IND/IDE Decision Worksheets

Worksheets to facilitate the development, review, and oversight of new drugs, biologics, and devices that require regulatory approval prior to dissemination

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Who?

This resource may be used by anyone at U-M.

When?

Available for download.

How much?

Free

What is this resource?

IND Decision Worksheet
This worksheet is intended as an exercise to help U-M investigators determine whether an IND may be required before initiating a new clinical study. This document can be provided to the IRB in support of an e-Research application prior to initiating an investigator-initiated clinical trial.

IND Decision Worksheet Reference Document
This document is intended to assist investigators when assessing the need for an IND and when completing the MICHR IND Decision Worksheet. The MIAP team will be happy to meet with any UM investigators to provide advice regarding the IND exemption status, IND process and support, FDA filing strategies, and protocol review and recommendations.

IDE Decision Worksheet
This worksheet is intended to help U-M investigators determine whether an IDE is required for FDA/IRBMED approval before initiating your investigator-initiated medical device clinical study. This document can be provided to the IRB in support of an eResearch application before initiating an investigator-initiated medical device clinical study.

IVD Risk Determination Worksheet
This document is intended to help UM investigators determine if an IDE application to the FDA may be required prior to initiating a new clinical study that involves an in vitro diagnostic device (IVD). IVD products are reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. This document should be completed for the IVD(s) utilized in your study, and then provided to the IRB in support of an eResearch application prior to initiating a Clinical Trial.

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Implementing operations that facilitate and support the quality and impact of research.

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