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Zoom Seminar: Electronic Informed Consent (eIC) in Research

By Julissa Acevedo 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.

Speakers:
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

Registration: https://bsdocr.bsd.uchicago.edu/fac-staff/education/registration-request/fundamentals.html
Zoom link will be provided upon registration.

Contact: Margaret Wieczorek
mwieczor@bsd.uchicago.edu
773-834-2860

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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, a BSD sponsor may request an account for you by filling out the BSDIS Collaborator Account Request Form. The BSDIS Help Desk will follow up on this request. CNET accounts do not allow access to REDCap.

EXTERNAL ACCOUNTS

To request accounts for users from external collaborating institutions, fill out the BSDIS Collaborator Account Request Form. The BSDIS Help Desk will follow up on this 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. They will need to complete their profile on this form in REDCap:

You can then add them to your project via the User Rights page with these steps:

1. Log into REDCap.
2. Click on the ‘My Projects’ tab.
3. Click on the project name.
4. Click on ‘User Rights’ under ‘Applications’.
5. Find and select the username in the ‘Add new user’ box.
6. Click on ‘Add with custom rights’.
7. Click boxes to assign rights to the new user.
8. Click on ‘Add user’.

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 (t.cri.___):
CRI Help Desk
support@rt.cri.uchicago.edu

Account questions? Contact REDCap Support.

REDCap 21 CFR Part 11

Compliance Statement

Research faculty and staff often use electronic applications to maintain records and create signatures necessary to support human research activities, some of which are governed by FDA regulations. Sponsors occasionally request certification of compliance with 21 CFR Part 11. This notice provides information about the University’s use of the REDCap system with Part 11 requirements. University researchers, sponsors, or others seeking certification of compliance for FDA-regulated studies, may rely on this compliance statement or may print out and maintain it with other required research documents.

Guidance Manual

University researchers may refer to this guidance manual to learn about the specific Part 11 criteria, and the associated REDCap features that meet said criteria.

Questions? Contact REDCap Support.