|
About the SDTM category
|
|
0
|
83
|
March 24, 2025
|
|
LBSTREFC about SD1076, SD1078 rule IDs
|
|
2
|
61
|
September 18, 2026
|
|
Future Plans on Validation Rules related to DM.RACE/DM.ETHNIC
|
|
1
|
140
|
May 13, 2026
|
|
SD1339: Missing EPOCH value when a start or observation date is provided
|
|
4
|
432
|
October 6, 2025
|
|
SD1066 Null IDVARVAL when RELYTPE populated
|
|
1
|
163
|
May 20, 2025
|
|
SD1151 / FDAB009
|
|
5
|
299
|
May 19, 2025
|
|
Many messages (false positives) "LBSTRESC value not found in 'Laboratory Test Standard Character Result' extensible codelist" for numeric values
|
|
10
|
502
|
March 13, 2025
|
|
SDTM.TS
|
|
9
|
621
|
March 13, 2025
|
|
NMPA recognization of NY variables and unplanned visits
|
|
0
|
79
|
March 13, 2025
|
|
SDTM/dataset variable label mismatch
|
|
1
|
274
|
March 7, 2025
|
|
STRESN value not matching STRESC value when the values are the same in XPT
|
|
3
|
231
|
December 27, 2024
|
|
Validation of CMDECOD values >200 characters
|
|
2
|
356
|
December 26, 2024
|
|
SDTM 3.2 IG PINNACLE MESSAGE
|
|
2
|
145
|
December 26, 2024
|
|
Query Regarding Label Updates for COVAL and TSVAL Variables
|
|
1
|
151
|
December 3, 2024
|
|
SD1297 should not present for Trial Phase Response "NOT APPLICABLE"
|
|
2
|
87
|
October 30, 2024
|
|
New born Child/Neonate Guidance Needed for SDTM Mapping
|
|
1
|
51
|
September 20, 2024
|
|
Pinnacle21 CLI
|
|
1
|
114
|
August 17, 2024
|
|
SD9999 and Associated Persons (AP)
|
|
8
|
122
|
August 12, 2024
|
|
SD2239 - Inconsistent value for -TPT
|
|
2
|
141
|
July 18, 2024
|
|
Extent of Value Level Metadata
|
|
7
|
260
|
July 16, 2024
|
|
DD0136 and DD0137 - Invalid dataset and variable label value
|
|
1
|
174
|
July 3, 2024
|
|
NMPA report Rules sheet Severity column definition
|
|
3
|
110
|
June 26, 2024
|
|
Missing class identification- validating datasets
|
|
1
|
89
|
June 24, 2024
|
|
SD1124: missing value for xxREASND when xxSTAT is NOT DONE
|
|
6
|
135
|
June 24, 2024
|
|
Record Qualifiers Variable vs Timing Variable
|
|
1
|
90
|
June 13, 2024
|
|
SD0063 is invalid in SDTM v3.3, but DD0137 is valid in Define-XML v2.1
|
|
7
|
340
|
June 13, 2024
|
|
TSVAL corresponding to EudraCT where TSPARMCD is REGID.
|
|
0
|
115
|
May 21, 2024
|
|
Support validation SDTM IG 3.4
|
|
13
|
339
|
May 16, 2024
|
|
Cannot convert to LBSTRESU
|
|
4
|
151
|
April 5, 2024
|
|
RFPENDTC
|
|
2
|
145
|
April 4, 2024
|