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Alyssa Hill

Alyssa Hill

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Before (1.0)

How to access the framework:

  • Survey settings > framework settings

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  • Required continual updating of the consent instrument, logic, etc, everytime a new consent version was applied

  • Multiple, different consent instruments and fields were needed to accommodate different languages, DAGs, etc.

  • E-consent framework was hosted in ‘survey settings’

After (2.0)

How to access the framework:

  • Online Designer < ‘e-consent framework and PDF snapshot’

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  • A single instrument and single descriptive field is continually used for all versions of a single consent document.

  • The single descriptive field can host multiple, different consent forms based on…

    • Participants language (if using MLM)

      • 1 active form for english

      • 1 active form for spanish

        • Both tied to the same field and instrument!

    • Data Access group

  • E-consent framework is now hosted in the designer page

Before e-consent 2.0 is released study teams should:

  1. Ensure the ‘version’ number in your framework settings is correct, as when 2.0 framework is rolled out whatever number you have listed here will be what is used by default in the new setting.

Note

e-Consent 2.0 will be release on xxxxx

The below update steps are provided to ensure you don’t have duplicate consent images/fields displayed in your consent.

After e-consent 2.0 is released updates to your instrument and settings must be made:

  1. Plan a time to update your project when participants will not be completing consent

  2. Mark you Consent survey as ‘Inactive’ via ‘survey settings’

  3. Review & update you current consent instrument so that only the below fields are left:

    1. Keep existing data capture fields as is (discrete fields, name, date, signature) (insert images)

    2. Reduce ‘descriptive’ fields so that only a single, empty descriptive exists (insert images)

      1. You’ll need to remove or hide the all but 1 descriptive field.

        • If your descriptive field host an image, remove the file

        • If your descriptive field host in-line text, remove the text

        • Use the @HIDDEN action tag to hide additional ‘descriptive’ fields (excluding the now blank field) The single, blank, descriptive field should not be hidden)

      2. Why? The e-consent document is now uploaded via the framework settings and NOT in the instrument itself.

  4. Version settings will be automatically mapped (insert Ashleys image) , however you will need to setup

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  5. Setup your new consent form via ‘+ Add Consent Form’ feature

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    1. Update version number if applicable

      1. Only applicable if you are uploaded a new version of what was previously in place

    2. Select your empty ‘descriptive’ field for the ‘Placement of consent form’

    3. Select ‘Consent Form (Inline PDF)’ to upload your consent PDF document

    4. Click ‘Add new consent form’ to finalize

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  6. Once the new settings & form is setup is complete, 're-activate' your survey! (via survey settings)