99 PV Red Sheet Practice Exam

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• Why is pharmacovigilance auditing important?
• Name a common challenge in PV data management and a mitigation strategy?
• Which statement best describes a direct-to-patient safety communication?
• MAX ALTITUDE on FMC provides which buffet margin?
• By 500 feet above TDZE, what is the required wings attitude?
• Why does the AOM caution against extending the flaps at or near flap placard limit speeds?
• Describe the role of direct healthcare professional communications (DHPCs) in risk communication.
• Who is the primary audience for a DHCP?
• What is a Medical Review in PV case processing?
• The buffet margin provided by MAX ALTITUDE on FMC equals:
• If the Captain starts taxiing before you call 'STANDING BY FLAPS', what should you do?
• Where do you find the CI?
• Explain the difference between a MedDRA preferred term and a preferred term in clinical coding.
• If ATC assigns a runway change due to weather, what risk factors could be affected?
• What is a Data Monitoring Committee (DMC) and when is it used?
• Which statement about Flight Deck Door Test timing is correct?
• You are in cruise with the autopilot on. If your control wheel were not level right now, what causes would you consider and what would you do?
• What distinguishes SUSAR from a standard adverse event?
• Name two examples of regulatory reporting outputs from PV systems.
• When must a security check be performed?
• What resources are readily available for altitude selection?
• Explain the concept of risk minimization measures (RMMs).
• Which regulation protects data privacy in pharmacovigilance?
• Which of the following would be considered a secondary pharmacovigilance data source?
• Which step in case processing evaluates how serious an adverse event is?
• What does the Lead Trial/Clinical Trial Adverse Event relation in pharmacovigilance refer to?
• What is a Pharmacovigilance System Master File (PSMF)?
• Which PV metric would you expect to find on a dashboard?
• What is the purpose of import/export of safety data between sponsors and CROs?
• Which activities are involved in case processing and adjudication in pharmacovigilance?
• ATO G is defined as:
• Which statement correctly distinguishes post-marketing safety signals from pre-marketing signals?
• What is the turbulent air penetration speed above 15,000 feet?
• What must be included in a CSR regarding patient consent?
• What are the turbulent air penetration speeds below 15,000 feet?
• Which item is NOT listed as a non-normal step printed on QRH?
• Which functions are typically involved in a cross-functional PV team?
• Which description best captures signal detection in pharmacovigilance, and which two methods are commonly used?
• Which PV metric would most directly reflect QA processes?
• What action is described as part of engine start abnormality steps?
• Which N1 value is the maximum for taxiing on taxiways?
• What is a Priori risk assessment in PV?
• What does risk minimization entail in PV?
• What is the normal recommended taxi speed?
• When is the use of autobrakes required?
• For MAX engines not FFOD, what is the engine stabilization time?
• Which statement best describes proactive pharmacovigilance?
• What methods can you use to exit a FMC Holding Pattern?
• What is a safety signal in pharmacovigilance?
• What is de-duplication in a safety database?
• Which statement best describes the action when the Captain taxis before you call STANDING BY FLAPS?
• Which statement best describes spontaneous post-authorization safety studies?
• ATO G stands for which term?
• Which limitation is a recognized issue with spontaneous reporting systems?
• What does a Safety Data Exchange Agreement (SDEA) govern?
• High CI vs Low CI: which statement is true?
• What is the role of pharmacovigilance in post-approval labeling changes?
• What are the stabilized approach criteria?
• Risks of low CI include what?
• If the ANTISKID INOP light illuminated when you moved the landing gear lever to down on final approach, what action would you take?
• What is the purpose of a Case Narrative in a CSR?
• In signal management, which step directly involves determining which signals require action and allocating resources?
• What does data minimization mean in PV data handling?
• For performance calculations, ATOG ensures:
• What is the correct guidance for selecting flap settings as you approach and decelerate below current flap maneuver speed?
