ACRP CCRC ACTUAL STUDYS ANSWERS AND
QUESTIONS SET A+
✔✔Which of the following tasks should a CRC complete prior to the enrollment of
subjects?
1. Conduct initial protocol training with site staff
2. Coordinate the process for completion of study related procedures and tests.
3. Inform primary care physician of subject's interest in the study.
4. Discontinue all excluded medications for potential subjects.
A. 1 and 2 only
B. 1 and 4 only
C. 2 and 3 only
D. 3 and 4 only - ✔✔A
Reason: Prior to screening subjects, site staff should be appropriately trained on the
protocol and study-related procedures. In addition, the role of the CRC is to coordinate
study-related testing with other departments. Informing the subject's primary care
physician of the subject's interest in the study is suggested by ICH-GCP, but only with
the consent of the subject, which is not presented in Option C. Finally, Option D is
incorrect because it is inappropriate to discontinue medications without informed
consent first being obtained from the subject.
✔✔Which of the following is a well-defined clinical study using a placebo to evaluate the
treatment group?
A. Open-label
B. Retrospective
C. Controlled
D. Active concurrent controlled - ✔✔C
Reason: This question is based on the definition of a controlled clinical trial; however,
control groups receiving no treatment or standard treatment (active concurrent control)
may also be used. These trials use the randomization process to assign subjects by
, element of chance to either the treatment of control group (placebo in this scenario), in
an effort to remove the potential of bias. In open-label trials, both trial subjects and the
investigators know what treatment has been given. Retrospective trials assess results
that are already known.
✔✔Which of the following would normally take place at a pre-study visit?
1. Evaluation of source documents
2. Review of protocol with an IRB/IEC member
3. Assessment of the site's equipment for the study
4. Discussion of the storage for the investigational product
A. 1 and 2
B. 1 and 4
C. 2 and 3
D. 3 and 4 - ✔✔D
Reason: 1. There can be no evaluation of source documentation at the pre-study visit,
because the study has not yet started at the site. 2. Discussions between the CRC and
the IRB/IEC are not standard practice. (3 and 4) The purpose of the visit is to decide
whether a site is suitable to conduct a study. The criteria are essentially the experience
and availability of the investigator and other personnel and the facilities available,
including equipment required by the protocol.
✔✔In order to ensure that an investigative site can provide adequate storage space for
the test article/investigational product and study supplies, the sponsor would conduct
A. An investigator's meeting
B. a pre-study site evaluation
C. an initiation visit
D. a telephone conference with the site - ✔✔B
Reason: ICH-GCP 5.6.1 and 5.18.3 suggest that, prior to the initiation of a clinical
investigation, sponsors should routinely confirm the existence of adequate facilities for
drug supply in their site-screening process prior to conducting the pre-study visit on-site
for confirmation. Adequate storage space should continue to be verified by the sponsor
at the initiation visit, as well as subsequent monitoring visits.
✔✔A CRA is responsible for which of the following during a monitoring visit?
1. Verifying subject protection
2. confirming source data
3. assuring protocol compliance
4. reviewing medical charts for potential subjects
A. 1, 2 & 3
QUESTIONS SET A+
✔✔Which of the following tasks should a CRC complete prior to the enrollment of
subjects?
1. Conduct initial protocol training with site staff
2. Coordinate the process for completion of study related procedures and tests.
3. Inform primary care physician of subject's interest in the study.
4. Discontinue all excluded medications for potential subjects.
A. 1 and 2 only
B. 1 and 4 only
C. 2 and 3 only
D. 3 and 4 only - ✔✔A
Reason: Prior to screening subjects, site staff should be appropriately trained on the
protocol and study-related procedures. In addition, the role of the CRC is to coordinate
study-related testing with other departments. Informing the subject's primary care
physician of the subject's interest in the study is suggested by ICH-GCP, but only with
the consent of the subject, which is not presented in Option C. Finally, Option D is
incorrect because it is inappropriate to discontinue medications without informed
consent first being obtained from the subject.
✔✔Which of the following is a well-defined clinical study using a placebo to evaluate the
treatment group?
A. Open-label
B. Retrospective
C. Controlled
D. Active concurrent controlled - ✔✔C
Reason: This question is based on the definition of a controlled clinical trial; however,
control groups receiving no treatment or standard treatment (active concurrent control)
may also be used. These trials use the randomization process to assign subjects by
, element of chance to either the treatment of control group (placebo in this scenario), in
an effort to remove the potential of bias. In open-label trials, both trial subjects and the
investigators know what treatment has been given. Retrospective trials assess results
that are already known.
✔✔Which of the following would normally take place at a pre-study visit?
1. Evaluation of source documents
2. Review of protocol with an IRB/IEC member
3. Assessment of the site's equipment for the study
4. Discussion of the storage for the investigational product
A. 1 and 2
B. 1 and 4
C. 2 and 3
D. 3 and 4 - ✔✔D
Reason: 1. There can be no evaluation of source documentation at the pre-study visit,
because the study has not yet started at the site. 2. Discussions between the CRC and
the IRB/IEC are not standard practice. (3 and 4) The purpose of the visit is to decide
whether a site is suitable to conduct a study. The criteria are essentially the experience
and availability of the investigator and other personnel and the facilities available,
including equipment required by the protocol.
✔✔In order to ensure that an investigative site can provide adequate storage space for
the test article/investigational product and study supplies, the sponsor would conduct
A. An investigator's meeting
B. a pre-study site evaluation
C. an initiation visit
D. a telephone conference with the site - ✔✔B
Reason: ICH-GCP 5.6.1 and 5.18.3 suggest that, prior to the initiation of a clinical
investigation, sponsors should routinely confirm the existence of adequate facilities for
drug supply in their site-screening process prior to conducting the pre-study visit on-site
for confirmation. Adequate storage space should continue to be verified by the sponsor
at the initiation visit, as well as subsequent monitoring visits.
✔✔A CRA is responsible for which of the following during a monitoring visit?
1. Verifying subject protection
2. confirming source data
3. assuring protocol compliance
4. reviewing medical charts for potential subjects
A. 1, 2 & 3
