. Author manuscript; available in PMC: 2011 Sep 3.

Published in final edited form as: N Engl J Med. 2011 Mar 3;364(9):852–860. doi: 10.1056/NEJMsa1012065

Table 1.

Scope of Interventional Studies Covered by Major Reporting Policies.^*

Policy Requirements^†	Registration	Results Reporting
FDAAA¹	Interventional studies of drugs, biologics, or devices (whether or not approved for marketing); phases 2 through 4; at least one U.S. site or IND or IDE	Same as registration scope, but interventional studies of drugs, biologics, or devices only after FDA-approved for any use
ICMJE⁸	Interventional studies of any intervention type, phase, or geographic location	Not applicable
EMA⁹^,¹⁰	Interventional studies of drugs and biologics (whether or not approved for marketing); phase 1 (pediatrics only); phases 2 through 4; at least one European Union site	Same as registration scope

For complete descriptions of policy requirements, see the references cited. EMA denotes European Medicines Agency, FDAAA Food and Drug Administration Amendments Act, ICMJE International Committee of Medical Journal Editors, IDE investigational device exemption, and IND investigational new drug application.

^†

ClinicalTrials.gov allows the reporting of interventional and observational studies that are in conformance with any applicable human subject or ethics review regulations (or equivalent) and any applicable regulations of the national (or regional) health authority (or equivalent).