> ProTECT III Tool Box
      ProTECT III
    Progesterone for Traumatic Brain Injury: Experimental Clinical Treatment: Phase III Clinical Trial

 

    Home

    ProTECT Background

    Contact Us

    Investigator Toolbox

    Calendar

    Project List

    Study Sites

    Employee

    Important Links

 

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).

More details...

 

Study Protocol

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

More details...

 

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.

More details...

 

FDA IND Protocol

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

More details...

 


 


 

 

Home | ProTECT Background | Contact Us | Investigator Toolbox | Calendar | Project List | Study Sites | Employee | Important Links |