• Why is cross-border pharmacovigilance data sharing important?
• Describe literature-derived case reports in PV.
• Which buffet margin value is associated with MAX ALTITUDE on FMC?
• What is the primary purpose of a Dear Healthcare Professional (DHCP) communication?
• In flight performance planning, MAX ALTITUDE on the FMC provides which buffet margin?
• For NON-MX base departures, what are the minimum oil quantities for NG and MAX respectively?
• Which document contains the Aborted Engine Start procedure?
• Which statement correctly contrasts primary and secondary pharmacovigilance data sources?
• In pharmacovigilance, which statement best describes a safety signal?
• Which of the following is not a typical element of a pharmacovigilance plan?
• What do you check before you say 'Clear Right'?
• If there is no STAR, what speed should be set?
• Why is timely case intake important in pharmacovigilance?
• The margin value produced by MAX ALTITUDE on FMC is:
• The buffet margin associated with MAX ALTITUDE on FMC is:
• Which stakeholder benefits most from patient safety communications?
• Explain the difference between planned PASS and spontaneous safety studies.
• Which of the following is NOT a purpose of patient safety communications?
• Which of the following is not a typical risk minimization action?
• How should you respond if you believe you have visual confirmation of the traffic during an RA?
• Which activity is NOT typically part of case processing and adjudication?
• Which is NOT typically a PV metric on a dashboard?
• How does GDPR impact PV activities?
• What is the maximum recommended N1 thrust value for taxiing on NON-CONGESTED RAMPS?
• Which condition is not a trigger for autobrakes?
• What should be evaluated when cleared to FL410?
• Why must you continue to follow TCAS commands even though you have traffic in sight?
• What communication with the cabin is required at Top of Descent?
• When might a Direct-to-Patient (DTP) safety communication be deployed?
• Delayed intake in PV can lead to which consequence?
• For a MAX, what is the recommended altitude reduction from FMC maximum altitude to avoid turbulence?
• What guidance does the AOM give you for flap extension speeds?
• Which base requires separate minimum oil quantities for NG and MAX?
• Which statement best characterizes a safety signal refinement study?
• What is the limitation associated with aileron trim?
• What is the role of the Qualified Person for Pharmacovigilance (QPPV) in the EU pharmacovigilance system?
• Which value represents the buffet margin produced by MAX ALTITUDE on FMC?
• What is the primary purpose of patient safety communications in pharmacovigilance?
• Name two key safety metrics used to monitor PV performance.
• If MAX ALTITUDE is engaged on the FMC, the indicated buffet margin is:
• What would you do if you experience continuous moderate turbulence at your current cruise altitude?
• Which tools are used for causality assessment in PV?
• Which statement best describes the DSUR focus?
• What is pharmacovigilance in the context of vaccines and a typical reporting system?
• What does a PV inspection primarily assess?
• Which statement best describes SUSAR reporting timelines?
• In an NG, ATC says rides are "light to occasional moderate turbulence." What do you do in this situation and why?
• In pharmacovigilance, what is the final communication step of the signal management workflow?
• If stabilized approach criteria are not met by 1,000 ft above TDZE, what should you do?
• What action is described as part of engine start abnormality steps?
• After taxi, what do you do if ATC issues an intersection takeoff?
• Which statement best describes ATOG?
• ATOG is used to determine which value for performance planning?
• What is a PSUR and how does it differ from a DSUR?
• What is the maximum recommended N1 thrust value for taxiing on congested ramps?
• What is the maximum allowable taxi speed on straight taxiways?
• Where do you find information on conducting a battery start?
• What is a safety sign-off in the PV workflow?
• What is the role of literature screening in pharmacovigilance?
• By 1,000 feet above TDZE, which elements must be established as part of stabilized approach criteria?
• Name two standard coding systems used for adverse events in PV.
• What are the turbulent air penetration speeds above 15,000 feet?
