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CCDM certification exam - Part 1 Questions
with Detailed Verified Answers
Question: Access Control
Ans✅ ✅: Policy and procedure that defines accessibility to a physical space or
electronic source of information. The policy usually includes the concept of audit trails,
either paper (ie.signature log) or electronic.
Question: Adverse Drug Reaction (ADR)
Ans✅ ✅: 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.
Question: Adverse Event (AE)
Ans✅ ✅: 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.
Question: Analysis Dataset/ Analysis File
Ans✅ ✅: 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)
Question: Annotated CRF
Ans✅ ✅: 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.
Question: Applicable Regulatory Requirements
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Ans✅ ✅: Any law(s) and regulation(s) addressing the conduct of clinical trials of
investigational products.
Question: Application Service Provider (ASP)
Ans✅ ✅: A vendor who provides, manages and distributes software based services
to customers over a network
Question: Approval (in relation to IRB)
Ans✅ ✅: 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
Question: Audit
Ans✅ ✅: 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.
Question: Audit Certificate
Ans✅ ✅: A declaration of confirmation by the auditor that an audit has taken place.
Question: Audit Report
Ans✅ ✅: A written evaluation by the sponsor's auditor of the results of the audit.
Question: Audit Trail
Ans✅ ✅: Documentation that allows reconstruction of the course of events.
Question: Batch Job
Ans✅ ✅: 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.
Question: Biologics
CCDM certification exam - Part 1 Questions
with Detailed Verified Answers
Question: Access Control
Ans✅ ✅: Policy and procedure that defines accessibility to a physical space or
electronic source of information. The policy usually includes the concept of audit trails,
either paper (ie.signature log) or electronic.
Question: Adverse Drug Reaction (ADR)
Ans✅ ✅: 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.
Question: Adverse Event (AE)
Ans✅ ✅: 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.
Question: Analysis Dataset/ Analysis File
Ans✅ ✅: 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)
Question: Annotated CRF
Ans✅ ✅: 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.
Question: Applicable Regulatory Requirements
, Page | 2
Ans✅ ✅: Any law(s) and regulation(s) addressing the conduct of clinical trials of
investigational products.
Question: Application Service Provider (ASP)
Ans✅ ✅: A vendor who provides, manages and distributes software based services
to customers over a network
Question: Approval (in relation to IRB)
Ans✅ ✅: 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
Question: Audit
Ans✅ ✅: 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.
Question: Audit Certificate
Ans✅ ✅: A declaration of confirmation by the auditor that an audit has taken place.
Question: Audit Report
Ans✅ ✅: A written evaluation by the sponsor's auditor of the results of the audit.
Question: Audit Trail
Ans✅ ✅: Documentation that allows reconstruction of the course of events.
Question: Batch Job
Ans✅ ✅: 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.
Question: Biologics
