With the launch of the enhanced Analytics Core (ACReS) request system on 3/17/2021, the Office of Clinical Research and the Center for Research Informatics are pleased to announce the launch of the pre-IRB consultation service for clinical research data and informatics requests.
Executive Director Dipti Ranganathan will now serve as the University of Chicago’s first Chief Privacy Officer (CPO). As CPO, Dipti will collaborate with University stakeholders to build and manage a privacy and data governance program, addressing administrative and research data. A national search for Dipti’s permanent successor as CRI Director will be launched soon, engaging multiple stakeholders across the Division. On an interim basis, CRI will be overseen by Julie Johnson, Associate Director of Clinical Research Informatics.
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.
BSD IRB, Associate Director of Education/Quality Assurance
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
In collaboration with the Human Imaging Research Office (HIRO), the CRI is for the first time making images available in our COVID-19 limited data mart. In addition to the structured data already in this data mart, which includes patient demographics, encounters, diagnoses, labs, medications, flow sheets, and procedures, researchers will now have access to HIRO imaging data. Chest radiographs are currently available, and chest CT scans will be added soon. These images are in the DICOM format, and access requires IRB approval for use of the limited data mart.
More information about these images is available in our Medical Imaging Tip Sheet. If you have any questions, please reach out to Julie Johnson at email@example.com or join us for online office hours.
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 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 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.
The CRI’s annual series of free training sessions in informatics research tools and techniques returns for the 2019-2020 academic year with a schedule focused around the popular topics of REDCap, high performance computing (HPC), and clinical data analytics. Julissa Acevedo will teach her annual trio of sessions in various aspects of REDCap in November, February, and April, beginning with an introduction to the basics. The CRI’s Manager of Scientific Computing Mike Jarsulic will offer an overview of CRI computing infrastructure in January and an HPC tutorial to coincide with a planned upgrade in May. In March, Tomasz Oliwa, PhD, and Brian Furner will present a session in how to enhance clinical data analytics with the technique of natural language processing.
View the schedule here, and make sure to sign up for the email list to be notified when seminars are available for registration!
Office hours are being moved from Thursdays to Wednesdays. Below is the schedule for the upcoming weeks:
October 30th, 12pm-3pm.
November 6th, no office hours available.
November 13th (and ongoing Wednesdays) 12pm-3pm.
Office hours are held in Peck Pavilion N161.
Please email REDCap Support to request an office hours time slot. Thank you.
The CRI welcomes our new director, Dipti Ranganathan.
In addition to leading our operations and strategic planning, Dipti also serves as Assistant Dean for Academic & Administrative Information Systems for the Biological Sciences Division (BSD), leading the implementation of new technology solutions to improve strategic decision-making and operational efficiency. She joined the BSD from University of Texas Southwestern, where she led strategic initiatives including technology support for clinical research, research administration, and academic and educational technology. Dipti has a Bachelor’s degree in Industrial Engineering and Operations Research from the University of California, Berkeley, a Master’s degree in Operations Research also from Berkeley, and a Master’s degree in Computer Science from the University of California, San Diego. She is a member of the American Medical Informatics Association and the Association for American Medical Colleges, Group on Information Resources.
Our former director, Dr. Sam Volchenboum, has been named Dean for Master’s Education in the BSD. He will now lead efforts to develop Master’s education programs in the BSD, beginning with a program in health sciences informatics. The CRI will continue to work with Sam as a research partner.