Clinical trials are registered with ClinicalTrials.gov via a web based data entry system called the Protocol Registration System (PRS).ClinicalTrials.gov allows the registration of trials that:
ClinicalTrials.gov facilitates registration of trials in accordance with the International Committee of Medical Journal Editors (ICMJE) initiative requiring prior entry of clinical trials in a public registry as a condition for publication.
Multi-site trials and multi-sponsor trials are susceptible to duplicate registration, thus care must be taken in how the trials are registered. For multi-sponsor trials it is the lead sponsor who should take responsibility for registration. It is critical that investigators and sponsors work together to ensure that a trial is registered once and only once.
There are two types of PRS accounts:
Frequently Asked Questions - on obtaining a PRS account and entering protocol data
PRS and U.S. Public Law 110-85 - H.R. 3850, Food and Drug Administration Amendments Act of 2007
FDAMA 113 - U.S. Food and Drug Administration Modernization Act, Section 113, concerning trials of investigational new drugs (IND)
Registering Clinical Trials with ClinicalTrials.gov - tri-fold PDF brochure
Data Element Definitions (DRAFT) - details on the information that is entered via the PRS
"Basic Results" Data Element Definitions (DRAFT) - details on the information that is entered about results via the PRS
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