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miércoles, 13 de marzo de 2013

"The informed consent to patient in Clinical Trials."

The informed consent needed be monitoring to take strongly care about patiente. Follow  that irecommended ensure subjects by University of Minnesota:


    -. Ensure the form contains all necessary criteria as required by FDA regulations, protocol requirements, 

       and IRB policies.
    -. Ensure the form is properly signed and dated by the subject.
    -. Ensure the subject reads and signs the correct version of the form.
    -. Ensure a Legally Authorized Representative or witness signs and dates the form when necessary.
    -. Ensure the investigative site has a well-defined informed consent procedure.
    -. Ensure the consenter is properly trained.
    -. Ensure a consent discussion has taken place in which the subject as time to ask questions.
    -. Ensure the consent process is completed before study procedures are initiated.

I add interesting English-Spanish glossary to build informed consent in spanish, by

Pablo Mugüerza, Lida Barbetti Vros, and Lorenzo Gallego-Borghini.

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