Team Elsa Pre-test

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