Data Science & Informatics FAQ

Researchers at the University of Notre Dame and Purdue University have access to Indiana CTSI Data & Informatics resources. However, they may need a Business Associate Agreement (BAA) to use some services, such as REDCap, CDIS, and INPC/OMOP. Other requirements may also apply. The Department of Health and Human Services is a great resource to learn more about BAAs.

Some services provided by the Indiana CTSI and its partners are complimentary. Examples include brief guidance and consultations; educational materials; and feasibility checks. Other service costs vary based on the service you need. Contact us for details.

Accrual to Clinical Trials (ACT) Network: A real-time, open-access platform for study group identification across multiple institutions.

ATLAS: An open-source software tool developed by the Observational Health Data Sciences and Informatics (OHDSI) community. It is used for exploring and analyzing large healthcare databases. ATLAS allows researchers to define patient cohorts, run studies, visualize health outcomes, and perform data analyses, all in a user-friendly interface. It helps in standardizing data and making it easier to conduct observational research across different data sources.

Leaf clinical database: A tool designed to help researchers and clinicians’ access and explore clinical data stored in health records. It provides a user-friendly interface that allows users to find patient information, identify patient cohorts, and gather insights from medical data for research purposes. Leaf is typically used to support clinical studies and quality improvement projects by simplifying the process of searching through complex health data.

Many informatics cores at the Indiana CTSI offer tools for integrating local data with external research networks. For example, researchers can use national platforms like the National COVID Cohort Collaborative (N3C) to share and analyze data across institutions. Integration typically requires meeting data-sharing agreements and regulatory requirements.

If you collect or use research data as a researcher at IU, that data is generally considered institutional data. Many of the same policies and processes as other institutional data also apply to research data. You can learn more about the most commonly referenced policies about institutional data at the Data Management Council website. Additional information related to university, campus, and unit-level policies related to information technology and data are available at the Information Security Office’s Information Security Policy site.

At IU, academic appointees, staff, and those in temporary positions that interact with institutional data (which includes research data) must complete the Data Protection and Privacy Tutorial maintained by the University Information Policy Office.

This training is to educate about the types of data IU collects, how it is classified, data handling responsibilities, and the basic privacy laws one must comply with as an employee of the university.

Please refer to the Regenstrief Institute’s privacy policy.

REDCap is primarily a flexible tool for data collection and management, allowing researchers to design surveys, collect data, and manage it securely. It’s ideal for a wide range of studies, including non-clinical research. REDCap can also be used for electronic consent for studies that are not FDA-regulated. It is not an option for studies requiring 21 CFR Part 11 compliant systems.

OnCore is a clinical research management system (CRMS) designed to manage the full lifecycle of clinical studies, including protocol management, participant tracking, financial management, and regulatory compliance. While REDCap focuses on data, OnCore is more about operational management of clinical studies.

Advarra eConsent is a 21 CFR Part 11 compliant module that is part of the Advarra eRegulatory system. It allows you to electronically route and sign consents for clinical research studies. It is recommended for any FDA-regulated study wishing to consent participants electronically where another Part 11 compliant platform is not provided but can be used for all studies desiring to consent electronically. There may be a cost associated with the use of Advarra eConsent for some studies.

Advarra EDC is 21 CFR Part 11 compliant system used for data collection and management, allowing researchers to collect data and manage it securely. It currently does not have survey capabilities, but these are scheduled for release in 2025. EDC is recommended for any FDA-regulated study wishing to collect data electronically where another Part 11 compliant platform is not provided. The use of Biostatistics Data Management services are required to build data collection forms for your study and should be considered in your budget.

Additional information regarding OnCore, Advarra eConsent and Advarra EDC is available from the Office of Clinical Research for Indiana.

Genomic Data Access Portal to access genomic data from archives using metadata driven application. There is also genomic data management workflow development that is available upon request.

CBioPortal, a clinical and genomic data analysis and visualization tool

IU and Regenstrief Institute offer several resources to support researchers at every stage of AI integration. Learn more about our AI resources for researchers.