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REDCap Status

By News, REDCap

Friday May 17, 3:45PM CST – REDCap is once again available for use. If you continue to experience system issues, please contact REDCap Support. We apologize for any inconveniences and greatly appreciate your patience during this time. Thank you.

OHRP Interactive Informed Consent Training

By REDCap

The Office for Human Research Protections (OHRP) has created and posted a brand new interactive informed consent training program entitled “Participant-Centered Informed Consent Training”.  It consists of 6 modules and is intended to provide training to help design, create, use, and review consent forms or templates.

This training is intended to provide education that will aid in providing research participants with understandable content in the consent form document so that the participant can better understand the research taking place and how their decision on whether to participate could impact them personally. OHRP notes in the training modules that when participants understand the research and potential personal impact, it promotes trust and engagement in research.  It is important to note that this training is not intended to be a comprehensive overview of the regulatory requirements of informed consent.

OHRP describes the intended audience of this training to be anyone from an investigator or research coordinator to an IRB reviewer or even someone designing electronic consent forms for an online platform. The training is available now on OHRP’s website.  OHRP will also be conducting a demonstration of this new interactive training program on February 23, 2024, at 12:00 PM EST via this Zoom link.

Original News Source: University of Chicago – Office of Clinical Research, February 2024 Newsletter (Volume 13, Issue 8)

FDA Updates Guidance on Collecting Race and Ethnicity Data

By REDCap

The FDA recently issued a draft guidance entitled “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products”. This guidance document would replace the current guidance document from 2016 entitled “Collection of Race and Ethnicity Data in Clinical Trials”. This new guidance document is meant to set FDA expectations and standards for collecting race and ethnicity data in submissions. Standardizing language and setting expectations for race and ethnicity data in this guidance document ensures that this data is consistently collected and reported to the FDA.

The FDA notes in this guidance document that collecting and reporting race and ethnicity data using standardized terminology is critically important in identifying population-specific signals, which while uncommon, have been observed in racially and ethnically diverse populations.

The draft guidance is proposing a two-question system for documenting race and ethnicity data in Clinical Trials and Clinical Studies using first “Are you Hispanic/Latino or not Hispanic/not Latino?” followed by “What is your race?”. They recommend the following options at a minimum for a response to this question regarding race: American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White.  They list OMB Policy Directive 15 recommended language regarding ethnicity and race question responses, noting that nonwhite is not demographic data that can be reported to the federal government. The FDA guidance recommends following best practices by having participants self-report their ethnicity and race rather than it being assigned by study team members, as well as instructing the participants to mark one or more race if needed in their self-report.

It is noted in the draft guidance that the FDA does recognize that racial and ethnicity data and recommendations provided in this guidance are focused in United States and may not be applicable to clinical trials that occur outside of the US and if more granularity is needed to follow the 2011 HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status.

The FDA also recommends in this guidance document that Investigation New Drug (IND), New Drug Applications (NDA), and Biologics License Applications (BLA) use the race and ethnicity guidelines laid out within this proposed guidance document to tabulate demographic data for new clinical trials and clinical studies.

This guidance document is open to comments from the public until April 29, 2024.

Original News Source: University of Chicago – Office of Clinical Research, February 2024 Newsletter (Volume 13, Issue 8)

REDCap Outage

By News, REDCap

January 18, 2024, 10:00am – If you are unable to access REDCap because of a 403 error message, please try the following: clear your browser’s cache, restart your browser, and log into vpn https://vpn.uchicago.edu, and then log into REDCap at  https://redcap.uchicago.edu/. If you are still unable to access the page, please reach out to us at redcap@uchicago.edu. Thank you for your patience and apologies again for any inconvenience. Please continue to follow this page for any further updates.

January 17, 2024, 12:00pm – We are currently experiencing a REDCap outage. The team is working to identify the cause and is working on restoring service. At this time, we do not have an estimate on when service will be restored. We apologize for the inconvenience. Please follow this page for all updates. Email redcap@uchicago.edu with any further questions.

