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Clinical Safety Data Management

E2A Clinical Safety Data Management: ___________________ Definitions and Standards for Expedited Reporting
The E2A ICH Guideline was finalised under _____ in _________. Step 4; October 1994
I: It is important to harmonise the way to gather and, if necessary, to take action on important ___________ arising during clinical development. clinical safety information
I:It is both practical and well-advised to regard pre-marketing and post-marketing clinical safety reporting concepts and practices as ______ [...] interdependent
I: There are two issues within the broad subject of clinical safety data management that are appropriate for harmonisation at this time: ____ (2 things) (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.
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." Adverse event (or experience)
II: Definition - All noxious and unintended responses to a medicinal product related to any dose should be considered ________. Means a casual relationship between product and event is at least a reasonable possibility (i.e cannot be ruled out). Adverse drug reactions
II: It is recommended that this term no longer be used and particularly should not be regarded as synonymous with adverse event or adverse reaction. Side effect
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). Unexpected adverse drug reaction
II: ____________ (not severity) serves as a guide for defining regulatory reporting obligations. Seriousness
II: A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: ________ (5 things) (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
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. at risk of death at the time of the event
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. medical and scientific
II: The purpose of expedited reporting is to make regulators, investigators, and other appropriate people aware of _________. new, important information on serious reactions
II: The following documents or circumstances will be used to determine whether an adverse event/reaction is expected: _____ (2 things) (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.
III: What should be reported? (two things) (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)
III: What is the notification time frame for fatal or life threatening unexpected ADRs? ASAP and no later than 7 calendar days from first knowledge by the sponsor
III: What is the time frame for the report on fatal or life threatening unexpected ADRs? (following initial notification) within 8 additional calendar days
III: What is the reporting time frame for all other (non-fatal/life threatening) serious, unexpected ADRs? ASAP but no later than 15 calendar days from first knowledge by the sponsor
III: For regulatory purposes, initial reports should be submitted within the prescribed time as long as the following minimum criteria are met: ______ (5 things) (1) an identifiable patient (2) a suspect medicinal product (3) an identifiable reporting source (4) an event or outcome identified as serious and unexpected (5) a reasonable causal relationship
III: The ________ form has been a widely accepted standard for expedited adverse event reporting. CIOMS-I
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. sponsor's
III: Breaking the blind for a single patient usually has _________ implications for the conduct of the clinical investigation or on the analysis of the final clinical investigation data. little or no significant
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. ambiguities and uncertainties
Attachment 1: What are the six key data elements for inclusion in expedited reports of serious adverse drug reactions? (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
Created by: wickerfurniture



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