general refreshers

Question 1

GCP

Answer 1

a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials. What does this mean to you? Being vigilant, aware, honest, accurate, holding myself and others accountable, always open to learn, refine, and find better ways to safely and ethically conduct trials.

Question 2

ACC CRU mission

Answer 2

The mission of the ACC CRU is to advance the science of cancer care, serve our patients by improving clinical outcomes, and offer the best available innovative care to trial participants.

Question 3

1572’s

Answer 3

agreement signed by the investigator to provide certain info to the sponsor and assure they will comply with FDA regulations while conducting a trial

Question 4

FDF’s

Answer 4

whether or not clinical investigators have disclosable financial interests or arrangements to the agency associated with the trial

Question 5

trial phases

Answer 5

I= first in human; is the treatment safe?  
II = if found safe, does the treatment work? 
III = it’s safe and it works, but is it better than what’s already available? 
IV = is there anything else we need to know? (looking at drugs already approved by FDA)