Research Toolkit

Review Regulatory and Training Requirements

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
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.

Trainings

RCR Core Curriculum
Required curriculum on the responsible conduct of research (RCR) for all University of Minnesota principal investigators, from the University's Office of the Vice President for Research (OVPR).

Collaborative Institutional Training Initiative (CITI)
Required for University researchers and staff listed on new exempt, biomedical, and social IRB applications. 

Privacy and Data Security Training
Required for all University principal investigators and research staff, to comply with HIPAA.

 Clinical Research Coordinator (CRC) Training Module
The CRC Training Module is 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).

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.

Data Monitoring Committee Training Module
This three-lecture module is designed to help train members of the data monitoring committees that oversee clinical trials. The module is a collaborative effort between the University of Minnesota and the University of Wisconsin.

Policies and guides

Guide to research compliance
Guidance from the OVPR on managing compliance issues that may arise during the course of a research project.

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.

Information Security Policy
University policy about securing private data, computers, and other electronic devices; information is available to request an exception to the policy.

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.

ClinicalTrials.gov registration
The University Institutional Review Board (IRB) requires all research projects to be registered on ClinicalTrials.gov, a national, searchable database that provides the public with information about current clinical research studies. 

Data safety monitoring (DSM) guidance
Resources and guidance on the OVPR website that can help you determine if a study needs formal, ongoing monitoring of data to protect research subjects.

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

Investigational New Drug (IND) or Device Exemption (IDE) resources
Resources on the Food and Drug Administration (FDA) website about administering an investigational drug or biological product to humans. 

IND/IDE assistance
Regulatory experts from CTSI can assist University researchers seeking an IND or IDE for research or treatment.

Medical device resources 
Information and databases on the FDA website about regulatory policies, and how to comply with the federal laws and regulations governing medical devices. 

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. 

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. 

Reporting a violation

UReport 
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 abuse@umn.edu.

Contact us

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