Initiate Required Regulatory Tasks

ClinicalTrials.gov 
A database of privately and publicly funded clinical studies conducted around the world. For assistance with this process, contact CTSI's ClinicalTrials.gov Support.

Data and Safety Monitoring Board (DSMB) Training Manual
Training manual provided by Tufts to be used for investigator-initiated studies with information and training for Principal Investigators, DSMB members, IRB members, biostatisticians, and research staff on how to work effectively with DSMBs

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).

Florence eBinders
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.

IRB (Institutional Review Board)
The IRB reviews research projects that involve human subjects to protect the rights and safety of human research subjects.

• New Study resources
• Investigator Manual
  Designed to guide you through policies, procedures, and resources related to the conduct of Human Research that are specific to the University of Minnesota. Covers topics such as:
  • Informed Consent Process
  • Exempt research;
  • International and cross-cultural research;
  • Vulnerable populations (including, but not limited to research with pregnant women, children, University students or employees).
• Human Research Protection Programs ToolKit Library
  A set of documents primarily for use and reference by the Human Research Protection Program (HRPP), IRB staff, and IRB members

Investigational New Drug (IND) or Investigation Device Exemption (IDE)
These Food and Drug Administration (FDA) websites describe the IND and IDE application processes and houses related resources.

• The IND/IDE Regulatory Director ([email protected]) within HRPP can help investigators determine whether a protocol requires a submission to the FDA.
• The FDA Inspection Readiness Guide helps study teams prepare for FDA inspections.
• For assistance with the IND/IDE process, contact CTSI's Regulatory Support staff.

Scientific Assessment
Scientific assessment is required by the IRB for medical research involving human subjects deemed to be greater than minimal risk. One source for a scientific assessment is the Human Research Protection Program (HRPP). Consult the HRPP job aid for details on how to submit materials to ETHOS to request a scientific assessment by HRPP.

Material Transfer Agreements (MTAs)
Material Transfer Agreements (MTAs) govern the transfer of tangible research materials—such as chemicals, plant- or animal-derived material or software—from one institution to another. They are legal contracts used to protect intellectual property rights, limit liability, and ensure that researchers are properly credited for their work. More information on requesting a MTA can be found on this Office for Technology Commercialization (OTC) website.

Report an Invention
University policy requires researchers report inventions that they believe may have commercial or public value to Technology Commercialization. More details on carrying this out can be found on the OTC website.

License Agreement Definitions and Documents
Downloadable templates of standard licensing documents and forms can be found on this Technology Commercialization website. These include a Confidential Disclosure Agreement (CDA), Material Transfer Agreement (MTA), and License Application.

CTSI Regulatory Support
Offers support for IRB submissions, project planning, IND and IDE applications, FDA inspections, clinical trial monitoring, clinicaltrials.gov registration, and more.

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.  

Regulatory Committees
Research may require approval from other committees, depending on the nature of the project. Examples of such groups include:

• Institutional Animal Care and Use Committee (IACUC): Reviews all projects involving animals
• Cancer Protocol Review Committee (CPRC): Evaluation and monitoring of all University clinical cancer research protocols
• All University Radiation Protection Committee: Reviews radiation protection policies governing the use of ionizing radiation throughout the University
• Institutional Biosafety Committee (IBC): Approves practices and procedures for research involving rDNA, infectious agents, and biological toxins