Exam (elaborations)
ACRP-CP CERTIFICATION EXAM TEST BANK. LATEST
- Course
- Institution
ACRP-CP CERTIFICATION EXAM TEST BANK. LATEST
[Show more]
Seller
Follow
samuelwachira
Content preview
ACRP-CP Certification ExamStudy online at https://quizlet.com/_f2sj4h
ACRP-CP CERTIFICATION EXAM TEST BANK. LATEST
2024-2025
1. What would be the first priority for an investigator when a subject wishes to
withdraw prematurely from the trial?: Try to obtain the subject's reason for
withdrawal.
2. CRO recently switched from paper CRF to an EDC system. The EDC system
must conform to the established requirements for: Validation
Accuracy
Reliability
Completeness
3. Part of a sponsor's responsibility pertaining to electronic trial data handling is to:
maintain an audit trail, data trail, and edit trail.
4. A research subject's responsibilities for study participation should be described
in the: ICF
5. What document would an investigator reference to learn more about the
previous clinical and nonclinical results of studies of the IP?: Investigators
brochure
6. During a multi site clinical study: whose responsibility is it to report subject
recruitment rate?: The CRA
7. 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: Obtain consent from
the subject for the study
8. 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...: A signed
clinical trial agreement between the site and sponsor is in place.
9. 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?: 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?: Wording indicating that there is no expected benefit should be included
11. 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
, ACRP-CP Certification Exam
Study online at https://quizlet.com/_f2sj4h
the signatures of the investigator and sponsor. What should the CRA do FIRST?:
Confirm dates of initial receipt of the sponsor protocol and the IRB submission dates.
12. In a multi arm: randomized clinical trial: one arm of the protocol was
terminated due to an increased risk of cancer in subjects. Who is responsible for
providing a written report to the IRB?: PI
13. Which of the following required elements should be included in a clinical trial
protocol?: Subject inclusion and exclusion criteria
14. Prior to archiving a study: documentation of IP destruction at the site should
be filed in the study files of the: PI and Sponsor
15. During a monitoring visit: what records would a CRA reference to verify a
subject's compliance to the study visit schedule and assessments?: Electronic medical
record
16. When considering participation in a study: the investigator should determine
if he...: Sees enough patients who would qualify for the study
17. New safety information has become available from the Sponsor about the IP
being used in a clinical trial. The investigator must: Submit a revised ICF to the IRB
noting the new safety information
18. Per ICH: an IRB must keep correspondence for at least how long after the
completion of a clinical trial?: 3 Years
19. When would an impartial witness be needed during the consent process for an
illiterate subject?: To observe the consent process
20. A study which seeks to determine the ideal dose and regimen of a new IP to
treat hypothyroidism is considered to be: Phase II
21. After completion of a study: the final trial close out monitoring report
prepared by the CRA should be filed in which of the following stakeholder files?:
The sponsors files
22. A blood sample collection is required to screen for bloodborne pathogens
before subject could be enrolled in a study. Where will subjects find information of
the procedures and any foreseeable risks or inconveniences?: ICF
23. When should a research study involving human subjects be registered in a
publicly accessible database?: Before recruiting the first subject
24. In the case of an incapacitated subject: who should receive a copy of the
signed and dated ICF?: The subjects legally acceptable representative
25. A medical student is approaches by a faculty member for possible
participation in a cricothyroidotomy simulation research study. Which of the
following increases risk to the study?: Consenting in the presence of figure of authority
26. The clinical trial phase that focuses on safety and human pharmacology in
healthy volunteers: Phase I
, ACRP-CP Certification Exam
Study online at https://quizlet.com/_f2sj4h
27. Who is ultimately responsible for all aspects of the research conducted at a
site?: Principal investigator
28. An international quality standard that is provided by ICH E6(R2) describing
safety: accuracy of trials and credibility of data: GCP
29. What event resulted in the Nuremburg Cod of 1949: Nazi Medical Experiments
30. In the case of an incapacitated subject: who should receive a copy of the
signed and dated ICF?: The subject's legally acceptable representative
31. Which of the following required elements should be included in a clinical trial
protocol?: The subject inclusion and exclusion criteria
32. During a multi-site clinical study: whose responsibility is it to report subject
recruitment rate?: The CRA
33. What document would an investigator reference to learn more about the
previous clinical and nonclinical results of studies of the IP?: IB
34. When considering participation in a study: the investigator should determine
if he/she: sees enough patients who would qualify for the study
35. During a monitoring visit: what records would a CRA reference to verify a
subject's compliance to the study visit schedule and assessments?: electronic medical
record
36. 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?: A research assistant who is certified to administer the psychometric test
37. . A research study: in which there is no intended clinical benefit to the subject:
is being submitted to the IRB/IEC. What benefit information should be included in
the ICF?: Wording indicating that there is no expected benefit should be included.
38. New safety information has become available from the Sponsor about the IP
being used in a clinical trial. The Investigator must: submit a revised ICF to the
IRB/IEC noting the new safety information.
39. A medical student is approached by a faculty member for possible
participation in a cricothyroidotomy simulation research study. Which of the
following increases risk to the subject?: Consenting in the presence of figure of
authority
40. Per ICH: an IRB/IEC must keep correspondence for at least how long after
the completion of a clinical trial?: 3 years
41. A CRA notices during an onsite visit that the date on IRB/IEC 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
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller samuelwachira. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $7.99. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
84669 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now