[Darwin Thukkan]

Hi David,

Sorry for the late response. I do not have much experience on Phase-I trial however i can provide my suggestion. The QC can be performed as per each milestone, based on duration of the study. QC must be performed during Maintenance phase since the error can be identified and rectified accordingly.

Thanks,
Darwin

[Darwin Thukkan]

Hi,

I agree with Marie. Site SOPs have to be at site only and we do not expect to file at sponsor TMF. List of SOPs reviewed during site selection or site initiation can be mentioned in Pre-Study Visit report or Site Initiation Visit report.

Thanks,
Darwin

[Darwin Thukkan]

Hi Maria,

It will be difficult to find documents if many countries participates in the study if you opt for 1st option. My suggestion to go for second option to avoid any confusions and it will be also easy for everyone to search a documents in respective country or site.

Thanks,
Darwin

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