ACRP PRACTICE TEST QUESTIONS WITH VERIFIED
ANSWERS; 100% CORRECT; GRADE A
A clinical trial is being conducted for hormone replacement. The trial
includes a diary. Which of the following would be considered an
objective parameter?
Question 45Answera.mood swingsb.
breast tenderness
c.
severity of hot flashes
d.
episodes of vaginal bleeding - correct answer- D
A clinical trial is being conducted to determine the safety and tolerability
of a new anti-emetic IP. The sponsor expects to enroll 20 subjects. This
would be considered a ______________ - correct answer- Phase I
A competent adult subject signs a consent form with an "X" and
indicates approval. Which of the following is the BEST action for the CRC
to take?
Question 34Answera.
Have the consent form notarized.
b.
Exclude the subject from the trial.
,c.
Document why the subject signed with an "X."
d.
Have the legal guardian sign the informed consent form - correct
answer- c
A CRA calls a CRC to schedule the final monitoring visit. The sponsor
requires that the PI be present. The only dates available for the CRA
conflict with the PI's schedule. To prepare for the visit, the CRC should:
1. reschedule the visit.
2. have the PI sign all documents prior to the visit.
3. discard unused trial documents.
4. notify the IRB/IRC - correct answer- reschedule the visit
A CRA calls to schedule a close-out visit. Per sponsor SOPs, the PI must
be present. The CRC informs the CRA that the PI will be out of the
country during the period when the CRA would like to visit. The CRC
should do which of the following?
Question 24Answera.
Obtain required PI signatures prior to departure.
b.
Reschedule the close-out visit for a later date.
c.
Conduct the visit as long as the PI is available by phone.
, d.
Conduct the visit as long as a subinvestigator is available - correct
answer- b.
Reschedule the close-out visit for a later date
A CRA is conducting a close-out visit at a site to review the regulatory
documents. The CRC has prepared the following documents to be filed
and/or sent to the sponsor: treatment decoding documentation, drug
accountability log, subject identification code list, documentation of IP
destruction, and final report to the IRB/IEC. Which of the following
actions should the CRC perform?
1. Send the treatment decoding documentation to the sponsor.
2. Remove the subject identification code list from the material to be
sent to the sponsor.
3. Send copies of the IP destruction forms to the sponsor.
4. Remove the drug accountability log from the material to be sent to
the sponsor - correct answer- 1, 2, and 3
A CRC has received three subject complaints of localized infection at the
venipuncture site. The CRC queries the phlebotomist and discovers that
when the first stick is unsuccessful, any additional sticks are done with
the same needle. This is in violation of the site's SOPs. Which of the
following actions should the CRC take?
1. Suggest review of proper specimen collection for the phlebotomist.
2. Document and report the findings.
3. Inform the IRB/IEC of the situation and the corrective action.
ANSWERS; 100% CORRECT; GRADE A
A clinical trial is being conducted for hormone replacement. The trial
includes a diary. Which of the following would be considered an
objective parameter?
Question 45Answera.mood swingsb.
breast tenderness
c.
severity of hot flashes
d.
episodes of vaginal bleeding - correct answer- D
A clinical trial is being conducted to determine the safety and tolerability
of a new anti-emetic IP. The sponsor expects to enroll 20 subjects. This
would be considered a ______________ - correct answer- Phase I
A competent adult subject signs a consent form with an "X" and
indicates approval. Which of the following is the BEST action for the CRC
to take?
Question 34Answera.
Have the consent form notarized.
b.
Exclude the subject from the trial.
,c.
Document why the subject signed with an "X."
d.
Have the legal guardian sign the informed consent form - correct
answer- c
A CRA calls a CRC to schedule the final monitoring visit. The sponsor
requires that the PI be present. The only dates available for the CRA
conflict with the PI's schedule. To prepare for the visit, the CRC should:
1. reschedule the visit.
2. have the PI sign all documents prior to the visit.
3. discard unused trial documents.
4. notify the IRB/IRC - correct answer- reschedule the visit
A CRA calls to schedule a close-out visit. Per sponsor SOPs, the PI must
be present. The CRC informs the CRA that the PI will be out of the
country during the period when the CRA would like to visit. The CRC
should do which of the following?
Question 24Answera.
Obtain required PI signatures prior to departure.
b.
Reschedule the close-out visit for a later date.
c.
Conduct the visit as long as the PI is available by phone.
, d.
Conduct the visit as long as a subinvestigator is available - correct
answer- b.
Reschedule the close-out visit for a later date
A CRA is conducting a close-out visit at a site to review the regulatory
documents. The CRC has prepared the following documents to be filed
and/or sent to the sponsor: treatment decoding documentation, drug
accountability log, subject identification code list, documentation of IP
destruction, and final report to the IRB/IEC. Which of the following
actions should the CRC perform?
1. Send the treatment decoding documentation to the sponsor.
2. Remove the subject identification code list from the material to be
sent to the sponsor.
3. Send copies of the IP destruction forms to the sponsor.
4. Remove the drug accountability log from the material to be sent to
the sponsor - correct answer- 1, 2, and 3
A CRC has received three subject complaints of localized infection at the
venipuncture site. The CRC queries the phlebotomist and discovers that
when the first stick is unsuccessful, any additional sticks are done with
the same needle. This is in violation of the site's SOPs. Which of the
following actions should the CRC take?
1. Suggest review of proper specimen collection for the phlebotomist.
2. Document and report the findings.
3. Inform the IRB/IEC of the situation and the corrective action.
