DGBCNCL¶
Table Description: Digital Biomarker Conclusion of Study
1.0 Data Dictionary¶
ITM_NAME |
DSCR_1.0 |
|---|---|
CNCLSTAT |
Conclusion - subject status |
WDDT |
Withdrawal date |
WDRSN5 |
Reason for withdrawal (alternate list 5) |
WDRSNCM |
Withdrawal comment |
1.0 Code Book¶
ITM_NAME |
CODE |
DECODE_1.0 |
|---|---|---|
CNCLSTAT |
1 |
Completed study per protocol |
CNCLSTAT |
2 |
Discontinued before planned conclusion |
CNCLSTAT |
3 |
Completed due to early study conclusion |
WDRSN5 |
1 |
Death of subject |
WDRSN5 |
2 |
Adverse Event (complete AE Log) |
WDRSN5 |
4 |
Current medical condition (complete log) |
WDRSN5 |
6 |
Inability to continue giving consent |
WDRSN5 |
7 |
Unwilling/unable to commit time/resource |
WDRSN5 |
8 |
Institutionalized |
WDRSN5 |
9 |
Lost to Follow-up |
WDRSN5 |
11 |
Pregnancy |
WDRSN5 |
12 |
Reason specified by the protocol |
WDRSN5 |
13 |
Did not tolerate study device |
WDRSN5 |
14 |
Non-compliance with study device |
WDRSN5 |
99 |
Other |