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anky1212
Junior

India,
2018-02-05 08:18

Posting: # 18344
Views: 1,845
 

 Accountability of Investigation product [Study Per­for­mance]

Dear All,

Please give your valuable suggestion/ response to below observation for Investigational product handling.

"Pharmacist was not protocol trained while handling of Investigational product i.e after receipt of IP, pharmacist had verified and made accountability of Investigational product against applicable receipt documents like COAs and other supporting documents".

Is protocol training required for IP verification and accountability of IPs?
Ohlbe
Hero

France,
2018-02-05 10:38

@ anky1212
Posting: # 18345
Views: 1,634
 

 Accountability of Investigation product

Dear anky1212,

I would expect the pharmacist to be informed of (or at least, to check the protocol for) any specific requirement or sponsor request, which would be different from the pharmacy's SOPs: are there specific storage conditions ? handling conditions ? how many IP units should be dispensed per subject ? etc.

Regards
Ohlbe
anky1212
Junior

India,
2018-02-05 12:08

@ Ohlbe
Posting: # 18347
Views: 1,623
 

 Accountability of Investigation product

Dear Ohlbe,

Thanks for your valuable response.

I would like to add that pharmacist have access to IRB approved protocol and can refer to that directly. But Protocol training of the same is required by Principal investigator or not.
Ohlbe
Hero

France,
2018-02-05 14:31

@ anky1212
Posting: # 18349
Views: 1,600
 

 Protocol training

Dear anky1212,

» I would like to add that pharmacist have access to IRB approved protocol and can refer to that directly.

Having access to a document and reading it is not quite the same thing...

» But Protocol training of the same is required by Principal investigator or not.

Please refer to ICH GCP:

§ 4.2.4: The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions.

Which does not mean that he should train them himself, only ensure that they are informed. Which could be limited to ensuring that they have read and understood the protocol and any other relevant document. If you have a system in place to document that the pharmacist has read the protocol, and to document his assessment of any impact it may have on what he is supposed to do, this could be OK.

But don't forget the new section 4.2.5:
The investigator is responsible for supervising any individual or party to whom the investigator delegates trial-related duties and functions conducted at the trial site.

Regards
Ohlbe
ElMaestro
Hero

Denmark,
2018-02-05 14:23

@ anky1212
Posting: # 18348
Views: 1,604
 

 Accountability of Investigation product

Hi Anky,

» Is protocol training required for IP verification and accountability of IPs?

As it see it, things are pretty simple:
Anyone named on the delegation log should be trained in the specific protocol. The functions you describe are clearly among the tasks that are one way or another important for certain elements of the trial, so they should be on the delegation log, and thus there really is no argument for not training the person in question.

If accountability is wrong after the trial and the person doing it has not received training then I have every reason to believe the authorities will butcher you for not having trained her/him. The root cause or at least a very good part of it will land exactly thereabouts.

if (3) 4

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.
Ohlbe
Hero

France,
2018-02-05 14:40

@ ElMaestro
Posting: # 18350
Views: 1,604
 

 Protocol training or job training ?

Dear ElMaestro,

» If accountability is wrong after the trial and the person doing it has not received training then I have every reason to believe the authorities will butcher you for not having trained her/him. The root cause or at least a very good part of it will land exactly thereabouts.

Yes, for sure. But there, I would make a difference between training on a specific task and protocol training. I would expect the trial site to have some SOPs covering all activities relating to IMP (receipt, storage, dispensing, accountability etc.). Any person involved in these tasks should be trained on these SOPs, and should not be delegated any of these tasks unless appropriately trained.

Now you receive a new trial with a nice protocol. The question would be, will the routine SOPs apply to that particular trial (in which case no additional training is required), or are there specificities that need to be addressed ? So each protocol needs to be read, understood and assessed, and any staff involved from there on should be informed.

The question then becomes, who should do it ? My concern is that the PI may not be the most qualified person to do it. There are chances that the pharmacist himself may actually be more qualified than the PI… In any case, the PI remains responsible for ensuring that there is such a system in place, and that the job is done.

Regards
Ohlbe
ElMaestro
Hero

Denmark,
2018-02-05 15:07

@ Ohlbe
Posting: # 18351
Views: 1,606
 

 Protocol training or job training ?

Hello Ohlbe,

» Now you receive a new trial with a nice protocol. The question would be, will the routine SOPs apply to that particular trial (in which case no additional training is required), or are there specificities that need to be addressed ? So each protocol needs to be read, understood and assessed, and any staff involved from there on should be informed.

Yes, there are two types of training. General training (you might say, the training that the job description merits, such as overarching IMP handling SOPs) and the study-specific training (presence or absence of any overriding IMP handling instructions in the protocol etc; this is the training that the clauses you refer to in ICH E6 relate most directly to).

» The question then becomes, who should do it ? My concern is that the PI may not be the most qualified person to do it. There are chances that the pharmacist himself may actually be more qualified than the PI… In any case, the PI remains responsible for ensuring that there is such a system in place, and that the job is done.

That is true, the pharmacist knows more about IMP handling than the PI. And the same for phlebotomists, statisticians etc. The PI knows how to be a PI (presumably or hopefully :-D).
"No man is an island". Training to me is not just about the person's individual own functions, but also an orientation that helps make the execution smooth, ethical and safe. It is generally appropriate that the overall responsibility rests with a single person even if she/he is not the most competent person to do each individual task. Training is a two-way street. Perhaps the last trial the CRO did on topical creams had an accountability issue so the next time such a formulation comes up the pharmacists suggests the PI to remind the dosing team of it, or to emphasize the signs of wrong IMP dosing on the subjects. The team generally benefits from being training together so that staff know who is on the team and who is not in case of irregularities. And so forth.

I am not a regulator so this is a personal view. I am also aware that theory and practice are sometimes different things.

if (3) 4

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.
anky1212
Junior

India,
2018-02-07 05:15

@ ElMaestro
Posting: # 18366
Views: 1,483
 

 Protocol training or job training ?

Thanks for your guidance.

In my case we do have well defined system SOP, "Receipt, Verification and accountability of IPs (Handling of Investigational Product)". Receipt, verification and accountability part, we do before protocol training. During these activities, We have IRB approved copy of protocol for verification of IP related information.

Second part, i.e. Dispensing, reconciliation etc. activities are carried out after obtaining protocol training and delegation.

Further, Receipt, verification and accountability activites are well defined in Job description.
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