[Marie-Christine Poisson-Carvajal]

Agree. Those files are hard to read when converted to pdf. The recommendation is to retain the native format. If you have a eTMF, your system may allow to upload documents in their native format.

[Marie-Christine Poisson-Carvajal]

Hi Katie, I also agree with everything said regarding Iron Mountain.

Marie-Christine

[Marie-Christine Poisson-Carvajal]

Hi David,

Basically agree with Darwin. There is no one size that fits all. In my opinion, the frequency or time points for TMF review should be flexible and adapted to the study. Usually, Phase 1 studies are of short duration and so I would recommend to perform a review at time of site close-out and then one at the end of the study. Again, frequency and/or time points/milestones should be determined by the study team at the beginning of the study and agreement recorded in the TMF management plan.

[Marie-Christine Poisson-Carvajal]

We do not file site-specific SOPs in the sponsor TMF. They should remain at the site and be available upon request as part of site selection, or during an audit or an inspection.

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