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Research Exempt from IRB Committee Review Category 1: Investigational Strategies in Educational Settings Version 2.1 Updated January 10, 2006. This application form is based on the University of Minnesota
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Any individual or organization involved in conducting investigational activities and who are required to comply with regulatory requirements may need category 1 investigational strategies. This may include pharmaceutical companies, research institutions, clinical trial sponsors, and investigators.

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Category 1 investigational strategies refer to research studies that involve the use of investigational drugs or devices that pose the least amount of risk to the participants.
Investigators and sponsors conducting research studies involving category 1 investigational strategies are required to file the necessary documentation with the appropriate regulatory authorities.
To fill out category 1 investigational strategies, investigators and sponsors must provide detailed information on the study design, investigational products used, safety monitoring plan, and informed consent procedures.
The purpose of category 1 investigational strategies is to ensure the safety and well-being of research participants while generating valuable data to support the development of new treatments.
Information such as study protocol, investigational product details, participant eligibility criteria, adverse event reporting procedures, and monitoring plan must be reported on category 1 investigational strategies.
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