ACRP CP CERTIFICATION EXAM QUESTIONS
AND ANSWERS 100% 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.
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
, 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
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
A medical student is approaches by a faculty member for possible participation in a
cricothyroidotomy simulation research study. Which of the following increases risk to the
study? - ANSWER Consenting in the presence of figure of authority
AND ANSWERS 100% 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.
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
, 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
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
A medical student is approaches by a faculty member for possible participation in a
cricothyroidotomy simulation research study. Which of the following increases risk to the
study? - ANSWER Consenting in the presence of figure of authority
