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CRA ACRP Practice Exam Questions & Answers w/ explanation
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CRA ACRP Practice Exam Questions & Answers w/ explanation
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CRA ACRP Practice ExamQuestions & Answers w/
explanation
A screening log is useful for determining which of the following?
1. trial reimbursement
2. subject IP compliance
3. active recruitment efforts
4. trends regarding evaluable subjects - -1 and 3 only.
E6 8.3.20 A screening log will provide evidence of an investigator's efforts to
recruit subjects even if they are unable to identify subjects that meet entry
criteria, which can help discriminate sites who are failing to make an effort to
recruit from sites who have been unable to enroll subjects despite
substantial efforts to do so. In addition, site contracts routinely contain
provisions that allow for payment for some or all of the screen failures
evaluated at the site, even if these subjects are not enrolled. Information on
subject IP compliance and evaluability is captured elsewhere and would not
appear on the screening log.
-A trial protocol amendment is required if there is
A. a replacement of a site.
B. a site investigator change.
C. an increase in the sample size.
D. a merger involving the sponsor. - -an increase in the sample size.
As per ICH E6 6.9.2, the number of subjects planned to be enrolled is a key
component of protocols and amendments. Any changes to the original
planned number of subjects would necessitate an amendment as it affects
the statistics linked to the study. While the ICH E6 6.1 states that the
sponsor's name and address, etc... are required, a merger does not
necessarily mean that there was a change in sponsor name or address, etc...
and therefore (D) is incorrect. The guidance also states, "...site specific
information may be provided on separate protocol page(s), or addressed in a
separate agreement..." which explains why (A) and (B) are not the best
answers.
-After IP has been shipped out to the trial site, the trial monitor discovers
that the investigator agreement has not been signed. Which of the following
are the BEST courses of action for the CRA to take?
,1. Check the site trial binder to ensure that the remainder of the trial
documents are in order.
2. Document that there was an oversight in shipping out IP prior to the
investigator agreement being signed.
3. Contact the site and ask them to ship back the IP to the CRA.
4. Instruct the site that they may not use the IP until the signed agreement is
received by the sponsor. - -2 and 4 only.
ICH 5.14.2IP should not be shipped until all required documentation is
received/review and approved from the investigator. Statements 1 & 3 do
not assist in correcting the issue, while statements 2 & 4 would be the best
course of action and would enable the CRA to document the issue as it
occurred and instructing the investigator not to use the IP until all required
documents were received and approved.
-A recruitment plan was developed by the research site for a new drug trial
that involves enrollment of population between the ages of 6-10 years old.
Which of the following activities should the CRA consider when reviewing the
site's plan?
1. Verify that the IRB/IEC has reviewed the plan.
2. Verify that the IRB/IEC has approved the plan.
3. Ensure the ICF includes assent and consent.
4. Ensure the IRB/IEC requirements for assent are met. - -2 and 4 only.
ICH E6 4.4.1 specifies that the IRB/IEC should provide approval of
recruitment proposals, and ICH E8 3.1.4.3 suggests that additional care
should be taken when approving the recruitment of vulnerable populations,
including minors. Children are generally not able to legally consent for
themselves, but should indicate their agreement to participate to the extent
they are capable of doing so. IRB/IECs often request that an age-appropriate
assent form be created for this purpose.
-When choosing a CRO to manage a clinical trial, which of the following are
required by ICH Guidelines?
1. Transfer of responsibilities must be documented in writing.
2. Responsibilities transferred to the CRO become the ultimate responsibility
of the CRO.
3. A sponsor must transfer all of the responsibilities to one CRO.
4. Obligations not described in any written agreement shall be deemed not
to have transferred. - -1 and 4 only.
ICH E6 5.2.1 supports that ultimate responsibility for data quality and
integrity always resides with the sponsor, making option 2 incorrect. ICH E6
, 5.2 does not state that a sponsor can only transfer responsibilities to one
CRO, therefore option 3 is incorrect.
-Which of the following activities should the CRA perform when reconciling
an SAE Report with the CRF?
1. Ensure causal relationship assessment is the same on the SAE report as
the AE CRF.
2. Verify the investigator agreement lists the hospital where the subject was
treated.
3. Submit initial and any follow-up SAE reports to the IRB/IEC.
4. Confirm medications in SAE-related medical records are recorded on the
CRF. - -1 and 4 only.
E6 5.18.4 states that the monitor should ensure the CRF is complete and
accurate, and is in agreement with source documents and other related trial
documents. (2) is wrong because investigator agreements are device
specific; also SAEs are independent of where the subject was treated. (3)
CRAs do not submit to the IRB/IEC.
-A subject has a history of dermatitis. During visit 2 of the trial, the subject
complained of a rash. The investigator interrupted the use of the IP and the
rash disappeared. At the next visit, the IP was restarted. One day later, the
rash reappeared. The investigator discontinued the subject from the trial.
The causality can be determined as probably related to the IP based on:
A. the placebo effect.
B. a positive rechallenge.
C .insufficient information.
D. the history of dermatitis. - -a positive rechallenge.
ICH E2A attachment 1 section 4 describes the collection of rechallenge
information in regard to AEs. Option A is incorrect as the placebo effect is the
measurement of efficacy in a placebo. While the history of dermatitis may be
thought of as explaining the rash, it is the rechallenge that helps to establish
this an IP effect.
-The purpose of trial-specific monitoring procedures is to provide:
A. a comprehensive safety review of the IP.
B. a small-scale version of company SOPs.
C. written guidelines for each individual trial.
D. federal regulations and company SOPs in a user-friendly format. - -written
guidelines for each individual trial.
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