CITI TRAINING GOOD CLINICAL PRACTICE
ESSENTIAL STUDY QUESTIONS AND ANSWERS
◉ Long-term toxicology of an experimental drug in animals most
likely refers to which part of drug development?
Answer: Preclinical
◉ Pharmacokinetics and pharmacodynamics of a new formulation
of an investigational drug most likely refers to which clinical phase
of a study in humans?
Answer: Phase I
◉ For a Phase I new drug study in humans, what is the primary
source of the data included in the initial Investigator's Brochure?
Answer: Preclinical data
◉ A primary purpose of the ICH is to:
Answer: Minimize the need for redundant research.
◉ The ICH GCP guidelines:
Answer: Set standards for the design, conduct, monitoring and
reporting of clinical research.
, ◉ ICH E6 describes standards that apply to:
Answer: Investigators, sponsors, and IRBs
◉ In the United States, following the ICH E6 guideline is:
Answer: Voluntary for FDA-regulated drug studies.
◉ The new ICH E6(R2) integrated addendum requires sponsors to
implement systems to manage quality throughout all stages of the
trial process. The system should use a risk-based approach including
which of the following?
Answer: Identification of study risks to determine which may safely
be omitted from continual monitoring.
◉ What is the status of ICH in U.S.?
Answer: It is a FDA guidance.
◉ ICH E6 has broader requirements than FDA or HHS concerning
confidentiality of medical records and access by third parties. If
investigators are complying with ICH E6 guideline, they must:
Answer: Clearly disclose to subjects in the informed consent form
that the monitor, auditor, IRB/IEC, and the regulatory authorities
may have access to the subject's medical records
ESSENTIAL STUDY QUESTIONS AND ANSWERS
◉ Long-term toxicology of an experimental drug in animals most
likely refers to which part of drug development?
Answer: Preclinical
◉ Pharmacokinetics and pharmacodynamics of a new formulation
of an investigational drug most likely refers to which clinical phase
of a study in humans?
Answer: Phase I
◉ For a Phase I new drug study in humans, what is the primary
source of the data included in the initial Investigator's Brochure?
Answer: Preclinical data
◉ A primary purpose of the ICH is to:
Answer: Minimize the need for redundant research.
◉ The ICH GCP guidelines:
Answer: Set standards for the design, conduct, monitoring and
reporting of clinical research.
, ◉ ICH E6 describes standards that apply to:
Answer: Investigators, sponsors, and IRBs
◉ In the United States, following the ICH E6 guideline is:
Answer: Voluntary for FDA-regulated drug studies.
◉ The new ICH E6(R2) integrated addendum requires sponsors to
implement systems to manage quality throughout all stages of the
trial process. The system should use a risk-based approach including
which of the following?
Answer: Identification of study risks to determine which may safely
be omitted from continual monitoring.
◉ What is the status of ICH in U.S.?
Answer: It is a FDA guidance.
◉ ICH E6 has broader requirements than FDA or HHS concerning
confidentiality of medical records and access by third parties. If
investigators are complying with ICH E6 guideline, they must:
Answer: Clearly disclose to subjects in the informed consent form
that the monitor, auditor, IRB/IEC, and the regulatory authorities
may have access to the subject's medical records
