|
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 |
|
|
randid |
|
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.
|
|
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
gender |
Query
|
study |
String |
100
|
Recommended |
Study; The code for each individual study |
|
|
studyid |
Query
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
siteid |
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
int1, interval |
Query
|
completed |
Integer |
|
Recommended |
Checks if completed |
0::3
|
0=No; 1=Yes; 2=Yes, lost; 3=Unverified
|
formcomp, frmcomp |
Query
|
subtrial_name |
Integer |
|
Recommended |
Name of subtrial |
1::3
|
1=Crossover; 2=Guanfacine; 3= Open Label MPH
|
|
Query
|
adl_q01 |
Integer |
|
Recommended |
Date of blood draw in days from the randomization date (ADL_Q01 = Date of blood draw - randomization date) |
|
|
drawdate |
Query
|
drawtime |
String |
20
|
Recommended |
time of blood draw |
|
|
adl_q02 |
Query
|
adl_q03 |
Integer |
|
Recommended |
Date of last study med taken in days from the randomization date (ADL_Q03 = Date of last dose of study medication - randomization date) |
|
-888=NA
|
datemed |
Query
|
adl_q04 |
String |
20
|
Recommended |
Time of last study med |
|
-888=NA
|
medtime |
Query
|
adl_q05 |
Integer |
|
Recommended |
Date of last anticonvulsant taken in days from the randomization date (ADL_Q05 = Date of last dose of anticonvulsant - randomization date) |
|
|
dateanti |
Query
|
adl_q06 |
String |
20
|
Recommended |
Time of last anticonvulsant |
|
|
antitime |
Query
|
adl_q07a |
Integer |
|
Recommended |
Phenytoin test ordered |
1;2
|
1=Yes 2=No
|
phenytn |
Query
|
adl_q07b |
Integer |
|
Recommended |
Carbamazepine test ordered |
1;2
|
1=Yes 2=No
|
carbamaz |
Query
|
adl_q07c |
Integer |
|
Recommended |
Valproate test ordered |
1;2
|
1=Yes 2=No
|
valproat |
Query
|
adl_q07d |
Integer |
|
Recommended |
Lamotrigine test ordered |
1;2
|
1=Yes 2=No
|
lamotrig |
Query
|
adl_q07e |
Integer |
|
Recommended |
Gabapentin test ordered |
1;2
|
1=Yes 2=No
|
gabapent |
Query
|
adl_q07f |
Integer |
|
Recommended |
Other1 test ordered |
1;2
|
1=Yes 2=No
|
other1 |
Query
|
adlq07fs |
String |
50
|
Recommended |
Other1 test specify |
|
|
spec1 |
Query
|
adl_q07g |
Integer |
|
Recommended |
Other2 test ordered |
1;2
|
1=Yes 2=No
|
other2 |
|
adlq07gs |
String |
50
|
Recommended |
Other2 test specify |
|
|
spec2 |
Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
studyday, visitdt |
Query
|
blooddraw |
Integer |
|
Recommended |
Was blood drawn for tests? |
1;2
|
1= Yes
2= No 1 Or 2 Or Is Null
|
blood |
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
|
|
Query
|
wk_seizure_med |
Integer |
|
Recommended |
Seizure. Medication Used (Details in next section) |
0;1
|
No = 0; Yes = 1;
|
|
Query
|
other_reason_nc |
String |
100
|
Recommended |
Other reason form was not completed |
|
|
|
Query
|
txrisp |
Integer |
|
Recommended |
treatment risperidone |
1;0;-7
|
0=No; 1=Yes;-7=Refused
|
|
Query
|
arioral |
Integer |
|
Recommended |
Code indicating aripiprazole oral |
|
Code=1
|
|
Query
|
carbacs |
Integer |
|
Recommended |
carbamazepine clinic signif |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
blfnrvallev |
Float |
|
Recommended |
Non-randomized medication - Valproate level |
|
ug/mL
|
|
Query
|
iaoth |
Integer |
|
Recommended |
other action taken |
0;1;-4;-5;-6;-7;-8
|
0=No; 1=Yes; -4=Missing; -5=N/A; -6=Unknown; -7=Refused; -8=Not on original form
|
|
|
aef008a |
String |
200
|
Recommended |
If other action taken, specify |
|
|
|
Query
|
log011 |
String |
50
|
Recommended |
Patients chart (e.g., hard copy, electronic, or other medical record) reviewed? |
0;1;-888;-999
|
0=No; 1=Yes; -888=Not Applicable; -999=Missing;
|
|
Query
|
valpcs |
Integer |
|
Recommended |
valproate clinically signif |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
carbrst |
Float |
|
Recommended |
Lab test result: Carbamazepine ug/ml |
|
|
|
Query
|
lamotrst |
Float |
|
Recommended |
Lab test result: Lamotrigine ug/ml |
|
|
|
Query
|
lamotsg |
Integer |
|
Recommended |
Lamotrigine: clinically significant |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
oth1rst |
Float |
|
Recommended |
Lab test result: Other 1: ug/ml |
|
|
|
Query
|
other1sg |
Integer |
|
Recommended |
Lab test result: Other 1: significant change? |
0;1; -7
|
0=No; 1=Yes; -7=Refused
|
|
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
|
form_explain |
Integer |
|
Recommended |
Why was this form not completed? |
86::99
|
99=Participant unable to complete due to cognitive impairment; 98=Participant unable to complete due to physical impairment; 97=Participant refused to begin/finish; 96=Participant completed but with less than best effort; 95=Participant unable to be contacted; 94=Participant deceased; 93=Participant withdrew consent; 92=Time constraints; 91=Rater forgot to administer; 90=Missed appointment; 89=Participant was terminated from study; 88=Other;87 = Not Done (reason unspecified); 86 = Not Applicable
|
|
Query
|
study_drug_team |
String |
30
|
Recommended |
Study drug |
|
Baseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline; Aripiprazole; NA
|
|