Monitoring the use of e-consent in the study's REDCap project is critical for the study team to ensure that: 1) there is valid documentation of informed consent for existing participants, 2) potential participants are presented with an updated and valid e-consent survey, and 3) data is not being collected for participants who did not consent. Failure to monitor e-consent use could result in reportable regulatory issues, and/or the loss of data collected from participants who were not properly consented.

The study team is responsible for monitoring their project. Our goal, with the information we've collected here, is to help the team get started with planning for how they carry out monitoring, by focusing on best practices and topics common to all projects set up for e-consent. 


Disclaimer: This page refers to features and functionality that are covered in Basics and Survey trainings, or well documented in REDCap itself. These features will not be described in detail here. For help with any of this functionality, once you've completed trainings and started building your e-consent project, please contact the REDCap Team or sign up for a drop-in.


Topics Covered:


Most Common Issues

The most common issues we have observed with study teams using REDCap for e-consent involve 1) staff using e-consent surveys for data entry, and 2) staff not managing revisions to their e-consent surveys.

Data Entry on E-Consent Surveys

The sole use of the REDCap e-consent survey is to record that informed consent was obtained from the participant using an electronic system. E-consent surveys are required to be completed as surveys, and never as data entry forms. This means: 

  • Study staff cannot use the e-consent survey for data entry to document a verbal consent obtained over for the phone or to document that paper consent was obtained.
  • When a staff consent attestation survey is required, staff must complete the attestation as a survey and not as a data entry form. 

When data entry issues on e-consent surveys do occur, this typically point to the need for improvements to the study team's e-consent instruction, documentation and training.

E-Consent Revisions

In order for the study staff to obtain the valid documentation of a participant completing an e-consent, the study staff must keep their REDCap e-consent survey up-to-date with the current version of their consent form approved by the IRB, while maintaining electronically, previous versions of the e-consent survey that have already been submitted by existing participants. This means:

  • Study staff making changes to the REDCap e-consent survey are required use the versioning technique described in the section on making e-consent revisions.
  • Because this is versions is an advanced technique, the study team should carefully consider which team members have user permissions to making these changes by applying the principle of least privilege to assigning REDCap user rights.


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Monitoring E-Consent Survey Submissions 

Monitoring activities are specific to the requirements of the study and the consent process approved by the IRB. The checklist below is intended as a starting place for monitoring e-consent submissions, by outlining tasks that are common to all projects using e-consent in REDCap.

If study teams discover discrepancies in their e-consent survey submissions, contact the REDCap Team for a consultation.

Consent / E-Consent Homepage


Intended Audience & Prerequisites

Intended Audience

  • Project point persons

  • Principal Investigators

Prerequisite Knowledge & Experience

  • Knowledge of consent process and requirements

  • Knowledge of IRB guidance for using e-consent in RECap
  • Knowledge of the study's REDCap project set-up



E-Consent Workflow in REDCap

↓ Study staff share the e-consent survey link with the participant.

↓ Participant completes the e-consent survey.

↓ REDCap saves a PDF copy of the submitted e-consent survey.

↓ Study staff provide participant with a copy of the submitted e-consent survey, or a copy of the consent form if the participant signature is not required.

↓ For a Consent and Authorization e-consent survey that requires the documentation of the study staff obtaining consent, study staff completes the Consent Attestation survey.

REDCap saves a PDF copy of the submitted attestation survey. 


Monitoring Checklist 


Information SheetInformation Sheet & AuthorizationFull Consent & Authorization
The e-consent survey was submitted as a survey.check mark check mark check mark 
The only contributor to e-consent survey was the participant.check mark check mark check mark 
The participant's first and last name was entered into the submitted e-consent survey.
check markcheck mark 
The timestamp documenting when the e-consent survey was submitted aligns with IRB approved and expired dates listed on the e-consent survey.check mark check mark check mark 
Based on the IRB approved and expired dates listed on the e-consent survey, the content/language of the submitted e-consent survey matches the content/language of the corresponding version of the IRB approved paper consent.check mark check mark check mark 
A PDF copy of the submitted e-consent survey was saved to the PDF Survey Archive in the File Repository.check mark check mark check mark 
The footer in the PDF copy of the e-consent survey contains date and time the survey  was submitted.check mark check mark check mark 
The footer of the PDF copy of the e-consent survey contains the participant's first and last name.
check markcheck mark

The staff attestation survey was submitted as a survey.



check mark

The submitted attestation contains the participant's first name, last name and date and time they submitted their e-consent.



check mark 

The staff's first and last name was entered into the submitted attestation survey.



check mark 

The PDF copy of the submitted attestation survey was saved to the PDF Survey Archive in the File Repository.



check mark

The footer of the PDF copy of attestation survey contains the participant's first and last name, and the date and time the attestation survey was submitted.



check mark


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Monitoring Data Collection for Consented Participants

There are various REDCap tools, such a Reports, that the study team can use to monitor that data collection on forms and surveys that require consent are only completed by participants who have e-consented. Below we cover an easy to use tool that almost all project using e-consent can set up to to help with this kind of monitoring.

Custom Dashboards

A custom dashboard is a customized view of the Record Status Dashboard. For monitoring data collection, we recommend the project point person create the following two custom dashboards: 1) consented participants, 2) non-consented participants. 

For projects solely using e-consent, in the consented participants dashboard, study staff would check that the form status for all e-consent surveys = (for a completed survey response). In the non-consented participants dashboard, study staff would check the form status for the all forms and/or surveys that can only be completed for a consented participant = f)for no data saved).

For help building custom dashboards, please sign up for a drop-in session.


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Monitoring Revisions to the E-Consent Survey & Related Settings

Any study staff assigned to a REDCap project with the user permission enabled for the Project Design and Setup user right will be able to modify the e-consent survey and any other components that may have been set up to distribute the e-consent survey and/or surveys with a consent dependency. The number one thing a study team using REDCap for e-consent can do to monitor e-consent and e-consent related revisions is to apply principle of least privilege in assigning user permission, and monitor user permissions throughout the lifecycle of the project to ensure principle of least privilege has been assigned. 

Below we list out best practices, common to all projects using e-consent, for monitoring revisions. Instructions for updating the e-consent survey are covered on the wiki page that covers making e-consent revisions.

Revision Monitoring Best Practices

  • User Permission Management
    • Create a User Role for the study staff managing the project. 
      • Only assign Project Design and Setup permissions to this role.
      • Assign no more than 2 users (the project point person and their back-up) to this role.
    • Limit how many users have permission enable to User Rights to restrict who can modify user permissions.
  • E-Consent Revision Training
  • Review Revisions
    • Enter Draft Mode and review the e-consent survey and check any changes against the instructions for making e-consent revisions.
    • If the Queue or Auto-Continue with logic Survey Setting is enabled, check that logic tests for participant indicating consent.


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