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September 16, 2022 at 11:32 am #4734
Thank you for responding to my question.
We are discussing the way to manage patient centric related documents, for sponsors’ responsibility for patient-centric operations is increasing.
Could you enlighten me on the basic idea how to categorize and keep the documents?
1. It happened pre site activation and enrollment.
We collected the questionnaire from patient advocacy group members.
2. We plan to fix the study specific patient material version1 based on the answers.
Perhaps we might take other questionnaires after site activations and enrollments by asking the subjects of the study, and amend the patient material in the future.