t*********l
发帖数: 778 | 1 小公司也没有用SDTM/ Adam
现在FDA要求提交部分数据。请问有什么标准吗？ 比如label长度不超过多少？
感谢 |
a****g
发帖数: 8131 | 2 there is an ebook on adam
i don't remember labels, but there are column name standards
check it out |
j********t
发帖数: 201 | 3
try the implementation guideline:
http://bancova.com/uploads/cdisc/SDTM%20Implementation%20Guide%
【在 t*********l 的大作中提到】
: 小公司也没有用SDTM/ Adam
: 现在FDA要求提交部分数据。请问有什么标准吗？ 比如label长度不超过多少？
: 感谢
|
t*********l
发帖数: 778 | 4 非常谢谢！ 现在时间来不及换成SDTM，因为突然要求数据。下周就给。
我想请教，在不用SDTM的情况，FDA有别的mandatory的要求吗？
【在 j********t 的大作中提到】
:
: try the implementation guideline:
: http://bancova.com/uploads/cdisc/SDTM%20Implementation%20Guide%
|
j********t
发帖数: 201 | 5 got your message from private box - sorry to reply late:
a few things that might be useful, but please contact your regulatory
department for the final formats:
1) even for non-cdisc compliant submission, it's useful to provide a define.
xml(use proc contents, ods tagsets.excel) and define.pdf (refers to http://www.lexjansen.com/pharmasug/2012/AD/PharmaSUG-2012-AD14.pdf).
2) limit length of variable names to 8 even SAS 9.2 or later goes beyond
that. (label length = 40).
3) make xpt files that let your define files link to them.
4) try to follow ADaM conventions (very less work is required compared to
SDTM) as much as you can to please FDA statisticians.
5) if your 小公司 is pharmaceutical, try to take the above suggestions. If
it is
Medical Devices, then life is much easier since CDRH is falling far behind
CDER in terms of CDIDSC compliance. |
