ACRP CP CERTIFICATION EXAM 2025
ACTUAL EXAM COMPLETE
ACCURATE EXAM QUESTIONS WITH
DETAILED VERIFIED ANSWERS (100%
CORRECT ANSWERS) /ALREADY
GRADED A+
What is the investigator's first priority when a
subject wishes to withdraw prematurely from the
trial? - ....ANSWER...to obtain the subject's reason
for withdrawal
CRC's can't adjust IP dose: even if they are a
qualified physician (T/F) - ....ANSWER...False. If a
CRC is a qualified physician they can adjust IP
dose
Following unblinding in the case of a suspected
serious unexpected adverse drug reaction: the
treatment assigned to the subject turns out to be
the comparator product. Who should the sponsor
inform? - ....ANSWER...The manufacturer of the
product and/or the regulatory authorities
,If there is a a serious unexpected adverse drug
reaction in a blinded trial: when should the
investigator unblind the subject? - ....ANSWER...The
investigator unblinds before reporting the SUADR: in
order to determine a safe treatment
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.
ACTUAL EXAM COMPLETE
ACCURATE EXAM QUESTIONS WITH
DETAILED VERIFIED ANSWERS (100%
CORRECT ANSWERS) /ALREADY
GRADED A+
What is the investigator's first priority when a
subject wishes to withdraw prematurely from the
trial? - ....ANSWER...to obtain the subject's reason
for withdrawal
CRC's can't adjust IP dose: even if they are a
qualified physician (T/F) - ....ANSWER...False. If a
CRC is a qualified physician they can adjust IP
dose
Following unblinding in the case of a suspected
serious unexpected adverse drug reaction: the
treatment assigned to the subject turns out to be
the comparator product. Who should the sponsor
inform? - ....ANSWER...The manufacturer of the
product and/or the regulatory authorities
,If there is a a serious unexpected adverse drug
reaction in a blinded trial: when should the
investigator unblind the subject? - ....ANSWER...The
investigator unblinds before reporting the SUADR: in
order to determine a safe treatment
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.
