|
About the SDTM category
|
|
0
|
55
|
March 24, 2025
|
|
SD1339: Missing EPOCH value when a start or observation date is provided
|
|
4
|
278
|
October 6, 2025
|
|
SD1066 Null IDVARVAL when RELYTPE populated
|
|
1
|
116
|
May 20, 2025
|
|
SD1151 / FDAB009
|
|
5
|
186
|
May 19, 2025
|
|
Many messages (false positives) "LBSTRESC value not found in 'Laboratory Test Standard Character Result' extensible codelist" for numeric values
|
|
10
|
334
|
March 13, 2025
|
|
SDTM.TS
|
|
9
|
426
|
March 13, 2025
|
|
NMPA recognization of NY variables and unplanned visits
|
|
0
|
63
|
March 13, 2025
|
|
SDTM/dataset variable label mismatch
|
|
1
|
190
|
March 7, 2025
|
|
STRESN value not matching STRESC value when the values are the same in XPT
|
|
3
|
128
|
December 27, 2024
|
|
Validation of CMDECOD values >200 characters
|
|
2
|
191
|
December 26, 2024
|
|
SDTM 3.2 IG PINNACLE MESSAGE
|
|
2
|
84
|
December 26, 2024
|
|
Query Regarding Label Updates for COVAL and TSVAL Variables
|
|
1
|
92
|
December 3, 2024
|
|
SD1297 should not present for Trial Phase Response "NOT APPLICABLE"
|
|
2
|
47
|
October 30, 2024
|
|
New born Child/Neonate Guidance Needed for SDTM Mapping
|
|
1
|
32
|
September 20, 2024
|
|
Pinnacle21 CLI
|
|
1
|
71
|
August 17, 2024
|
|
SD9999 and Associated Persons (AP)
|
|
8
|
62
|
August 12, 2024
|
|
SD2239 - Inconsistent value for -TPT
|
|
2
|
83
|
July 18, 2024
|
|
Extent of Value Level Metadata
|
|
7
|
109
|
July 16, 2024
|
|
DD0136 and DD0137 - Invalid dataset and variable label value
|
|
1
|
79
|
July 3, 2024
|
|
NMPA report Rules sheet Severity column definition
|
|
3
|
54
|
June 26, 2024
|
|
Missing class identification- validating datasets
|
|
1
|
55
|
June 24, 2024
|
|
SD1124: missing value for xxREASND when xxSTAT is NOT DONE
|
|
6
|
57
|
June 24, 2024
|
|
Record Qualifiers Variable vs Timing Variable
|
|
1
|
52
|
June 13, 2024
|
|
SD0063 is invalid in SDTM v3.3, but DD0137 is valid in Define-XML v2.1
|
|
7
|
211
|
June 13, 2024
|
|
TSVAL corresponding to EudraCT where TSPARMCD is REGID.
|
|
0
|
63
|
May 21, 2024
|
|
Support validation SDTM IG 3.4
|
|
13
|
178
|
May 16, 2024
|
|
Cannot convert to LBSTRESU
|
|
4
|
79
|
April 5, 2024
|
|
RFPENDTC
|
|
2
|
68
|
April 4, 2024
|
|
Using the Latest terminology version is the best practice?
|
|
1
|
78
|
April 4, 2024
|
|
Define CRF Page Numbers
|
|
1
|
88
|
February 18, 2024
|