ACRP-CP Certification UPDATED
ACTUAL Exam Questions and CORRECT
Answers
What would be the first priority for an investigator when a subject wishes to withdraw
prematurely from the trial? - CORRECT 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 - CORRECT ANSWER - Validation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling is to - CORRECT
ANSWER - maintain an audit trail, data trail, and edit trail.
A research subject's responsibilities for study participation should be described in the -
CORRECT ANSWER - ICF
What document would an investigator reference to learn more about the previous clinical and
nonclinical results of studies of the IP? - CORRECT ANSWER - Investigators brochure
During a multi site clinical study: whose responsibility is it to report subject recruitment rate? -
CORRECT 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 - CORRECT 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... - CORRECT 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? - CORRECT 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? - CORRECT
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? - CORRECT 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?
- CORRECT ANSWER - PI
Which of the following required elements should be included in a clinical trial protocol? -
CORRECT 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 - CORRECT 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? - CORRECT ANSWER - Electronic medical
record
, When considering participation in a study: the investigator should determine if he... - CORRECT
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 - CORRECT 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? - CORRECT ANSWER - 3 Years
When would an impartial witness be needed during the consent process for an illiterate subject? -
CORRECT 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 - CORRECT 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? - CORRECT 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? - CORRECT ANSWER - ICF
When should a research study involving human subjects be registered in a publicly accessible
database? - CORRECT ANSWER - Before recruiting the first subject
In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF? -
CORRECT ANSWER - The subjects legally acceptable representative
ACTUAL Exam Questions and CORRECT
Answers
What would be the first priority for an investigator when a subject wishes to withdraw
prematurely from the trial? - CORRECT 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 - CORRECT ANSWER - Validation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling is to - CORRECT
ANSWER - maintain an audit trail, data trail, and edit trail.
A research subject's responsibilities for study participation should be described in the -
CORRECT ANSWER - ICF
What document would an investigator reference to learn more about the previous clinical and
nonclinical results of studies of the IP? - CORRECT ANSWER - Investigators brochure
During a multi site clinical study: whose responsibility is it to report subject recruitment rate? -
CORRECT 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 - CORRECT 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... - CORRECT 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? - CORRECT 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? - CORRECT
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? - CORRECT 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?
- CORRECT ANSWER - PI
Which of the following required elements should be included in a clinical trial protocol? -
CORRECT 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 - CORRECT 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? - CORRECT ANSWER - Electronic medical
record
, When considering participation in a study: the investigator should determine if he... - CORRECT
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 - CORRECT 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? - CORRECT ANSWER - 3 Years
When would an impartial witness be needed during the consent process for an illiterate subject? -
CORRECT 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 - CORRECT 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? - CORRECT 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? - CORRECT ANSWER - ICF
When should a research study involving human subjects be registered in a publicly accessible
database? - CORRECT ANSWER - Before recruiting the first subject
In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF? -
CORRECT ANSWER - The subjects legally acceptable representative
