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:

• are approved by a human subject review board (or equivalent) and
• conform to the regulations of the appropriate national health authorities.

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.

Organizations and investigators wishing to register trials must first apply for a PRS account via the links provided below. Within two business days, ClinicalTrials.gov will create the account and send email with instructions on how to login to the PRS, so that you can register your trials.

There are two types of PRS accounts:

1. Organization accounts generally have multiple users and are used to register all the trials being conducted at an organization.
   Apply for an organization account
2. Individual accounts are used to register trials conducted by a single investigator.
   Apply for an individual account

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