About the IIS Program
An investigator-initiated study is a research effort in which the principal investigator (PI) not only designs
and implements the study, but also acts as the study sponsor. Although the word "sponsor" is commonly
used to mean any kind of support, it has a specific meaning for scientific research. The sponsor is the
individual (or entity) responsible for understanding and complying with any and all regulatory
requirements related to the study. The companies cannot act as the sponsor for third-party research
studies.
As a study sponsor, the PI is responsible for:
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Designing the protocol and conducting the scientific investigation
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Understanding and complying with any and all pertinent laws, regulations, and guidelines
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Understanding and complying with any and all requirements of institution(s) with which they are associated
or in which research will occur
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Reporting safety data to regulatory authorities, the IRB/IEC, and the company
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Registering the study on a public website, if applicable
Under the IIS program, the PI is also responsible for:
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Disclosing business affiliations
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Meeting applicable deadlines
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Submitting study status updates as required in the study agreement
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Informing the company of key study-related milestones or events
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Delivering a draft manuscript of publishable quality upon completion of the study
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