ClinicalTrials.gov Data Definitions for Protocol Registration and Results System (PRS) Organization Account Application Form

April 18, 2017

1. Sponsor Information

The sponsoring organization is the entity with primary responsibility for initiating and conducting the studies to be registered. When a clinical study is conducted under a U.S. Food and Drug Administration (FDA) investigational new drug application (IND) or investigational device exemption (IDE), the IND or IDE holder is considered the sponsor. When a clinical study is not conducted under an IND or IDE, the organization who initiates the study, by preparing and/or planning the study, and who has authority and control over the study, is considered the sponsor.

• Type of Organization * (select one)
  
  • Government agency
  • Industry
  • University
  • Nonprofit organization
  • Other

• Country *
  Country of the sponsoring organization

• Organization Name *
  Official name of the sponsoring organization

• Organization Address *
  Mailing address for the headquarters of the sponsoring organization, including street address, city, state or province, ZIP or postal code, and country

• Organization Abbreviations and Acronyms
  Other names used by the sponsoring organization

• Parent Organizations (if applicable)
  Name of one or more larger organizations with which the sponsoring organization is affiliated and the relationship (such as subdivision, division, or department) of the sponsoring organization to each parent organization

• Name of Individual *
  Name of the individual who is a designated employee of the sponsoring organization that is the responsible party. This person may be contacted by ClinicalTrials.gov to verify information about the sponsoring organization and must have the authority to represent the sponsoring organization.

  Note: "Responsible party" means with respect to a clinical study, the sponsor of the clinical study, as defined in 21 CFR 50.3. If not subject to FDA IND or IDE regulations, then the organization who initiates the study, by preparing and/or planning the study, and who has authority and control over the study.

• Phone *
  Primary phone number for the individual representing the sponsoring organization that is the responsible party. Use the format 800-555-5555 within the United States and Canada. Otherwise, provide the full number, including the country code.

• Email *
  Primary electronic mail address for the individual representing the sponsoring organization that is the responsible party.

• Organization Web Site
  Official Web address of the sponsoring organization

• Funding Organization
  Official name of the primary funding source for the studies to be registered, if different from the sponsoring organization. In cases involving multiple funding sources, enter the one that provides the greatest amount of funding.

• Administrator Name *
  Full name of the person who is authorized by the sponsoring organization to update and maintain data in the Protocol Registration and Results System (PRS). The PRS Administrator will also serve as the point of contact for questions about the sponsoring organization's data.

• Affiliation
  Official name of the organization with which the PRS Administrator is affiliated, if different from the sponsoring organization

• Administrator Phone *
  Primary phone number for the PRS Administrator. Use the format 800-555-5555 within the United States and Canada. Otherwise, provide the full number, including the country code.

• Administrator Email *
  Primary electronic mail address for the PRS Administrator

• Regulatory Authority *
  Name of the organization with regulatory authority over the studies to be registered. This can be a national (e.g., Health Canada) or international health authority (e.g., European Medicines Agency). If such governmental oversight is not applicable, provide the name of the institutional review board or ethics committee that reviews the studies (e.g., Australian Human Research Ethics Committee, University Institutional Review Board).

• Regulatory Authority Address *
  Mailing address for the regulatory authority, including street address, city, state or province, ZIP or postal code, and country