ACRP CCRC 2027 SETS ANSWERS AND QUESTIONS
SET A+
✔✔
✔✔Which of the following statements accurately reflects ICH-GCP's requirements
regarding informed consent process?
1. ICH-GCP does not require that the PI personally obtain the informed consent
2. The IRB/IEC reviewing the research at a particular site should be aware of who will
obtain informed consent.
3. A copy of the signed consent document must be provided to the subject.
4. ICH-GCP does not suggest that the case history for each study subject shall
document consent was obtained prior to study participation.
A. 1, 2 & 3
B. 1, 2 & 4
C. 1, 3 & 4
D. 2, 3 & 4 - ✔✔C
Reason: ICH-GCP does not require that the PI personally obtain the informed consent.
However, a copy shall be given to the person signing the form. It also states that it
should be signed and dated. There is no requirement to document in the case history
that informed consent was obtained, although this is often covered by local
requirements or policies. Similarly, ICH-GCP does not require information about who is
involved in obtaining consent. However, individual countries or states will have
IRBs/IECs with their own local requirements and/or procedures in addition to those
stipulated in ICH GCP and these may require information about who will be involved in
the consent process itself.
✔✔An investigator conducts and completes the informed consent process with a
subject, who then completes all of the day 1 requirements and is ready to leave. The
CRC notices that the investigator neglected to sign the informed consent document, and
the CRC will not be able to obtain the investigator's signature on the consent form for
, several hours. The protocol indicates that the ICH-GCP Guidelines will be followed
throughout the study.
A. Give the subject an unsigned copy of the consent form
B. Mail the completely signed consent to the subject.
C. Keep the subject around until the investigator is available.
D. Sign for the investigator and provide the subject with a copy - ✔✔B
✔✔A CRA has sent the site a pre-study informational packet in preparation for an
upcoming site visit. For the staff to know as much about the history of the drug as
possible, they should read the
A. Study protocol
B. Informed consent
C. Investigational plan
D. Investigator's brochure - ✔✔D
✔✔A subject presents to the doctor's office with a recent onset of decreased
hemoglobin at visit 4. Decreased hemoglobin is listed in the risk information contained
in the investigator's brochure. Which of the following should the CRC do?
A. Document decreased hgb as an AE
B. Reported decreased hgb as an unexpected AE
C. Complete SAE form & submit w/n 24 hours
D. Add "decreased hgb" to the comments section in the CRF - ✔✔A
As decreased hemoglobin has its onset during the course of the study, it should be
documented as an adverse event, even when consistent w/ the risks noted in the IB.
Because it is a known risk, it would not be considered unexpected. It also would not be
considered serious. As this meets the definition of an adverse event, it would be
inappropriate to capture it solely in the comment field of a CRF.
✔✔A site is conducting a study in which Drug A is being compared to Drug B. The study
medication is administered in the hospital and continued after discharge. Peak and
trough blood levels are ordered to be drawn each morning while the subject is
hospitalized. Upon review of the hospital records, the CRC discovers that five of the 10
subjects enrolled did not have the ordered blood work on the day of discharge.
The CRC should:
1. Inform the IRB/IEC immediately
2. record the errors in the source docments
3. note "not done" on the CRF
4. Review the discharge procedures with the staff.
A. 1, 2 & 3
B. 1, 2 & 4
SET A+
✔✔
✔✔Which of the following statements accurately reflects ICH-GCP's requirements
regarding informed consent process?
1. ICH-GCP does not require that the PI personally obtain the informed consent
2. The IRB/IEC reviewing the research at a particular site should be aware of who will
obtain informed consent.
3. A copy of the signed consent document must be provided to the subject.
4. ICH-GCP does not suggest that the case history for each study subject shall
document consent was obtained prior to study participation.
A. 1, 2 & 3
B. 1, 2 & 4
C. 1, 3 & 4
D. 2, 3 & 4 - ✔✔C
Reason: ICH-GCP does not require that the PI personally obtain the informed consent.
However, a copy shall be given to the person signing the form. It also states that it
should be signed and dated. There is no requirement to document in the case history
that informed consent was obtained, although this is often covered by local
requirements or policies. Similarly, ICH-GCP does not require information about who is
involved in obtaining consent. However, individual countries or states will have
IRBs/IECs with their own local requirements and/or procedures in addition to those
stipulated in ICH GCP and these may require information about who will be involved in
the consent process itself.
✔✔An investigator conducts and completes the informed consent process with a
subject, who then completes all of the day 1 requirements and is ready to leave. The
CRC notices that the investigator neglected to sign the informed consent document, and
the CRC will not be able to obtain the investigator's signature on the consent form for
, several hours. The protocol indicates that the ICH-GCP Guidelines will be followed
throughout the study.
A. Give the subject an unsigned copy of the consent form
B. Mail the completely signed consent to the subject.
C. Keep the subject around until the investigator is available.
D. Sign for the investigator and provide the subject with a copy - ✔✔B
✔✔A CRA has sent the site a pre-study informational packet in preparation for an
upcoming site visit. For the staff to know as much about the history of the drug as
possible, they should read the
A. Study protocol
B. Informed consent
C. Investigational plan
D. Investigator's brochure - ✔✔D
✔✔A subject presents to the doctor's office with a recent onset of decreased
hemoglobin at visit 4. Decreased hemoglobin is listed in the risk information contained
in the investigator's brochure. Which of the following should the CRC do?
A. Document decreased hgb as an AE
B. Reported decreased hgb as an unexpected AE
C. Complete SAE form & submit w/n 24 hours
D. Add "decreased hgb" to the comments section in the CRF - ✔✔A
As decreased hemoglobin has its onset during the course of the study, it should be
documented as an adverse event, even when consistent w/ the risks noted in the IB.
Because it is a known risk, it would not be considered unexpected. It also would not be
considered serious. As this meets the definition of an adverse event, it would be
inappropriate to capture it solely in the comment field of a CRF.
✔✔A site is conducting a study in which Drug A is being compared to Drug B. The study
medication is administered in the hospital and continued after discharge. Peak and
trough blood levels are ordered to be drawn each morning while the subject is
hospitalized. Upon review of the hospital records, the CRC discovers that five of the 10
subjects enrolled did not have the ordered blood work on the day of discharge.
The CRC should:
1. Inform the IRB/IEC immediately
2. record the errors in the source docments
3. note "not done" on the CRF
4. Review the discharge procedures with the staff.
A. 1, 2 & 3
B. 1, 2 & 4
