[Mai Nishihara]

Hi Maria, thank you for your comment on my question. You have given me a clear picture of TMF telling the study story and documents can be filed by CROs under the sponsor’s appropriate access management.
Thank you for your valuable time.

[Mai Nishihara]

Hi Elvin,

I just wanted to say a huge thank you for sharing your foresight and ideas!
Your explanation gave me to take pause to think about our risk management along with patient centricity.

• This reply was modified 1 year, 7 months ago by Mai Nishihara.

[Mai Nishihara]

Dear Elvin,

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.

[Mai Nishihara]

Dear Eldin

Thank you for posting the document.
Watching your session online, I looked forward to having some guidance from FDA.
The attached email you shared really helps me to get a clear picture.

Warm Regards
Mai

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