|
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 |
|
|
CATIEID |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
visit_date |
|
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.
|
|
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
gender |
Query
|
visitid |
Integer |
|
Recommended |
MetaTrial Visit ID |
|
System variable: unique code for each type of visit -use to merge files
|
|
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
visitnum |
Query
|
truncvis |
Integer |
|
Recommended |
Truncated Visit Number |
|
Created variable: provides a numeric visit number for all visits, including unscheduled and end of phase
|
|
Query
|
phase_ct |
String |
20
|
Recommended |
Current Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase. |
Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase; Screening; Phase 1
|
|
phase |
Query
|
colldy |
Integer |
|
Recommended |
Collection Day |
|
Number of days from study baseline to date of sample collection
|
COLLECDY |
|
testname |
String |
50
|
Recommended |
Laboratory Test Name |
|
|
form |
Query
|
repeat |
Integer |
|
Recommended |
Flag for Repeat of Lab Test |
0;1
|
0=No;1=Yes, missing otherwise
|
|
Query
|
testgrp |
String |
50
|
Recommended |
Laboratory Test Group |
|
|
|
|
testcode |
String |
10
|
Recommended |
Laboratory Test Code |
|
|
|
|
collectm |
String |
20
|
Recommended |
Collection Time |
|
|
|
Query
|
rstatus |
String |
1
|
Recommended |
Record Status |
|
X=result for this lab test not available; 0 or missing = result for this lab test is availalbe
|
form_status |
Query
|
resultyp |
String |
1
|
Recommended |
Type Of Result |
N;T
|
N=numeric, T=text
|
|
|
result |
String |
100
|
Recommended |
Reported Result |
|
|
value |
Query
|
units |
String |
50
|
Recommended |
Reported Unit |
|
|
unit |
|
hinorm |
String |
50
|
Recommended |
Normal Range Reported High Value |
|
|
referang, sitref |
|
lonorm |
String |
50
|
Recommended |
Normal Range Reported Low Value |
|
|
|
|
cvresult |
String |
50
|
Recommended |
Result in Conventional Units |
|
|
|
Query
|
resn |
Float |
|
Recommended |
Numeric Result |
|
Takes the value of CVRESULT. If CVRESULT has a > or < sign, then the sign is removed before creating RESN.
|
|
Query
|
cvunits |
String |
10
|
Recommended |
Conventional Units |
|
|
|
Query
|
cvhinorm |
Float |
|
Recommended |
Normal Range Conventional High Value |
|
|
|
Query
|
cvlonorm |
Float |
|
Recommended |
Normal Range Conventional Low Value |
|
-999=negative; 999=normal
|
|
Query
|
alertflg |
String |
2
|
Recommended |
Alert Flag |
H; TH; PH; L;PL; TL
|
H=High;TH=High, telephone the site;PH=panic high; L=Low; TL=Low, telephone the site; PL=panic low
|
|
Query
|
base1f |
Integer |
|
Recommended |
Phase 1/1A Baseline Flag |
|
1=Yes for all records meeting this criteria
|
|
Query
|
last1f |
Integer |
|
Recommended |
Phase 1/1A Last Value Flag |
|
1=Yes for all records meeting this criteria
|
|
Query
|
baseval1 |
Float |
|
Recommended |
Phase 1/1A Baseline Value |
|
value for each particular lab test at phase-specific baseline; retained across all records for that lab test.
|
|
Query
|
chgval1 |
Float |
|
Recommended |
Phase 1/1A Change from Baseline |
|
Phase-specific change (within each phase, change is calculated from that phase's baseline measurement)
|
|
Query
|
base1bf |
Integer |
|
Recommended |
Phase 1B Baseline Flag |
|
1=Yes for all records meeting this criteria
|
|
Query
|
last1bf |
Integer |
|
Recommended |
Phase 1B Last Value Flag |
|
1=Yes for all records meeting this criteria
|
|
Query
|
basval1b |
Float |
|
Recommended |
Phase 1B Baseline Value |
|
value for each particular lab test at phase-specific baseline; retained across all records for that lab test.
|
|
Query
|
chgval1b |
Float |
|
Recommended |
Phase 1B Change from Baseline |
|
Phase-specific change (within each phase, change is calculated from that phase's baseline measurement)
|
|
Query
|
base2f |
Integer |
|
Recommended |
Phase 2 Baseline Flag |
|
1=Yes for all records meeting this criteria
|
|
Query
|
last2f |
Integer |
|
Recommended |
Phase 2 Last Value Flag |
|
1=Yes for all records meeting this criteria
|
|
Query
|
baseval2 |
Float |
|
Recommended |
Phase 2 Baseline Value |
|
value for each particular lab test at phase-specific baseline; retained across all records for that lab test.
