1
ACRP-CP Certification Exam| most recent
|COMPLETE MOST TESTED QUESTIONS
AND VERIFIED ANSWERS | (100% correct
solutions)|GET IT A+ RIGHT!!
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
,2
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
,3
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
, 4
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
When should a research study involving human subjects be registered in a
publicly accessible database? - (ANSWER)Before recruiting the first subject
In the case of an incapacitated subject: who should receive a copy of the signed
and dated ICF? - (ANSWER)The subjects legally acceptable representative
ACRP-CP Certification Exam| most recent
|COMPLETE MOST TESTED QUESTIONS
AND VERIFIED ANSWERS | (100% correct
solutions)|GET IT A+ RIGHT!!
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
,2
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
,3
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
, 4
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
When should a research study involving human subjects be registered in a
publicly accessible database? - (ANSWER)Before recruiting the first subject
In the case of an incapacitated subject: who should receive a copy of the signed
and dated ICF? - (ANSWER)The subjects legally acceptable representative
