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Electronic Transmission of CSR Testing procedure with INFARMEDATTN: All Marketing Authorization Holders / Sponsors of Clinical TrialsThis document focuses on the testing procedure to be followed by
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The Electronic Transmission of ICSR is a document required to be submitted to the required address to provide specific information. It needs to be filled-out and signed, which can be done manually, or using a particular software like PDFfiller. It allows to fill out any PDF or Word document directly from your browser (no software requred), customize it according to your requirements and put a legally-binding e-signature. Once after completion, you can send the Electronic Transmission of ICSR to the relevant receiver, or multiple recipients via email or fax. The blank is printable as well thanks to PDFfiller feature and options offered for printing out adjustment. In both digital and physical appearance, your form should have a neat and professional look. You may also save it as the template for further use, without creating a new document again. Just edit the ready form.

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Electronic transmission of ICSR refers to the electronic submission of Individual Case Safety Reports to regulatory authorities and other stakeholders.
Marketing Authorization Holders (MAHs) are required to file electronic transmission of ICSR.
Electronic transmission of ICSR can be filled out using a specified format such as E2B(R3) and submitted through the appropriate electronic submission system.
The purpose of electronic transmission of ICSR is to ensure timely and standardized reporting of individual case safety information to regulatory authorities for pharmacovigilance purposes.
Information such as patient demographics, medical history, adverse events, drug information, and reporter details must be reported on electronic transmission of ICSR.
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