Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Apply for PRS Organization Account

OMB NO: 0925-0586 EXPIRATION DATE: 08/31/2015 Burden Statement
Each entity submitting data to ClinicalTrials.gov must adhere to the following terms and conditions, which are intended to ensure the accuracy, currency and validity of the data.
  1. Only data for studies that are in conformance with applicable human subjects or ethics review regulations (or equivalent) and applicable regulations of the national (or regional) health authority (or equivalent) may be submitted;
  2. Notice of changes in recruitment status must be provided as soon as possible, but not later than 30 days after such changes. All other submitted data must be reviewed, verified, and updated as necessary not less than every 12 months at a minimum.
  3. The submitting organization is responsible for the completeness and accuracy of the data submitted to ClinicalTrials.gov.
  4. Trial data must be submitted in English.
  5. Multiple groups within a single entity (e.g., company, university, government agency) must share a single PRS organization account.
  6. Previous versions of study data will be available to the public, although the default view will be the most recent version.
(Accept Required) Accept Do Not Accept
Sponsor Information The sponsoring organization is the entity with primary responsibility for initiating and conducting the study to be registered.
Type of Organization * :
Country * :
Organization Name * :
Organization Address * :
Organization Abbreviations and Acronyms :
Parent Organizations ,
if any:
Official Representative * :
Phone * :
Please enter a valid phone number, including area code.
Email * :
Organization URL (optional):
Funding Organization :
 
Administrator Information: The administrator is the person authorized by the sponsor to update the information in the Protocol Registration and Results System (PRS) and will serve as the point of contact for the ClinicalTrials.gov staff.
Administrator Name * :
Affiliation (if not the sponsor):
Administrator Phone * :
Please enter a valid phone number, including area code.
Administrator Email * :
 
Regulatory Information: The regulatory authority may be a national or international health authority, an institutional review board or an ethics committee.
Regulatory Authority * :
Regulatory Authority Address * :

To the best of my knowledge, the above information is true and correct. Questions about this form and the Protocol Registration and Results System (PRS) may be sent to register@ClinicalTrials.gov.