Page History

...

Responsible Party

Indicate the party who is responsible for the trial. Select one of the following options:

• Sponsor - Name of primary organization that oversees implementation of study and is responsible for data analysis. For applicable clinical trials, sponsor is defined in 21 CFR 50.3. For further elaboration on the definition of Sponsor with respect to responsible party, see http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf.

• Principal Investigator - Primary medical researcher in charge of carrying out a clinical trial's protocol.
• Sponsor-Investigator - Responsible party is both the sponsor and the investigator.

Investigator*

If the Responsible Party is the Principal Investigator, this field is pre-populated with the name you entered for the Principal Investigator in the Lead Organization/Principal Investigator section.

If the Responsible Party is the Sponsor-Investigator, this field is pre-populated with the name you entered for the Principal Investigator in the Lead Organization/Principal Investigator section. To change the investigator's name, click Look Up Sponsor, and follow the instructions in Searching for Persons.

Investigator Title*

This field is pre-populated. Enter a new title in the field provided if other than Principal Investigator.

Investigator Affiliation*

This field is pre-populated with the organization you entered as Sponsor.

If the Responsible Party is the Principal Investigator, you can change the affiliated organization. To change the investigator's affiliation, click Look Up Organization, and follow the instructions in Searching for Organizations.