ACRP Exam (NEW 2024/ 2025 Update)
Questions and Verified Answers| 100%
Correct| Graded A
QUESTION
A document that describes the objective(s), design, methodology, statistical considerations and
organization of a trial is a:
a. protocol
b. monitoring plan
c. investigator agreement
d. information sheet
Answer:
a
QUESTION
Which phase of trial primarily focuses on confirming effectiveness and establishing a safety
profile in subjects with the disease or condition and other concurrent illnesses and medications?
a. phase 1
b. phase 2
c. phase 3
d. phase 4
Answer:
c
QUESTION
Which of the following are possible methods of recruiting study subjects?
a. researching the condition under study to better understand it
b. advertisements and physician referrals
c. offering large payments for participation
d. enrolling every patient that comes to the facility
,Answer:
b
QUESTION
Which of the following is not considered a source document?
a. subject's medical records
b. PET scan results for the subject
c. subject's private calendar
d. informed consent signed by subject
Answer:
c
QUESTION
Essential documents permit all of the following EXCEPT
a. noncompliance with GCP for the study investigator
b. evaluation of the conduct of a trial and the quality of the data produced
c. confirmation of the validity and integrity of the data collected
d. reconstruction of events by auditors, monitors and regulatory inspectors
Answer:
a
QUESTION
Who is responsible for reviewing and approving advertising used for subject recruitment?
a. irb
b. sponsor
c. principal investigator
d. clinical research coordinator
Answer:
,a
QUESTION
A study budget must be:
a. unlimited
b. finalized by the FDA
c. very strict
d. somewhat flexible
Answer:
d
QUESTION
The research staff that conducts the informed consent discussion and signs the informed consent
form must be
a. a RN, LPN, NP or MD
b. trained and delegated
c. qualified, trained, and delegated
d. a BS, BA, MD or PhD
Answer:
c
QUESTION
ICH GCP E6 R2 states that informed consent is documented by means of a:
a. written and dated informed consent form
b. written and signed informed consent form
c. written, signed and dated informed consent form
d. written, initialed and signed informed consent form
Answer:
c
, QUESTION
Case report forms (CRFs) are typically developed by the ____ and the ____ performs source
document verification
Answer:
sponsor; CRA
QUESTION
What aspect of data recording and collection is most likely to trigger an automated system query
in an electronic case report form?
a. investigator handwriting
b. non-timely submission of form
c. coordinator handwriting
d. missing information or blank fields
Answer:
d
QUESTION
The FDA uses the term ____ to refer to the case report form and its supporting documents,
including any source documents
Answer:
case histories
QUESTION
Costs that are incurred even if a subject is never enrolled are:
Answer:
fixed costs
Questions and Verified Answers| 100%
Correct| Graded A
QUESTION
A document that describes the objective(s), design, methodology, statistical considerations and
organization of a trial is a:
a. protocol
b. monitoring plan
c. investigator agreement
d. information sheet
Answer:
a
QUESTION
Which phase of trial primarily focuses on confirming effectiveness and establishing a safety
profile in subjects with the disease or condition and other concurrent illnesses and medications?
a. phase 1
b. phase 2
c. phase 3
d. phase 4
Answer:
c
QUESTION
Which of the following are possible methods of recruiting study subjects?
a. researching the condition under study to better understand it
b. advertisements and physician referrals
c. offering large payments for participation
d. enrolling every patient that comes to the facility
,Answer:
b
QUESTION
Which of the following is not considered a source document?
a. subject's medical records
b. PET scan results for the subject
c. subject's private calendar
d. informed consent signed by subject
Answer:
c
QUESTION
Essential documents permit all of the following EXCEPT
a. noncompliance with GCP for the study investigator
b. evaluation of the conduct of a trial and the quality of the data produced
c. confirmation of the validity and integrity of the data collected
d. reconstruction of events by auditors, monitors and regulatory inspectors
Answer:
a
QUESTION
Who is responsible for reviewing and approving advertising used for subject recruitment?
a. irb
b. sponsor
c. principal investigator
d. clinical research coordinator
Answer:
,a
QUESTION
A study budget must be:
a. unlimited
b. finalized by the FDA
c. very strict
d. somewhat flexible
Answer:
d
QUESTION
The research staff that conducts the informed consent discussion and signs the informed consent
form must be
a. a RN, LPN, NP or MD
b. trained and delegated
c. qualified, trained, and delegated
d. a BS, BA, MD or PhD
Answer:
c
QUESTION
ICH GCP E6 R2 states that informed consent is documented by means of a:
a. written and dated informed consent form
b. written and signed informed consent form
c. written, signed and dated informed consent form
d. written, initialed and signed informed consent form
Answer:
c
, QUESTION
Case report forms (CRFs) are typically developed by the ____ and the ____ performs source
document verification
Answer:
sponsor; CRA
QUESTION
What aspect of data recording and collection is most likely to trigger an automated system query
in an electronic case report form?
a. investigator handwriting
b. non-timely submission of form
c. coordinator handwriting
d. missing information or blank fields
Answer:
d
QUESTION
The FDA uses the term ____ to refer to the case report form and its supporting documents,
including any source documents
Answer:
case histories
QUESTION
Costs that are incurred even if a subject is never enrolled are:
Answer:
fixed costs
