SCREEN
Table Description:
Detailed notes for this table are included below.
1.0 Description: Screening / Demographics
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:
2.0 Code Book
ITM_NAME |
CODE |
DECODE_1.0 |
|---|---|---|
APPRDX |
1 |
Parkinson’s disease |
APPRDX |
2 |
Healthy Control |
APPRDX |
3 |
SWEDD |
APPRDX |
4 |
Prodromal |
APPRDX |
5 |
Genetic Cohort - PD |
APPRDX |
6 |
Genetic Cohort - Unaffected |
APPRDX |
7 |
Genetic Registry - PD |
APPRDX |
8 |
Genetic Registry - Unaffected |
APPRDX |
9 |
AV133 |
GENDER |
0 |
Female of child bearing potential |
GENDER |
1 |
Female of non-child bearing potential |
GENDER |
2 |
Male |
HISPLAT |
0 |
No |
HISPLAT |
1 |
Yes |
HISPLAT |
2 |
Unknown or not reported |
P3GRP |
1 |
Hyposmia |
P3GRP |
2 |
RBD |
P3GRP |
3 |
LRRK2 |
RAASIAN |
0 |
No |
RAASIAN |
1 |
Yes |
RAASIAN |
2 |
Unknown or not reported |
RABLACK |
0 |
No |
RABLACK |
1 |
Yes |
RABLACK |
2 |
Unknown or not reported |
RAHAWOPI |
0 |
No |
RAHAWOPI |
1 |
Yes |
RAHAWOPI |
2 |
Unknown or not reported |
RAINDALS |
0 |
No |
RAINDALS |
1 |
Yes |
RAINDALS |
2 |
Unknown or not reported |
RANOS |
0 |
No |
RANOS |
1 |
Yes |
RANOS |
2 |
Unknown or not reported |
RAWHITE |
0 |
No |
RAWHITE |
1 |
Yes |
RAWHITE |
2 |
Unknown or not reported |
REFERRAL |
1 |
Site Personnel |
REFERRAL |
2 |
PCP |
REFERRAL |
4 |
Family or Friend |
REFERRAL |
10 |
Newspaper/Magazine Article |
REFERRAL |
11 |
Newspaper/Magazine Ad |
REFERRAL |
14 |
Radio/TV Ad |
REFERRAL |
15 |
Radio/TV Story |
REFERRAL |
16 |
Online News/Blog/Other |
REFERRAL |
17 |
Out of Home Ad |
REFERRAL |
18 |
Event |
REFERRAL |
30 |
Advocacy Organization |
REFERRAL |
31 |
Support Group |
REFERRAL |
48 |
Social Media |
REFERRAL |
50 |
Study Website |
REFERRAL |
53 |
Site Website |
REFERRAL |
54 |
Study Web Ad |
REFERRAL |
58 |
Clinicaltrials.gov |
REFERRAL |
59 |
PDtrials.org |
REFERRAL |
60 |
Specialist |
REFERRAL |
67 |
23andMe |
REFERRAL |
68 |
Widespread Recruitment Initiative (WRI) |
REFERRAL |
69 |
Genetic Coordination Core (GCC) |
REFERRAL |
71 |
MJFF Communication |
REFERRAL |
72 |
Another PD Subject |
REFERRAL |
73 |
Fox Trial Finder |
REFERRAL |
80 |
1-800 Call center |
REFERRAL |
99 |
Other (specify in comments) |
RSNDEC |
1 |
Confidentiality issues |
RSNDEC |
3 |
Protocol too restrictive |
RSNDEC |
4 |
Protocol too time intensive |
RSNDEC |
5 |
Travel requirements |
RSNDEC |
6 |
Family advised declining |
RSNDEC |
7 |
Physician advised declining |
RSNDEC |
8 |
Enrolled in other study |
RSNDEC |
9 |
Not interested |
RSNDEC |
11 |
Risks of Protocol |
RSNDEC |
12 |
Did not agree to lumbar puncture |
RSNDEC |
99 |
Other (specify in comments) |
RSNEXC |
1 |
Exclusionary medication |
RSNEXC |
2 |
Other medical, psychiatric, or surgical |
RSNEXC |
3 |
Disease too advanced |
RSNEXC |
4 |
DX uncertain |
RSNEXC |
6 |
Did not meet other inclusion criteria |
RSNEXC |
8 |
Enrolled in other study |
RSNEXC |
12 |
Abnormal Safety Labs |
RSNEXC |
13 |
SPECT Scan |
RSNEXC |
99 |
Other (specify in comments) |
Missing Columns
ITM_NAME |
DSCR_1.0 |
|---|---|
APPRDX |
Appropriate Diagnosis |
BIRTHDT |
Date of Birth |
COMM |
Comment |
CONSNTDT |
Informed consent date |
CURRENT_APPRDX |
Current Appropriate Diagnosis |
DECLINED |
Declined |
EXCLUDED |
Excluded |
GENDER |
Gender |
HISPLAT |
Ethnicity: Is subject Hispanic/Latino |
P3GRP |
Prodromal group type |
PRJENRDT |
Projected Enrollment Date |
RAASIAN |
Identify self as Asian |
RABLACK |
Identify self as Black/African American |
RAHAWOPI |
Identify self as Hawaiian/Other Pacif Is |
RAINDALS |
Identify self as Am Indian/Alaska Native |
RANOS |
Race not specified |
RANOSCM |
Race not specified comments |
RAWHITE |
Identify self as White |
REFERNAM |
Medical Professional referral |
REFERRAL |
Referral source |
RSNDEC |
Reason for Declining |
RSNEXC |
Reason for Exclusion |
SIGNCNST |
Signed Consent |
Details
The SCREEN CRF exists in both 1.0 and 2.0, but is limited to only capturing information on a participant’s demographics in 2.0 (gender, handedness, ethnicty, race). In 1.0, the scope also included other information about a participant, such as consent, referrals, and a participant’s status in the study (excluded or declined). The model name SCREEN is a legacy reference to PPMI 1.0’s CRF title “Screening/Demographics”.
SOA and Cohorts
Depending on a participant’s cohort, the timing of when this CRF is completed will vary. For Healthy Control, Parkinson’s Disease, and PD Genetic Cohort participants, this form is completed at Screening or at any Transition Activity. A Transition Activity is the first 2.0 visit for a 1.0 participant that is transitioning into the 2.0 study. For participants in the Prodromal Cohort, this form is completed at the Baseline visit or at a Transition Activity.
Here are details on some of the key differences between variables in this table between PPMI 1.0 and 2.0:
SEX and CHLDBEAR
In PPMI 1.0 the variable GENDER had 3 options: Female of child bearing potential, Female of non-child bearing potential, and Male. In PPMI 2.0 this has been replaced by two separate variables: SEX which records biological sex (Female or Male) and CHLDBEAR which records child bearing potential for Females (Yes or No) and will be Null for Males.
HANDED
The variable capturing a participant’s handedness was moved to this table from SOCIOECO (where it existed in 1.0).
ASHKJEW, BASQUE, AFICBERB
All three of these questions capture details on a participant’s ethnicity that were not captured in 1.0.
DECLINED, EXCLUDED
Both of these questions are now captured in the SCRNFAIL table, in the SCFAILRSN variable.
RSNDEC
This variable is now captured in the SCRNFAIL table.
SIGNCNST, CONSNTDT
Information on a participant’s consent can be found in the CONSENT table.