ACRP-CP Preparedness baseline Exam
knowledge Questions with Expertly written
solution 2024/2025
Investigator - correct answer A person responsible for the
conduct of the clinical trial at a trial site. If a trial is conducted
by a team of individuals at a trial site, the investigator is the
responsible leader of the team and may be called the principal
investigator.
Investigator's Brochure - correct answer A compilation of the
clinical and nonclinical data on the investigational product(s)
which is relevant to the study of the investigational product(s) in
human subjects
Legally Acceptable Representative - correct answer An
individual or juridical or other body authorized under applicable
law to consent, on behalf of a prospective subject, to the
subject's participation in the clinical trial.
Monitoring - correct answer The act of overseeing the
progress of a clinical trial, and of ensuring that it is conducted,
recorded, and reported in accordance with the protocol,
Standard Operating Procedures (SOPs), Good Clinical Practice
(GCP), and the applicable regulatory requirement(s).
Nonclinical Study - correct answer Biomedical studies not
performed on human subjects.
,Protocol - correct answer A document that describes the
objective(s), design, methodology, statistical considerations, and
organization of a trial. Usually also gives the background and
rationale for the trial, but these could be provided in other
documents.
Quality Assurance (QA) - correct answer All those planned and
systematic actions that are established to ensure that the trial is
performed and the data are generated, documented (recorded),
and reported in compliance with Good Clinical Practice (GCP)
and the applicable regulatory requirement(s).
Quality Control (QC) - correct answer The operational
techniques and activities undertaken within the quality
assurance system to verify that the requirements for quality of
the trial-related activities have been fulfilled.
Randomization - correct answer The process of assigning trial
subjects to treatment or control groups using an element of
chance to determine the assignments in order to reduce bias.
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction
(Serious ADR) - correct answer Any untoward medical
occurrence that at any dose:- results in death,
- is life-threatening,
- requires inpatient hospitalization or prolongation of existing
hospitalization,
- results in persistent or significant disability/incapacity,
or
- is a congenital anomaly/birth defect
, Source Data - correct answer All information in original
records and certified copies of original records of clinical
findings, observations, or other activities in a clinical trial
necessary for the reconstruction and evaluation of the trial.
_________________ are contained in source documents (original
records or certified copies).
Source Documents - correct answer Original documents, data,
and records (e.g., hospital records, clinical and office charts,
laboratory notes, memoranda, subjects' diaries or evaluation
checklists, pharmacy dispensing records, recorded data from
automated instruments, copies or transcriptions certified after
verification as being accurate copies, microfiches, photographic
negatives, microfilm or magnetic media, x-rays, subject files, and
records kept at the pharmacy, at the laboratories and at medico-
technical departments involved in the clinical trial).
Sponsor-Investigator - correct answer An individual who both
initiates and actually conducts, alone or with others, a clinical
investigation, i.e., under whose immediate direction the test
article is administered or dispensed to, or used involving, a
subject.
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.,
Investigator's Brochure for an unapproved investigational
product or package insert/summary of product characteristics for
an approved product).
