As the sponsor, what do you do with the raw data collected on the wearable devices in DCT trials. We understand you retain some of the summary data but what about the raw data? Does it need to be retained somewhere for Long term (25 years) for data integrity purposes?
It sounds like these wearable devices quality only with a validated interface to capture the raw data. It seems like a valid question. I’m curious about first inspection findings in that regard.
In 2021 WHO ECSPP 55th Report _ Annex 4 Guideline on data integrity, Raw data is equal to Source data. So from my view, they must be retained if the data (composing into the “Summary”) are critical.
.