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Harshita Shivhare (Unlicensed)

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  1. Coded consent statement should be defined in the “Consents” of the OpenSpecimen instance. In case it isn’t, please refer to this wiki page to add the coded consents: Coded Consents

  2. Identify the fields for which information is to be recorded along with consent responses. For instance, the e-signature, the full name as provided in identity proof, the date of signature etc. These fields are to be added in a “Consent “Consent Custom Fields” Fields” form attached at “Consent “Consent Document Custom Fields” Fields” level. In order Refer this wiki page to add different control types to the custom form, refer this wiki page.

    Few pointers to keep in mind:

    1. Refrain from adding repetitive controls to the form. For example, ‘participant name’ is the same as the ‘patient name’ is the same as the ‘full name of the participant’. One control can be used by changing the captions as needed in the HTML.

    2. A single “Consent Custom Fields” form is maintained across the system and the fields from this form can be used across all CPs in 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.

    Once the fields have been added to the form, they have to be defined in the HTML to add it to the consent document (detailed steps under this)

    1. Detailed steps are explained below, under this.

Designing the document

This can be done in 3 steps:

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Refer the below section of HTML for defining these above custom fields in the consent document:

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Adding the consent document to the CP

Here is how you can upload the above-created Follow the below steps to add a consent document to the collection protocol:

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titleAdding a consent document to the CP

  1. From the navigation menu, go to Collection Protocols list page > CP Overview > Consents tab

  2. This would lead you User is redirected to the list page of the Cp CP level consents. Click on “Add” from the screen.

  3. A pop-up appears for user to enter Enter the name of the consent document in the “Title” field, the version in the “Revision” field and upload the HTML file in the “Document File” field. All three fields are mandatory. Click on “Add”.

  4. It will be visible at the end of the consent statements in the list view.

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The title, version and the document all can be updated for eConsent document. It can be done by clicking the “Edit” icon from the consents list page.

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titleSteps to edit eConsent document

  1. Go to the CP Overview > Consents

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

  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”.

Add Revision

The same A consent document can have different 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 document.

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Consent HTML file can be downloaded from the CP consents tab. This can be used to update the text, statements, and details and re-upload as a new consent file. This saves the re-work of designing the document from scratch.

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The order of consent documents can be changed using the “Sort” option. T It is mandatory to put a sort order in front of each document.

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titleSteps to re-order the consent documents

  1. Go to CP Overview > Consents > Sort

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  2. Enter the sort order starting from 1. Click “Update”.

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  3. While choosing to add the consents for a participant, these documents appear in the same order as specified.

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