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Registeradverse reaction reporting [Regulatives / Guidelines]
Dear Pravin
The reportings of SAEs are to be defined by proper SOPs developed in complinace with the GCP and applicable regulatory requirements (Schedule Y in your case...and mine too
).
The format defined by the schedule Y can be accessed here. Besides this, there will be some SOP driven forms, as well.
The formats shall include few necessary inputs viz.
"when, what and how" of the event occurred
outcome, if available
details of the study
management of the event
The timelines for the reporting of the SAE are to be strictly followed as per GCP. The authorities to be informed would normally include IRB, DCGI and pharmacovigilance division of your organisation.
i hope the query is answered to some extent. Any further inputs from other researchers would be appreciated.
regards,
Dr Kshitij Soni
Ranbaxy, India
❝ Give me a Idea About the serious advese event reporting form of formats
The reportings of SAEs are to be defined by proper SOPs developed in complinace with the GCP and applicable regulatory requirements (Schedule Y in your case...and mine too
).The format defined by the schedule Y can be accessed here. Besides this, there will be some SOP driven forms, as well.
The formats shall include few necessary inputs viz.
"when, what and how" of the event occurred
outcome, if available
details of the study
management of the event
The timelines for the reporting of the SAE are to be strictly followed as per GCP. The authorities to be informed would normally include IRB, DCGI and pharmacovigilance division of your organisation.
i hope the query is answered to some extent. Any further inputs from other researchers would be appreciated.
regards,
Dr Kshitij Soni
Ranbaxy, India
Complete thread:
- adverse reaction reporting makula_001 2006-12-04 08:40 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- adverse reaction reporting Jaime_R 2006-12-04 14:08
- adverse reaction reporting Dr.Pravin 2006-12-07 07:01
- adverse reaction reportingdrks 2006-12-08 16:16
- GCP Regulation in India Helmut 2006-12-08 21:53
- adverse reaction reportingdrks 2006-12-08 16:16
Ing. Helmut Schütz