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Phase US Connect 2019 Paper SA13Piloting the Clinical Data Specialist Role within Regulatory Review Joy Li, US Food and Drug Administration, Silver Spring MD, USA Run Li, US Food and Drug Administration,
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The form is designed to outline the responsibilities and qualifications of clinical data specialists involved in the regulatory review process.
Clinical data specialists and regulatory affairs professionals involved in submitting clinical data for regulatory review must file this form.
To fill out the form, provide accurate details about your professional role, qualifications, and the specifics of the clinical data being submitted.
The purpose of the form is to standardize the reporting of clinical data specialists' roles and ensure compliance during the regulatory review process.
The information required includes the specialist's name, qualifications, role description, relevant experience, and the clinical data being reviewed.
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