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Is there a need to file the “Statement on compliance Regulation (EU) 2016/679 (GDPR)” in the sponsor’s TMF? If yes, what is the appropriate artifact?
More background of this document:
– Purpose of this document: It is used by the sponsor to declare that data have been and will be collected and processed in accordance with the General Data Protection Regulation (EU) 2016/679 (GDPR).
– Link to the document template: https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fhealth.ec.europa.eu%2Fdocument%2Fdownload%2F8818971e-a8b5-48af-a648-9468612c0a4c_en%3Ffilename%3Dcompliance_reg2016_679_template_en.docx&wdOrigin=BROWSELINK
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