FDA Registration of Clinical Trial for WMDROC

---

PRS Information

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
Presentations with audio and slides relevant to providing data to ClinicalTrials.gov:

• Overview of ClinicalTrials.gov
• Key FDAAA Issues
• Protocol Registration System (PRS) Information and Data Review Process
• Protocol Registration System (PRS) Accounts and Registration
• Results: Participant Flow Module
• Results: Baseline Characteristics Module
• Results: Outcome Measures and Statistical Analyses Module
• Results: Adverse Events Module

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

U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894

National Institutes of Health, Department of Health & Human Services

Copyright and Privacy Policy, Freedom of Information Act, Accessibility

2.   Application Completed  Thank you for submitting your Protocol Registration System (PRS) account application. The ClinicalTrials.gov team will review the information and contact you if there are any questions. When the account is created you will receive email with instructions on how to login to the PRS so that you can register your trials. Questions? Contact us at register@clinicaltrials.gov. The account creation process can take up to five business days. If you have not received email from us within five business days, please contact us at register@clinicaltrials.gov. Return to PRS Information Page

3. 

ClinicalTrials.gov Protocol Registration System Account 이 메일에 대한 추가작업 보낸사람 : ClinicalTrials gov Registration"register@clinicaltrials.gov주소록에 추가 | 수신차단하기 보낸시간 : 2011-09-06 (화) 23:50:01 [GMT +09:00 (서울, 도쿄)] 받는사람 :

Message generated by ClinicalTrials.gov Protocol Registration System ____________________________________________________________________ A PRS account has been created for you. The PRS URL is https://register.clinicaltrials.gov. To login, you will need the following information: Organization: WMDROC User Name: XXxx(비공개) Password: xxxxxxxx(비공개) Please login and change your password as soon as possible. Also verify that the following information is correct. Full Name: son Su Kim E-Mail: tmsla001@naver.com If you have questions about the system or have trouble logging in, please contact your organization's PRS administrator (register@clinicaltrials.gov). Send message to PRS User Information Organization: WMDROC Username: SKim Full Name: Example: John J Smith, MD Email Address: Enter your full email address. Example: jsmith@mail.nih.gov Important messages from ClinicalTrials.gov will be sent to this address. Send message to PRS PRS Administrators Main Menu Organization: World Muscular Dystrophy Removing-Out Center (WMDROC) User: son Su Kim (SKim) PRS Administrator Email Address PRS Staff (prs_admin)   register@clinicaltrials.gov