Pra Training - Novartis Program - 04 Jun 2020
Questions and Answers
- 1.
How do you document any training before a SIV?
- A.
Remote monitoring report
- B.
Site Initiation Visit report
- C.
Contact report
- D.
Monitoring report
Correct Answer
C. Contact reportExplanation
Contact report.Rate this question:
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- 2.
Who orders regulatory binders for a site?
- A.
SSL
- B.
CTA
- C.
CSM
- D.
CRA
Correct Answer
D. CRAExplanation
The regulatory binders are requested by CRARate this question:
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- 3.
Who updates Impact My Sites with the actual SIV date once it is completed?
- A.
SSL
- B.
CSM
- C.
CRAM
- D.
CRA
Correct Answer
D. CRAExplanation
The CRA updates IMPACT with the actual SIV date once is completed.Rate this question:
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- 4.
Who is responsible to ensure the site has received a protocol amendment?
- A.
CRA
- B.
CTA
- C.
SSL
- D.
CSM
Correct Answer
A. CRAExplanation
The SSL tracks in a spreadsheet. For central IRB approvals, the SSL will manage them.Rate this question:
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- 5.
Who is responsible to track the IRB approval date in a trial?
- A.
CRA
- B.
CTA
- C.
CSM
- D.
SSL
Correct Answer
D. SSLExplanation
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:
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- 6.
Who is responsible to send protocol amendments or IBs to the sites?
- A.
SSL
- B.
CSM
- C.
CRA
- D.
CTA
Correct Answer
A. SSLExplanation
CSMs are responsible to send via one Connect, Secured e-mail or One-driveRate this question:
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- 7.
As a CRA, are you responsible to ensure the site has received the Investigator's brochure?
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
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:
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- 8.
When there is a PI change, the CRA is responsible to complete a PI change form. Where is this form found?
- A.
Web Consumer
- B.
One connect
- C.
US TMO SharePoint library
- D.
Site Cockpit
Correct Answer
C. US TMO SharePoint libraryExplanation
US TMO SharePoint library as this is a local process.Rate this question:
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- 9.
Who is responsible to file the PI change form in Subway or CREDI?
- A.
CSM
- B.
SSL
- C.
CRAM
- D.
CRA
Correct Answer
D. CRAExplanation
The correct answer is CRA. In Subway or CREDI, the person responsible for filing the PI change form is the CRA.Rate this question:
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- 10.
Who is responsible to create the s-TOC?
- A.
CRA
- B.
CSM
- C.
SSL
- D.
CTA
Correct Answer
C. SSLExplanation
SSL is responsible to create the S-TOC and the CRA is responsible to update it.Rate this question:
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- 11.
After the RIS is signed, is the CRA responsible to send notification of a FDA 1572 change to DRA?
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
True. The CRA send the notification of FDA 1572 changing to Drug Regulatory Affairs.Rate this question:
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- 12.
The CRA is always responsible to update site personnel in IMPACT.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
The CSM also updates in Progress.Rate this question:
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- 13.
Rollover or extension studies that were screened and participated in the pre-requisite trial require a SSV?
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
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:
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- 14.
All documents related to a 1572 change need to be filed in CREDI/Subway prior to sending the notification to DRA?
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
In addition, DRA (Drug Regulatory Affairs) ensure everything is good to go to ship drug to the site.Rate this question:
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- 15.
The safety notifications can be only acknowledged in One Connect
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
The safety notifications can be downloaded or printed.Rate this question:
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- 16.
Who can acknowledge a safety notification in a site?
- A.
PI
- B.
Regulatory coordinator
- C.
Sub-I
- D.
All above
Correct Answer
D. All aboveExplanation
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:
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- 17.
Investigator's brochure needs to be sent to PI during the start-up phase.
- A.
True
- B.
False
Correct Answer
B. FalseExplanation
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:
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- 18.
When you are transferring a site to an another CRA, a remote report or on-site visit report is required.
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
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:
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- 19.
Provides relevant information related to the site, any trackers, system access during the handover process is an obligation of the:
- A.
CRAM
- B.
Transferring CRA
- C.
Receiving CRA
- D.
CSM
Correct Answer
B. Transferring CRAExplanation
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:
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- 20.
Who is responsible to assign a receiving CRA to the trial site in CTMS system?
- A.
Transferring CRA
- B.
CRAM
- C.
SSL
- D.
CSM
Correct Answer
D. CSMExplanation
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:
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- 21.
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?
- A.
SSUARF Clinical Users - requires manager approval
- B.
SSUARF Site Users - requires manager approval
- C.
SSUARF Site Users - does not require manager approval
- D.
SSUARF Trial Data Manager
Correct Answer
C. SSUARF Site Users - does not require manager approvalExplanation
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:
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- 22.
Regarding the Field Monitor Responsibility log, all the sentences are correct, with the EXCEPTION of:
- A.
It is a mandatory form
- B.
Completed from Site Selection Visit to Close-out Visit
- C.
To be updated when CRA responsibilities changes
- D.
Start date of incoming CRA should match the end date of outgoing CRA
Correct Answer
B. Completed from Site Selection Visit to Close-out VisitExplanation
It is completed from SIV to COVRate this question:
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Current Version
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Mar 14, 2023Quiz Edited by
ProProfs Editorial Team -
Jun 03, 2020Quiz Created by
Marcio Silva
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