SCRNFAIL¶
Table Description: Screen Fail
Detailed notes for this table are included below.
View Source CRFs¶
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 |
|---|---|---|
SCFAILRSN |
Reason for screen fail |
NUMBER |
RSNDEC |
Reason for Declining |
NUMBER |
2.0 Code Book¶
ITM_NAME |
CODE |
DECODE_2.0 |
|---|---|---|
RSNDEC |
1 |
Risks of Protocol |
RSNDEC |
2 |
Confidentiality issues |
RSNDEC |
3 |
Protocol too time intensive |
RSNDEC |
4 |
Changed mind about lumbar puncture |
RSNDEC |
5 |
Travel requirements |
RSNDEC |
6 |
Family or caregiver/informant advised declining |
RSNDEC |
7 |
Physician (other than Site Investigator) advised declining |
RSNDEC |
8 |
Enrolled in other study |
RSNDEC |
9 |
No longer interested |
RSNDEC |
99 |
Other |
SCFAILRSN |
1 |
Eligibility Criteria |
SCFAILRSN |
2 |
Participant declined participation prior to completing baseline visit |
Details¶
The SCRNFAIL table is a new table that captures information on why a participant failed PPMI 2.0 Screening. It is completed on an as-needed basis throughout the course of the study. This form is also automatically triggered if any response in the CONSENT form is no, or if any answer in the INEX form violates the inclusion/exclusion criteria (i.e., “no” for an inclusion question, or “yes” for an exclusion question).
SCFAILRSN
The SCFAILRSN variable (Reason for Screen Fail) has two possible options: “Eligibility Criteria” (participant was excluded for a violation of eligibility criteria), or “Participant declined participation prior to completing baseline visit”. In PPMI 1.0, these two options (excluded and declined) were captured as separate variables in the SCREEN CRF (DECLINED and EXCLUDED). These variables can potentially be derived in a future state from the SCFAILRSN variable.
RSNDEC
In PPMI 1.0, RSNDEC (Reason for Declining) was captured in the SCREEN CRF. It was moved to the SCRNFAIL table in PPMI 2.0 to help consolidate information on failed screens into one table.