Pra Training - Novartis Program - 04 Jun 2020

Reviewed by Editorial Team
The ProProfs editorial team is comprised of experienced subject matter experts. They've collectively created over 10,000 quizzes and lessons, serving over 100 million users. Our team includes in-house content moderators and subject matter experts, as well as a global network of rigorously trained contributors. All adhere to our comprehensive editorial guidelines, ensuring the delivery of high-quality content.
Learn about Our Editorial Process
| By Marcio Silva
M
Marcio Silva
Community Contributor
Quizzes Created: 1 | Total Attempts: 60
| Attempts: 61
SettingsSettings
Please wait...
  • 1/22 Questions

    How do you document any training before a SIV?

    • Remote monitoring report
    • Site Initiation Visit report
    • Contact report
    • Monitoring report
Please wait...
About This Quiz

This PRA Training quiz for the Novartis program on 04 Jun 2020 covers roles in clinical trial management, including documentation, regulatory responsibilities, and site communication.

Pra Training - Novartis Program - 04 Jun 2020 - Quiz

Quiz Preview

  • 2. 

    Who updates Impact My Sites with the actual SIV date once it is completed?

    • SSL

    • CSM

    • CRAM

    • CRA

    Correct Answer
    A. CRA
    Explanation
    The CRA updates IMPACT with the actual SIV date once is completed.

    Rate this question:

  • 3. 

    As a CRA, are you responsible to ensure the site has received the Investigator's brochure?

    • True

    • False

    Correct Answer
    A. True
    Explanation
    As a CRA (Clinical Research Associate), it is indeed the responsibility to ensure that the site has received the Investigator's brochure. The Investigator's brochure contains important information about the investigational product, including its composition, pharmacological properties, and potential risks and benefits. It is crucial for the site to have this document as it helps the investigators and site staff to make informed decisions and conduct the study safely and ethically. Therefore, the statement "True" is correct.

    Rate this question:

  • 4. 

    Rollover or extension studies that were screened and participated in the pre-requisite trial require a SSV?

    • True

    • False

    Correct Answer
    A. False
    Explanation
    Rollover or extension studies that were screened and participated in the pre-requisite trial do not require a site selection visit (SSV). This means that these studies do not need to go through the process of selecting a site for conducting the study. The participants and screening process have already been established in the pre-requisite trial, so there is no need for an additional SSV. Therefore, the answer is False.

    Rate this question:

  • 5. 

    Who can acknowledge a safety notification in a site?

    • PI

    • Regulatory coordinator

    • Sub-I

    • All above

    Correct Answer
    A. All above
    Explanation
    All of the above options (PI, Regulatory coordinator, and Sub-I) can acknowledge a safety notification in a site. This means that any of these individuals have the authority and responsibility to acknowledge and respond to safety notifications in a site.

    Rate this question:

  • 6. 

    Provides relevant information related to the site, any trackers, system access during the handover process is an obligation of the:

    • CRAM

    • Transferring CRA

    • Receiving CRA

    • CSM

    Correct Answer
    A. Transferring CRA
    Explanation
    During the handover process, it is the responsibility of the Transferring CRA to provide relevant information related to the site, any trackers, and system access. This means that the Transferring CRA is obligated to share all necessary information and resources with the Receiving CRA, ensuring a smooth transition and continuity of operations.

    Rate this question:

  • 7. 

    Who is responsible to ensure the site has received a protocol amendment?

    • CRA

    • CTA

    • SSL

    • CSM

    Correct Answer
    A. CRA
    Explanation
    The SSL tracks in a spreadsheet. For central IRB approvals, the SSL will manage them.

    Rate this question:

  • 8. 

    Who is responsible to file the PI change form in Subway or CREDI?

    • CSM

    • SSL

    • CRAM

    • CRA

    Correct Answer
    A. CRA
    Explanation
    The correct answer is CRA. In Subway or CREDI, the person responsible for filing the PI change form is the CRA.

    Rate this question:

  • 9. 

    The safety notifications can be only acknowledged in One Connect

    • True

    • False

    Correct Answer
    A. False
    Explanation
    The safety notifications can be downloaded or printed.

    Rate this question:

  • 10. 

    When you are transferring a site to an another CRA, a remote report or on-site visit report is required.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    When transferring a site to another CRA (Clinical Research Associate), it is necessary to provide a remote report or an on-site visit report. These reports help ensure that the transfer process is properly documented and that all necessary information is communicated between the parties involved. This allows for a smooth transition and ensures that the site is being properly managed and monitored by the new CRA. Therefore, the statement "True" is correct.

    Rate this question:

  • 11. 

    Who is responsible to track the IRB approval date in a trial?

