Good Clinical Practice
PROTECT
Spain
100

This individual is ultimately responsible for how a clinical trial is conducted at a study site.

Principal Investigator

100

In which country were the first PROTECT sites activated?

United States

100

What is the capital city of Spain?

Madrid

200

This document lists study staff, roles, and tasks assigned by the PI.

Delegation Log

200

PROTECT has an expected enrollment period of approximately how long?

12 months

200

What sweet treat is commonly dipped into thick hot chocolate in Spain?

Churros

300

This term refers to the study drug or product being tested in a clinical trial.

Investigational Medicinal Product (IMP) or Investigational Product (IP).

300

How many participants are planned for enrollment?

120

300

Which two Spanish soccer clubs play in the famous rivalry known as “El Clásico”?

Real Madrid and FC Barcelona

400

This is a qualified physician designated by the Principal Investigator to perform protocol-required clinical assessments and trial-related medical procedures.

Sub-Investigator

400

What ECOG performance status is required for enrollment?

0 or 1

400

What is Spain’s famous rice dish that originated in Valencia?

Paella

500

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

500

Approximately how long is participation in PROTECT for an individual participant?

6 months

500

What is the traditional Spanish custom of eating small portions of different foods called?

Tapas

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