Good Clinical Practice
This individual is ultimately responsible for how a clinical trial is conducted at a study site.
Principal Investigator
In which country were the first PROTECT sites activated?
United States
What is the capital city of Spain?
Madrid
This document lists study staff, roles, and tasks assigned by the PI.
Delegation Log
PROTECT has an expected enrollment period of approximately how long?
12 months
What sweet treat is commonly dipped into thick hot chocolate in Spain?
Churros
This term refers to the study drug or product being tested in a clinical trial.
Investigational Medicinal Product (IMP) or Investigational Product (IP).
How many participants are planned for enrollment?
120
Which two Spanish soccer clubs play in the famous rivalry known as “El Clásico”?
Real Madrid and FC Barcelona
This is a qualified physician designated by the Principal Investigator to perform protocol-required clinical assessments and trial-related medical procedures.
Sub-Investigator
What ECOG performance status is required for enrollment?
0 or 1
What is Spain’s famous rice dish that originated in Valencia?
Paella
This is the process by which a participant voluntarily confirms their willingness to take part in a clinical trial after being informed of all relevant aspects of the study.
Informed Consent
Approximately how long is participation in PROTECT for an individual participant?
6 months
What is the traditional Spanish custom of eating small portions of different foods called?
Tapas