vivekb2
☆    

India,
2017-02-20 11:12

Posting: # 17087
Views: 2,257
 

 Retention of clinical biosamples / blank matrices [Regulatives / Guidelines]

Please suggest for Retention period of (human) clinical biosamples / blank matrices.
Regards
Vivek


Edit: Please don’t shout[Helmut]
Ohlbe
★★★

France,
2017-02-20 11:51

@ vivekb2
Posting: # 17090
Views: 1,956
 

 Retention of clinical biosamples / blank matrices

Dear Vivek,

I am not aware of any retention period mentioned in any of the main BE guidelines. It is a matter of agreement between the sponsor and the CRO.

Usually CROs keep the samples until the study report is approved by the sponsor. This makes sense, of course. Some sponsors will ask the CRO to keep the samples until the application is approved. Most CROs will charge for storage beyond a few months.

In any case it makes little sense to store the samples beyond their demonstrated stability period. If they are stored for a longer duration: I would recommend to store QC samples along with them. If the samples need to be re-analysed, you can then demonstrate stability (or instability).

Regards
Ohlbe
jag009
★★★

NJ,
2019-04-23 17:22

@ Ohlbe
Posting: # 20211
Views: 369
 

 Retention of clinical biosamples / blank matrices

Hi Ohlbe,

» Usually CROs keep the samples until the study report is approved by the sponsor. This makes sense, of course. Some sponsors will ask the CRO to keep the samples until the application is approved. Most CROs will charge for storage beyond a few months.

Do you know why some sponsors want to have their samples kept until application approved? From EMA or FDA, is there a requirement mentioned in any of the guidances? We are doing this (store samples) as well and I wonder why we need to if the age of the samples exceeds the long term stability date. I asked my folks and their answer was "we can always ask the CRO to extended the stability" :confused:

Thanks
J
ElMaestro
★★★

Denmark,
2019-04-23 18:15

@ jag009
Posting: # 20212
Views: 363
 

 Retention of clinical biosamples / blank matrices

Hi jag,

» "we can always ask the CRO to extended the stability" :confused:

"...if we stored the samples along with appropriate QC's."

The thing is regulators throw a curve ball every now and then. Sometimes there is even a degree of rationale behind it. If the study is inspected or someone asks for re-analysis or any other activity of this type then you simply have much better chances of answering if you have the samples and the QCs still frozen.
CRO compliance suddenly questioned by an evil inspector? Send the B-set to another CRO, show BE with those samples, and Bob's your uncle!

I could be wrong, but...
Best regards,
ElMaestro
Ohlbe
★★★

France,
2019-04-24 11:54

@ jag009
Posting: # 20219
Views: 332
 

 Retention of clinical biosamples / blank matrices

Hi John,

» Do you know why some sponsors want to have their samples kept until application approved?

"Because we've always done it", I guess...

» From EMA or FDA, is there a requirement mentioned in any of the guidances?

EMA: no. FDA: not that I know of.

» We are doing this (store samples) as well and I wonder why we need to if the age of the samples exceeds the long term stability date.

I agree with ElMaestro: some sponsors just want to be on the safe side and only repeat the bioanalytical part rather than the whole study if the lab messed up somewhere. There was a time also when guidelines or requirements were not as clear as they can be now and an Agency would unexpectedly ask for the metabolite in addition to the parent, or similar stuff.

Regards
Ohlbe
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2019-04-24 12:22

@ jag009
Posting: # 20220
Views: 331
 

 Retention of clinical biosamples / blank matrices

Hi John,

» I asked my folks and their answer was "we can always ask the CRO to extended the stability" :confused:

I agree with what ElMaestro wrote. See also the end of this post. If you pay for extended storage, why not?

Cheers,
Helmut Schütz
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