Special Requirements for Non-Interventional Studies with Participating Sites in the European Union Sample Clauses

Special Requirements for Non-Interventional Studies with Participating Sites in the European Union. If Institution conducts a multicenter non-interventional Study (prospective or retrospective), special requirements relating to reporting of Adverse Events will apply to any Participating Site located in the European Union (“EU”). Requirements relating to retention of Study records and availability of those records to audit may also apply to the EU site and the Institution, depending on the nature of the Study. These additional requirements, based on applicable EU legislation, will be identified in the Study Order for each such Study. If Institution wishes to add a Participating Site located in the EU after execution of a Study Order that did not contemplate inclusion of an EU site, Institution will notify Pfizer. Addition of an EU Participating Site to such a Study will require amendment of Section 8 of the Study Order to reflect these additional requirements.

Related to Special Requirements for Non-Interventional Studies with Participating Sites in the European Union

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