|
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, stepid, subjid |
|
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.
|
age |
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
comments, gender |
Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
studyday, visitdt |
Query
|
certcode |
Integer |
|
Recommended |
stepbd certification code |
|
|
|
Query
|
race |
String |
30
|
Recommended |
Race of study subject |
American Indian/Alaska Native; Asian; Hawaiian or Pacific Islander; Black or African American; White; More than one race; Unknown or not reported; Other Non-White; Other
|
|
|
Query
|
agege15 |
Integer |
|
Recommended |
current age ge 15 years |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
inmdd |
Integer |
|
Recommended |
IN: meets DSM-IV criteria |
0;1;-7;-9
|
0=No; 1=Yes; -9=unknown; -7=refused
|
dsmivcri |
Query
|
ptcon |
Integer |
|
Recommended |
Patient consented |
|
0=No; 1=Yes
|
cnsnt, consent |
Query
|
dschizo |
Integer |
|
Recommended |
dsm iv criteria shizoaffective |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
preginfo |
Integer |
|
Recommended |
inform md of pregnancy |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
noncompl |
Integer |
|
Recommended |
unwilling or unable to comply |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
novisit |
Integer |
|
Recommended |
unable to attend scp visit |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
noread |
Integer |
|
Recommended |
patient cannot read |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
nowrite |
Integer |
|
Recommended |
patient cannot write |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
noenglsh |
Integer |
|
Recommended |
patient not fluent in english |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
ncoth |
Integer |
|
Recommended |
NC: other reason |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
ccwork |
Integer |
|
Recommended |
patient given coll care wrkbk |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
ccvideo |
Integer |
|
Recommended |
patient given coll care video |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
site_id, site_uid, siteid |
Query
|
ethnicity |
String |
30
|
Recommended |
Ethnicity of participant |
|
|
|
Query
|
study |
String |
100
|
Recommended |
Study; The code for each individual study |
|
|
studyid |
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
int1, interval, visit_name |
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
|
ols_q1 |
Integer |
|
Recommended |
Entering Open Label? |
0;1
|
0=No; 1=Yes
|
enroldate_olstudy |
Query
|
ols_q2 |
Integer |
|
Recommended |
Reason for not entering |
1::10
|
1=Toxicity or side effects related to study medication
2=Medical reason unrelated to study medication
3=Termination by principal investigator because of non medical reasons 4=Failed to return to clinic
5=Declined study participation
6 = Moved from area (current or pending)
7 = Death (Complete Serious Adverse Events Form)
8 = Subject no longer eligible to participate. 9 = School unable/no longer willing to participate
10 = Other
|
enr04b |
Query
|
incl01 |
Integer |
|
Recommended |
Parents provide written consent |
0;1
|
0=No; 1=Yes
|
|
Query
|
incl02 |
Integer |
|
Recommended |
Age 4 years 6 months to 14 years of age inclusive |
0;1
|
0=No; 1=Yes
|
|
Query
|
incl03 |
Integer |
|
Recommended |
Diagnosis of PDD/Aspergers/Autism |
0::4
|
0=No; 1=Yes; 2=Current; 3=In partial remission; 4= Past
|
|
Query
|
incl04 |
Integer |
|
Recommended |
Med free CGI for PDD >= 4 |
0;1;-7;-9
|
0=No; 1=Yes; -7=refused; -9=unknown
|
|
Query
|
incl05 |
Integer |
|
Recommended |
