ACRP-CP CERTIFICATION EXAM COMPLETE QUESTIONS AND
ANSWERS 2024-2025| GUARANTEED PASS| GET IT CORRECT !!
What would be the first priority for an investigator when a subject wishes to withdraw
prematurely from the trial? - (answer)Try to obtain the subject's reason for withdrawal.
CRO recently switched from paper CRF to an EDC system. The EDC system must conform to
the established requirements for - (answer)Validation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling is to -
(answer)maintain an audit trail, data trail, and edit trail.
以下是关于“生物
A research subject's responsibilities 呼吸作用：生物学的核
for study participation should be described in the -
心能量过程
(answer)ICF
引言
呼吸作用是所有生物体
生命活动的基础。它是
What document would an investigator reference to learn more about the previous clinical and
将有机物分解为简单化
合物并释放能量的过程
nonclinical results of studies of the IP? - (answer)Investigators brochure
，能量通常以ATP（三磷
酸腺苷）的形式储存，
为生物体的代谢活动提
供动力。本论文旨在详
细探讨呼吸作用的机制
,During a multi site clinical study: whose responsibility is it to report subject recruitment rate? -
(answer)The CRA
An unconscious adult subject was enrolled in a study after obtaining consent from an LAR: and
protocol therapy was initiated. The subject showed significant improvement in his clinical
condition: and regained consciousness. The Investigator should inform the subject about the
study and - (answer)Obtain consent from the subject for the study
A site is in the start up phase of an industry sponsored phase 3 trial: and has received IRB
approval. The site can begin enrolling subjects after... - (answer)A signed clinical trial agreement
between the site and sponsor is in place.
A site is screening potential subjects for a study looking at mild cognitive impairment. One of the
以下是关于“生物
inclusion criteria is a score of 25 or less on a psychometric test: a research specific tool which
measures cognitive ability. Which of the following individuals can administer the psychometric
呼吸作用：生物学的核
心能量过程
test to the potential subjects? - (answer)A research assistant who is certified to administer the
psychometric test 引言
呼吸作用是所有生物体
生命活动的基础。它是
将有机物分解为简单化
合物并释放能量的过程
，能量通常以ATP（三磷
酸腺苷）的形式储存，
为生物体的代谢活动提
供动力。本论文旨在详
细探讨呼吸作用的机制
,A research study: in which there is no intended clinical benefit to the subject: is being submitted
to the IRB. What benefit information should be included in the ICF? - (answer)Wording
indicating that there is no expected benefit should be included
A CRA notices during an onsite visit that the date on IRB approval letter for a protocol is prior to
the effective date indicated on the cover page of the protocol and the signatures of the
investigator and sponsor. What should the CRA do FIRST? - (answer)Confirm dates of initial
receipt of the sponsor protocol and the IRB submission dates.
In a multi arm: randomized clinical trial: one arm of the protocol was terminated due to an
increased risk of cancer in subjects. Who is responsible for providing a written report to the IRB?
- (answer)PI
Which of the following required elements should be included in a clinical trial protocol? -
以下是关于“生物
(answer)Subject inclusion and exclusion criteria
呼吸作用：生物学的核
心能量过程
Prior to archiving a study: documentation of IP destruction at the site should be filed in the study
引言
files of the - (answer)PI and Sponsor
呼吸作用是所有生物体
生命活动的基础。它是
将有机物分解为简单化
合物并释放能量的过程
During a monitoring visit: what records would a CRA reference to verify a subject's compliance
，能量通常以ATP（三磷
to the study visit schedule and assessments? - (answer)Electronic medical record
酸腺苷）的形式储存，
为生物体的代谢活动提
供动力。本论文旨在详
细探讨呼吸作用的机制
, When considering participation in a study: the investigator should determine if he... -
(answer)Sees enough patients who would qualify for the study
New safety information has become available from the Sponsor about the IP being used in a
clinical trial. The investigator must - (answer)Submit a revised ICF to the IRB noting the new
safety information
Per ICH: an IRB must keep correspondence for at least how long after the completion of a
clinical trial? - (answer)3 Years
When would an impartial witness be needed during the consent process for an illiterate subject? -
(answer)To observe the consent process
以下是关于“生物
A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism
呼吸作用：生物学的核
is considered to be - (answer)Phase II
心能量过程
引言
呼吸作用是所有生物体
After completion of a study: the final trial close out monitoring report prepared by the CRA
生命活动的基础。它是
将有机物分解为简单化
should be filed in which of the following stakeholder files? - (answer)The sponsors files
合物并释放能量的过程
，能量通常以ATP（三磷
酸腺苷）的形式储存，
为生物体的代谢活动提
供动力。本论文旨在详
细探讨呼吸作用的机制
ANSWERS 2024-2025| GUARANTEED PASS| GET IT CORRECT !!
