Pharmacovigilance Assessment by ClinSkill | Oct 22, 2018 | 5 comments Welcome to the Quiz on Pharmacovigilance Name Email address Signal Documents are automatically reassessed:Every yearSix-monthly basis, for two yearsQuarterly basis, every yearQuarterly basis, for two yearsAs 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_______________.ProbablePossibleCertainConditionalThe scope of the SOP does not need to clearly state that it applies to adverse events that occur at sites/organisation/institution:TrueFalseA 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 theseEpidemiological investigations focus onDetermining when the exposureIdentifying the exposureIdentifying casesAll 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 theseBias is a:Systematic errorRandom errorBoth of theseNone of theseFollowing are the negative criteria for selecting a signal:High Potential RelevanceNot SeriousUnexpectedHigh PotentialRegulatory reporting for multiple case reports over a specified time period is termed as:Aggregate ReportingExpedited ReportingInterim ReportingAll of theseCIOMS 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 SciencesIndividual 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 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 daysA mathematical model to assess many factors isPropensity scoreMultivariate analysisSensitivity analysisNone of theseAny 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 asSUSARSAEAEADRADRs in Clinical Trials can be detected by :Adverse drug event questionnaireComputerized screeningMedication order screeningNone of theseEach SUSAR report is identified by which of the following?Sponsor protocol code numberSponsor’s case numberEUDRACT numberSuspected product informationStudy subject codeAll 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 friendsAccidental intravenous injection of __________ can lead to fatal cardiac arrhythmias.PhenylephrineLidocaineEpinephrineBupivacaineThe PSUR usually include:FormulationDosage formsIndicationsAll of theseAd hoc studies are analyses ofSecular trendsCohortsCasesDataTime is Up! 5 Comments Suresh on June 4, 2021 at 12:05 pm Looking for PV domain online training Reply komal yadav on April 29, 2021 at 6:10 pm Good for revision. Reply Aman Sharma on July 16, 2021 at 11:14 am I want to work with PV company and also this score card is not gud for me I know what my limit and from ahead ill push my limits towards good knowledge regarding PV Thank uh Aman Sharma Reply 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.
Aman Sharma on July 16, 2021 at 11:14 am I want to work with PV company and also this score card is not gud for me I know what my limit and from ahead ill push my limits towards good knowledge regarding PV Thank uh Aman Sharma Reply
Looking for PV domain online training
Good for revision.
I want to work with PV company and also this score card is not gud for me I know what my limit and from ahead ill push my limits towards good knowledge regarding PV
Thank uh
Aman Sharma
Ok
the exam pattern is good