ICH GCP Exam 2024/2025 fully solved &
updated
FDA - ANSWER-Food and Drug Administration
ICH - ANSWER-International Conference of Harmonization - homogenized
regulations in many drug markets including the US, EU, and Japan.
GCP - ANSWER-Good Clinical Practice
Bioavailability - ANSWER-The degree to which a drug is absorbed or becomes
available to a specified location within the body
Clinical Trial - ANSWER-Any study, utilizing human subjects, which studies the
pharmacological and/or pharmacodynamic effect of an investigational product,
and discovers adverse effects, adsorption, distribution, metabolism, and
excretion of an investigational product, and to establish the efficacy and safety of
the investigational product.
Pharmacodynamics - ANSWER-The effects of an investigational agent when in
the body.
Pharmacogenetics - ANSWER-The genetic markers that may predict the effects of
an investigational agent.
Placebo - ANSWER-An inactive substance that looks the same as, and is
administered in the same way as the investigational product.
Pharmacokinetics - ANSWER-Describes how the agent moves through and is
excreted from the body.
, FDA 1571 - ANSWER-Is the Investigational New Drug (IND) application that must
be submitted to the FDA 30 days prior to the start of the clinical study. This
includes all of the information about the investigational product obtained during
preclinical studies.
Phase I - ANSWER-Usually performed with normal, healthy volunteers.
Determines dosage, toxicity, pharmacokinetics, and pharmacodynamics. In
cancer studies, due to the toxicity of drugs, end-stage patients are typically
utilized.
Phase II - ANSWER-Performed with a limited amount of subjects in a controlled
study. Determines the short-term risks and the preliminary effectiveness.
Phase III - ANSWER-Performed with a large number of patients in controlled and
uncontrolled studies. Determines the long-term safety of the investigational
product, the efficacy of the investigational product, and to confirm the findings of
the Phase II study.
New Drug Application - ANSWER-Once the clinical studies have concluded and
the safety and efficacy of the inverstigational product has been proven, the
sponsor then submits a NDA which is reviewed by the FDA. If approved, opens
the investigational product to marketing within the US.
Regulation - ANSWER-A law enforced by a regulatory agency within the
government.
CRF - ANSWER-According to ICH-GCP, the CRF is a form that records all relevant
protocol related information which is then reported to the sponsor for each trial-
related subject.
Clinical Data Management (CDM) - ANSWER-Assures collection, integration, and
availability data at appropriate quality and cost. Also supports the conduct,
management, and analysis of data across studies.
Clinical Data Manager - ANSWER-Ensures that the data is collected, validated,
complete, and consistent.
Database Lock - ANSWER-At the end of a study, the clinical data manager
declares the data collected final and submits these data for statistical analysis
(sometimes called "database freeze").
updated
FDA - ANSWER-Food and Drug Administration
ICH - ANSWER-International Conference of Harmonization - homogenized
regulations in many drug markets including the US, EU, and Japan.
GCP - ANSWER-Good Clinical Practice
Bioavailability - ANSWER-The degree to which a drug is absorbed or becomes
available to a specified location within the body
Clinical Trial - ANSWER-Any study, utilizing human subjects, which studies the
pharmacological and/or pharmacodynamic effect of an investigational product,
and discovers adverse effects, adsorption, distribution, metabolism, and
excretion of an investigational product, and to establish the efficacy and safety of
the investigational product.
Pharmacodynamics - ANSWER-The effects of an investigational agent when in
the body.
Pharmacogenetics - ANSWER-The genetic markers that may predict the effects of
an investigational agent.
Placebo - ANSWER-An inactive substance that looks the same as, and is
administered in the same way as the investigational product.
Pharmacokinetics - ANSWER-Describes how the agent moves through and is
excreted from the body.
, FDA 1571 - ANSWER-Is the Investigational New Drug (IND) application that must
be submitted to the FDA 30 days prior to the start of the clinical study. This
includes all of the information about the investigational product obtained during
preclinical studies.
Phase I - ANSWER-Usually performed with normal, healthy volunteers.
Determines dosage, toxicity, pharmacokinetics, and pharmacodynamics. In
cancer studies, due to the toxicity of drugs, end-stage patients are typically
utilized.
Phase II - ANSWER-Performed with a limited amount of subjects in a controlled
study. Determines the short-term risks and the preliminary effectiveness.
Phase III - ANSWER-Performed with a large number of patients in controlled and
uncontrolled studies. Determines the long-term safety of the investigational
product, the efficacy of the investigational product, and to confirm the findings of
the Phase II study.
New Drug Application - ANSWER-Once the clinical studies have concluded and
the safety and efficacy of the inverstigational product has been proven, the
sponsor then submits a NDA which is reviewed by the FDA. If approved, opens
the investigational product to marketing within the US.
Regulation - ANSWER-A law enforced by a regulatory agency within the
government.
CRF - ANSWER-According to ICH-GCP, the CRF is a form that records all relevant
protocol related information which is then reported to the sponsor for each trial-
related subject.
Clinical Data Management (CDM) - ANSWER-Assures collection, integration, and
availability data at appropriate quality and cost. Also supports the conduct,
management, and analysis of data across studies.
Clinical Data Manager - ANSWER-Ensures that the data is collected, validated,
complete, and consistent.
Database Lock - ANSWER-At the end of a study, the clinical data manager
declares the data collected final and submits these data for statistical analysis
(sometimes called "database freeze").
