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WorksheetsTeam Elsa Pre-test
Total questions: 20
Worksheet time: 10mins
What does eQMS stands for?
A. Electronic Qualities Management System
B. Electronic Quality Monitoring System
C. Electronic Quality Management System
D. None of the above
Who identifies the Lead QA to perform the audit?
A. QA Line Manager
B. Designee
C. Head of Vendor QA
D. A and B
True or False. In responding to the Audit report, Lead QA agrees and approves the final CAPA and applicable EC which is being done within 14 calendar days from day of issuance of audit report.
A. True
B. False
C. Maybe
While planning audits, who is responsible for submitting a ticket through IQVIA Support Portal to enter audits to IQVIA eQMS?
A. FSL
B. SEL
C. Designee
D. All of the above
E. None of the above
CEVA stands for?
A. Clarification of Event and Validating Adjudication
B. Clinical Event Validation and Adjudication
C. Clinical Evidence Validity Adjustment
D. Certification of Evidence, Validation and Adjustment
True or False: In Endpoint Processing and Adjudication, CP is responsible for the queries and the site for outstanding source documents.
A. True
B. False
C. Maybe
Which of the following performs User Acceptance Testing(UAT):
A. LS CEVA Systems SME
B. CEVA test writer
C. CEVA Tester
D. All performs UAT
Who compiles EP dossier as specified in the EMP?
A. CEVA Processor
B. CEVA Clinical Reviewer
C. CEVA Lead
D. None of the above
True or False: A planning meeting will be held with the WFL to discuss the upcoming document and agree upon timelines and deliverables.
A. True
B. False
C. Maybe
The following are responsibilities of RR Team EXCEPT:
A. Submits the report
B. Provides the submission date to the AR Specialist for entry in the PSA platform
C. Prepares the cover letters
D. Performs QC of the final formatted report
Which of the following is/are benefit(s) of ONLINE REVIEW?
A. Ensure timely review
B. Replace costly face-to-face meetings
C. Reduce travel time
D. All of the above
In FORMATTING, which of the following is the responsibility of AR QC Reviewer?
A. Finalizes the report for submission
B. Performs QC of the final formatted report
C. Both A and B
D. None of the above
PBRER stands for:
A. Persona Breaking Re-Evaluation Report
B. Periodic Benefit Risk Evaluation Report
C. Professional Benefit Risk Evaluation Report
D. Periodic Benefit Re-Evaluation Response
Annual PADERs are due to be submitted to FDA within how many calendar days of data lock point?
A. 15 days
B. 30 days
C. 45 days
D. 60 days
Quarterly PADERs are due to the FDA within how many calendar days of the data lock point?
A. 15 days
B. 30 days
C. 45 days
D. 60 days
True or False. If an error is found in the first draft of the report, it is important to send an update to the customer by resending a revision/second version of the first draft of the report
A. True
B. False
C. Maybe
The Call for Information (CFI) may include the following as applicable, EXCEPT:
A. Investigator Brochure
B. Worldwide Marketing Approval Status
C. Last Development Safety Update Report(DSUR)
D. All of the above
E. None of the above
Who performs medical review of the DSUR assessing the significance of the data collected in the reporting period in relation to patient exposures and the known safety profile of the products upon receipt of the draft report (if contracted)?
A. MSA
B. QC Specialist
C. SO Team
D. RR Specialist
Who processes and completes all individual cases (ICSRs) received during the reporting period and informs the LL specialist when completed within 7 calendar days of the DLP?
A. MSA
B. QC Specialist
C. SO Team
D. RR specialist
The purpose of this meeting is to interpret the results and to help the AR Specialist understand the key messages the customer would like presented in the document
A. Planning meeting
B. Data interpretation meeting
C. Draft meeting
D. First meeting
