You can use this new REDCap e-consent Framework to obtain electronic consent from research participants enrolling in FDA regulated studies. FDA-regulated studies investigate a drug, medical device or biologic.

With this new e-consent Framework, there are now two REDCap e-Consent Templates:

1. The CTSI e-Consent template for use with non-FDA regulated studies; and
2. The 21 CFR Part 11 e-Consent Template for use with FDA-regulated studies.

You can find the new template in REDCAP under the Choose a project template section under the New Project view – please see screenshot below.

Process to request access to the 21 CFR Part 11 e-Consent Template

Before submitting a request to access the 21 CFR Part 11 e-Consent Template, all study team members who are involved in the consent process must complete the 21 CFR Part 11: REDCap e-consent Workflow training. The 21 CFR Part 11 e-Consent Template meets the FDA’s requirements for electronic signatures, so you must use this consent template when you obtain electronic consent from research participants for FDA regulated studies. The REDCap system administrator will verify proof of training for all study team members before approving your project request.

How does the 21 CFR Part 11 e-Consent Template differentiate from the CTSI e-Consent Template?

The 21 CFR Part 11 e-Consent Template is only for FDA regulated studies. The CTSI e-Consent Template is available to obtain electronic consent for studies that are not FDA-Regulated. The CTSI template is also available under REDCap’s Choose a Project template section under the New Project view.

How to access the e-Consent trainings?

1. Visit https://www.e-gcrme.com/ctsi/
2. If you haven’t done so, register for an account with your University of Miami email address.
3. Select the e-Consent course you want and click on “enroll me” to add it. This will allow you to view the video and materials. Direct course links are here:
   CTSI e-Consent Template for non-FDA regulated studies
   21 CFR Part 11 for FDA regulated studies

You will be able to download a training certificate upon training completion to store for your records. When you submit your research project request to use either of these e-Consent templates, you will be asked if you and the members on your team who will obtain electronic consent have completed this required training. You only need to complete the training for the e-Consent option that you plan to use – you do not need to complete the 21 CFR Part 11: REDCap e-Consent Workflow training to use the CTSI e-Consent Template. Likewise, you also do not need to complete the CTSI e-Consent training to use the 21 CFR Part 11 e-Consent Template.

Questions & Feedback

For any questions, please email [email protected]. We also welcome your feedback on your use and experience with the new 21 CFR Part 11 e-Consent Template.

Epic SlicerDicer is UChart’s self-service reporting tool. It provides intuitive and customizable data exploration abilities to sift through large populations of patients, enabling analysis of trends in patients and identification of patient cohorts for research purposes. Requests to reidentify lists from cohorts identified in SlicerDicer should be submitted through Service-Now using the Data Broker Services (Clinical) Request form. For questions related to using SlicerDicer for research, please email [email protected].

Accessing SlicerDicer

You have access to Epic (UChart) but SlicerDicer is not enabled

• Send an email to [email protected] noting that you require access.

You do not have Epic (UChart) access

• Your manager must request access on your behalf

User Training Video

A basic SlicerDicer training video and related slide deck are available in our webinar platform here. First time users will need to register for an account with your University of Miami email address. Once registered, follow the link and click “Enroll me” to view the video and materials.

The ONENESS Research Solution (ORS) is a research query tool created collaboratively between the University of Miami and Jackson Health System that utilizes a data repository and master patient index based on clinical data contributed by both organizations.

It allows for clinical research teams at both UM and JHS to query de-duplicated and de-identified patient data and generate aggregate counts, enabling preparatory-for-research activities, cohort discovery, and other clinical research activities.

ORS serves to make a positive impact on health and health equity in South Florida by providing researchers with the data they need to better align clinical research questions with the needs and funding opportunities available for eligible research cohorts.  

Features: 

• Data repository – ORS includes 7 years of historical data from both the University of Miami and Jackson Health System electronic health records.  
• Data domains added to the ORS repository include allergies, demographics (de-identified), conditions/diagnoses, visits and admissions, social history, medications, immunizations, procedures, vitals, and lab component results. 
• Master patient index – Patients with data in both institutions are harmonized so that data across both sites are integrated into a single patient record.  
• Data export – Export data of aggregate counts. 
• Queries – Save query filters/settings for future use and query/filter fields with date/time stamps. 
• Re-identification – Saved queries associated with approved IRB protocols can be re-identified to provide study teams with patient-level MRN lists for further approved usage (e.g., chart review, prospective trial recruitment, etc). 

The University Research Informatics Data Environment, also known as URIDE, is a web-based platform that aggregates and visualizes de-identified data from multiple clinical systems UHealth UChart data and Health Choice Network data.

With URIDE, clinical research investigators and their teams can easily explore demographics, diagnoses, procedures, vitals, medications, labs, notes, allergies, comorbidities, locations, physicians, and much more.

Why Use URIDE?
UM investigators conducting scientific research may want to explore de-identified patient data for:

• study design
• feasibility analysis
• grant submission
• or other applications in which population assessments need to be conducted

The Secure Workbench provides a virtual environment whereby University of Miami faculty and staff can analyze clinical and research identified or de-identified data in a secure system. The Secure Workbench is pre-loaded with analytical and mathematical applications such as SAS, Excel, MATLAB, R Studio, Minitab, and Maple. Access to the Internet is restricted to sites related to the applications installed. Only Secure Workbench Administrators and the Office of Privacy and Data Security’s Data Broker have the capability and are permitted to move data in and out of the Secure Workbench. The Workbench servers are hosted by the University Miami Information Technology Department.

To request access and assistance, e-mail [email protected].