    • CRA

    • CTA

    • CSM

    • SSL

    Correct Answer
    A. SSL
    Explanation
    SSL, which stands for Site Study Lead, is responsible for tracking the IRB (Institutional Review Board) approval date in a trial. The Site Study Lead is typically a member of the research team who oversees the study at a specific site or clinical research center. They play a crucial role in ensuring that all necessary approvals and documentation are in place before the trial can proceed. Tracking the IRB approval date is important to ensure that the study is conducted ethically and in compliance with regulations.

    Rate this question:

  • 12. 

    Carol Smith is a new data coordinator of your site. You need to request a OCRDC account for her. Which kind of form do you choose in SNOW?

    • SSUARF Clinical Users - requires manager approval

    • SSUARF Site Users - requires manager approval

    • SSUARF Site Users - does not require manager approval

    • SSUARF Trial Data Manager

    Correct Answer
    A. SSUARF Site Users - does not require manager approval
    Explanation
    The correct answer is "SSUARF Site Users - does not require manager approval." This form should be chosen in SNOW to request an OCRDC account for Carol Smith because it does not require manager approval. This means that the data coordinator can directly request the account without needing approval from their manager.

    Rate this question:

  • 13. 

    Who is responsible to send protocol amendments or IBs to the sites?

    • SSL

    • CSM

    • CRA

    • CTA

    Correct Answer
    A. SSL
    Explanation
    CSMs are responsible to send via one Connect, Secured e-mail or One-drive

    Rate this question:

  • 14. 

    After the RIS is signed, is the CRA responsible to send notification of a FDA 1572 change to DRA?

    • True

    • False

    Correct Answer
    A. True
    Explanation
    True. The CRA send the notification of FDA 1572 changing to Drug Regulatory Affairs.

    Rate this question:

  • 15. 

    All documents related to a 1572 change need to be filed in CREDI/Subway prior to sending the notification to DRA?

    • True

    • False

    Correct Answer
    A. True
    Explanation
    In addition, DRA (Drug Regulatory Affairs) ensure everything is good to go to ship drug to the site.

    Rate this question:

  • 16. 

    Who is responsible to assign a receiving CRA to the trial site in CTMS system?

    • Transferring CRA

    • CRAM

    • SSL

    • CSM

    Correct Answer
    A. CSM
    Explanation
    The Clinical Site Manager (CSM) is responsible for assigning a receiving Clinical Research Associate (CRA) to the trial site in the CTMS system. The CSM is in charge of managing the overall operations and coordination of clinical trials at the site, including assigning CRAs to specific trials. They ensure that the CRAs are properly trained and equipped to carry out their responsibilities effectively.

    Rate this question:

  • 17. 

    Regarding the Field Monitor Responsibility log, all the sentences are correct, with the EXCEPTION of:

    • It is a mandatory form

    • Completed from Site Selection Visit to Close-out Visit

    • To be updated when CRA responsibilities changes

    • Start date of incoming CRA should match the end date of outgoing CRA

    Correct Answer
    A. Completed from Site Selection Visit to Close-out Visit
    Explanation
    It is completed from SIV to COV

    Rate this question:

  • 18. 

    The CRA is always responsible to update site personnel in IMPACT.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    The CSM also updates in Progress.

    Rate this question:

  • 19. 

    Who orders regulatory binders for a site?

    • SSL

    • CTA

    • CSM

    • CRA

    Correct Answer
    A. CRA
    Explanation
    The regulatory binders are requested by CRA

    Rate this question:

  • 20. 

    When there is a PI change, the CRA is responsible to complete a PI change form. Where is this form found?

    • Web Consumer

    • One connect

    • US TMO SharePoint library

    • Site Cockpit

    Correct Answer
    A. US TMO SharePoint library
    Explanation
    US TMO SharePoint library as this is a local process.

    Rate this question:

  • 21. 

    Who is responsible to create the s-TOC?

    • CRA

    • CSM

    • SSL

    • CTA

    Correct Answer
    A. SSL
    Explanation
    SSL is responsible to create the S-TOC and the CRA is responsible to update it.

    Rate this question:

  • 22. 

    Investigator's brochure needs to be sent to PI during the start-up phase.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    Per ICH GCP E6(R2) §5.6.2, before entering an agreement with an investigator/institution to conduct a trial, the sponsor should provide the investigator(s)/institution(s) with the protocol and an up-to-date Investigator Brochure, and should provide sufficient time for the investigator/institution to review the protocol and the information provided.

    Rate this question:

Quiz Review Timeline (Updated): Mar 14, 2023 +

Our quizzes are rigorously reviewed, monitored and continuously updated by our expert board to maintain accuracy, relevance, and timeliness.

  • Current Version
  • Mar 14, 2023
    Quiz Edited by
    ProProfs Editorial Team
  • Jun 03, 2020
    Quiz Created by
    Marcio Silva
Back to Top Back to top
Advertisement
×

Wait!
Here's an interesting quiz for you.

We have other quizzes matching your interest.