100% raw data presentation in BA report [Bioanalytics]

posted by ElMaestro  – Belgium?, 2018-05-18 19:22 (889 d 21:14 ago) – Posting: # 18788
Views: 1,847

Hi Jag,

» Does anyone know what items are required to be presented in the "100% Raw data" tables in a BA report (For FDA)? Is there such a list of required items?

I agree with the above. There is no good definition of 100% raw data.
The problem is not only "100%" but also "raw".

In a standard LC-MS/MS setup the raw data (what the data acquisition card is measuring) is a current at a voltage sampled every dt milliseconds. That voltage is the raw data. It is converted directly (linearly, 1:1) into cps. From this everything else is derived. On top of that is the audit trail (whodunnit, and when, and why) and meta data like bunching, smoothing, and weird stuff.
It is my belief that if you list data that allow a full reconstruction of Conc versus time for all subjects (all injections) then you are meeting FDA's expectations. Most CROs do this without really listing full result tables in the reports, but some even do that.
There is no list; try and look what is fed into the cdisc files from different CROs :-)

I could be wrong, but...

Best regards,

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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