 

REDCap Support Email Address Change

By News, REDCap

Details: This is to inform our UChicago REDCap user community of a change to our REDCap Support email address. On December 1st, the new email address will change to redcap@uchicago.edu. Please use the new email address for your support requests or inquiries. Support requests generated within REDCap (production moves, project changes, etc.) will automatically use the new email address. The ‘Contact REDCap Administrator’ blue button in the lower left corner of your projects will also use the new address. Please kindly refrain from directly emailing our REDCap Administrator’s Outlook email address, as our goal is to offer a single point of contact with redcap@uchicago.edu allowing us to improve service delivery, streamline workflows, and measure metrics.

Who Is Affected: All University of Chicago REDCap users (including external collaborators)

A note on password help: Passwords are not managed by REDCap Support. For BSDAD or UCHAD password help, please visit the UCMIT Service Now Portal or for external collaborator account password help, please email BSDIS at bsdis@bsd.uchicago.edu.

Questions, comments, feedback? Please contact us via our REDCap Inbox.

Thank you for your support and continued use of REDCap!

(Post Date: 11/9/23)

Do you have expertise in data management? Experience with REDCap? Looking for a leadership role?

By News, REDCap

If so, please consider applying for a new Director of Data management role at UChicago available for a new aging, Alzheimer’s and related dementia research center led by Dr. Rogalski.  The best candidate for this position would have extensive experience with research data management including building databases, extracting and cleaning data, gathering datasets, harmonizing data between disparate datasets or databases and organizing internal and external data requests. The center will be utilizing REDCap databases, so REDCap expertise and database experience is highly recommended.

Please consider applying here: https://uchicago.wd5.myworkdayjobs.com/en-US/External/job/Data-Science–Sr-Specialist_JR22663

*Please note, this is not a CRI job posting. It is a courtesy posting for a new UChicago research center.

New Survey Feature: Google reCAPTCHA

By News, REDCap

The new Google reCAPTCHA feature can be enabled to help protect your Public Survey Links from abuse from ‘bots’, which are automated software programs that might enter trash data into your survey. A ‘captcha’ is a turing test to tell humans and bots apart. It is easy for humans to solve, but hard for bots and other malicious software to figure out. By enabling Google reCAPTCHA on your public survey, you can block automated software while helping welcome your survey participants to begin your survey with ease. The Google reCAPTCHA functionality can be enabled on the Public Survey Link page of your project, after which the Public Survey Link will display the reCAPTCHA checkbox and “I’m not a robot” text on a survey page prior to allowing the participant to view the public survey. Note: A survey participant will never have to pass the reCAPTCHA test more than once per day on a given device/computer. The new feature only works for Public Survey Links and not for custom survey links. Please contact REDCap Support with any questions.

REDCap Downtime and Upgrade

By News, REDCap

Event: REDCap Scheduled Downtime and Upgrade

Date/Time:Monday, May 1st, 2023, 5PM-7PM

Website: https://redcap.uchicago.edu

Reason: An urgent upgrade to a newer version of the software is required to apply critical security fixes issued by REDCap.

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

Impact: REDCap will be unavailable during this downtime. Unavailability is further defined as:

  • Survey emails and Alerts & Notifications will be halted until the upgrade is complete.
  • Survey links will be inaccessible and will display a ‘REDCap is offline’ message when clicked on.
  • API activity will be halted until the upgrade is complete.
  • 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.

Updates: As soon as the upgrade is complete, communication will go out confirming its completion, as well as details of the newest features and functionality which are also part of this upgrade.

Questions?
 Please email UChicago REDCap Support.

PRFS Planned Outage 4/22-4/23

By News, REDCap

On Saturday 4/22 and Sunday 4/23, PRFS will be out of service for the IT Infrastructure Team to perform an upgrade. During this time, PRFS (Lab Shares) and services relying on PRFS (e.g. Gardner) will be unavailable. Even if you’re able to connect to storage shares, please refrain from doing so until the upgrade has been completed. Please plan accordingly and email support@rt.cri.uchicago.edu with any questions.