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    Progesterone for Traumatic Brain Injury: Experimental Clinical Treatment: Phase III Clinical Trial



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Investigators Tool Box

Below is a link to important documents. The most up to date documents are maintained on this site. A change log for each document is also available. Printed versions should refer to this website for the latest version or should be updated regularly.

Investigators Brochure

The Investigator's Brochure (IB) provides a summary of the chemical, biological, and metabolic properties and the known toxicological data related to the study drug (progesterone).

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Study Protocol

The study protocol is the up to date instructions on how to run the study.

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Manual of Operations

The manual of operations is a comprehensive document that contains all the study operations details. It includes contact information, SOPs, AE and SAE definitions and other important information.

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FDA IND Protocol

The FDA protocol is the IND proposal submitted to the FDA for approval

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