ICH E6 (R2) - glossary and guidelines -
CCRA Exam ACTUAL QUESTIONS AND
CORRECT ANSWERS
WHat is the purpose of te ICH GCP guidelines - CORRECT ANSWERS✅✅to provide a
unified standard for the European Union (EU), Japan and the United States to facilitate the
mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
what does the ICH E6 (R2) guideline cover? - CORRECT ANSWERS✅✅Guideline for
good clinical practice
why was an addendum (R2) added to ICH E6? - CORRECT ANSWERS✅✅Evolutions in
technology and risk management processes and the need to increase eficiency
This ICH GCP Guideline Integrated Addendum provides a unified standard for which
countries? - CORRECT ANSWERS✅✅the European Union, Japan, the United States,
Canada, and Switzerland
define the following: a response to a drug which is noxious and unintended and which occurs
at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for
modification of physiological function - CORRECT ANSWERS✅✅Adverse drug reaction
what is an AE - CORRECT ANSWERS✅✅Any untoward medical occurrence in a patient
or clinical investigation subject administered a pharmaceutical product and which does not
necessarily have a causal relationship with this treatment.
what is the difference with a ADR and AE - CORRECT ANSWERS✅✅an ADR has a
relationship with the drug. an AE doesn't necessarily have a causaul relationship; but has a
temporal association
this is an examination of trial related activities and documents to determine whether the
evaluated trial related activities were conducted, and the data were recorded, analyzed and
accurately reported according to the protocol, sponsor's standard operating procedures
(SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s) -
CORRECT ANSWERS✅✅audit
CCRA Exam ACTUAL QUESTIONS AND
CORRECT ANSWERS
WHat is the purpose of te ICH GCP guidelines - CORRECT ANSWERS✅✅to provide a
unified standard for the European Union (EU), Japan and the United States to facilitate the
mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
what does the ICH E6 (R2) guideline cover? - CORRECT ANSWERS✅✅Guideline for
good clinical practice
why was an addendum (R2) added to ICH E6? - CORRECT ANSWERS✅✅Evolutions in
technology and risk management processes and the need to increase eficiency
This ICH GCP Guideline Integrated Addendum provides a unified standard for which
countries? - CORRECT ANSWERS✅✅the European Union, Japan, the United States,
Canada, and Switzerland
define the following: a response to a drug which is noxious and unintended and which occurs
at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for
modification of physiological function - CORRECT ANSWERS✅✅Adverse drug reaction
what is an AE - CORRECT ANSWERS✅✅Any untoward medical occurrence in a patient
or clinical investigation subject administered a pharmaceutical product and which does not
necessarily have a causal relationship with this treatment.
what is the difference with a ADR and AE - CORRECT ANSWERS✅✅an ADR has a
relationship with the drug. an AE doesn't necessarily have a causaul relationship; but has a
temporal association
this is an examination of trial related activities and documents to determine whether the
evaluated trial related activities were conducted, and the data were recorded, analyzed and
accurately reported according to the protocol, sponsor's standard operating procedures
(SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s) -
CORRECT ANSWERS✅✅audit
