Common use of SUSARs Clause in Contracts

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

Appears in 2 contracts

Sources: Clinical Study Agreement, 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

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