ACRP-CP Certification Exam Questions
and Answers
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.
A research subject's responsibilities for study participation should be described in the - Answer-ICF
What document would an investigator reference to learn more about the previous clinical and
nonclinical results of studies of the IP? - Answer-Investigators brochure
,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
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 test to the potential
subjects? - Answer-A research assistant who is certified to administer the psychometric test
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? - Answer-
Subject inclusion and exclusion criteria
, Prior to archiving a study: documentation of IP destruction at the site should be filed in the study files of
the - Answer-PI and Sponsor
During a monitoring visit: what records would a CRA reference to verify a subject's compliance to the
study visit schedule and assessments? - Answer-Electronic medical record
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
A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is
considered to be - Answer-Phase II
After completion of a study: the final trial close out monitoring report prepared by the CRA should be
filed in which of the following stakeholder files? - Answer-The sponsors files
A blood sample collection is required to screen for bloodborne pathogens before subject could be
enrolled in a study. Where will subjects find information of the procedures and any foreseeable risks or
inconveniences? - Answer-ICF
and Answers
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.
A research subject's responsibilities for study participation should be described in the - Answer-ICF
What document would an investigator reference to learn more about the previous clinical and
nonclinical results of studies of the IP? - Answer-Investigators brochure
,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
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 test to the potential
subjects? - Answer-A research assistant who is certified to administer the psychometric test
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? - Answer-
Subject inclusion and exclusion criteria
, Prior to archiving a study: documentation of IP destruction at the site should be filed in the study files of
the - Answer-PI and Sponsor
During a monitoring visit: what records would a CRA reference to verify a subject's compliance to the
study visit schedule and assessments? - Answer-Electronic medical record
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
A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is
considered to be - Answer-Phase II
After completion of a study: the final trial close out monitoring report prepared by the CRA should be
filed in which of the following stakeholder files? - Answer-The sponsors files
A blood sample collection is required to screen for bloodborne pathogens before subject could be
enrolled in a study. Where will subjects find information of the procedures and any foreseeable risks or
inconveniences? - Answer-ICF
