CCDM PRACTICE EXAM QUESTIONS AND
DETAILED SOLUTIONS 2026
▶ Audit. Answer: A systematic and independent examination of trial-
related activities and documents to determine whether the trial-related
activities being evaluated were conducted and the data were recorded,
analyzed and accurately reported according to the protocol, the sponsor's
SOPs, GCP, and applicable 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.
▶ Batch Job. Answer: A series of procedures run in an electronic system
that perform specific tasks, such as data validation, query generation,
external data upload, or lab reference range normalization.
▶ Biologics. Answer: A biological product (is. vaccine or blood serum)
used in medicine.
▶ Binding/Masking. Answer: A procedure in which one or more parties is
kept unaware of treatment assignments.
▶ Single Blind Study. Answer: Study in which the subjects do not know if
they are in the experimental or the control group.
▶ Double Blind Study. Answer: An experiment in which neither the
participant nor the researcher knows whether the participant has received
the treatment or the placebo
, ▶ 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.
▶ CDISC. Answer: Clinical Data Interchange Standards Consortium
▶ Central Lab. Answer: A vendor contracted for a clinical trial that
processes samples collected from subjects an dprovides results of lab test
or other medical analysis (in
ECG, pathology results) to the sponsor.
▶ Change Control. Answer: A procedure that defines how planned
changes to any part of a computer system are handled in a manner as to
maintain compliance with required functionality of that system. The
procedure ensures changes to the system don't unexpectedly impact
functionality of systems.
▶ Checklist. Answer: (ASQ) A tool used to ensure all important steps or
actions in an operation have been taken.
▶ Clinical Laboratory Improvement Amendments (CLIA). Answer: Passed
in 1988; establishes quality standards for all laboratory testing; ensures the
accuracy, reliability, and timeliness of patient test results, regardless of
where the test is performed
▶ Clinical Trial/Study. Answer: An investigation using human subjects
intended to discover or verify clinical, pharmalogical, or pharmacodynamic
effects of an investigational product or to identify AEs and/or to study
absorption, distribution, metabolism, and excretion of an investigational
product for the purpose of ascertaining its safety and/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.
▶ Code Libraries. Answer: A repository of validated programming logic
that can be used in the collection, review or analysis of clinical trial data.
DETAILED SOLUTIONS 2026
▶ Audit. Answer: A systematic and independent examination of trial-
related activities and documents to determine whether the trial-related
activities being evaluated were conducted and the data were recorded,
analyzed and accurately reported according to the protocol, the sponsor's
SOPs, GCP, and applicable 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.
▶ Batch Job. Answer: A series of procedures run in an electronic system
that perform specific tasks, such as data validation, query generation,
external data upload, or lab reference range normalization.
▶ Biologics. Answer: A biological product (is. vaccine or blood serum)
used in medicine.
▶ Binding/Masking. Answer: A procedure in which one or more parties is
kept unaware of treatment assignments.
▶ Single Blind Study. Answer: Study in which the subjects do not know if
they are in the experimental or the control group.
▶ Double Blind Study. Answer: An experiment in which neither the
participant nor the researcher knows whether the participant has received
the treatment or the placebo
, ▶ 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.
▶ CDISC. Answer: Clinical Data Interchange Standards Consortium
▶ Central Lab. Answer: A vendor contracted for a clinical trial that
processes samples collected from subjects an dprovides results of lab test
or other medical analysis (in
ECG, pathology results) to the sponsor.
▶ Change Control. Answer: A procedure that defines how planned
changes to any part of a computer system are handled in a manner as to
maintain compliance with required functionality of that system. The
procedure ensures changes to the system don't unexpectedly impact
functionality of systems.
▶ Checklist. Answer: (ASQ) A tool used to ensure all important steps or
actions in an operation have been taken.
▶ Clinical Laboratory Improvement Amendments (CLIA). Answer: Passed
in 1988; establishes quality standards for all laboratory testing; ensures the
accuracy, reliability, and timeliness of patient test results, regardless of
where the test is performed
▶ Clinical Trial/Study. Answer: An investigation using human subjects
intended to discover or verify clinical, pharmalogical, or pharmacodynamic
effects of an investigational product or to identify AEs and/or to study
absorption, distribution, metabolism, and excretion of an investigational
product for the purpose of ascertaining its safety and/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.
▶ Code Libraries. Answer: A repository of validated programming logic
that can be used in the collection, review or analysis of clinical trial data.
