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

Please watch this 20 minute video to learn all about eConsent. If your study is planning to use REDCap for eConsent, please contact the CRI REDCap Administrator Julissa Acevedo for assistance early in project development and to obtain the eConsent form template.

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.

System: REDCap https://redcap.uchicago.edu

Date/Time: Wednesday, February 5^th, 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.