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13. Do I Have to Register my Human Research on clinicaltrials.gov?

Organizations or clinical investigators with primary responsibility for initiating and conducting clinical trials may submit trial data to ClinicalTrials.gov using the Protocol Registration System (PRS). A trial must be approved by a human subject review board and must conform to the regulations of the appropriate national health authorities, in order to be registered.

 

For more information visit the PRS Information Page.

Investigators or sponsors for trials which have been registered with ClinicalTrials.gov by another individual or organization should contact that data provider directly with any questions or concerns regarding the information posted on ClinicalTrials.gov.

 

U.S. Public Law 110-85 (FDAAA)The Food and Drug Administration Amendments Act of 2007 (FDAAA or US Public Law 110-85) was passed on September 27, 2007. The law requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices.

 

For more information about this law and requirements for sponsors and/or investigators, visit the PRS and U.S. Public Law 110-85 Information Page.

 

Protocol Registration System (PRS)

 

Registration of Clinical Trials

Clinical trials are registered with ClinicalTrials.gov via a web based data entry system called the Protocol Registration System (PRS).

 

ClinicalTrials.gov allows the reporting of trials that:

  • Are in conformance with any applicable human subject or ethics review regulations (or equivalent) and
  • Are in conformance with any applicable regulations of the national (or regional) health authority (or equivalent)

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.

 

Account Application Process

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

 

If you already have an account but have forgotten the password or other information required to login, use the "Forgot password" link on the PRS login page on the web at register.clinicaltrials.gov   Questions? Contact us at register@clinicaltrials.gov

 

Additional Information

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 and Reporting Results 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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