Exam (elaborations)
Investigational New Drugs (GCP) Questions and answers 2024/2025
- Course
- GCP
- Institution
- Johns Hopkins University
Investigational New Drugs (GCP) Questions and answers 2024/2025
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Solution 2024/2025Pepper
Investigational New Drugs (GCP)
A. Phase 1
If a drug has never been tested in humans before and the goal of the initial study is to establish the safety and
pharmacokinetics of a single ascending dose in healthy subjects, this study is considered a _____ study.
A. Phase 1
B. Phase 2
C. Phase 3
D. Phase 4
B. Phase 2
A study conducted in a small number of participants, with a specific disease and investigating a number of doses of a
drug to assess safety, is usually considered a _______ study.
A. Phase 1
B. Phase 2
C. Phase 3
D. Phase 4
A. Ensuring all subjects are consented appropriately and documented using the IRB approved Informed Consent form.
An Investigator participating in a clinical trial is responsible for protecting the rights, safety, and welfare of trial
participants. Part of this responsibility is:
A. Ensuring all subjects are consented appropriately and documented using the IRB approved Informed Consent form.
B. Making sure that target enrollment goals are met.
C. Enrolling subjects into the study who meet the exclusion criteria.
D. Ensuring that the names of all subjects participating in the study are available to the general public.
D. Phase 4
After a drug has been approved for marketing, FDA may ask the company selling the drug to continue to examine the
safety of the drug when used long term. These studies are usually considered _____ studies.
A. Phase 1
B. Phase 2
C. Phase 3
D. Phase 4
C. 30
The sponsor must wait _____ calendar days after IND submission before initiating research activities in support of an
Investigational New Drug application (IND).
A. 7
B. 15
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