CRC questions with actual answers.
Adverse Drug Reaction (ADR) ANS -An unintended reaction to a drug taken at a normal dose.
Adverse Event (AE) ANS -Any untoward medical occurrence in a study subject administered a
pharmaceutical product
Serious Adverse Event (SAE) ANS -Any untoward medical occurrence at any dose that results in death, is
life-threatening, requires hospitalization (or prolongation of hospitalization), results in persistent or
significant disability, or is a birth defect.
Data Management ANS -The process of handling data generated and collected during a trial. It usually
involves data entry, data cleaning, and database management.
Case Report Form (CRF) ANS -A record of the information collected from a subject during a trial. The
information that is collected is based on what the protocol specifies.
Demographic Data ANS -Includes sex, age, medical history, and other such relevant information.
Device ANS -An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or
other similar or related article, including any component, part or accessor, which is intended for use in
the diagnosis, cure, treatment or prevention of disease. A device does not achieve its intended purpose
through chemical action in the body and is not depended upon being metabolized to achieve its
purpose.
Drug ANS -An article (other than food) intended for use in the diagnosis, cure, mitigation, treatment or
prevention of disease in man or other animals.
Pharmacokinetic Data (PK) ANS -Can include measures of absorption, distribution, localization, and
excretion of a drug
Adverse Drug Reaction (ADR) ANS -An unintended reaction to a drug taken at a normal dose.
Adverse Event (AE) ANS -Any untoward medical occurrence in a study subject administered a
pharmaceutical product
Serious Adverse Event (SAE) ANS -Any untoward medical occurrence at any dose that results in death, is
life-threatening, requires hospitalization (or prolongation of hospitalization), results in persistent or
significant disability, or is a birth defect.
Data Management ANS -The process of handling data generated and collected during a trial. It usually
involves data entry, data cleaning, and database management.
Case Report Form (CRF) ANS -A record of the information collected from a subject during a trial. The
information that is collected is based on what the protocol specifies.
Demographic Data ANS -Includes sex, age, medical history, and other such relevant information.
Device ANS -An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or
other similar or related article, including any component, part or accessor, which is intended for use in
the diagnosis, cure, treatment or prevention of disease. A device does not achieve its intended purpose
through chemical action in the body and is not depended upon being metabolized to achieve its
purpose.
Drug ANS -An article (other than food) intended for use in the diagnosis, cure, mitigation, treatment or
prevention of disease in man or other animals.
Pharmacokinetic Data (PK) ANS -Can include measures of absorption, distribution, localization, and
excretion of a drug
