|
SDTM variables, defined for use in human clinical trials, do not fit the SEND model and must NEVER be used in the submission of non-clinical studies
|
|
3
|
53
|
September 6, 2018
|
|
SD0018 Invalid value for CLTESTCD variable
|
|
1
|
18
|
May 26, 2017
|
|
What version of the FDA's SEND Validation Rules are being used by the Validator?
|
|
0
|
28
|
May 23, 2017
|
|
SE0055 SEND/Dataset variable type mismatch
|
|
4
|
72
|
November 12, 2016
|
|
SEND specific CT and Validation
|
|
0
|
17
|
October 14, 2016
|
|
SD0007: Inconsistent value for standard unit. Please switch to warning.
|
|
4
|
62
|
February 13, 2015
|
|
SE0063: SEND/dataset variable label mismatch: LBSTNRC, Reference Range for Char Rslt-Std Unit
|
|
1
|
26
|
January 23, 2015
|
|
Define-XML 2.0 ?
|
|
4
|
64
|
September 10, 2014
|
|
Non-unique value for TSSEQ variable within TSPARMCD?
|
|
3
|
63
|
August 21, 2014
|
|
Validator 1.5 SEND rules issues
|
|
8
|
128
|
April 17, 2014
|
|
FDA rule implementation
|
|
13
|
166
|
March 10, 2014
|
|
IllegalArgumentException when validating a tab-delimited dataset
|
|
6
|
54
|
March 3, 2014
|
|
Downloadable 1.4.1 version vs. public SVN version
|
|
0
|
16
|
September 20, 2013
|
|
FDA valication rules for SEND
|
|
1
|
42
|
September 13, 2013
|
|
Validator 1.4 new validation criteria?
|
|
5
|
85
|
April 2, 2013
|
|
Error missing: Domain files present but not in define.xml file
|
|
2
|
51
|
February 26, 2013
|
|
Generate Define.xml File for SEND
|
|
3
|
63
|
October 29, 2012
|
|
SE0063: SEND/dataset variable label mismatch
|
|
5
|
70
|
March 30, 2012
|
|
SEND rules
|
|
4
|
65
|
July 29, 2011
|
|
SEND 3.0 Release
|
|
5
|
87
|
May 4, 2011
|