|
subjectkey |
GUID |
|
Required |
The NDAR Global Unique Identifier (GUID) for research subject |
NDAR*
|
|
|
|
src_subject_id |
String |
20
|
Required |
Subject ID how it's defined in lab/project |
|
|
bid |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
|
|
interview_age |
Integer |
|
Required |
Age in months at the time of the interview/test/sampling/imaging. |
0::1440
|
Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.
|
dema1 |
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
dema2, gender |
Query
|
adja1r |
Integer |
|
Recommended |
Adjudication Report Number |
|
|
|
Query
|
adja2a |
Integer |
|
Recommended |
Endpoint Assessment Result |
1;2;3
|
Definite study endpoint-1; Possible study endpoint (more information needed)-2; Event not a study endpoint-3
|
|
Query
|
adja3 |
Integer |
|
Recommended |
Adjudicators assessment of endpoint date |
|
|
|
Query
|
sae_13 |
Integer |
|
Recommended |
1.7 Psychiatric condition requiring hospitalization |
0;1
|
0=No; 1=Yes
|
adja4a |
Query
|
adja4b |
Integer |
|
Recommended |
Need for crisis intervention |
0;1
|
1=Yes; 0=No Indicate all criteria defining the study endpoint (select all that apply):
|
|
Query
|
adja4c |
Integer |
|
Recommended |
Clinician decision that oral antipsychotic medications cannot be discontinued in less than eight weeks |
0;1
|
1=Yes; 0=No Indicate all criteria defining the study endpoint (select all that apply):
|
|
Query
|
adja4d |
Integer |
|
Recommended |
Clinician decision of failed efficacy defined by discontinuation of study medication due to inadequate therapeutic benefit |
0;1
|
1=Yes; 0=No Indicate all criteria defining the study endpoint (select all that apply):
|
|
Query
|
adja4e |
Integer |
|
Recommended |
Clinician decision that ongoing treatment with an adjunctive oral antipsychotic medication, in addition to continued treatment with the assigned LAIAM is necessary |
0;1
|
1=Yes; 0=No Indicate all criteria defining the study endpoint (select all that apply):
|
|
Query
|
adja5a |
Integer |
|
Recommended |
Admission to a crisis stabilization unit |
0;1
|
1=Yes; 0=No Indicate all criteria defining the study endpoint (select all that apply):
|
|
Query
|
adja5b |
Integer |
|
Recommended |
Admission to an emergency department |
0;1
|
1=Yes; 0=No Indicate all criteria defining the study endpoint (select all that apply):
|
|
Query
|
adja5c |
Integer |
|
Recommended |
Admission to intensive outpatient treatment program, partial hospitilization program, or equivalent |
0;1
|
1=Yes; 0=No Indicate all criteria defining the study endpoint (select all that apply):
|
|
Query
|
adja5d |
Integer |
|
Recommended |
A substantial increase in frequency of outpatient visits |
0;1
|
1=Yes; 0=No Indicate all criteria defining the study endpoint (select all that apply):
|
|
Query
|
adja6 |
Integer |
|
Recommended |
Date of endpoint review/adjudication |
0::999
|
|
|
|
version_form |
String |
121
|
Recommended |
Form used/assessment name |
|
|
vers |
Query
|
fseqno |
Integer |
|
Recommended |
Sequence Number |
0::999
|
The FSEQNO variable in the ADJ form has a special interpretation compared to other forms.
For example, ADJ FSEQNO of '1' can be thought of as being '001', FSEQNO of '2' can be thought of as
being '002', and FSEQNO of '3' can be thought of as being '003'.
The first digit of FSEQNO relates to the corresponding ENF sequence number at that visit and the third
digit relates to the specific adjudicator who completed the adjudication form.
|
|
Query
|
visitid |
Integer |
|
Recommended |
MetaTrial Visit ID |
|
System variable: unique code for each type of visit -use to merge files
|
|