ACRP CCRC GCP Exam Questions and Answers Grade A+
Good Clinical Practice (GCP) - Answer-A standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance
that the data and reported results are credible and accurate, and that the rights, integrity, and
confidentiality of trial subjects are protected.
Adverse Drug Reaction (ADR) - Pre-approval with a new drug - Answer-All noxious and
unintended responses to a medicinal product related to any dose
- therapeutic doses not established
Adverse Drug Reaction (ADR) - Marketed Medicinal Products - Answer-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
Adverse Event (AE) - Answer-Any untoward medical occurence in a patient or clinical
investigation subject administered a pharmaceutical product and which does not necessarily
have a causal relationship with this treatment
- any unfavourable and unintended sign (including lab findings), symptom, or disease temporally
associated with the use of a medicinal (investigational) product
- whether or not related to the medicinal (investigational) product
Applicable Regulatory Requirement(s) - Answer-Any law(s) and regulation(s) addressing the
conduct of clinical trials of investigational products
Approval (in relation to IRB) - Answer-The affirmative decision of the IRB that the clinical trial
has been reviewed and may be conducted at the institution site within the constraints set forth
by the IRB, the institution, GCP, and the applicable regulatory requirements
Audit - Answer-A systematic and independent 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 accroding to the protocol, sponsor's
standard operating procedures (SOPs), GCP, and the applicabale regulatory requirements
Audit Certificate - Answer-A declaration of confirmation by the auditor that an audit has taken
place
Audit Report - Answer-A written evaluation by the sponsor's auditor of the results of the audit
Audit trail - Answer-Documentation that allows reconstruction of the course of events
, Blinding/Masking - Answer-One or more parties to the trial are kept unaware of the treatment
assingment(s)
Single Blinding - Answer-The subject(s) being unaware
Double Blinding - Answer-Subject(s), investigator(s), monitor, and in some cases data analyst(s)
are unaware of the treatment assignments
Case Report Forms (CRFs) - Answer-A printed, optical, or electronic document designed to
record all of the protocol required information to be reported to the sponsor on each trial
subject
Clinical Trial/Study - Answer-Any investigation in human subjects intended to discover or verify
the clinical, pharmacological and/or other pharmacodynamic effects of an investigational
product(s0, and/or to identify any adverse reactions to an investigational product, and/or to
study absorption, distribution, metabolism, and excretion of an investigational product with the
objet of ascertaining its safety and/or efficacy
Clinical Trial/Study Report - Answer-A written description of a trial/study of any therapeutic,
prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and
statistical description, presentations, and analyses are fully integrated into a single report
Comparator (Product) - Answer-An investigational or marketed product (i.e. active control), or
placebo, used as a reference in a clinical trial
Compliance (in relation to trials) - Answer-Adherence to all the trial-related requirements, GCP
requirements, and the applicable regulatory requirements
Confidentiality - Answer-Prevention of disclosure, to other than authorized individuals, of a
sponsor's proprietary informaion or of a subject's identity
Contract - Answer-A written, dated, and signed agreement between two or more involved
parties that sets out any arrangements on delegation and distribution of tasks and obligations
and, if appropriate, on financial matters
- the protocol may serve as the basis of a contract
Coordinating Committee - Answer-A committee that a sponsor may organize to coordinate the
conduct of a multicentre trial
Coordinating Investigator - Answer-An investigator assigned the responsibility for the
coordination of investigators at different centres participating in a multicentre trial
Contract Research Organization (CRO) - Answer-A person or an organization contracted by the
sponsor to perform one or more of a sponsor's trial-related duties and functions
Good Clinical Practice (GCP) - Answer-A standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance
that the data and reported results are credible and accurate, and that the rights, integrity, and
confidentiality of trial subjects are protected.
Adverse Drug Reaction (ADR) - Pre-approval with a new drug - Answer-All noxious and
unintended responses to a medicinal product related to any dose
- therapeutic doses not established
Adverse Drug Reaction (ADR) - Marketed Medicinal Products - Answer-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
Adverse Event (AE) - Answer-Any untoward medical occurence in a patient or clinical
investigation subject administered a pharmaceutical product and which does not necessarily
have a causal relationship with this treatment
- any unfavourable and unintended sign (including lab findings), symptom, or disease temporally
associated with the use of a medicinal (investigational) product
- whether or not related to the medicinal (investigational) product
Applicable Regulatory Requirement(s) - Answer-Any law(s) and regulation(s) addressing the
conduct of clinical trials of investigational products
Approval (in relation to IRB) - Answer-The affirmative decision of the IRB that the clinical trial
has been reviewed and may be conducted at the institution site within the constraints set forth
by the IRB, the institution, GCP, and the applicable regulatory requirements
Audit - Answer-A systematic and independent 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 accroding to the protocol, sponsor's
standard operating procedures (SOPs), GCP, and the applicabale regulatory requirements
Audit Certificate - Answer-A declaration of confirmation by the auditor that an audit has taken
place
Audit Report - Answer-A written evaluation by the sponsor's auditor of the results of the audit
Audit trail - Answer-Documentation that allows reconstruction of the course of events
, Blinding/Masking - Answer-One or more parties to the trial are kept unaware of the treatment
assingment(s)
Single Blinding - Answer-The subject(s) being unaware
Double Blinding - Answer-Subject(s), investigator(s), monitor, and in some cases data analyst(s)
are unaware of the treatment assignments
Case Report Forms (CRFs) - Answer-A printed, optical, or electronic document designed to
record all of the protocol required information to be reported to the sponsor on each trial
subject
Clinical Trial/Study - Answer-Any investigation in human subjects intended to discover or verify
the clinical, pharmacological and/or other pharmacodynamic effects of an investigational
product(s0, and/or to identify any adverse reactions to an investigational product, and/or to
study absorption, distribution, metabolism, and excretion of an investigational product with the
objet of ascertaining its safety and/or efficacy
Clinical Trial/Study Report - Answer-A written description of a trial/study of any therapeutic,
prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and
statistical description, presentations, and analyses are fully integrated into a single report
Comparator (Product) - Answer-An investigational or marketed product (i.e. active control), or
placebo, used as a reference in a clinical trial
Compliance (in relation to trials) - Answer-Adherence to all the trial-related requirements, GCP
requirements, and the applicable regulatory requirements
Confidentiality - Answer-Prevention of disclosure, to other than authorized individuals, of a
sponsor's proprietary informaion or of a subject's identity
Contract - Answer-A written, dated, and signed agreement between two or more involved
parties that sets out any arrangements on delegation and distribution of tasks and obligations
and, if appropriate, on financial matters
- the protocol may serve as the basis of a contract
Coordinating Committee - Answer-A committee that a sponsor may organize to coordinate the
conduct of a multicentre trial
Coordinating Investigator - Answer-An investigator assigned the responsibility for the
coordination of investigators at different centres participating in a multicentre trial
Contract Research Organization (CRO) - Answer-A person or an organization contracted by the
sponsor to perform one or more of a sponsor's trial-related duties and functions
