Clinical Safety Data Management
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show | Definitions and Standards for Expedited Reporting
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The E2A ICH Guideline was finalised under _____ in _________. | show 🗑
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I: It is important to harmonise the way to gather and, if necessary, to take action on important ___________ arising during clinical development. | show 🗑
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show | interdependent
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show | (1) the development of standard definitions and terminology for key aspects of clinical safety reporting
(2) the appropriate mechanism for handling expedited (rapid) reporting, in the investigational (i.e., pre-approval) phase.
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II: Definition - Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment." | show 🗑
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show | Adverse drug reactions
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show | Side effect
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II: Definition - An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational medicinal product). | show 🗑
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II: ____________ (not severity) serves as a guide for defining regulatory reporting obligations. | show 🗑
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show | (1) results in death, (2) is life threatening , (3) requires inpatient hospitalization or prolongation of hospitalization, (4) results in persistent or significant disability/incapacity, (5) is a congenital anomaly/birth defect
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II: The term "life-threatening" in the definition of "serious" refers to an event in which the patient was _________; it does not refer to an event which hypothetically might have caused death if it were more severe. | show 🗑
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II: An event that may require intervention to prevent one of the outcomes defining a serious adverse event should usually also be considered as serious. ________________ judgement should be exercised. | show 🗑
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II: The purpose of expedited reporting is to make regulators, investigators, and other appropriate people aware of _________. | show 🗑
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show | (1) Investigator's Brochure when the product is not yet approved for marketing in the country
(2) Reports which add significant information on specificity or severity of a known, already documented serious ADR constitute unexpected events.
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show | (1) Single cases of serious events and unexpected ADRs (2) other observations that might materially influence the benefit-risk assessment or overall conduct of the trial (e.g major safety finding from relevant animal study)
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III: What is the notification time frame for fatal or life threatening unexpected ADRs? | show 🗑
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III: What is the time frame for the report on fatal or life threatening unexpected ADRs? (following initial notification) | show 🗑
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III: What is the reporting time frame for all other (non-fatal/life threatening) serious, unexpected ADRs? | show 🗑
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III: For regulatory purposes, initial reports should be submitted within the prescribed time as long as the following minimum criteria are met: ______ (5 things) | show 🗑
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show | CIOMS-I
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III: It is the ________ responsibility to decide whether active comparator (placebo) drug reactions should be reported to the other manufacturer and/or directly to appropriate regulatory agencies. | show 🗑
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show | little or no significant
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III: To avoid __________, an ADR that qualifies for expedited reporting with one presentation of a product or product use, should be reported or referenced to regulatory filings across other product presentations and uses. | show 🗑
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show | (1) Patient details, (2) Suspected medicinal products, (3) Other treatments, (4) Details of suspected AE/ADR, (5) Details of reporter of event, (6) administrative and sponsor/company details
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