Informed consent and patient recruitment procedure

Tagged: EU CTR; CTIS

This topic has 0 replies, 1 voice, and was last updated 1 week, 3 days ago by Jackie Fu.

Viewing 0 reply threads

Author

Posts
- April 26, 2024 at 8:53 am #5144
  
  Jackie Fu
  Participant
  
  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
Author

Posts

Viewing 0 reply threads

You must be logged in to reply to this topic.