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ICH E2A
Clinical Safety Data Management
| Question | Answer |
|---|---|
| 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 |
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