[Vp-reproduce-subgroup] Fwd: Update: Draft Guidance: Assessing Credibility of Computational Modeling and Simulation

[Jacob Barhak]

OK  James,

You are answering the question about funding

The decision is yours.

If you declare those grants, it will mean your time spent on this paper was
covered by those grants out of taxpayer funds. Otherwise it means you
volunteered your time freely.

Since you asked again, I added your funding.

I ask in return that when you report this paper in your grant report, I ask
that you mention that a major contribution for this paper was by volunteers
that were not funded through your funding sources - it is important that
funding sources know that their contribution to this work was minor and
adjust accordingly - otherwise a wrong impression may be created .

Hopefully it is the last edit.

               Jacob





On Thu, Jan 27, 2022 at 10:32 PM James Glazier <jaglazier at gmail.com> wrote:

> Dear Jacob. I would prefer to have my grants acknowledged, since they
> support my work on reproducibility. However,  I understand that this
> request could cause an inconvenience to you concerning consistency among
> the coauthors.
>
> Jag
>
> On Thu, Jan 27, 2022, 10:37 PM Jacob Barhak <jacob.barhak at gmail.com>
> wrote:
>
>> Greetings reproducibility and integration groups,
>>
>> John Rice has sent this message. about the FDA document:
>>
>> https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions
>>
>> And indeed this is relevant to our work - in fact this was my suggestion
>> for the next activity.
>>
>> FDA has released a request for comments for a document drafted. We
>> actually referred to this document in our paper.
>>
>> I was planning to start a discussion on this paper so we can
>> submit responses, either individually or as a group or sub-groups after we
>> finish with the paper.
>>
>> Yet since the paper is almost done and time is running short, it is
>> perhaps a good idea to discuss this now.
>>
>> Looking forward to your feedback.
>>
>>                Jacob
>>
>>
>> _______________________________________________
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>>
>
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