|
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 |
|
|
patid, randid, subject_id, subjectid |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
pregn_event, visit_date |
|
interview_age |
Integer |
|
Required |
Age in months at the time of the interview/test/sampling/imaging. |
0 :: 1260
|
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, preg1 |
Query
|
pregn_01 |
Integer |
|
Recommended |
Is information about this pregnancy available? |
0;1
|
0=No; 1=Yes
|
|
Query
|
pregn_01a |
Integer |
|
Recommended |
live birth |
0;1
|
0=No; 1=Yes
|
|
Query
|
pregn_01b |
Integer |
|
Recommended |
Clinical Termination |
0;1
|
0=No; 1=Yes
|
|
Query
|
pregn_01c |
Integer |
|
Recommended |
Any apparent abnormalities? |
0;1
|
0=No; 1=Yes
|
|
|
pregn_01d |
String |
250
|
Recommended |
a. list abnormalities |
|
|
|
|
pregn_01e |
String |
250
|
Recommended |
b. list abnormalities |
|
|
|
|
pregn_01f |
String |
250
|
Recommended |
c. list abnormalities |
|
|
|
Query
|
pregn_01g |
Integer |
|
Recommended |
stillbirth |
0;1
|
0=No; 1=Yes
|
|
Query
|
pregn_01h |
Integer |
|
Recommended |
miscarriage |
0;1; -9
|
0=No; 1=Yes; -9=Incomplete
|
|
|
eterm6prg |
Date |
|
Recommended |
pregnant date |
|
|
pregn_date_reported |
|
subject_description |
String |
4,000
|
Recommended |
Subject related information (e.g the affection, phenotype, disease information, etc.). |
|
|
|
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
site_uid |
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
prex_interval, visit_name |
|
session_id |
String |
20
|
Recommended |
session ID/screening ID |
|
|
screeningid |
|
version_form |
String |
121
|
Recommended |
Form used/assessment name |
|
|
form_name |
Query
|
pregnant |
Integer |
|
Recommended |
Patient is currently pregnant |
0::2;-7; 999
|
0=No; 1=Yes;2=DK;-7= Refused; 999=Legimately skipped
|
prgntyn |
|
rprtdt |
Date |
|
Recommended |
Pregnancy Date Reported |
|
|
|
|
lstmnsdt |
Date |
|
Recommended |
Pregnancy Start date of last menses |
|
|
|
|
confdt |
Date |
|
Recommended |
Pregnancy Date confirmed |
|
|
|
|
anbrthdt |
Date |
|
Recommended |
Pregnancy Anticipated date of childbirth |
|
|
|
Query
|
numpreg |
Integer |
|
Recommended |
number of pregnancies |
|
|
nmbrpreg |
Query
|
nrmdeliv |
Integer |
|
Recommended |
Number of Normal Deliveries |
|
|
|
Query
|
miscar |
Integer |
|
Recommended |
Number of miscarriages |
|
|
spnmscrg |
|
prghxoth |
String |
250
|
Recommended |
Other Pregnancy History |
|
|
|
Query
|
outcm |
Integer |
|
Recommended |
Pregnancy Outcome |
1::7
|
1=Not known at this date; 2=Still Birth; 3=Uneventful (normal/healthy baby); 4=Neonatal death; 5=Induced Abortion; 6=Spontaneous Abortion; 7=Birth defects
|
|
|
comments_misc |
String |
4,000
|
Recommended |
Miscellaneous comments on study, interview, methodology relevant to this form data |
|
|
acpreg, comments |
|
outcmdt |
Date |
|
Recommended |
Pregnancy Outcome Date |
|
|
|
|
study |
String |
100
|
Recommended |
Study; The code for each individual study |
|
|
studyid |
Query
|
week |
Float |
|
Recommended |
Week in level/study |
|
99=week 10-week 14
|
interval |
|
date_updated |
Date |
|
Recommended |
Date record updated |
|
|
edit_date |
Query
|
prex_mnrchdat_x |
Integer |
|
Recommended |
Day of Menarche |
|
|
q02 |
Query
|
rlhqlql |
Integer |
|
Recommended |
Patient's status is childbearing potential |
|
1=No; 2=Yes; 9=unknown
|
prex_q01, q01 |
Query
|
contrac |
Integer |
|
Recommended |
Contraception use |
1::5
|
1=None; 2=OBC; 3=Barrier; 4=Abstinence; 5=Other
|
prex_q03 |
Query
|
pregnan |
Integer |
|
Recommended |
pregnancy test |
0::6;-7;9
|
0=Negative; 1=Positive; 2=Test not conducted; -7=Refused; 9=NA;3=Not pregnant (per pregnancy test); 4=Not pregnant (has not reached menarche); 5=Pregnancy suspected, but not confirmed; 6 = Equivocal
|
preg2, prex_q05, q05 |
Query
|
completed |
Integer |
|
Recommended |
Checks if completed |
0::3
|
0=No; 1=Yes; 2=Yes, lost; 3=Unverified
|
frmcomp, prex_frmcomp, pt01 |
Query
|
bcstat |
Integer |
|
Recommended |
Current Birth Control or Reproductive Status |
1::12; 99
|
1=Oral; 2=Hormonal Injections; 3=Hormonal Implants; 4=Contraceptive Patches; 5=Ring; 6=Intrauterine device, hormonal; 7=Intrauterine device, non-hormonal; 8=Barrier method; 9=Spermicide; 10 Post-menopausal for > 1 year; 11=Bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; 12=Abstinence; 99 = other
|
q03 |
|
p_med_bc |
String |
65
|
Recommended |
Describe type of birth control |
|
|
q04 |
Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
studyday |
Query
|
ci_enrolled |
Integer |
|
Recommended |
Participant enrolled |
0;1
|
0=No; 1=Yes
|
enrolled |
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
|
|
|
specify |
String |
200
|
Recommended |
If "Other", (pregnancy test N/A) specify - TEXT |
|
|
|
Query
|
ifna |
Integer |
|
Recommended |
If N/A checked (pregnancy test), please select one reason |
1::3
|
1 = Male; 2 = Premanarche; 3 = Other (specify)
|
|
Query
|
pepregt |
Integer |
|
Recommended |
Pregnancy test type |
1::3; -9
|
1 = Urine 2 = Serum 3 = Test not conducted; -9=unknown
|
|
Query
|
sigp1 |
Integer |
|
Recommended |
Physician signature present |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
sigd1 |
Integer |
|
Recommended |
Physician/PI signature date (days since randomization) |
|
|
|
Query
|
sub8a_9 |
Integer |
|
Recommended |
N/A |
1::3; -99; 77; 88
|
1= Yes ; 2= No ; -99= NA; 77= Refused ; 88= Missing; 3=not assessed
|
|
|
ptlot |
String |
500
|
Recommended |
Lot Number |
|
|
|
|
ptex |
Date |
|
Recommended |
Expiration Date |
|
|
|
|
aescode |
Integer |
|
Recommended |
Staff code number of person completing this form |
|
999= Missing Data
|
|
|
ccc2datecomp |
Date |
|
Recommended |
Date Completed |
|
|
pt0 |
|
preg3 |
Integer |
|
Recommended |
If equivocal, what was the retest result |
1::3
|
1 = Positive ; 2 = Negative ; 3 = Equivocal
|
preg03 |