SOCRA CERTIFICATION FINAL EXAM ACTUAL QUESTIONS
AND SOLUTIONS RATED A+
✔✔Certification - ✔✔The official notification by the institution to the supporting
department or agency, in accordance with the requirements of this policy, that a
research project or activity involving human subjects has been reviewed and approved
by an IRB in accordance with an approved assurance. (45 CFR, sec. 46.102)
✔✔Adverse Drug Reaction (ADR) - ✔✔All noxious and unintended responses to a
medicinal product related to any dose. (ICH GCP E6 1.1)
✔✔Adverse Event (AE) - ✔✔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. (ICH GCP E6 1.2)
✔✔Applicable Regulatory Requirements - ✔✔Any laws and regulations addressing the
conduct of clinical trials of investigational products (ICH GCP E6 1.4)
✔✔Audit - ✔✔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 according to the
protocol, sponsors SOPs, GCP and the applicable regulatory requirements. (ICH GCP
E6 1.6)
✔✔Audit Certificate - ✔✔A declaration of the confirmation by the auditor that an audit
has taken place. (ICH GCP E6 1.7)
✔✔Audit Report - ✔✔A written evaluation by the sponsor's auditor of the results of the
audit. (ICH GCP E6 1.8)
✔✔Audit Trail - ✔✔Documentation that allow reconstruction of the course of events.
(ICH GCP E6 1.9)
✔✔Blinding/Masking - ✔✔A procedure in which one or more parties to the trial are kept
unaware of the treatment assignment. (ICH GCP E6 1.10)
✔✔Case Report Form (CRF) - ✔✔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. (ICH GCP E6 1.11)
✔✔Clinical Trial/Study Report - ✔✔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 analysis are fully integrated into a
single report. (ICH GCP E6 1.13)
, ✔✔Comparator (Product) - ✔✔An investigational or marketed product (i.e. active
control). or placebo, used as a reference in a clinical trial. (ICH GCP E6 1.14)
✔✔Compliance - ✔✔Adherence to all the trial related requirements, GCP requirements
and the applicable regulatory requirements. (ICH GCP E6 1.15)
✔✔Confidentiality - ✔✔Prevention or disclosure, to other than authorized individuals, of
a sponsor's proprietary information or of a subject's identity. (ICH GCP E6 1.16)
✔✔Contract - ✔✔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. (ICH GCP E6 1.17)
✔✔Coordinating Committee - ✔✔A committee that a sponsor may organize to
coordinate the conduct of a multicentre trial. (ICH GCP E6 1.18)
✔✔Coordinating Investigator - ✔✔An investigator assigned the responsibility for the
coordination of investogators at different centres participating in a multicentre trial. (ICH
GCP E6 1.19)
✔✔Contract Research Organization (CRO) - ✔✔A person or an organization
(commercial academic or otherwise) contracted by the sponsor to perform one or more
of a sponsor's trial-related duties and functions. (ICH GCP E6 1.20)
✔✔Direct Access - ✔✔Permission to examine, analyze, verify, and reproduce any
records and reports that are important to the evaluation of a clinical trial. (ICH GCP E6
1.21)
✔✔Documentation - ✔✔All records, in any form, that describe or record the methods,
conduct and or results of a trial, the factors affecting the trial and the actions taken. (ICH
GCP E6 1.22)
✔✔Essential Documents - ✔✔Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of the data produced. (ICH GCP E6
1.23)
✔✔Good Clinical Practice (GCP) - ✔✔A standard for the design, conduct, performance,
monitoring, auditing, recording, analysis, 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 the trial subjects are protected. (ICH GCP E6 1.24)
✔✔Independent Data Monitoring Committee (IDMC) - ✔✔May be established by the
sponsor to assess at intervals the progress of a clinical trial, the safety data, and the
critical efficacy endpoints. (ICH GCP E6 1.25)
AND SOLUTIONS RATED A+
✔✔Certification - ✔✔The official notification by the institution to the supporting
department or agency, in accordance with the requirements of this policy, that a
research project or activity involving human subjects has been reviewed and approved
by an IRB in accordance with an approved assurance. (45 CFR, sec. 46.102)
✔✔Adverse Drug Reaction (ADR) - ✔✔All noxious and unintended responses to a
medicinal product related to any dose. (ICH GCP E6 1.1)
✔✔Adverse Event (AE) - ✔✔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. (ICH GCP E6 1.2)
✔✔Applicable Regulatory Requirements - ✔✔Any laws and regulations addressing the
conduct of clinical trials of investigational products (ICH GCP E6 1.4)
✔✔Audit - ✔✔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 according to the
protocol, sponsors SOPs, GCP and the applicable regulatory requirements. (ICH GCP
E6 1.6)
✔✔Audit Certificate - ✔✔A declaration of the confirmation by the auditor that an audit
has taken place. (ICH GCP E6 1.7)
✔✔Audit Report - ✔✔A written evaluation by the sponsor's auditor of the results of the
audit. (ICH GCP E6 1.8)
✔✔Audit Trail - ✔✔Documentation that allow reconstruction of the course of events.
(ICH GCP E6 1.9)
✔✔Blinding/Masking - ✔✔A procedure in which one or more parties to the trial are kept
unaware of the treatment assignment. (ICH GCP E6 1.10)
✔✔Case Report Form (CRF) - ✔✔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. (ICH GCP E6 1.11)
✔✔Clinical Trial/Study Report - ✔✔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 analysis are fully integrated into a
single report. (ICH GCP E6 1.13)
, ✔✔Comparator (Product) - ✔✔An investigational or marketed product (i.e. active
control). or placebo, used as a reference in a clinical trial. (ICH GCP E6 1.14)
✔✔Compliance - ✔✔Adherence to all the trial related requirements, GCP requirements
and the applicable regulatory requirements. (ICH GCP E6 1.15)
✔✔Confidentiality - ✔✔Prevention or disclosure, to other than authorized individuals, of
a sponsor's proprietary information or of a subject's identity. (ICH GCP E6 1.16)
✔✔Contract - ✔✔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. (ICH GCP E6 1.17)
✔✔Coordinating Committee - ✔✔A committee that a sponsor may organize to
coordinate the conduct of a multicentre trial. (ICH GCP E6 1.18)
✔✔Coordinating Investigator - ✔✔An investigator assigned the responsibility for the
coordination of investogators at different centres participating in a multicentre trial. (ICH
GCP E6 1.19)
✔✔Contract Research Organization (CRO) - ✔✔A person or an organization
(commercial academic or otherwise) contracted by the sponsor to perform one or more
of a sponsor's trial-related duties and functions. (ICH GCP E6 1.20)
✔✔Direct Access - ✔✔Permission to examine, analyze, verify, and reproduce any
records and reports that are important to the evaluation of a clinical trial. (ICH GCP E6
1.21)
✔✔Documentation - ✔✔All records, in any form, that describe or record the methods,
conduct and or results of a trial, the factors affecting the trial and the actions taken. (ICH
GCP E6 1.22)
✔✔Essential Documents - ✔✔Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of the data produced. (ICH GCP E6
1.23)
✔✔Good Clinical Practice (GCP) - ✔✔A standard for the design, conduct, performance,
monitoring, auditing, recording, analysis, 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 the trial subjects are protected. (ICH GCP E6 1.24)
✔✔Independent Data Monitoring Committee (IDMC) - ✔✔May be established by the
sponsor to assess at intervals the progress of a clinical trial, the safety data, and the
critical efficacy endpoints. (ICH GCP E6 1.25)
