Reply To: Filing Site-Specific SOPs

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January 28, 2020 at 3:51 am #2806
Darwin Thukkan
Participant

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