Meet parent and teacher SNAP-IV criteria |
0;1;-7;-9
|
0=No; 1=Yes; -7=refused; -9=unknown
|
|
Query
|
incl06 |
Integer |
|
Recommended |
Mental age >= 18 months |
0;1
|
0=No; 1=Yes
|
|
Query
|
excl01 |
Integer |
|
Recommended |
Mental age < 18 months |
0;1
|
0=No; 1=Yes
|
|
Query
|
excl02 |
Integer |
|
Recommended |
DSM diagnosis requiring pharmacotherapy |
0;1
|
0=No; 1=Yes
|
|
Query
|
excl03 |
Integer |
|
Recommended |
Significant medical condition |
0;1;-7;-9
|
0=No; 1=Yes; -7=refused; -9=unknown
|
|
Query
|
excl04 |
Integer |
|
Recommended |
Diastolic BP out of range |
0;1
|
0=No; 1=Yes
|
|
Query
|
excl05 |
Integer |
|
Recommended |
Concurrent treatment with another psychotropic medication within one to three weeks of baseline |
0;1
|
0=No; 1=Yes
|
|
Query
|
excl06 |
Integer |
|
Recommended |
Subject weighs less than 16 kg |
0;1;-7;-9
|
0=No; 1=Yes; -7=refused; -9=unknown
|
|
Query
|
excl07 |
Integer |
|
Recommended |
Hypersensitive to Guanfacine |
0;1;-7;-9
|
0=No; 1=Yes; -7=refused; -9=unknown
|
|
Query
|
excl08 |
Integer |
|
Recommended |
Exclusion criteria exception used for this subject ? |
0;1;-7;-9
|
0=No; 1=Yes; -7=refused; -9=unknown
|
|
Query
|
enrolln |
Integer |
|
Recommended |
Was subject enrolled |
0;1
|
0=No; 1=Yes
|
|
Query
|
enr_d1 |
Integer |
|
Recommended |
Did Subj. meet Inclu./Exclu.? |
0;1
|
0=No; 1=Yes
|
|
Query
|
enr_d2 |
Integer |
|
Recommended |
Date of case review in days from the Guanfacine enrollment date (ENR_D2 = Date of case review - Guanfacine enrollment date) |
|
|
|
Query
|
guan_01 |
Integer |
|
Recommended |
Presence of a chronic tic disorder |
0;1
|
0=No; 1=Yes
|
|
Query
|
guan_02 |
Integer |
|
Recommended |
History of MPH Non-Response |
0;1
|
0=No; 1=Yes
|
|
Query
|
guan_03 |
Integer |
|
Recommended |
MPH Non-Responder in MPH arm |
0;1
|
0=No; 1=Yes
|
|
Query
|
guan_04 |
Integer |
|
Recommended |
Entered MPH Arm but did not tolerate or had adverse reaction |
0;1
|
0=No; 1=Yes
|
|
Query
|
reas01 |
Integer |
|
Recommended |
Parent refused child take medication |
0;1
|
0=No; 1=Yes
|
q01 |
Query
|
reas02 |
Integer |
|
Recommended |
Parent declined other reason |
0;1
|
0=No; 1=Yes
|
q02 |
Query
|
reas03 |
Integer |
|
Recommended |
Subject refused to take medication |
0;1
|
0=No; 1=Yes
|
q03 |
Query
|
reas04 |
Integer |
|
Recommended |
Subject refused other reason |
0;1
|
0=No; 1=Yes
|
q04 |
Query
|
reas05 |
Integer |
|
Recommended |
Failed to return to clinic |
0;1
|
0=No; 1=Yes
|
q05 |
Query
|
reas06 |
Integer |
|
Recommended |
Improved prior to randomization |
0;1
|
0=No; 1=Yes
|
q06 |
Query
|
reas07 |
Integer |
|
Recommended |
Severe family problems preclude |
0;1
|
0=No; 1=Yes
|
q07 |
Query
|
reas08 |
Integer |
|
Recommended |
Failed inclusion criteria |
0;1
|
0=No; 1=Yes
|
q08 |
Query
|
reas09 |
Integer |
|
Recommended |
Met exclusion criteria |
0;1
|
0=No; 1=Yes
|
q09 |
Query
|
reas10 |
Integer |
|
Recommended |
Other reason |
0;1; -9
|
0=No; 1=Yes; -9=NA
|
q10 |
Query
|
enrl_ord |
Integer |
|
Recommended |
Order of Enrollment - The first subject enrolled in the Guanfacine Trial (i.e., the earliest enrollment date) has ENRL_ORD = 1, the second subject enrolled has ENRL_ORD = 2, the third has ENRL_ORD = 3, etc. Subjects enrolled on the same day are given the same number. |
|
Derived variable, not on CRF
|
|
Query
|
crossday |
Integer |
|
Recommended |
Days since MPH trial randomization (CROSSDAY = Guanfacine Enrollment Date - MPH Randomization Date) |
|
Derived variable, not on CRF
Only applicable to those subjects that participated in both the Randomized MPH Trial and the Guanfacine Trial. Data are blank for all other subjects.
