Review Regulatory and Training Requirements
Find resources related to regulatory and training requirements in research.
Consultations and services
Regulatory support and planning
Regulatory experts from the Clinical and Translational Science Institute (CTSI) can provide support for project planning, IND and IDE applications, FDA inspections, clinical trial monitoring, and more.
Access your University of Minnesota employee training record
Human Research Training Tool
The Human Research Training tool was designed exclusively for University of Minnesota clinical research professionals who work with human participants, and their supervisors to help them identify and maintain the appropriate training, certification, credentials, and immunizations required to perform research with human participants.
Training Hub is the University of Minnesota’s system for required and optional training. Anyone affiliated with the University of Minnesota can use this system to view and track their training.
Reporting Center in MyU
A tool for University faculty, employees, and students, the Reporting Center is found under the Key Links heading on a user's MyU page. There is a record of all completed training (RCR, HIPAA, Organizational Effectiveness, etc.), maintained by University Information Management Systems (IMS).
Research Education Reports
This responsible conduct of research (RCR) database shows a record of RCR and human subjects protection training only.
RCR Core Curriculum
Required curriculum on the responsible conduct of research (RCR) for all University of Minnesota principal investigators, from the University's Research and Innovation Office.
Collaborative Institutional Training Initiative (CITI)
Required for University researchers and staff listed on new exempt, biomedical, and social IRB applications.
- CITI refresher courses: Basic human subjects protection CITI refresher courses are required every three years.
- CITI Group 1 (health and biological/medical applications): Researchers and staff on health and biological/medical applications are required to take the CITI Group 1 Biomedical Research Investigators and Key Personnel training course.
- CITI Group 2 (social and behavioral applications): Researchers and staff on social and behavioral applications are required to take the CITI Group 2 Behavioral or Humanist Research Investigators and Key Personnel training course.
HIPAA Privacy Training
All employees and students must complete both HIPAA and Information Security Awareness training to be considered compliant. This training consists of two separate training courses that you may complete online:
Clinical Research Coordinator (CRC) Training Modules
The CRC Training Modules are on-demand training for coordinators at the University and beyond who support primary investigators and teams who conduct research with human subjects.
Foundations for Research Professionals
CTSI's Foundations for Research Professionals training program aims to help increase knowledge and application of clinical research coordinator competencies among research professionals at the University of Minnesota. The training has been developed for clinical research coordinators (CRCs) new to research or new to the University of Minnesota (<1 year).
Research Ethics Training Module
A self-paced course designed to help research professionals learn and review regulations and best practices for biomedical and behavioral science research ethics. This free course is administered by CTSI.
Administrators and the Responsible Conduct of Research
This Department of Health and Human Services tutorial provides research administrative staff with a review of the regulatory and policy environment with a discussion of the ethical issues that administrative staff may experience.
Policies and guides
Risk Intelligence and Compliance Team
The Risk Intelligence and Compliance Team (RIACT) supports the research community by facilitating the investigation of research compliance concerns, overseeing research ethics and compliance education, and assisting other ethics, regulatory, and financial compliance programs across the University.
Health Information Privacy & Compliance Office
The Health Information Privacy & Compliance Office is responsible for ensuring that individually identifiable health information is handled appropriately across the entire University.
Data Security Classification
Policies and information pertaining to the data security classification system University uses to ensure all data and the systems on which it is stored, accessed or transmitted have appropriate security controls.
A database of privately and publicly funded clinical studies conducted around the world. For assistance with this registration and ongoing update process, contact CTSI's ClinicalTrials.gov Support.
Institutional Review Board (IRB) Key Resources
Resources and information on the IRB's points of emphasis, including the Investigator Manual and training requirements, for conducting research involving human subjects in accordance with the guidelines set forth by the University.
Export Controls and International Projects Officer
Support and information for University faculty and staff regarding University policy and federal regulations governing technology transfers to non-U.S. personnel, shipments abroad, and international transactions having certain foreign policy and national security implications.
Clinical research resources
Clinical Research Project Status Tool
Provides University research teams with a dashboard for clinical research studies making it possible to view data from OnCore Clinical Trial Management System, ETHOS, EFS, CTR Portal and ClinicalTrials.gov all in one place.
Electronic data capture (EDC) tool
Manage study data while maintaining 21 CFR Part 11 compliance with Advarra EDC, an electronic data capture tool. The tool is ideal for investigator-initiated, FDA-regulated studies, or researchers who want greater integration with the OnCore clinical trial management system (CTMS).
Fairview Research Administration
Fairview Research Administration facilitates the use of investigational devices within the Fairview system, including arranging billing to insurance; this site includes information on how to get started.
This tool replaces paper forms and physical binders for study management, giving research teams an efficient, compliant way to electronically sign, manage, store, and collaborate on study documents.
Human specimens resources
Information on the Clinical Laboratory Improvement Amendments (CLIA) website about federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease.
- The IND/IDE Regulatory Director ([email protected]) within HRPP can help investigators determine whether a protocol requires a submission to the FDA.
- For assistance with the IND/IDE process, contact CTSI's Regulatory Support staff.
Reporting a violation
A tool for the University community to confidentially report any law or policy violations in research practice.
Reporting and Notifying Individuals of Information Security Breaches Information on reporting and communicating suspected information security breaches of University data. Reports of information security breaches must be reported to University Information Security at [email protected].