ACRP 141 E xam Study Guide Questions with Complete Solutions 100% Verified
2024/2025
What individual serves as the primary liaison between the sponsor and the investigator? - Correct Answer monitor Who is responsible for verifying that the investigator follows the approved protocol and all approved amendments? - Correct Answer monitor Who must be notified if a trial is suspended or terminated prematurely? - Correct Answer the sponsor should promptly inform the investigator/institutions and the regulatory authorities of the termination or suspension and the reasons for the termination or suspension Who must the monitor inform of CRF entry errors, omissions, or illegibly? - Correct Answer investigator factoral design - Correct Answer Used for the specific purpose of examining interaction of A and B; 2 or more treatments are evaluated simultaneously through the use of varying combinations of the treatments
- A alone
- B alone
- both A & B (useful in determining joint effects of A & B)
- neither A or B
*another important use of the design is to establish the dose-response characteristics of the simultaneous use of treatments C & D What are the purposes of multi center trials? - Correct Answer 1. an accepted way of evaluating a new medication more efficiently; may present as the only practical means of accruing sufficient subjects to satisfy the trial objective within a reasonable time-frame 1 / 3
- to provide a better bias for the subsequent generalization of its findings
- to determine the tolerability of the dose range expected to be needed for later clinical studies and to
- characterization of a drug's absorption, distribution, metabolism, and excretion continues throughout
- determine the dose(s) and regimen for phase III trials
- include evaluation of potential study endpoints, therapeutic regimens, and target populations
- determine short term side effects and risks associated with the drug
phase I (human pharmacology) - Correct Answer SAFETY; starts with the initial administration of an investigational new drug into humans; small # of study subjects 20-80 aspects of phase 1 trials
determine the nature of adverse reactions that can be expected
the development plan -pharmacodynamic studies and studies relating drug blood levels to response (PK/PD studies) may be conducted healthy volunteer subjects or in patients with the target disease phase II (therapeutic exploratory) - Correct Answer EFFICACY; the primary objective is to explore therapeutic efficacy in patients; studies are typically conducted in a group of patients who are selected by relatively narrow criteria, leading to a relatively homogenous population and are closely monitored; early studies often utilize dose escalation designs; several 100 subjects goal
phase III (therapeutic confirmatory) - Correct Answer LONG-TERM SAFETY/SURVIVAL; primary objective is to demonstrate, or confirm therapeutic benefit; designed to confirm the preliminary evidence accumulated in phase II that a drug is safe and effective for use in the intended indication and recipient population; they complete the information needed to support adequate instructions for use of the drug (official product information); several 100 - 1000's of subjects studies may further explore the dose-response relationship, or explore the drug's use in wider populations, in different stages of disease, or in combination with another drug *end of phase III is when NDA is sent to the FDA for approval 2 / 3
phase IV (therapeutic use) - Correct Answer POST MARKET; begins after drug approval; are all studies (other than routine surveillance) performed after drug approval and related to the approved indication; address FDA requirements for additional information not in NDA commonly conducted studies include additional drug-drug interaction, dose-response or safety studies, and studies designed to support use under the approved indication, e.g. mortality/morbidity studies, epidemiological studies adverse event - Correct Answer any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment e.g. abnormal laboratory finding, symptom, or disease adverse drug reaction - Correct Answer all noxious and unintended responses to a medicinal product related to any dose phrase "responses to a medicinal products," means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility unexpected adverse drug reaction - Correct Answer an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. IB for an unapproved investigational medicinal product)
- expedited reporting is required for additional occurrences of the reaction
serious adverse event (experience) or reaction - Correct Answer any untoward medicinal occurrence
that at any dose:
- results in death
- is life-threatening (pt. was a risk of death at the time of the event)
- requires inpatient hospitalization or prolongation of existing hospitalization
- / 3