在临床试验数据分析中，生成SDTM、ADaM的Define之后，我们会用Pinnacle 21软件进行检测其是否符合CDSIC的标准。对于软件生成的issue (ERROR, WARNING)，我们要进行解释, 对于SDTM，通常解释附在提交Study Data Reviewer’s Guide文件中(sdrg.pdf)。文件中的Issue Summary会对Pinnacle 21检测出的问题一一解释。下面分享一些Issue的解释说明：
| Dataset | Diagnostic | Explanation |
|---|---|---|
| AE | Missing End Time-Point value | AE end dates were not captured for Clinical Non-vertebral Fracture Summary form. |
| AE | No qualifiers set to 'Y', when AE is Serious | Serious AE criteria were not reported for two events each for USUBJID = xx-xxxx and xx- xxxx. |
| AE | AE start date is after the latest Disposition date | The study is still ongoing. Subjects have not completed their end of study visits. |
| AE | Duplicate records in AE domain | AE's natural key include AETERM and AESPID |
| AE | AEACN value not found in ‘Action Taken with Study Treatment’ non-extensible codelist | CRF design included value 'Investigational product dose altered or withheld', no CDISC synonym exists therefore a sponsor-defined codelist was used. |
| AE | AELOC value not found in 'Anatomical Location' extensible codelist | Code list extended to include anatomical location values CARPAL, FEMUR DISTAL... |
| CE | Model permissible variable added into standard domain | SDTM model variable may be added into standard domains according to its domain general class. Variables VISIT and VISITNUM were added. |
| CM | Model permissible variable added into standard domain | SDTM model variable may be added into standard domains according its domain general class. Variable CMXXXX was added. |
| CM | Missing End Time-Point value | The end dates were not collected for Historical Steroid Medications. |
| CM | Missing Start Time-Point value | Start dates were unknown and hence not provided for these concomitant medications. The start dates were not collected for Historical Steroid Medications. |
| CM | Missing value for CMDOSU, when CMDOSE, CMDOSTXT or CMDOSTOT is provided | There are records where CMDOSTXT is populated but CMDOSU is missing. There is no dose unit that is appropriate to map to CMDOSU. Dose unit is described in CMDOSTXT on Glucocorticoid Use form. |
| CM | CMDOSFRQ value not found in 'Frequency' extensible codelist | The code list was extended to include values HS, Q2S... |
| CM | CMDOSU value not found in 'Unit' extensible codelist | The code list was extended to include OTHER as this was a CRF collected value. |
| CM | CMROUTE value not found in 'Route of Administration' extensible codelist | The code list was extended to include GASTROSTOMY, INHALED and OTHER |
| CO | CODTC is populated, when comment is a child record of another domain | CODTC is populated for records related to LB to help identify the timing of comments from laboratory and central imaging vendor. |
| DA | Permissible variable with missing value for all records | VISIT variable is included along with expected variable VISITNUM. Both VISITNUM and VISIT variables were blank in DA dataset |
| DA | Duplicate records | DA's natural key include DASPID |
| DM | No Exposure record found for subject | These 7 subjects were not treated, they withdrew from study prior to receiving any investigational product. This is represented in ACTARM and ACTARMCD with values as ‘NOT TREATED’ and ‘NOTTRT’ respectively |
| DM | RFENDTC is not provided for a randomized subject | Study is still ongoing. Subjects have not completed their end of treatment visits. |
| DM | No baseline result in PC for subject | Pharmacokinetic Concentrations data was only collected for subjects enrolling in the sub-study. Hence baseline records are missing in PC for these subjects |
| DM | ACTARMCD does not equal ARMCD | 7 subjects were randomized but not treated, so ACTARMCD = NOTTRT. Subjects XXX1 and XXX2 were randomized to receive AAA, however they received some doses of BBB. ARMCD is randomized and ACTARMCD is actual treatment received by the subject |
| DM | RACE value not found in 'Race' extensible codelist | The code list was extended to include ‘OTHER’. |
| DV | High risk of truncated value for DVTERM variable | Supplemental qualifiers were added to store text > 200 characters. |
| LB | Missing value for LBSTRESU, when LBSTRESC is provided | Original unit values were not collected for some records for these tests in raw dataset. For LBTESTCD ‘XXXX’ and ‘XXXX’, some results were collected as qualitative measures |
| LB | Missing value for LBREASND, when LBSTAT is ‘NOT DONE’ | Reason for test not performed was not collected on the CRF for local labs. |
| LB | Value for LBORRES is populated, when LBSTAT is ‘NOT DONE’ | There was an issue with vendor Laboratory data. These records with valid test results had the status variable marked incorrectly as ‘Not Done’. The values in LBSTAT and LBREASND where kept as-is based on vendor transferred data. |
| MH | Variable not recommended for use | MHOUT is permissible for addition. |
| MH | Redundancy in paired variables values | XXX standardly populates category variables and at times, a value may match another variable’s value. |
| TS | Model permissible variable added into standard domain | SDTM model variable may be added into standard domains according its domain general class. Variables TSVAL1, TSVAL2 and TSVAL3 were added to accommodate TSVAL text >200 characters |
| TS | SDTM/dataset variable label mismatch | TSVAL1, TSVAL2 and TSVAL3 were added to store text >200 characters; the label should match the parent label |
| TS | Invalid TSVAL value for COMPTRT | Value is assigned as per the protocol comparator drug i.e. XXX. The actual substance name is ‘XXX AAA’ |
| VS | Missing value for VSORRESU, when VSORRES is provided | For subject XXXX temperature was not taken and a value of 0 was entered into the database. Unit was not collected for this record |
以上。
