eConsent REDCap Template Instructions

Instructions:

The template as provided is comprehensive so that it can be used as a starting point for all projects. (I.E., adult, pediatric, etc.) This instructional guide in conjunction with the knowledge articles and training materials should be followed to modify the template to meet study needs.

1 Step 1) Create your development project using the template
2 Step 2) Add discrete fields
3 Step 3) Enable e-consent framework and version

NOTE: Never delete the Documentation of Informed Consent instrument.

This instrument is required for ALL consent projects!

Step 1) Create your development project using the template

From you redcap homepage, click ‘+New Project’
Provide a title
Select a purpose
- If using the template for the first time, we suggest creating a practice project so you become familiar with the versioning process before implementing to a research project
Project creation option: ‘use a template’

There are 2 to start from when requesting a project:

eConsent REDCap Extensive Template: Includes contact info, adult, children, LAR, witness, and interpreter electronic consents, manual (paper) consent upload, and documentation of informed consent instruments.
eConsent REDCap Simple Template: Includes contact info, adult electronic consent, manual (paper) consent upload, and documentation of informed consent instruments.

Choose ‘eConent REDCap Template’

Click ‘Create Project’
Wait for approval

Step 2) Add discrete fields

Your Consent document may host specific discrete fields that aren’t included in the template. e.g. Future contact, DNA storage, etc.
Add any discrete fields as applicable
When editing the instruments remember to follow standards based on your specific project type:

FDA Regulated Project	Remote-Contactless Consent (Non-FDA)	In-Person Consent projects (Non-FDA)

FDA Regulated Project	Remote-Contactless Consent (Non-FDA)	In-Person Consent projects (Non-FDA)
21 CFR Part 11 Validated Project instance required Only 1 signature capture permitted per instrument Requires the study team’s documentation of informed consent & attestation is captured separately using a data entry instrument.	Only 1 signature capture permitted per consent survey Requires the study team’s documentation of informed consent & attestation is captured separately using a data entry instrument.	Permissible to incorporate up to five signatures within the consent survey framework settings Requires the study team’s documentation of informed consent is captured separately using a data entry instrument.

If using the Extensive Template delete any instruments not needed for your study (assent, LAR, PPF, Interpreter)

Participant Contact Info - This form is used by study personnel to gather information about participants interested in being part of the study.

If participant age is to be used to determine which consent form should be sent (i.e., under age 18 send parental permission form), the participant date of birth (dob) and age (age_at_contact) fields in the Participant Contact Info instrument can be used for survey distribution logic.

Manual (paper) Consent Upload - This form is used by study personnel to upload signed physical consent documents.

If using Manual Consent Upload instrument and multiple forms may need to be uploaded, copy the "Upload copy of signed consent" field as needed to allow for more than 1 upload.

eConsent Adult - This survey is used by an adult subject to collect informed consent.

In the case where participants are under 7 years old, only the parental permission survey is needed. This survey does not require the participant's signature, but requires the participant's name, date of birth, parent's name, parent's signature, and date signed.
For participants aged 7 to 17, an assent survey is needed. This requires the same information as the example above - participants name, date of birth, signature, and date of signature.
When participants are under the age of 18, a parent must also sign a parental permission survey.

eConsent Assent - This survey is used by a subject ages 7 -17 to collect informed consent.

Separate Assent Forms:

If you are using separate Assent forms for ages 7-12 and 13-17, please make a copy of the eConsent Assent instrument by selecting “choose Action” on the instrument and click “copy” then label it appropriately. You may want to edit the variable names to match your Assent types.

eConsent Parent Permission Form (PPF) - This survey is used by the parent of a subject under the age of 18 to collect informed consent.

eConsent Legally Authorized Representative (LAR) - This survey is used to collect informed consent by the legally authorized representative of a subject who is unable to provide consent.

eConsent Witness - This survey is used by the witness to a subject who is unable to read or sign the consent form.

eConsent Interpreter - This survey is used by the interpreter for non-English speaking subjects who are unable to read the consent form.

Documentation of Informed Consent (attestation) - This form is used by study personnel to document attestation and the informed consent process to comply with IRB policy for any potential future IRB audit.

If doing in-person consent ONLY:

The attestation statement field can be removed from the Documentation of Informed Consent instrument.

Step 3) Enable e-consent framework and version

Follow the knowledge article e-Consent Initial Set-Up (steps 2-4) to set up e-Consent Framework and version to meet your project needs. Lastly, test the process as if you were a participant!

Utah CTSI REDCap Support