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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:

Designing the protocol and conducting the scientific investigation
Understanding and complying with any and all pertinent laws, regulations, and guidelines
Understanding and complying with any and all requirements of institution(s) with which they are associated or in which research will occur
Reporting safety data to regulatory authorities, the IRB/IEC, and the company
Registering the study on a public Website, if applicable

Under the IIS program, the PI is also responsible for:

Disclosing business affiliations
Meeting applicable deadlines
Submitting study status updates as required in the study agreement
Informing the company of key study-related milestones or events
Delivering a draft manuscript and/or a final draft report of publishable quality upon completion of the study

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