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Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries

Titles (3)

Short Titles

Short Titles - House of Representatives

Short Titles as Introduced

Trial and Experimental Studies Transparency Act of 2012

Official Titles

Official Titles - House of Representatives

Official Title as Introduced

To amend title IV of the Public Health Service Act to expand the clinical trial registry data bank, and for other purposes.

Actions Overview (1)

Date Actions Overview
05/16/2013Introduced in House

All Actions (3)

Date All Actions
05/17/2013Referred to the Subcommittee on Health.
Action By: Committee on Energy and Commerce
05/16/2013Referred to the House Committee on Energy and Commerce.
Action By: House of Representatives
05/16/2013Introduced in House
Action By: House of Representatives

Cosponsors (3)

* = Original cosponsor
CosponsorDate Cosponsored
Rep. Waxman, Henry A. [D-CA-33]* 05/16/2013
Rep. DeLauro, Rosa L. [D-CT-3]* 05/16/2013
Rep. Schakowsky, Janice D. [D-IL-9]* 05/16/2013

Committees (1)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Reports
House Energy and Commerce05/16/2013 Referred to
House Energy and Commerce Subcommittee on Health05/17/2013 Referred to

No related bill information was received for H.R.2031.

Latest Summary (1)

There is one summary for H.R.2031. View summaries

Shown Here:
Introduced in House (05/16/2013)

Trial and Experimental Studies Transparency Act of 2012 [sic] or TEST Act - Amends the Public Health Service Act to expand the clinical trials that must be reported to the clinical trial registry data bank to include: (1) any interventional study of a drug, device, or biological product conducted outside of the United States the results of which are submitted to the Secretary of Health and Human Services (HHS) as support for approval of an application; and (2) postmarket surveillance of a class II or class III device that involves data collection from human subjects. Defines "interventional study" to mean a study in human beings in which individuals are assigned by an investigator, based on a protocol, to receive specific interventions to evaluate their effects on biomedical health-related outcomes.

Requires submission to the data bank of supporting documents, including protocol documents and consent documents used to enroll subjects into the trial. Requires the responsible party for a clinical trial to submit clinical trial information to the data bank before the first patient is enrolled in the trial.

Requires the Director of the National Institutes of Health (NIH) to post the information submitted to the data bank within 30 days after the submission is determined to meet the quality criteria established by the Director.

Revises time frames for the reporting of results data to the clinical trial registry.

Requires the Director and the Commissioner of Food and Drugs (FDA) to report on the number of clinical trials with information submitted to the registry and steps taken to enforce compliance with such reporting requirements.