View Source

42 C.F.R. § 11.62

What requirements apply to applicable clinical trials for which submission of clinical trial information has been determined by the Director to be necessary to protect the public health?

§ 11.62 What requirements apply to applicable clinical trials for which submission of clinical trial information has been determined by the Director to be necessary to protect the public health?

(a) A responsible party who receives notification that the Director has determined that posting of clinical trial information for an applicable clinical trial described in paragraph (b) of this section is necessary to protect the public health must submit clinical trial information as specified in paragraph (c) of this section.

(b) An applicable clinical trial subject to this section must be either:

(1) An applicable clinical trial of an approved, licensed, or cleared drug product (including a biological product) or device product that has a primary completion date on or after September 27, 1997; or

This document is only available to subscribers. Please log in or purchase access.
Purchase Login

About SCCE

The Society of Corporate Compliance and Ethics (SCCE) is a non-profit, member-based professional association. SCCE supports our members' work with education, news, and discussion forums. We are a community of leaders, defining and shaping the corporate compliance environment across a wide range of industries and geographic regions. In developing and maintaining effective ethics and compliance programs, our members strengthen and protect their companies.

952.933.4977

About HCCA

The Health Care Compliance Association (HCCA), is a 501(c)6 non-profit, member-based professional association. HCCA was established in 1996 and is headquartered in Minneapolis, MN. We provide training, certification, and other resources to over 10,000 members. Our members include compliance officers and staff from a wide range of organizations, including hospitals, research facilities, clinics and technology service providers.

952.988.0141

Facebook Twitter LinkedIn
Copyright © 2024 by Society of Corporate Compliance and Ethics (SCCE) & Health Care Compliance Association (HCCA). No claim to original US Government works. All rights reserved. All information provided through this site, including without limitation all information such as the “look and feel” of the site, data files, graphics, text, photographs, drawings, logos, images, sounds, music, video or audio files on this site, is owned and/or licensed by SCCE & HCCA or its suppliers and is subject to United States and international copyright, trademark and other intellectual property laws. Any third party logos and/or content provided herein is owned by such third parties and is used by permission herein. Your use of this site to is subject to our Terms Of Use and Privacy Statement.
Cookie settings