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CITI Training: Revised Common Rule – Complete Study Guide and Practice Questions

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This document covers the key concepts of the CITI Training Revised Common Rule, including the ethical principles of human subjects research, informed consent, institutional review boards (IRBs), exempt and expedited research, vulnerable populations, and federal regulatory requirements. It includes organized study notes, key definitions, and practice questions with answers to help learners prepare for CITI training modules and certification assessments. The material is structured for efficient review and reinforces the regulatory and ethical standards governing human subjects research.

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CITI TRAINING: REVISED
COMMON RULE WITH VERIFIED
QUESTIONS AND ANSWERS
GRADED A+ 2026 VERSION!!
Which of the following is accurate regarding electronic signatures? - answer-Specifically
allowed by the Final Rule



The Final Rule added the requirement that: - answer-Key information essential to
decision making receive priority by appearing at the beginning of the consent document
and being presented first in the consent discussion.



Research approved on 1 September 2019 conducted by a regulated entity would be
subject to: - answer-Final Rule (2018 Requirements)



The compliance date for cooperative review is: - answer-Three years from publishing the
2017 Final Rule in the Federal Register



Broad consent for storage, maintenance, and secondary research use may be obtained:
- answer-In lieu of a full informed consent



The following category of research was added to the "Exempt Research" section at
46.104: - answer-Benign behavioral interventions



The two exempt research categories that always require limited IRB review as a
condition of exemption are: Storage or maintenance for secondary research for which
broad consent is required (Category 7) and which of the following? - answer-Secondary
research for which broad consent is required (Category 8)



The Final Rule's general compliance date is: - answer-21 January 2019

, The Final Rule revised the definition of "written or in writing" to clarify: - answer-That
these terms include electronic formats



The definition of "research" was expanded to: - answer-List activities that are
specifically deemed not to be research



The Final Rule made revisions to the following definition: - answer-Human subject



Which of the following definitions was added by the Final Rule? - answer-Written or in
writings



Why was adding the definition of public health authority important? - answer-Certain
public health surveillance activities are now excluded from the definition of research



The three new terms added to the definitions section include: - answer-Clinical trial,
public health authority, and written or in writing



Benign behavioral interventions are activities that: - answer-Pose little risk of harm to
subjects



Which of the following definitions remained unchanged in the Final Rule? - answer-
Institutional Review Board (IRB)



Identify the new term added by the Final Rule that should be used for determining which
studies require posting of the IRB-approved consent form used to enroll subjects: -
answer-Clinical trial



The term "vulnerable" was: - answer-Not included in the definitions section



Examples of vulnerable populations in the Final Rule no longer include: - answer-
Pregnant women

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