ACRP CCRC Study Guide (NEW 2024/ 2025
Update) Questions and Verified Answers|
100% Correct| Grade A
QUESTION
Legally Acceptable Representative (LAR)
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 CT.
QUESTION
Monitoring
Answer:
The act of overseeing the progress of a CT, and of ensuring that it is conducted, recorded, and
reported in accordance with the protocol, SOPs, GCP, and the applicable regulatory
requirement(s).
QUESTION
Monitoring Report
Answer:
A written report from the monitor to the sponsor after each site visit and/or other trial-related
communication according to the sponsor's SOPs.
QUESTION
Multicenter Trial
Answer:
A clinical trial conducted according to a single protocol but at more than one site, and therefore,
carried out by more than one investigator.
,QUESTION
Nonclinical Study
Answer:
Biomedical studies not performed on human subjects.
QUESTION
IEC Opinion
Answer:
The judgment and/or the advice provided by an Independent
Ethics Committee (IEC).
QUESTION
Protocol
Answer:
A document that describes the objective(s), design, methodology, statistical considerations, and
organization of a trial.
Usually gives the background and rationale for the trial, but could be provided in other related
documents.
QUESTION
Protocol Amendment
Answer:
A written description of changes to or formal clarification of a protocol. (ICH GCP E6 1.45)
QUESTION
Quality Assurance (QA)
Answer:
All those planned and systematic actions that are established to ensure that the trial is performed
ad the data are generated, doc- umented, and reported in compliance with GCP and the
applicable regulatory requirements.
,QUESTION
Quality Control (QC)
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.
QUESTION
Randomization
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.
QUESTION
Regulatory Authorities
Answer:
Bodies having the power to regulate.
In the ICH GCP Guideline, the expression includes the authorities that review submitted clinical
data and those that conduct inspections (see 1.29).
These bodies are sometimes referred to as competent authorities.
QUESTION
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious
ADR)
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
QUESTION
Source data
, Answer:
All information in original records and certified copies of original records of clinical findings,
observations, or other activities in a clinical trial neces- sary for the reconstruction and
evaluation of the trial.
QUESTION
Source Documents
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 au- tomated 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 a
medico-technical departments involved in the clinical trial).
QUESTION
Sponsor
Answer:
An individual, company, institution, or organization which takes re- sponsibility for the
initiation, management, and/or financing of a clinical trial
QUESTION
Sponsor-Investigator
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. The term does not include any other person other than an
individual, e.g. corporation or agency. (21 CFR, sec. 50.3)
QUESTION
Standard Operating Procedures (SOPs)
Answer:
Detailed, written instructions to achieve uniformity of the performance of a specific function.
Update) Questions and Verified Answers|
100% Correct| Grade A
QUESTION
Legally Acceptable Representative (LAR)
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 CT.
QUESTION
Monitoring
Answer:
The act of overseeing the progress of a CT, and of ensuring that it is conducted, recorded, and
reported in accordance with the protocol, SOPs, GCP, and the applicable regulatory
requirement(s).
QUESTION
Monitoring Report
Answer:
A written report from the monitor to the sponsor after each site visit and/or other trial-related
communication according to the sponsor's SOPs.
QUESTION
Multicenter Trial
Answer:
A clinical trial conducted according to a single protocol but at more than one site, and therefore,
carried out by more than one investigator.
,QUESTION
Nonclinical Study
Answer:
Biomedical studies not performed on human subjects.
QUESTION
IEC Opinion
Answer:
The judgment and/or the advice provided by an Independent
Ethics Committee (IEC).
QUESTION
Protocol
Answer:
A document that describes the objective(s), design, methodology, statistical considerations, and
organization of a trial.
Usually gives the background and rationale for the trial, but could be provided in other related
documents.
QUESTION
Protocol Amendment
Answer:
A written description of changes to or formal clarification of a protocol. (ICH GCP E6 1.45)
QUESTION
Quality Assurance (QA)
Answer:
All those planned and systematic actions that are established to ensure that the trial is performed
ad the data are generated, doc- umented, and reported in compliance with GCP and the
applicable regulatory requirements.
,QUESTION
Quality Control (QC)
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.
QUESTION
Randomization
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.
QUESTION
Regulatory Authorities
Answer:
Bodies having the power to regulate.
In the ICH GCP Guideline, the expression includes the authorities that review submitted clinical
data and those that conduct inspections (see 1.29).
These bodies are sometimes referred to as competent authorities.
QUESTION
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious
ADR)
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
QUESTION
Source data
, Answer:
All information in original records and certified copies of original records of clinical findings,
observations, or other activities in a clinical trial neces- sary for the reconstruction and
evaluation of the trial.
QUESTION
Source Documents
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 au- tomated 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 a
medico-technical departments involved in the clinical trial).
QUESTION
Sponsor
Answer:
An individual, company, institution, or organization which takes re- sponsibility for the
initiation, management, and/or financing of a clinical trial
QUESTION
Sponsor-Investigator
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. The term does not include any other person other than an
individual, e.g. corporation or agency. (21 CFR, sec. 50.3)
QUESTION
Standard Operating Procedures (SOPs)
Answer:
Detailed, written instructions to achieve uniformity of the performance of a specific function.
