CONCL¶
Table Description: Conclusion of Study Participation
Detailed notes for this table are included below.
View Source CRFs¶
1.0 CRFs: Click on any PAG_NAME link below to be taken to the CRF used in the PPMI 1.0 Study.
2.0 CRFs: Click on any PAG_NAME link below to be taken to a screenshot of how this eCRF is currently implemented in the PPMI 2.0 Study.
2.0 Data Dictionary¶
Table Constraints: PATNO, VISIT_ID
ITM_NAME |
DSCR |
ITM_TYPE |
DSCR_1.0 |
ITM_TYPE_1.0 |
|---|---|---|---|---|
WDDT |
Withdrawal date |
DATE |
Withdrawal date |
DATE |
WDRSN |
Reason for withdrawal |
NUMBER |
Reason for withdrawal |
CHAR |
WDRSNCM |
Reason for withdrawal comment |
TEXT |
Withdrawal comment |
CHAR |
WDRSNPD |
Did increasing PD disability contribute to the decision to withdraw from PPMI 2? |
BOOLEAN |
||
COMPLT |
Did the subject complete the study? |
BOOLEAN |
Did the subject complete the study? |
CHAR |
2.0 Code Book¶
ITM_NAME |
CODE |
DECODE_2.0 |
DECODE_1.0 |
|---|---|---|---|
COMPLT |
0 |
No |
No |
COMPLT |
1 |
Yes |
Yes |
WDRSN |
1 |
Adverse event |
Adverse Event (complete AE Log) |
WDRSN |
2 |
Completed study per protocol |
Lost to follow-up |
WDRSN |
3 |
Death |
Subject withdrew consent (specify) |
WDRSN |
4 |
Family, care-partner, or social issues |
Pregnancy |
WDRSN |
5 |
Lost to follow up |
Protocol violation |
WDRSN |
6 |
Non-compliance with study procedures |
Death of subject |
WDRSN |
7 |
Transportation/Travel issues (ex: logistics or travel, moved away from study site) |
Investigator decision (specify) |
WDRSN |
8 |
Institutionalized |
|
WDRSN |
9 |
Subject transitioning to a new cohort |
Clinical Monitor decision (specify) |
WDRSN |
10 |
Subject withdrew consent (specify) |
Sponsor decision (specify) |
WDRSN |
11 |
Investigator decision (specify) |
Primary Care Physician decision (specify |
WDRSN |
12 |
Sponsor decision (specify) |
Informant / Caregiver decision (specify) |
WDRSN |
13 |
Informant / Caregiver decision (specify) |
Institutionalized |
WDRSN |
14 |
Inability to continue giving consent |
|
WDRSN |
15 |
Other (specify) |
|
WDRSN |
20 |
Other |
Subject transitioning to a new cohort |
WDRSNPD |
0 |
No |
|
WDRSNPD |
1 |
Yes |
Details¶
The CONCL table captures the Conclusion of Study Particpation form. All participants in the PPMI 2.0 Study use this form on an as-needed basis. Early Imaging Sub-Study participants use the AVCONCL CRF.
WDRSN
The possible values for this variable have been harmonized to account for versions of the form that were used both in the original and extended phases of the PPMI study. “Other” in the extended version was recoded from 8 to 20 and codes 9-15 were added to account for possible values in the original version of the form. Codes 4, 9, 11, and 13 from the original version are not accounted for as they were never used in that phase.