ClinicalTrials.gov Data Definitions for Protocol Registration and Results System (PRS) Individual 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.
- Registering IND/IDE Studies?
*
Indicate whether any clinical studies are being conducted under an IND or IDE application filed with the U.S. FDA. Selected Yes/No.
- 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
- Organization Contact
*
Name of the official contact person at the 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.
- Organization Phone
*
Primary phone number for the organization contact. Use the format 800-555-5555 within the United States and Canada. Otherwise, provide the full number, including the country code.
- Organization Email
*
Primary electronic mail address for the organization contact.
- 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.
2. Investigator Information
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Investigator Name
*
Full name of the person who is individual designated as responsible party by the sponsor or individual who both initiates and conducts the study.
Note: "Responsible party" means with respect to a clinical study, the sponsor (or sponsor-investigator) of the clinical study, as defined in 21 CFR 50.3; or the principal investigator of such clinical study if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the study, has access to and control over the data from the clinical study, has the right to publish the results of the study, and has the ability to meet all of the requirements for the submission of clinical study information.
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Affiliation
Official name of the organization with which the investigator is affiliated, if different from the sponsoring organization
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Investigator Phone
*
Primary phone number for the investigator. Use the format 800-555-5555 within the United States and Canada. Otherwise, provide the full number, including the country code
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Investigator Email
*
Primary electronic mail address for the investigator
3. Regulatory Information
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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).
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Regulatory Authority Address
*
Mailing address for the regulatory authority, including
street address, city, state or province, ZIP or postal code, and country