One of the TS domain Validation rule is : IF healthy volunteers = “N” then TDIGRP must be present and not null. Here is a phase 1 study, the population is Subjects with Mild and Moderate Hepatic Impairment , and the objective is to assess the Pharmacokinetics. The healthy volunteers flag should be “N” or “Y”? If the healthy volunteers flag is “N”, what is the TDIGRP?
Hi Siru Zhou,
For Healthy Subjects Population:
- TSPARMCD = ‘HLTSUBJI’
- TSVAL = ‘Y’
If study subjects are part of the diagnosis group for the study drug, then TSVAL for TDIGRP record must be a valid term from SNOMED dictionary.
In cases where studies enroll both healthy volunteers and those that are part of the diagnosis group for the study drug, then it is recommended that TSVAL for ‘HLTSUBJI’ would be set to ‘N’ and then to create two records for TSPARMCD = ‘TDIGRP’. One record where TSVAL = ‘HEALTHY SUBJECTS’ and the other where TSVAL was populated with the condition being studied.
Kind Regards,
Sergiy