logo/cumc_stamp_hiccc.png">         <td>
    </td>           <td style="text-align: right; padding: 10px;">  <strong>First Name:</strong> {{cpr.participant.firstName}}
          <div id="osPageCounter" style="position: absolute; bottom: 12px; right: 5px;"> </div>td>
           </td>    </tr>
     </tr>       </tbody>table>
      </table>   </ec!-page-footer> </div>
</ec-print-template>

Upload Consent Document in OpenSpecimen

...

#else --> // This section will be used to print the information while printing
            <table style="width: 80%; border: 2px solid black; margin-left: auto;" ng-if="1 == 0">
               <tr>
                  <td>
                     <strong>Last Name:</strong> $cpr.participant.lastName
                  </td>
                  <td>
                     <strong>First Name:</strong> $cpr.participant.firstName
                  </td>
               </tr>
            </table>
          <!-- #end -->
         </div>

Image Added

20. 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.

Image Added

Example: PDF

Image Added

Example HTML code for the above document:

Code Block

language	html

<ec-print-template>
<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://bb.cuimc.columbia.edu/os-test/logo/RS2133_RS460_Columbia_CUIMC_H_B_RGB_A.png">
      </div>
    </div>
  </ec-page-header>

  <ec-page-footer>
    <table style="border-top: 2px solid #ddd; position:relative;height: 70px; display: inline-block; width: 100%; padding: 8px 8px;">
      <tbody>
        <tr>
          <td style="text-align: left;">
            <img style="height: 70px; width: 300px;"  src="https://bb.cuimc.columbia.edu/os-test/logo/cumc_stamp_hiccc.png">
          </td>
          <td style="text-align: right; padding: 10px;">
              <div id="osPageCounter" style="position: absolute; bottom: 12px; right: 5px;"> </div>
          </td>
        </tr>
      </tbody>
    </table>
  </ec-page-footer>
</div>
</ec-print-template>

Upload Consent Document in OpenSpecimen

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

...

ADVANCED: This is used for creating a combination of rules using ‘and’ and ‘or’.
For example,
The below will be true if either (consent 1 is yes AND consent 2 is yes) OR consent 3 is yes.

...

The expression in the box defines the rule which allows collection. It can be edited by clicking on “Edit”.

Consents Digests

OpenSpecimen provides two options to receive the consent digest, which described below. User will get receive the participants and consent document information is yes) OR consent 3 is yes.

...

The expression in the box defines the rule which allows collection. It can be edited by clicking on “Edit”.

Consents Digests

OpenSpecimen provides two options to receive the consent digest, which described below. User will get receive the participants and consent document information who consented on that day(within 24hrs).

Site based Recipients? → No, The user has to specify a list of users and those users will get the consent digest email.

Site based Recipients? → Yes, The user has to specify a sites and user groups and those users from groups will receive the digest emails

What information is present in Digest Email?

The digest email has the information on the patient who consented on that day(within 24hrs) .

Site based Recipients? → No, The user has to specify a list of users and those users will get the consent digest email.

or who updated the consent document on that day for that patient along with the date. Furthermore, you can configure when to send the digest email, like Hourly, Monthly, Daily, On Demand etc.

Expand

title	Click here to see screenshots...

Digests Settings: Site based Recipients? → Yes

...

What information is present in Digest Email?

...

Image Added

Digests Settings: Site based Recipients? → No

Image Added

Digests Email Example:

Image Added

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

Navigates to Home → Jobs
Search For “Consent response” as below
Image Added
Click on three dots and edit
Set up the job based on your requirements like daily, Hourly, etc
Image Added

Reuse Participant Consents

At many centers, participant consents are registered or collected only once as per the IRB guidelines and reused in multiple studies.

From v10.3, A new setting has been added to the CP consents tab, this allows consent responses to be shared between multiple collection protocols, streamlining the consent management process.

Expand

title	Click here to see screenshots...

Digests Settings: Site based Recipients? → Yes

Image Removed

Digests Settings: Site based Recipients? → No

Image Removed

Digests Email Example:

Image Removed

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

Navigates to Home → Jobs
Search For “Consent response” as below
Image Removed
Click on three dots and edit
Set up the job based on your requirements like daily, Hourly, etc
Image Removed

Reuse Participant Consents

At many centers, participant consents are registered or collected only once as per the IRB guidelines and reused in multiple studies.

From v10.3, A new setting has been added to the CP consents tab, this allows consent responses to be shared between multiple collection protocols, streamlining the consent management process.

Expand

title	Click here to see screenshots...

To add consents from another CP

Go to the CP Overview > Consents

Image Removed

How to copy consents from another CP.

Go to Collection Protocol Overview Page.
Click on the Consents Tab.
Click on the ⚙️ Set button and choose the CP from which you want to copy consents.

Image Added

Points to remember :

No new consent tiers or documents can be added in the receiver CP.
Consent responses cannot be added/updated via receiver CP registrations.
The participants' consent responses can be seen in the read-only mode in the receiver CPs with the option to print the consent document.
Since the consents for participants is copied to receiver CP, openspecimen users can distribute specimens collected for the receiver CP.

Version	Old Version 59	New Version Current
Changes made by	Ashish Vishwakarma	Ashish Vishwakarma
Saved on	Dec 28, 2023	Jan 09, 2025

Versions Compared

Key

Upload Consent Document in OpenSpecimen

Upload Consent Document in OpenSpecimen

Consents Digests

Consents Digests

What information is present in Digest Email?

What information is present in Digest Email?

Reuse Participant Consents

Reuse Participant Consents

Points to remember :

Page Comparison

Versions Compared

Key

Upload Consent Document in OpenSpecimen

Upload Consent Document in OpenSpecimen

Consents Digests

Consents Digests

What information is present in Digest Email?

What information is present in Digest Email?

Reuse Participant Consents

Reuse Participant Consents

Points to remember :