Pharmacovigilance Assessment by ClinSkill | Oct 22, 2018 | 2 comments Welcome to the Quiz on Pharmacovigilance Name Email address According to Schedule-Y, sponsor should report SAE to - Regulatory Authorities as well as to all Investigators participating in trial within: 7 calendar days 14 working days 7 working days 24 hours 14 calendar daysIndividual case reports of adverse drug reactions & adverse event should be transmitted from Identified reporting sources to regulatory authorities and Pharmaceutical companies Clinical investigator via the sponsor to Ethics Committee Within Regulatory authorities and Pharmaceutical companies All of theseCIOMS stands for___________. Council for International Organizations of Medical Sciences Council for Indian Organization of Medical Sciences Council for International Organizations of Medicinal Sciences Council for Indian Organization of Medicinal SciencesAs 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_______________. Probable Possible Certain ConditionalEpidemiological investigations focus on Determining when the exposure Identifying the exposure Identifying cases All of theseAd hoc studies are analyses of Secular trends Cohorts Cases DataA rapid increase in reporting regulatory intervention (prevention) is advised when: When too many AE's are observed When too many ADR's are observed Both A and B None of theseFollowing are the negative criteria for selecting a signal: High Potential Relevance Not Serious Unexpected High PotentialThe scope of the SOP does not need to clearly state that it applies to adverse events that occur at sites/organisation/institution: True FalseBias is a: Systematic error Random error Both of these None 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 as SUSAR SAE AE ADRA mathematical model to assess many factors is Propensity score Multivariate analysis Sensitivity analysis None of theseAccidental intravenous injection of __________ can lead to fatal cardiac arrhythmias. Phenylephrine Lidocaine Epinephrine BupivacaineRegulatory reporting for multiple case reports over a specified time period is termed as: Aggregate Reporting Expedited Reporting Interim Reporting All of theseADRs in Clinical Trials can be detected by : Adverse drug event questionnaire Computerized screening Medication order screening None of theseEach SUSAR report is identified by which of the following? Sponsor protocol code number Sponsor’s case number EUDRACT number Suspected product information Study subject code All 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 Intake Case Triage Case entry None of theseThe PSUR usually include: Formulation Dosage forms Indications All of theseDuring the generation and development of safety data and risk minimization action plans, the following is of importance: To protect patients and their privacy To protect patients and their pets To protect patients and their property To protect patients and their friendsSignal Documents are automatically reassessed: Every year Six-monthly basis, for two years Quarterly basis, every year Quarterly basis, for two yearsTime is Up! 2 Comments Henry.email@example.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.