CCRC Exam Prep
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Adverse Drug Reaction (ADR) - Answer-All noxious and unintended responses to a medicinal product related to any
dose
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Adverse Event (AE) - Answer-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--any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a
medicinal product, whether or not related to the medicinal product
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Applicable Regulatory Requirements - Answer-Any law(s) and regulation(s) addressing the conduct of clinical trials of
investigational products
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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 according to the protocol, sponsor's standard operating procedures, (SOPs), Good Clinical Practice (GCP),
and the applicable regulatory requirement(s)
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Audit Certificate - Answer-A declaration of confirmation by the auditor that an audit has taken place
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Audit Report - Answer-A written evaluation by the sponsor's auditor of the results of the audit
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Audit Trail - Answer-Documentation that allows reconstruction of the course of events
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Blinding/Masking - Answer-A procedure in which one or more parties to the trial are kept unaware of the treatment
assignment(s).
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Case Report Form (CRF) - 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.
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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(s), and/or to identify any
adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion
of an investigational product(s) with the object of ascertaining its safety and/or efficacy
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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
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Comparator (Product) - Answer-An investigational or marketed product, or placebo, used as a reference in a clinical
trial.
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Confidentiality - Answer-Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary
information or of a subject's identity.
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,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.
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Coordinating Committee - Answer-A committee that a sponsor may organize to coordinate the conduct of a
multicenter trial.
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Coordinating Ivestigator - Answer-An investigator assigned the responsibility for the coordination of investigators at
different centers participating in a multicenter trial
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Contract Research Organization (CRO) - Answer-A person or an organization (commercial, academic, or other)
contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions.
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Direct Access - Answer-Permission to examine, analyze, verify, and reproduce any records and reports that are
important to evaluation of a clinical trial
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Documentation - Answer-All records, in any form that describe or record the methods, conduct, and/or results of a
trial, the factors affecting a trial, and the actions taken
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Essential Documents - Answer-Documents which individually and collectively permit evaluation of the conduct of a
study and the quality of the data produced
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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
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Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data
Monitoring Committee) - Answer-An independent data-monitoring committee that may be established by the sponsor
to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to
recommend to the sponsor whether to continue, modify, or stop a trial
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Impartial Witness - Answer-A person, who is independent of the trial, who cannot be unfairly influenced by people
involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable
representative cannot read, and who reads the informed consent form and any other written information supplied to
the subject
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Independent Ethics Committee (IEC) - Answer-An independent body constituted of medical professionals and non-
medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human
subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and
approving / providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the
methods and material to be used in obtaining and documenting informed consent of the trial subjects.
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Informed Consent - Answer-A process by which a subject voluntarily confirms his or her willingness to participate in a
particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to
participate--documented by means of a written, signed and dated informed consent form
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Inspection - Answer-The act by a regulatory authority of conducting an official review of documents, facilities, records,
and any other resources that are deemed by the authorities to be related to the clinical trial and that may be located
at the site of the trial, at the sponsor's and/or contract research organization's (CRO's) facilities, or at other
establishments deemed appropriate by the regulatory authorities
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Interim Clinical Trial/Study Report - Answer-A report of intermediate results and their evaluation based on analyses
performed during the course of a trial
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Investigational Product - Answer-A pharmaceutical form of an active ingredient or placebo being tested or used as a
reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or
packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to
gain further information about an approved use.
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Investigator - Answer-A person responsible for the conduct of the clinical trial at a trial site.
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Investigator's Brochure - Answer-A compilation of the clinical and nonclinical data on the investigational product(s)
which is relevant to the study of the investigational product(s) in human subjects.
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Legally Acceptable Representative - Answer-An individual or juridical or other body authorized under applicable law
to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.
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Monitoring - Answer-The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted,
recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical
Practice (GCP), and the applicable regulatory requirement(s).
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Monitoring Report - Answer-A written report from the monitor to the sponsor after each site visit and/or other trial-
related communication according to the sponsor's SOPs.
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Nonclinical Study - Answer-Biomedical studies not performed on human subjects
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Quality Assurance (QA) - Answer-All those planned and systematic actions that are established to ensure that the
trial is performed ad the data are generated, documented, and reported in compliance with GCP and the applicable
regulatory requirements
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Quality Control (QC) - Answer-The operational techniques and activities undertaken within the quality assurance
system to verify that the requirements for quality of the trial-related activities have been fulfilled
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Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR) - Answer-Any untoward medical
occurrence that at any dose:
-results in death
-is life-threatening
-requires inpatient hospitalization or prolongation of existing hospitalization
-results in persistent or significant disability/incapacity
-is a congenital anomaly/birth defect
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Source Data - Answer-All information in original records and certified copies of original records of clinical findings,
observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial
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Source Documents - Answer-Original documents, data, and records.
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Sponsor - Answer-An individual, company, institution, or organization which takes responsibility for the initiation,
management, and/or financing of a clinical trial