|
|
Query
|
chgval2 |
Float |
|
Recommended |
Phase 2 Change from Baseline |
|
Phase-specific change (within each phase, change is calculated from that phase's baseline measurement)
|
|
Query
|
base3f |
Integer |
|
Recommended |
Phase 3 Baseline Flag |
|
1=Yes for all records meeting this criteria
|
|
Query
|
last3f |
Integer |
|
Recommended |
Phase 3 Last Value Flag |
|
1=Yes for all records meeting this criteria
|
|
Query
|
baseval3 |
Float |
|
Recommended |
Phase 3 Baseline Value |
|
value for each particular lab test at phase-specific baseline; retained across all records for that lab test.
|
|
Query
|
chgval3 |
Float |
|
Recommended |
Phase 3 Change from Baseline |
|
Phase-specific change (within each phase, change is calculated from that phase's baseline measurement)
|
|
|
lmealtm |
String |
10
|
Recommended |
Time of last meal |
|
|
|
|
ldosetm |
String |
10
|
Recommended |
Time of last dose |
|
|
|
Query
|
ldosedy |
Integer |
|
Recommended |
Day of last dose |
|
Number of days from study baseline to date of last dose
|
|
Query
|
lmealdy |
Integer |
|
Recommended |
Day of last meal |
|
Number of days from study baseline to date of last meal
|
|
Query
|
visday |
Integer |
|
Recommended |
Number of days from study baseline to date of visit |
|
|
|
|
accessno |
String |
25
|
Recommended |
Accession Number |
|
Uniquely identifies each blood draw
|
|
Query
|
visnum |
Float |
|
Recommended |
Numeric Visit Number |
|
-1.5 = Pre-Screening; -1 = Screening; 0 = Baseline; ## = Visit ## (from 1 to 10); Whole numbers = standard monthly visits; #.001 - #.009 = Unscheduled; #.1 = End of Phase 1; #.2 = End of Phase 2; #.3 = End of Phase 3; #.4 = End of Open Choice Phase; #.5 = End of Study; #.6 = Genetic Analysis; 1000=all visits
|
|
Query
|
chgval2s |
Float |
|
Recommended |
Phase 2 Change from Study Baseline |
|
Change from Phase 1 baseline to Phase 2
|
|
Query
|
chgval3s |
Float |
|
Recommended |
Phase 3 Change from Study Baseline |
|
Change from Phase 1 baseline to Phase 3
|
|
Query
|
baseocf |
Integer |
|
Recommended |
Phase OC Baseline Flag |
1
|
1=Yes for all records meeting this criteria
|
|
Query
|
basevloc |
Float |
|
Recommended |
Phase OC Baseline Value |
|
value for each particular lab test at phase-specific baseline; retained across all records for that lab test.
|
|
Query
|
chgvaloc |
Float |
|
Recommended |
Phase OC Change from Baseline |
|
Phase-specific change (within each phase, change is calculated from that phase's baseline measurement)
|
|
Query
|
chgvalos |
Float |
|
Recommended |
Phase OC Change from Study Baseline |
|
Change from Phase 1 baseline to Open Choice Phase
|
|
Query
|
lastocf |
Integer |
|
Recommended |
Phase OC Last Value Flag |
1
|
1=Yes for all records meeting this criteria
|
|
Query
|
avnumcig |
Integer |
|
Recommended |
Average Number of Cigarettes |
|
|
|
Query
|
ls_result |
Integer |
|
Recommended |
Result |
1;2;3
|
1=Normal;2=Abnormal-Not clinically significant;3=Abnormal-Clinically significant
|
clinsignif |
Query
|
lineno |
Integer |
|
Recommended |
Line number (lines per participant) |
0::150
|
|
|
Query
|
iecsig |
Integer |
|
Recommended |
Investigator signature on form. |
0;1
|
0=No; 1= Yes
|
|
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
siteid |
Query
|
days_baseline |
Integer |
|
Recommended |
Days since baseline |
|
|
|
|
comments_misc |
String |
4,000
|
Recommended |
Miscellaneous comments on study, interview, methodology relevant to this form data |
|
|
|
|
flwup1 |
String |
250
|
Recommended |
Followup 1 |
|
|
fupplan |
Query
|
rangelevel |
Integer |
|
Recommended |
Range Level |
1::3
|
1 = Within Range; 2 = High; 3 = Low
|
|
|
recentmealtime |
String |
5
|
Recommended |
Time of most recent meal. HH:MM |
|
24 hour clock
|
|
|
lastdosedt |
Date |
|
Recommended |
Date of last dose |
|
MM/DD/YYYY
|
|
|
lastdosetime |
String |
5
|
Recommended |
Time of last drug dose. HH:MM |
|
24 hour clock
|
|
|
secondlastdosedt |
Date |
|
Recommended |
Date of second to last dose |
|
MM/DD/YYYY
|
|
|
secondlastdosetime |
String |
5
|
Recommended |
Time of second to last drug dose. HH:MM |
|
24 hour clock
|
|
|
thirdlastdosedt |
Date |
|
Recommended |
Date of third to last dose |
|
MM/DD/YYYY
|
|
|
thirdlastdosetime |
String |
5
|
Recommended |
Time of third to last drug dose. HH:MM |
|
24 hour clock
|
|
|
recentmealdt |
Date |
|
Recommended |
Date of most recent meal |
|
MM/DD/YYYY
|
|