• In pharmacovigilance, what is the role of blinding in a safety study?
• Which statement best describes timely intake in pharmacovigilance?
• Which statement best defines a case series in pharmacovigilance and its significance?
• What is the goal of a DHPC (Drug Safety Communication)?
• Which two primary sources provide the majority of spontaneous adverse event reports worldwide?
• In pharmacovigilance, what does case intake refer to?
• What does a periodic safety update report (PSUR) typically include?
• What is a pharmacovigilance plan and its typical elements?
• What is the risk of operating with one pack/bleed air source?
• Which practice best supports comprehensive safety surveillance across populations?
• Which outcome is achieved by effective patient safety communications?
• What does 'coding' involve in case processing of adverse events?
• How long must you operate the engines at or near idle prior to shutting them down on MAX engines?
• What is a Case Safety Report (CSR) and what must it contain to be considered complete?
• How do an adverse event (AE) and an adverse drug reaction (ADR) differ?
• Which choice best describes a pharmacovigilance metrics dashboard?
• Which tools are commonly used for causality assessment in pharmacovigilance?
• Why is data quality essential in pharmacovigilance databases?
• What is the purpose of proactive reporting programs in pharmacovigilance?
• What is the primary purpose of a Risk Management Plan (RMP) for a medicinal product?
• What are the key components of a safety database in pharmacovigilance?
• Explain the term de-identified data and its importance in PV reporting.
• For an NG, what is the recommended altitude reduction from FMC maximum altitude to avoid turbulence?
• Which N1 value is the maximum for taxiing on congested ramps?
• Which statement best describes a blind or double-blind pharmacovigilance study?
• Which statement best describes de-duplication in adverse event reporting?
• Which statement describes the function of a causality assessment step in case processing?
• What is the purpose of reporting outputs in a safety database?
• What is a Bayesian approach in signal detection and what is its primary advantage?
• What is the primary objective of pharmacovigilance (PV)?
• Which of the following is a permitted reason to switch from TA/RA to TA in the transponder?
• If ATC revises a descent clearance to descend and maintain FL180, what altimeter setting are you required to use?
• Minimum oil quantity for departure from MX base?
• What are the risks of operating with one pack/bleed air source?
• Which statement about the autobrake and stopping margin is correct?
• Which item must be considered when cleared to FL410?
• A pharmacovigilance metrics dashboard would most likely help PV teams to monitor which area?
• When does the Captain need to arrange for oil service on a terminating flight?
• In a MAX, ATC says rides are "light to occasional moderate turbulence." What do you do in this situation and why?
• What components comprise an exposure term in PV data?
• What is a signal management workflow in pharmacovigilance?
• What are spontaneous reporting systems and their limitations?
• What is the primary source of post-approval safety signals?
• How do you define rollback?
• After responding to an RA, when must you return to your previous clearance?
• What is a safety signal?
• What is a potential consequence of extending flaps near placard limit speeds?
• Which elements belong in a PV staff training program?
• What defines a rollback?
• What is a DSUR and when is it typically required?
• The MAX ALTITUDE setting on the FMC yields which buffet margin?
• What is the minimum engine oil quantity for the next flight from KDAL?
• Where do you find information on conducting a start without the APU?
• Which base has a fixed minimum oil quantity of 70% for departure, regardless of engine type?
• What is the NG engine stabilization time?
• What extra FMC steps for descent are necessary with a low CI?
• What is the purpose of PSURs or DSURs in PV?
• Define a Benefit-Risk Assessment in PV.
• How is an acceptable autobrake setting determined for landing?
• Which statement best differentiates a DHCP from a DTP communication?
• What is the maximum recommended N1 thrust value for taxiing on NON-CONGESTED RAMPS?
• What is the turbulent air penetration speed below 15,000 feet?
• When must you complete the Flight Deck Door Test?
• How long must you operate the engines at or near idle prior to shutting them down on NG engines?