1. Organization/Sponsor Information

The sponsoring organization is the entity with primary responsibility for initiating and conducting the trial(s) to be registered. For trials associated with Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications with the U.S. FDA, the IND/IDE holder is the sponsor.

Type of Organization (select one)

• Government Agency - sponsoring or supporting clinical research
• Industry
• University
• Nonprofit Organization
• Other

Country
Country of the sponsoring organization.

Organization Name
Official name of sponsoring organization.

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

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

Parent Organizations (if applicable)
Name(s) of larger organization(s) with which the sponsoring organization is affiliated and relationship(s), such as subdivision, division, or department.

Official Representative
Name of official contact person at sponsoring organization. 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.

Official Representative Phone
Primary phone number for the official representative, including country code, area code, and extension.

Official Representative Email
Primary email address for the official representative.

Organization URL
Official Web address of the sponsoring organization.

Funding Organization
Official name of the primary funding source for the trials 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 person who is authorized by the sponsor to update and maintain data in the PRS. The Administrator will also serve as the point of contact for questions about the sponsor's data.

Affiliation
Official name of organizational affiliation of the Administrator, if different from the sponsoring organization.

Administrator Phone
Primary phone number of the Administrator, including country code, area code, and extension.

Administrator Email
Email address for contacting the administrator.

Regulatory Authority
Name of the organization with regulatory authority over the trials to be registered. This may be a national or international health authority (e.g., Health Canada). If such governmental oversight is not applicable, list the name of an institutional review board or ethics committee that reviews the trials (e.g., "Australian Human Research Ethics Committee", "University Institutional Review Board").

Regulatory Authority Address
Mailing address of the regulatory authority, including street address, city, state or province, postal code, and country.