Definitions

Question 1

What is quality assurance?

Answer 1

Planned and systematic activities to ensure that quality is maintained during the trial and that data are generated, documented and reported according to GCP and regulatory requirements. (Actions to ensure errors don’t happen)

Question 2

What is quality control?

Answer 2

Ooperational activities taken to verify that the requirements for quality have been fulfilled (Checking if errors did happen).

Question 3

Serious Adverse Events (SAEs) or Serious Adverse Drug Reactions (Serios ADRs) are untoward medical occurrences that at any dose _______.

Answer 3

• Result in death
• Are life threatening
• Require inpatient hospitalization or prolonged hospitalization
• Result in persistent or significant disability/incapacity
• Is a congenital anomaly or birth defect.

Question 4

What is an Unexpected Adverse Drug Reaction?

Answer 4

Any adverse reaction in which the nature or severity is not consistent with the product information for the trial (Investigators brochure, etc.)

Question 5

According to ICH GCP, whom are generally considered vulnerable populations?

Answer 5

Individuals whose willingness to volunteer may be or have a higher chance of being unduly influenced by their expected benefits of participating or perceived retaliation of not participating.