Research Registration

Clinical Trials Registration:

FDA Required Clinical Trial Registration Information

"Applicable clinical trials" generally include interventional studies (with one or more arms) of drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the U.S, involves a drug, biologic, or device that is manufactured in the US (or its territories), or is conducted under an investigational new drug application (IND) or investigational device exemption (IDE).

Protocol Registration System Information
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.
 
2. Individual accounts are used to register trials conducted by a single investigator when the organization does not have an account.



Apply for an account

Defense Technical Information Center (DTIC) Registration:

All investigators must submit project reports within 90 days of closure/completion to the Defense Technical Information Center (DTIC) in accordance with the DTIC site instructions click here accompanied by an Standard Form 298.

 
1. For studies funded with RDT&E, Army or RDT&E, DHP ensure technical reports are prepared in accordance with AR 70-31 and follow the format established in American National Standards Institute (ANSI) /National Information Standards Organization (NISO) 39.18-2005 or its revisions.
 
2. Ensure all CI/research publications and presentations are approved through appropriate clearance procedures IAW AR 360-1 prior to release.