SUSARs. Pursuant to a sponsor’s safety reporting obligations under 21 CFR 312.32(c)(1), Pfizer will report to the Principal Investigator all Serious Unexpected Suspected Adverse Reactions (“SUSARs”). Principal Investigator will receive and review SUSAR reports. Pfizer shall report to the responsible IRB/IEC any SUSARs for the Investigational Drug in the given Clinical Trial taking place in the territory of the Czech Republic. Institution will retain SUSAR reports consistent with Section 11.3 of this Agreement. 19.4
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SUSARs. Pursuant to a sponsor’s safety reporting obligations under 21 CFR 312.32(c)(1), Pfizer will report to the Principal Investigator all Serious Unexpected Suspected Adverse Reactions (“SUSARs”). Principal Investigator will receive and review SUSAR reportsreports and if appropriate according to local requirements. Pfizer shall report to the responsible IRB/IEC any SUSARs for the Investigational Drug in the given Clinical Trial taking place in the territory of the Czech Republic. Institution will retain SUSAR reports consistent with Section 11.3 of this Agreement. 19.4
Appears in 1 contract
Sources: Clinical Study Agreement
SUSARs. Pursuant to a sponsor’s safety reporting obligations under 21 CFR 312.32(c)(1), Pfizer will report to the Principal Investigator all Serious Unexpected Suspected Adverse Reactions (“SUSARs”). Principal Investigator will receive and review SUSAR reportsreports and if appropriate according to local requirements. Pfizer shall report to the responsible IRB/IEC any SUSARs for the Investigational Drug in the given Clinical Trial taking place in the territory of the Czech Republic. Institution will retain SUSAR reports consistent with Section 11.3 of this Agreement. 19.4.
Appears in 1 contract
Sources: Clinical Study Agreement