(DOWNLOAD) "Informed Consent Elements (US Food and Drug Administration Regulation) (FDA) (2018 Edition)" by The Law Library " eBook PDF Kindle ePub Free

eBook details

Title: Informed Consent Elements (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
Author : The Law Library
Release Date : January 06, 2018
Genre: Law,Books,Professional & Technical,
Pages : * pages
Size : 177 KB

Description

The Law Library presents the complete text of the Informed Consent Elements (US Food and Drug Administration Regulation) (FDA) (2018 Edition).
Updated as of May 29, 2018

The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank. The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM) which was created by statute. The submission of clinical trial information to this data bank also is required by statute. This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.

This ebook contains:
- The complete text of the Informed Consent Elements (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- A dynamic table of content linking to each section
- A table of contents in introduction presenting a general overview of the structure