Hi,

In CDISC submission,  the define.pdf document should be prepared.
I work on a non-CDISC study but it seems that i need to prepare a
similar document.
As I never do it, i am a bit lost on what should i do and how should i
do this document.

Does someone have a documentation on this or maybe examples that I
could see to have an idea of what shoud i obtain?

Thanks in advance,

Check the FDA Study Data Spcifications:

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissi=
onRequirements/ElectronicSubmissions/UCM199759.pdf

or

http://preview.tinyurl.com/4q6q387


On Jan 20, 8:55=A0am, "Audrey M." <amore...@yahoo.fr> wrote:
> Hi,
>
> In CDISC submission, =A0the define.pdf document should be prepared.
> I work on a non-CDISC study but it seems that i need to prepare a
> similar document.
> As I never do it, i am a bit lost on what should i do and how should i
> do this document.
>
> Does someone have a documentation on this or maybe examples that I
> could see to have an idea of what shoud i obtain?
>
> Thanks in advance,