CCDM CERTIFICATION EXAM QUESTIONS
AND VERIFIED ANSWERS 2026
▶ Adverse Drug Reaction (ADR). Answer: In the pre-approval clinical
experience with a new medicinal product or its new usages, particularly as
the therapeutic dose(s) may not be established: all noxious and unintended
responses to a medicinal product related to any dose should be considered
adverse drug reactions.
▶ Adverse Event (AE). Answer: In a subject or clinical-investigation
subject administered a pharmaceutical product, any untoward medical
occurrence which does not necessarily have a relationship with the
treatment.
▶ Analysis Dataset/ Analysis File. Answer: The final data set, including
derived items and excluding redundant data points, which is used to
perform the analyses required for safety assessment, efficacy assessment,
submission to regulatory authorities, or other review. (Can be 1 or more
files)
▶ Annotated CRF. Answer: A document that maps the names of collected
items to their corresponding database tables, variable item names, forms,
visits and any other objects needed for someone to correctly analyze data
collected in a trial. Required for someone to understand where variables for
analysis originate.
▶ Applicable Regulatory Requirements. Answer: Any law(s) and
regulation(s) addressing the conduct of clinical trials of investigational
products.
▶ Application Service Provider (ASP). Answer: A vendor who provides,
manages and distributes software based services to customers over a
network
▶ 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,
Good Clinical Practice (GCP), and the applicable regulatory requirements
▶ 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
AND VERIFIED ANSWERS 2026
▶ Adverse Drug Reaction (ADR). Answer: In the pre-approval clinical
experience with a new medicinal product or its new usages, particularly as
the therapeutic dose(s) may not be established: all noxious and unintended
responses to a medicinal product related to any dose should be considered
adverse drug reactions.
▶ Adverse Event (AE). Answer: In a subject or clinical-investigation
subject administered a pharmaceutical product, any untoward medical
occurrence which does not necessarily have a relationship with the
treatment.
▶ Analysis Dataset/ Analysis File. Answer: The final data set, including
derived items and excluding redundant data points, which is used to
perform the analyses required for safety assessment, efficacy assessment,
submission to regulatory authorities, or other review. (Can be 1 or more
files)
▶ Annotated CRF. Answer: A document that maps the names of collected
items to their corresponding database tables, variable item names, forms,
visits and any other objects needed for someone to correctly analyze data
collected in a trial. Required for someone to understand where variables for
analysis originate.
▶ Applicable Regulatory Requirements. Answer: Any law(s) and
regulation(s) addressing the conduct of clinical trials of investigational
products.
▶ Application Service Provider (ASP). Answer: A vendor who provides,
manages and distributes software based services to customers over a
network
▶ 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,
Good Clinical Practice (GCP), and the applicable regulatory requirements
▶ 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
