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makula_001 ● 2006-12-04 09:40 (6352 d 02:01 ago) Posting: # 377 Views: 6,234 |
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what is the contents of adverse drug reaction reporting sheet |
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Jaime_R ★★ Barcelona, 2006-12-04 15:08 (6351 d 20:33 ago) @ makula_001 Posting: # 378 Views: 5,346 |
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Dear makula_001, it would be nice, starting you post with a salutation, and finish with some kind of greeting  See Instructions.htm#Etq (especially under the headings Be polite! and Be specific!) ❝ what is the contents of adverse drug reaction reporting sheet Which country are you talking about? Some general principles for e.g., the EU can be found here. Or have a look at FDA's MedWATCH... Many countries have a system for electronic submission of AE reporting in place. — Regards, Jaime |
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Dr.Pravin ☆ Ahmedabad, 2006-12-07 08:01 (6349 d 03:39 ago) @ makula_001 Posting: # 385 Views: 5,172 |
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Give me a Idea About the serious advese event reporting form of formats — Dr.Pravin Ahir Co-Investigator, Accutest Research Pvt.Lab.(I), Ltd. Ahmedabad |
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drks ☆ 2006-12-08 17:16 (6347 d 18:24 ago) @ Dr.Pravin Posting: # 387 Views: 5,344 |
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Dear Pravin ❝ 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 |
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Helmut ★★★   Vienna, Austria, 2006-12-08 22:53 (6347 d 12:47 ago) @ drks Posting: # 388 Views: 5,433 |
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— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz