CCDM certification exam - Part 1 Questions and answers Newest RATED A+ 2025/2026

CCDM certification exam - Part 1 Questions and answers
Newest RATED A+ 2025/2026
Access Control - Policy and procedure that defines accessibility to a physical space or electronic
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source of information. The policy usually includes the concept of audit trails, either paper
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(ie.signature log) or electronic.
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Il` Adverse Drug Reaction (ADR) - In the pre-approval clinical experience with a new medicinal
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Il` product or its new usages, particularly as the therapeutic dose(s) may not be established: all
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Il` noxious and unintended responses to a medicinal product related to any dose should be
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Il` considered adverse drug reactions. Il` Il` Il`




Il` Adverse Event (AE) - In a subject or clinical-investigation subject administered a pharmaceutical
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Il` product, any untoward medical occurrence which does not necessarily have a relationship with
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Il` the treatment.
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Il` Analysis Dataset/ Analysis File - The final data set, including derived items and excluding
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Il` redundant data points, which is used to perform the analyses required for safety assessment,
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Il` efficacy assessment, submission to regulatory authorities, or other review. (Can be 1 or more
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Il` files)



Il` Annotated CRF - A document that maps the names of collected items to their corresponding
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Il` database tables, variable item names, forms, visits and any other objects needed for someone to
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Il` correctly analyze data collected in a trial. Required for someone to understand where variables
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Il` for analysis originate.
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Il` Applicable Regulatory Requirements - Any law(s) and regulation(s) addressing the conduct of
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Il` clinical trials of investigational products.
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Il` Application Service Provider (ASP) - A vendor who provides, manages and distributes software
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Il` based services to customers over a network
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, Il` Approval (in relation to IRB) - The affirmative decision of the IRB that the clinical trial has been
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Il` reviewed and may be conducted at the institution site within the constraints set forth by the IRB,
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Il` the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements
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Il` Audit - A systematic and independent examination of trial-related activities and documents to
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Il` determine whether the trial-related activities being evaluated were conducted and the data were
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Il` recorded, analyzed and accurately reported according to the protocol, the sponsor's SOPs, GCP,
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Il` and applicable regulatory requirements.
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Il` Audit Certificate - A declaration of confirmation by the auditor that an audit has taken place.
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Il` Audit Report - A written evaluation by the sponsor's auditor of the results of the audit.
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Il` Audit Trail - Documentation that allows reconstruction of the course of events.
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Il` Batch Job - A series of procedures run in an electronic system that perform specific tasks, such as
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Il` data validation, query generation, external data upload, or lab reference range normalization.
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Il` Biologics - A biological product (is. vaccine or blood serum) used in medicine.
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Il` Binding/Masking - A procedure in which one or more parties is kept unaware of treatment Il` Il` Il` Il` Il` Il` Il` Il` Il` Il` Il` Il` Il` Il`




Il` assignments.



Il` Single Blind Study - Study in which the subjects do not know if they are in the experimental or the
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Il` control group. Il`




Il` Double Blind Study - An experiment in which neither the participant nor the researcher knows
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Il` whether the participant has received the treatment or the placebo
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