What would be the first priority for an investigator when a subject wishes to withdraw
prematurely from the trial? - (answer)Try to obtain the subject's reason for withdrawal.
CRO recently switched from paper CRF to an EDC system. The EDC system must conform to
the established requirements for - (answer)Validation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling is to -
(answer)maintain an audit trail, data trail, and edit trail.
以下是关于“生物
A research subject's responsibilities 呼吸作用：生物学的核
for study participation should be described in the -
心能量过程
(answer)ICF
引言
呼吸作用是所有生物体
生命活动的基础。它是
What document would an investigator reference to learn more about the previous clinical and
将有机物分解为简单化
合物并释放能量的过程
nonclinical results of studies of the IP? - (answer)Investigators brochure
，能量通常以ATP（三磷
酸腺苷）的形式储存，
为生物体的代谢活动提
供动力。本论文旨在详
细探讨呼吸作用的机制
,During a multi site clinical study: whose responsibility is it to report subject recruitment rate? -
(answer)The CRA
An unconscious adult subject was enrolled in a study after obtaining consent from an LAR: and
protocol therapy was initiated. The subject showed significant improvement in his clinical
condition: and regained consciousness. The Investigator should inform the subject about the
study and - (answer)Obtain consent from the subject for the study
A site is in the start up phase of an industry sponsored phase 3 trial: and has received IRB
approval. The site can begin enrolling subjects after... - (answer)A signed clinical trial agreement
between the site and sponsor is in place.
A site is screening potential subjects for a study looking at mild cognitive impairment. One of the
以下是关于“生物
inclusion criteria is a score of 25 or less on a psychometric test: a research specific tool which
measures cognitive ability. Which of the following individuals can administer the psychometric
呼吸作用：生物学的核
心能量过程
test to the potential subjects? - (answer)A research assistant who is certified to administer the
psychometric test 引言
呼吸作用是所有生物体
生命活动的基础。它是
将有机物分解为简单化
合物并释放能量的过程
，能量通常以ATP（三磷
酸腺苷）的形式储存，
为生物体的代谢活动提
供动力。本论文旨在详
细探讨呼吸作用的机制
,A research study: in which there is no intended clinical benefit to the subject: is being submitted
to the IRB. What benefit information should be included in the ICF? - (answer)Wording
indicating that there is no expected benefit should be included
A CRA notices during an onsite visit that the date on IRB approval letter for a protocol is prior to
the effective date indicated on the cover page of the protocol and the signatures of the
investigator and sponsor. What should the CRA do FIRST? - (answer)Confirm dates of initial
receipt of the sponsor protocol and the IRB submission dates.
In a multi arm: randomized clinical trial: one arm of the protocol was terminated due to an
increased risk of cancer in subjects. Who is responsible for providing a written report to the IRB?
- (answer)PI
Which of the following required elements should be included in a clinical trial protocol? -
以下是关于“生物
(answer)Subject inclusion and exclusion criteria
呼吸作用：生物学的核
心能量过程
Prior to archiving a study: documentation of IP destruction at the site should be filed in the study
引言
files of the - (answer)PI and Sponsor
呼吸作用是所有生物体
生命活动的基础。它是
将有机物分解为简单化
合物并释放能量的过程
During a monitoring visit: what records would a CRA reference to verify a subject's compliance
，能量通常以ATP（三磷
to the study visit schedule and assessments? - (answer)Electronic medical record
酸腺苷）的形式储存，
为生物体的代谢活动提
供动力。本论文旨在详
细探讨呼吸作用的机制
, When considering participation in a study: the investigator should determine if he... -
(answer)Sees enough patients who would qualify for the study
New safety information has become available from the Sponsor about the IP being used in a
clinical trial. The investigator must - (answer)Submit a revised ICF to the IRB noting the new
safety information
Per ICH: an IRB must keep correspondence for at least how long after the completion of a
clinical trial? - (answer)3 Years
When would an impartial witness be needed during the consent process for an illiterate subject? -
(answer)To observe the consent process
以下是关于“生物
A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism
呼吸作用：生物学的核
is considered to be - (answer)Phase II
心能量过程
引言
呼吸作用是所有生物体
After completion of a study: the final trial close out monitoring report prepared by the CRA
生命活动的基础。它是
将有机物分解为简单化
should be filed in which of the following stakeholder files? - (answer)The sponsors files
合物并释放能量的过程
，能量通常以ATP（三磷
酸腺苷）的形式储存，
为生物体的代谢活动提
供动力。本论文旨在详
细探讨呼吸作用的机制
