Clinical Research and GCP Update

Version 3: Changes since Version 2.6

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SUSAR Reports to PIs: Q & A Version Three, Feb 2021 (& V 2.4, 2.6) • Item 7.30 of Version 3 (previously Item 7.28 , V2.3; item 7.29 V 2.4 & 2.6) has changed and might appear confusing. • Question :- Should sponsors also send SUSARs to investigators of a clinical trial? • Answer :- “Sponsor …. and should expedite the reporting of all SUSARs to all concerned investigators /institutions (ICH E6)… • Versions 2.4, 2.6 & 3 have added the following sentence “ …. The most important thing is to inform investigators of safety profile changes, not of individual SUSAR reports”. • So one sentence says “all SUSARs to all concerned investigators” and the second sentence says NOT individual SUSAR reports. • They suggest:- “For example, information derived from SUSAR reports could be provided via investigators’ letters including both an updated benefit-risk evaluation and risk mitigation measures”.

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