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Zoom Seminar: Electronic Informed Consent (eIC) in Research

By News, REDCap

Date and Time: Wednesday, January 27, 2020 9:00 AM – 10:30 AM

Description: This session will provide an overview of regulatory guidelines, requirements, and implementation processes for eIC. It will also provide an overview of the REDCap processes and functionality for eIC. This training is recommended for individuals who would like to get familiar with the Electronic Informed Consent (eIC) process.

James Lynch
BSD IRB, Associate Director of Education/Quality Assurance
Julissa Acevedo
BSD CRI, REDCap Administrator/Senior Systems Analyst

Offered by: Office of Clinical Research and Center for Research Informatics

Zoom link will be provided upon registration.

Contact: Margaret Wieczorek

REDCap eConsent

By News, REDCap

Information on Use of Electronic Informed Consent: Use of Electronic signatures and Electronic Consent has been proposed as one solution to the challenges researchers have encountered during the COVID 19 epidemic to potentially reduce exposure risk to patients, subject and staff. Electronic Informed Consent (eIC) should follow the same regulatory guidelines and provide the same information as paper ICF. It is not meant to replace the informed consent process between research participant and study staff. There are additional considerations when using eIC as outlined by Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA).

  • eIC must be collected in a platform that is 21 CFR 11 compliant which includes an audit trail of who obtained consent, date and time of consent and archived copy of executed consent.
  • All versions of the eIC form and informed consent procedure must be IRB approved prior to subject recruitment.
  • Copy of executed eIC must be provided to the subject.
  • All eIC must be archived in secure location and available for monitoring and auditing.
  • If eIC is being used remotely (ie the potential subject is not present) verification of the authenticity of the subject must be built into the informed consent process:
    • For UChicago Patients including provision of birthday, last 4 of ssn or other identifying questions
    • For Non patients and/or LAR of UChicago patients who cannot havee demographic verification built into the eConsent platform, studies must describe how they will obtain visual checks of identify documentation and capturing Drivers license number, state ID number
    • Documentation of the informed consent process will be essential for subjects who are recruited remotely

The UChicago eConsent template is available as a project template. Create a new project, and select the template which is located at the end of the template list of projects.

  • For new studies: This template can be serve as your study project, where you can add the rest of your study’s forms and/or surveys to the project.
  • For existing studies: Once you modify the e-consent template instruments to your study needs, you can export the instrument zip files and import them into your existing project via Draft Mode.

Please contact the CRI REDCap Administrator Julissa Acevedo for further assistance.

REDCap New Features

By News, REDCap

REDCap has been successfully upgraded to version 9.5.6. Listed below are the newest features. Click here to learn more about these new features and many other improvements.

  • Alerts & Notifications – The Alerts & Notifications feature allows you to construct alerts and send customized email notifications. These notifications may be sent to one or more recipients and can be triggered or scheduled when a form/survey is saved and/or based on conditional logic whenever data is saved or imported.
  • Rich Text Editor – Users may optionally utilize the rich text editor for styling field labels or section headers with many text-formatting options; available for any field on an instrument, survey invitations, and survey confirmation emails.
  • Missing Data Codes – Fields that have a blank/missing value may be marked with a custom ‘Missing Data Code’ to note why the value is blank. These missing codes may be used to aid in data analysis by specifying why a field lacks a value.
  • File Version History for File Upload Fields – This feature allows a new file to be uploaded onto a File Upload field that already has a file uploaded for it. If a file has already been uploaded, the field will have a new link “Upload new version”, and after being clicked, it will allow the user to upload another file without having to delete the existing one.
  • New Action Tag @HIDDEN-PDF – Hides the field only in the downloaded PDF of one or more instruments (including blank PDFs, PDFs with data, and compact PDFs with data).
  • New API Method “Import Repeating Instruments and Events” – Allows users to import a list of the repeated instruments and repeating events for a project as a means of setting which instruments and events should be repeatable.

Please contact REDCap Support with any questions.

REDCap Downtime and Upgrade

By News, REDCap

System: REDCap

Date/Time: Wednesday, February 5th, 2020, 5PM-7PM

Who Is Affected: All UChicago REDCap users, including non-UChicago external collaborators, mobile app users, API users, survey participants

Impact: REDCap will be unavailable during this time in order to upgrade to a new version of the software.

  • Survey emails will be halted until the upgrade is complete.
  • Survey links will be inaccessible and will display a REDCap is offline message when clicked on.
  • Mobile app users are STRONGLY encouraged to sync any data on their devices back to their REDCap project BEFORE the upgrade begins. Although not encouraged, offline data collection may continue in the app during the upgrade, however the online sync process will not be available until the upgrade is complete.

At approximately 7PM (or sooner), another email will be sent confirming the upgrade completion, and details of the newest features and functionality.

Questions? Please email REDCap Support.

Announcing REDCap Office Hours

By News, REDCap

Want to discuss if REDCap is right for your study or project?
Want another set of eyes to look over your project design?
Need technical help with field or form problem?

The CRI would like to announce the implementation of a new service – weekly REDCap office hours at the medical campus. Every Thursday from 1:00-3:00pm, you can visit CRI’s Peck Conference Room (N161A) to meet with our resident REDCap Administrator Julissa Acevedo. No appointment is necessary, but please email your question to Julissa ahead of time. We hope you take advantage of and enjoy this new service.

REDCap Feedback Survey

By News, REDCap

Many thanks to UChicago’s REDCap community for their ongoing use of REDCap. Below is a link to an anonymous survey which asks for your feedback on topics such as training, support, and REDCap itself. Our goal is to use this feedback to help us identify areas of improvement.

2019 REDCap Feedback Survey

This link is NOT unique to you so feel free to share it with UChicago colleagues. This survey should take about 5-20 minutes to complete depending on the level of feedback you would like to provide. If you need more time, there is also a “Save & Return Later” option. The survey will remain open until Thursday, May 30th.

As a thank you for participating in our survey, you will be eligible to enter a raffle for REDCap branded products. After submitting your feedback survey, you will be directed to a new survey to complete a raffle entry. Your contact information will not be tied to your feedback responses, as they are two separate surveys. If you are one of our randomly selected winners, we will contact you on Friday, May 31st.

Thank you in advance for your time and participation!

REDCap Scheduled Downtime and Upgrade


System: REDCap

Date/Time: Wednesday, February 27th, 2019, 6pm

Who Is Affected: All UChicago REDCap users, including non-UChicago external collaborators, mobile app users, API users, survey participants

Start: REDCap will be unavailable on Wednesday, February 27th beginning at 6pm in order to upgrade to a new version of the software.

During: The site will remain unavailable for approximately 2 hours (6PM-8PM). Please note the following:

  • REDCap mobile app users are STRONGLY encouraged to sync any data on their devices back to the REDCap project BEFORE the upgrade begins. Although not encouraged, offline data collection may continue in the app during the upgrade, however the online sync process will not be available until REDCap is available again after the upgrade.
  • REDCap survey links will be inaccessible and will display a “REDCap is offline” message when clicked on.

End: At approximately 8PM, another communication will go out confirming REDCap has been upgraded and is once again available for use. REDCap’s newest features will be communicated as well.

Questions? Please contact REDCap Support.

CRI’s REDCap expert invited to teach for Vanderbilt’s REDCapU

By News, REDCap

CRI Business Systems Analyst and resident REDCap expert Julissa Acevedo was recently invited to present for Vanderbilt University’s REDCapU, an online teaching tool to educate REDCap administrators so that they can better support their end users. Julissa presented on the topic of REDCap surveys for a webinar that was attended by 157 registrants from 120 institutions across 19 countries.

Julissa shares her deep knowledge of REDCap with researchers here through the CRI Seminar Series, training materials, and personal consultations.