Pharmacovigilance Assessment by ClinSkill | Oct 22, 2018 | 2 comments Welcome to the Quiz on Pharmacovigilance Name Email address Each SUSAR report is identified by which of the following?Sponsor protocol code numberSponsor’s case numberEUDRACT numberSuspected product informationStudy subject codeAll of theseThe process of electronically receiving a case within Argus Safety after it has been physically received by the Drug Safety team is called:Case IntakeCase TriageCase entryNone of theseSignal Documents are automatically reassessed:Every yearSix-monthly basis, for two yearsQuarterly basis, every yearQuarterly basis, for two yearsAny untoward medical occurrence n a patient or clinical trial subject administered a pharmaceutical product and which does not necessarily have to have a causal relation with this treatment is known asSUSARSAEAEADRIndividual case reports of adverse drug reactions & adverse event should be transmitted fromIdentified reporting sources to regulatory authorities and Pharmaceutical companiesClinical investigator via the sponsor to Ethics CommitteeWithin Regulatory authorities and Pharmaceutical companiesAll of theseRegulatory reporting for multiple case reports over a specified time period is termed as:Aggregate ReportingExpedited ReportingInterim ReportingAll of theseThe scope of the SOP does not need to clearly state that it applies to adverse events that occur at sites/organisation/institution:TrueFalseBias is a:Systematic errorRandom errorBoth of theseNone of theseDuring the generation and development of safety data and risk minimization action plans, the following is of importance:To protect patients and their privacyTo protect patients and their petsTo protect patients and their propertyTo protect patients and their friendsADRs in Clinical Trials can be detected by :Adverse drug event questionnaireComputerized screeningMedication order screeningNone of theseAd hoc studies are analyses ofSecular trendsCohortsCasesDataEpidemiological investigations focus onDetermining when the exposureIdentifying the exposureIdentifying casesAll of theseAccording to Schedule-Y, sponsor should report SAE to - Regulatory Authorities as well as to all Investigators participating in trial within:7 calendar days14 working days7 working days24 hours14 calendar daysAccidental intravenous injection of __________ can lead to fatal cardiac arrhythmias.PhenylephrineLidocaineEpinephrineBupivacaineCIOMS stands for___________.Council for International Organizations of Medical SciencesCouncil for Indian Organization of Medical SciencesCouncil for International Organizations of Medicinal SciencesCouncil for Indian Organization of Medicinal SciencesThe PSUR usually include:FormulationDosage formsIndicationsAll of theseA rapid increase in reporting regulatory intervention (prevention) is advised when:When too many AE's are observedWhen too many ADR's are observedBoth A and BNone of theseFollowing are the negative criteria for selecting a signal:High Potential RelevanceNot SeriousUnexpectedHigh PotentialAs per WHO definitions, A clinical event, including a laboratory test abnormality, with a reasonable time sequence to administration of the drug but which could also be explained by concurrent disease or other drugs or chemicals is known as_______________.ProbablePossibleCertainConditionalA mathematical model to assess many factors isPropensity scoreMultivariate analysisSensitivity analysisNone of theseTime is Up! 2 Comments Henry.gregoryade@gmail.com on February 11, 2020 at 7:49 am Ok Reply chakravarthi on January 6, 2020 at 7:25 am the exam pattern is good Reply Submit a Comment Cancel replyYour email address will not be published. Required fields are marked *Comment Name * Email * Website Save my name, email, and website in this browser for the next time I comment.
Ok
the exam pattern is good