jag009
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NJ,
2018-05-18 16:23
(932 d 08:05 ago)

(edited by jag009 on 2018-05-18 16:34)
Posting: # 18784
Views: 2,244
 

 100% raw data presentation in BA report [Bioanalytics]

Hi,

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?

The reason I asked is because I have came across reports from several labs and they don't have the same # of items presented in this "100% raw data" table. Of course the crucial ones are presented, but some such as dilution factor, analysis date, IS and analyte retention times are absent from the tables generated by some labs.

Thanks
John
Helmut
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Vienna, Austria,
2018-05-18 16:57
(932 d 07:31 ago)

@ jag009
Posting: # 18787
Views: 1,899
 

 100% raw data presentation in BA report

Hi John,

» 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?

FDA – no idea.
In the EU inspectors love to see the time of analysis of each sample (in order to check whether the batch was interrupted and/or the validated bench-top/autosampler stability exhausted). Hence, a table with these columns:

sample № – timestamp – subject id – sample № / period (or: scheduled time) – period – concentration

If’ve seen ones where the dilution factor or alternatively a lower sample volume (if validated) is given in an additional column. Never saw retention times in any table. 20% of chromatograms are mandatory over here and nowadays most CROs provide 100% anyway. If an assessor is interested in the RTs (s)he can look it up there.

» […] I have came across reports from several labs and they don't have the same # of items presented in this "100% raw data" table. Of course the crucial ones are presented, but some such as dilution factor, analysis date, IS and analyte retention times are absent from the tables generated by some labs.

OK, that’s a different story. Never seen a single table including everything (would be confusing – at least for me). Generally different ones:
  • Results of unknows (as above)
  • Calibrators
  • QC samples
  • Repeats
  • ISR

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ElMaestro
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Belgium?,
2018-05-18 19:22
(932 d 05:06 ago)

@ jag009
Posting: # 18788
Views: 1,873
 

 100% raw data presentation in BA report

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 :-)

Pass or fail!
ElMaestro
jag009
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NJ,
2018-05-24 03:20
(926 d 21:08 ago)

@ ElMaestro
Posting: # 18809
Views: 1,661
 

 100% raw data presentation in BA report

Thank you guys.
John
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