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Author Topic: SAE reporting to DCGI  (Read 6728 times)

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Offline Dr.Ajaykumar

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SAE reporting to DCGI
« on: Tue, 10 Nov 2009 »
Dear Friends,

I would really appreciate if someone from Pharmacovigilance could help me out on this: Does serious adverse event reporting to authorities in India for clinical trials includes events occurring only in India or does it require reporting of events occurring in other countries.

Thanks and Regards,

Offline nitin

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Re: SAE reporting to DCGI
« Reply #1 on: Tue, 10 Nov 2009 »
Dear Dr.Ajay,
If the trial is taking place in india and submission also in india,then feel it shud be reported to indian authorities only.
If the trial is a global  multi centric then the concerned authorities shud be informed
Dr.Nitin Kulkarni

Offline Dr.Yashodha Reddy

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Re: SAE reporting to DCGI
« Reply #2 on: Mon, 23 Nov 2009 »
Hi Dr.Ajay,

Serious adverse events occurred in a global clinical trial and if India is also a part of global trial then, the SAEs should be submitted to DCGI.

An excerpt from ICH-E2A guideline: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (Section III A, B, C)

All adverse drug reactions (ADRs) that are both serious and unexpected are subject to expedited reporting. This applies to reports from spontaneous sources and from any type of clinical or epidemiological investigation, independent of design or purpose. It also applies to cases not reported directly to a sponsor or manufacturer (fro example, those found in regulatory authority-generated ADR registries or in publications). The source of a report (investigation, spontaneous, other) should always be specified.

Expedited reporting of recations which are serious but expected will ordinarily be inappropriate. Expedited reporting is also inappropriate for serious events from clinical investigations that are considered not related to study product, whether the event is expected or not. Similarly, non-serious adverse reactions whether expected or not, will ordinarilty not be subject to expedited reporting.

Information obtained by a sponsor or manufacturer on serious, unexpected reports from any source should be submitted on an expedited basis to appropriate regulatory authorities if the minimum criteria for expedited reporting can be met.

The CIOMS-I from has been a widely accepted standard for expedited adverse event reporting.  All reports must be sent to those regulators or other official parties requiring them 9as appropriate for the local situation) in countries where the drug is under development.

Offline jil saini

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Re: SAE reporting to DCGI
« Reply #3 on: Mon, 21 Feb 2011 »


Offline raju21103

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Re: SAE reporting to DCGI
« Reply #4 on: Sun, 6 Mar 2011 »
Correct me if i am wrong.....

"Unexpected SAE" must be reported to sponsor with 24 EC with 7 working days...

TO FDA within 14 calender days...i hope i am correct??

Offline avijay_86

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Re: SAE reporting to DCGI
« Reply #5 on: Wed, 9 Mar 2011 »
According to schedule Y “Any unexpected serious adverse event (SAE) during the trial should be communicated promptly (within 14 calendar days) by the Sponsor to the Licensing Authority”.

newbielink: [nonactive]

(iv)               [/size][/color][/font]Any unexpected serious adverse event (SAE) (as defined in GCP Guidelines) occurring during a clinical trial should be communicated promptly (within 14 calendar days) by the Sponsor to the Licensing Authority and to the other Investigator(s) participating in the study (see Appendix XI).

The word 'EVENT' means there is no need of causal relationship.



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