vish14184
★    

India,
2008-10-13 12:55
(6469 d 03:26 ago)

Posting: # 2521
Views: 3,022
 

 Adverse event or ADRs details [Regulatives / Guidelines]

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Dear All,

I would like to know that,

In protocol Adverse event section we speccify all Adverse event and ADR available in literature. Now my question are,

1. Is it necessary to cover all AE and ADR details in Subject Information sheet (SIS)?

2. Is it enough to inform volunteers main AEs or ADRs through Subject information sheet (SIS) during ICF presentation?

Regards
Vishal Nakrani
 
Ohlbe
★★★

France,
2008-10-13 20:03
(6468 d 20:18 ago)

@ vish14184
Posting: # 2524
Views: 2,388
 

 Adverse event or ADRs details

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Dear Vishal,

I would suggest to list at least all adverse events in the approved package leaflet (or patient information sheet, or whatever you call it) of the product in your country, if it is available, and the adverse events listed in the package leaflet of the reference product that you use.

Regards
Ohlbe
 
debabrata
●    

2008-10-14 12:30
(6468 d 03:51 ago)

@ vish14184
Posting: # 2527
Views: 2,388
 

 Adverse event or ADRs details

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Hi vishal,

As far as BA/BE is concern, event which is very common and frequent should be listed in the SIS. However it is better to capture all the events, specifically observed during PMS if possible.

--
Edit: Full quote removed. Please see this post! [Helmut]
 
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