100% satisfaction guarantee Immediately available after payment Both online and in PDF No strings attached
logo-home
Previously searched by you
Previously searched by you
logo
ACRP CP FINAL EXAM LATEST 2023 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE $18.99   Add to cart
Quickly navigate to
Preview
  2.  
  3. ACRP CP
  4.  
  5. ACRP CP

Exam (elaborations)

ACRP CP FINAL EXAM LATEST 2023 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE
 4 views  0 purchase
  • Course
  • ACRP CP
  • Institution
  • ACRP CP

ACRP CP FINAL EXAM LATEST 2023 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE

Preview 3 out of 19  pages

Document information

  • December 4, 2023
  • 19
  • 2023/2024
  • Exam (elaborations)
  • Questions & answers

Subjects

  • acrp cp final exam latest 2023 real exam 150 quest
  • acrp cp final exam latest 2023 real exam 150
  • acrp cp final exam latest 2023 real exam

Written for

  • ACRP CP
  • ACRP CP

Seller

avatar-seller
NurseEdwin

Reviews received

Content preview

ACRP CP FINAL EXAM LATEST 2023 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE What would be the first priority for an investigator wh en a subject wishes to withdraw prematurely from the trial? - ANSWER - Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for: - ANSWER - Validation, accuracy, reliability, completeness Part of a sponsor's responsibility pertaining to electronic trial data handling is to - ANSWER - maintain an audit trail, data trail, and edit trail. A research subject's responsibilities for study participation should be described in the: - ANSWER - ICF What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? - ANSWER - Investigators brochure During a multi site clinical study, whose responsibility is it to report subject recruitment rate? - ANSWER - The CRA 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 - ANSWER - Obtain consent from the subject for the study A site is in the start up phase of an industry spo nsored phase 3 trial, and has received IRB approval. The site can begin enrolling subjects after... - ANSWER - A signed clinical trial agreement between the site and sponsor is in place A site is screening potential subjects for a study looking at mild cog nitive 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? - ANSWER - 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 informatiom should be included in the ICF? - ANSWER - Wording indicating that there is no expected benefit should be included 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 the sign atures of the investigator and sponsor. What should the CRA do FIRST? - ANSWER - Confirm dates of initial receipt of the sponsor protocol and the IRB submission dates. 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? - ANSWER - PI Which of the following required elements should be included in a clinical trial protocol? - ANSWER - Subject inclusion and exclusion criter ia Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the - ANSWER - PI and Sponsor During a monitoring visit, what records would a CRA reference to verify a subject's compliance to the study visi t schedule and assessments? - ANSWER - Electronic medical record When considering participation in a study, the investigator should determine if he... - ANSWER - Sees enough patients who would qualify for the study New safety information has become availab le from the Sponsor about the IP being used in a clinical trial. The investigator must: - ANSWER - Submit a revised ICF to the IRB noting the new safety information Per ICH, an IRB must keep correspondence for at least how long after the completion of a cl inical trial? - ANSWER - 3 Years When would an impartial witness be needed during the consent process for an illiterate subject? - ANSWER - To observe the consent process A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is considered to be: - ANSWER - Phase II After completion of a study, the final trial close out monitoring report prepared by the CRA should be filed in which o f the following stakeholder files? - ANSWER - The sponsors files 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 foreseeabl e risks or inconveniences? - ANSWER - ICF When should a research study involving human subjects be registered in a publicly accessible database? - ANSWER - Before recruiting the first subject In the case of an incapacitated subject, who should receive a co py of the signed and dated ICF? - ANSWER - The subjects legally acceptable representative 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? - ANSWER - Consenting in the presence of figure of authority Phase I - ANSWER - The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers Who is ultimately responsible for all aspects of the research conducted at a site? - ANSWER - Principal investigator Define GCP - ANSWER - An int ernational quality standard that is provided by ICH E6(R2) describing safety, accuracy of trials and credibility of data What event resulted in the Nuremburg Cod of 1949 - ANSWER - Nazi Medical Experiments

The benefits of buying summaries with Stuvia:

Guaranteed quality through customer reviews

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

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

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 NurseEdwin. Stuvia facilitates payment to the seller.

Will I be stuck with a subscription?

No, you only buy these notes for $18.99. You're not tied to anything after your purchase.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews)

70840 documents were sold in the last 30 days

Founded in 2010, the go-to place to buy study notes for 14 years now

Start selling
$18.99
  • (0)
  Add to cart