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The CRI is proud to offer REDCap, a self-managed, secure, web-based solution designed to support data collection strategies for research studies.


Note: If you would like to use REDCap for COVID-19 research, please refer to this summary of available resources and find further information here.

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NEWS

May 05
0

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.

 

ABOUT REDCAP

WHAT IS REDCAP?

REDCap is a self-managed, secure, web-based solution that is designed to support data collection strategies for research studies. Its free use is offered by the Center for Research Informatics (CRI). This easy-to-use and intuitive tool provides functionality and features to enable researchers to rapidly develop databases and surveys for collecting and managing research data. Your data is securely kept on BSD servers at the Kenwood Data Center.

The REDCap project was initiated at Vanderbilt University and includes more than 4,000 active institutional partners from CTSAs, GCRCs, RCMI, and other institutions, including the University of Chicago, in a collaborative international consortium. The consortium contributes to the continuing evolution of the tool and provides a valuable sounding board and testing resource for the Vanderbilt team. REDCap is currently in production use or development build status for more than 868,000 projects, with over 1,200,000 end users in over 130 countries spanning numerous research focus areas across the consortium. Here at the University, we have over 6,000 projects with over 5,900 end users.

WHY USE REDCAP?

REDCap offers the following features:

  • Fast. Quick project start-up. Data entry forms and surveys can be implemented without the need for a programmer.
  • Easy. Intuitive user interface and workflow, readily available online training materials, and assistance from the CRI all make it easy to get started.
  • Fully customizable. You are in control of shaping your database.
  • Web-based. Enter data or build your database from anywhere in the world over a secure web connection with authentication and data logging.
  • Secure. Backed up offsite nightly and hosted in a secure environment maintained by the CRI.
  • Data hosting. No need to worry about security issues regarding third party websites hosting your private data.
  • Data import. Import data from Microsoft Excel and Access (csv files).
  • Data export. Export data to Excel, SAS, Stata, R, and SPSS.
  • Audit trail. Track data manipulation, project changes, imports, and exports by date and user.
  • Advanced features. Mid-study modifications, auto-validation, branching logic, and calculated fields.
  • Scheduling. Utilize a built-in project calendar and scheduling module for organizing your events and appointments.
  • Reports and stats. Online tool allows you to view reports of your data, export your reports, and turn your reports into plots, graphs, and statistics.
  • Autonomous user management. Research groups have complete autonomy and control to add new users and set several levels of specific user rights.
  • Multi-site access. REDCap can be used by researchers from multiple sites and institutions.
  • Survey participant list. Build a list of email contacts, create custom email invitations, and track who responds.
  • Anonymous surveys. Keep your participant responses anonymous (default), or if desired, responses from email contacts can be identified.
  • Survey PDF. Generate a PDF version of your survey for printing to collect responses offline.
  • Mobile app. Available for iOS and Android for offline data collection by the project team.

Note: REDCap is not intended for use with FDA-governed clinical trials. For assistance with FDA-governed clinical trials, please contact veloshelpbsd@bsd.uchicago.edu.

 

WHERE TO START

 

REDCap allows users to build and manage online surveys and databases quickly and securely. Users have the freedom to start their projects and begin designing their forms and surveys often within a few short minutes. Start with our training page to help you learn the basics of REDCap via training videos, training manuals, advanced features, quick tips, and FAQs. You can then log in to REDCap with either your BSDAD or UCHAD account and explore the Help&FAQ page for additional help within the application itself. If you need further help at this point, email REDCap Support to set up a working session with the CRI’s REDCap Administrator.

STILL UNSURE?

We can help you determine whether REDCap is an appropriate solution for your research data collection needs by providing a brief demo and discussing whether REDCap is a good fit for your project. Please email REDCap Support to set up a consultation session with the CRI’s REDCap Administrator.

MEET OUR REDCAP EXPERT

Julissa Acevedo, the CRI’s resident REDCap Administrator since 2012, is the point of contact for all REDCap inquiries at the University of Chicago. Julissa has personally guided many investigators with their study design and she takes pride in providing exceptional technical support. An active member of the REDCap Consortium, she attends REDCapCon annually to collaborate with other REDCap experts to further advance the use of REDCap here at the University. Prior to joining the CRI, Julissa developed and supported various applications at Motorola, Bank of America, and the U.S. Census Bureau.

 

ACCOUNTS & PASSWORDS

NEW USERS

New users can log in to REDCap using either a BSDAD or UCHAD account (use only one account). If you do not have either account, see External Accounts section below. CNET accounts do not allow access to REDCap.

EXTERNAL ACCOUNTS

To request accounts for external collaborators from other institutions, a sponsor with a BSD account may request access for them via this online request form. Our CRI Help Desk will follow up on the request.

ADDING A USER TO A PROJECT

Please do not add the user’s email address to the project’s User Rights page, as this will not work. The user first needs to log into REDCap to register their account. You can then add them to your project via the User Rights page.

PASSWORD RESETS

There is no self-service password reset utility in REDCap. If you need password help, please contact the appropriate help desk below:

BSDAD or UCHAD Accounts:
UCMIT Service Desk
773-702-3456
ucmitservicedesk@uchospitals.edu

Collaborator Accounts:
CRI Help Desk
support@rt.cri.uchicago.edu

Account questions? Contact REDCap Support.