If Any Adverse events occur even after signing of ICD The Investigator must noted all AEs
AE means Suppose If the subject moving on the road with drowsiness after taking of Study Drug.Then he met an accident.The investigator must report this as an AE.After that he will reveal abnormality with Study Medication.
AEs can be notified by the sponsor to all Investigators Then the investigator must inform to EC with in 7 day.
If an AE can be identified by the investigator he must inform to Sponsor within 24hrs of time AE occured.
AE Consideration:
Basically every ADR is an AE, but all AEs are not ADRs,In an ADR ,we can sat that it is due to the drugBt in case of an AE , the causality is nt certain and needs to be assessed
Yes.. The 'D' alphabet makes the difference..when causally related to the drug, it is called 'ADR' and when uncertain 'AE' is used so as not to blame the drug..
Adverse drug reactions:all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.Adverse Event (or Adverse Experience)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 treatmentSo here you can see the difference between adverse drug reaction and adverse even that, Adverse drug reaction is definitely related to drug. It has the causal relationship with drug. whereas adverse event not necessarily be due to drug. The event may be may not be related to drug.
SAE:A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose:* results in death,* is life-threatening,* requires inpatient hospitalisation or prolongation of existing hospitalisation,* results in persistent or significant disability/incapacity, or* is a congenital anomaly/birth defect.An adverse event/reaction will become SAE only if it meets the above mentioned requirements as defined in the above definition.SAE may have some expectedness as per it's applicable product information. then it is an expected SAE. If it is an unexpected SAE as defined below it will be called as SUSARs.The term SUSAR defined in ICH GCP is as follows:An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., for applicable product information include Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) So if the SAE seen is not mentioned in the applicable product information then it will be reported as SUSAR.So SUSAR's are not expected as per applicable product information of the drug. So these are unexpected SAEsSo to summarise the post:Adverse drug reaction: Causality definitely related to drugAdverse drug event : Causality may or may not be related to drug.SAE: severity of AE or adverse reactions should fullfil the criteria mentioned in the SAE definition.SUSAR: nature or severity unexpected as per the applicable product information.
AE means Suppose If the subject moving on the road with drowsiness after taking of Study Drug.Then he met an accident.The investigator must report this as an AE.After that he will reveal abnormality with Study Medication.
AEs can be notified by the sponsor to all Investigators Then the investigator must inform to EC with in 7 day.
If an AE can be identified by the investigator he must inform to Sponsor within 24hrs of time AE occured.
AE Consideration:
Basically every ADR is an AE, but all AEs are not ADRs,In an ADR ,we can sat that it is due to the drugBt in case of an AE , the causality is nt certain and needs to be assessed
Yes.. The 'D' alphabet makes the difference..when causally related to the drug, it is called 'ADR' and when uncertain 'AE' is used so as not to blame the drug..
Adverse drug reactions:all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.Adverse Event (or Adverse Experience)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 treatmentSo here you can see the difference between adverse drug reaction and adverse even that, Adverse drug reaction is definitely related to drug. It has the causal relationship with drug. whereas adverse event not necessarily be due to drug. The event may be may not be related to drug.
SAE:A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose:* results in death,* is life-threatening,* requires inpatient hospitalisation or prolongation of existing hospitalisation,* results in persistent or significant disability/incapacity, or* is a congenital anomaly/birth defect.An adverse event/reaction will become SAE only if it meets the above mentioned requirements as defined in the above definition.SAE may have some expectedness as per it's applicable product information. then it is an expected SAE. If it is an unexpected SAE as defined below it will be called as SUSARs.The term SUSAR defined in ICH GCP is as follows:An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., for applicable product information include Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) So if the SAE seen is not mentioned in the applicable product information then it will be reported as SUSAR.So SUSAR's are not expected as per applicable product information of the drug. So these are unexpected SAEsSo to summarise the post:Adverse drug reaction: Causality definitely related to drugAdverse drug event : Causality may or may not be related to drug.SAE: severity of AE or adverse reactions should fullfil the criteria mentioned in the SAE definition.SUSAR: nature or severity unexpected as per the applicable product information.
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