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Is there a need to file the “Informed consent and patient recruitment procedure” in the sponsor’s TMF? If yes, what is the appropriate artifact? Is 01.01.06 Recruitment Plan the appropriate one?
More background:
– Purpose of this document: Used by sponsors to describe the recruitment arrangements and/or informed consent procedure.
– Link to the document template: https://health.ec.europa.eu/document/download/dbe5bb25-dd62-4286-95b9-bd8d3ec8678d_en?filename=informedconsent_patientrecruitmentprocedure_en.pdf
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