|
|
|
session_id |
String |
20
|
Recommended |
session ID/screening ID |
|
|
screeningid |
|
version_form |
String |
121
|
Recommended |
Form used/assessment name |
|
|
form_name |
Query
|
randrdy |
Integer |
|
Recommended |
Is subject ready for randomization? |
0;1
|
0=No; 1=Yes
|
|
|
ran004 |
String |
10
|
Recommended |
Randomization number/coding |
|
|
rndnum |
|
date_updated |
Date |
|
Recommended |
Date record updated |
|
|
edit_date |
Query
|
elgbsgn |
Integer |
|
Recommended |
Site PI signed off Eligibility Confirmation form |
0;1
|
0=No;1=Yes
|
|
Query
|
dayscons |
Integer |
|
Recommended |
days since consent |
|
|
cnsntdat |
Query
|
mpdat |
Float |
|
Recommended |
days from enrollment |
|
|
|
Query
|
project_status |
Integer |
|
Recommended |
Current status in project |
1::15
|
1=Evaluation in progress; 2=Refused consent; 3=Ineligible/excluded; 4=Active stage 1; 5=Active stage 2; 6=Active HC control; 7=Completed HC control; 8=Stage 1 complete terminal; 9=Stage 2 complete; 10=Abnormal termination; 11=Withdrew consent; 12=In washout; 13=Dropped out/non compliant; 14=Project Completed; 15=Screened Only
|
status |
Query
|
enr04a |
Integer |
|
Recommended |
Could subject be located |
0;1
|
1=Yes; 0=No
|
|
Query
|
sitedatasource_1 |
Integer |
|
Recommended |
Source of Data: Site |
0;1; -888; -999
|
0=False; 1=True; -888=Not Applicable; -999=Missing;
|
infosrcr |
Query
|
sitedatasource_phone |
Integer |
|
Recommended |
Source of Data: Telephone |
0;1; -888; -999
|
0=False; 1=True; -888=Not Applicable; -999=Missing;
|
infosrct |
Query
|
sitedatasource_physician |
Integer |
|
Recommended |
Source of Data: Physician |
0;1; -888; -999
|
0=False; 1=True; -888=Not Applicable; -999=Missing;
|
infosrcp |
Query
|
ssq2a |
Integer |
|
Recommended |
Any anti-convulsant? |
0;1
|
0 = No; 1 = Yes
|
anticonv, takedrug |
Query
|
med_sequence |
Integer |
|
Recommended |
Med Sequence number |
|
|
seq |
Query
|
ci_enrolled |
Integer |
|
Recommended |
Participant enrolled |
0;1
|
0=No; 1=Yes
|
enrolled |
|
treatment_name |
String |
200
|
Recommended |
treatment name |
|
|
treatgrp |
|
suicidesafeplan01 |
Integer |
|
Recommended |
Create a safety plan with every participant at baseline appointment. Send it to them and save it on box. At post and follow-up visits review safety plan. For people without SI: remind them the plan is available, ask if they want to change anything on their plan, and make sure they have access to a copy. Was a safety plan created /reviewed for/with participant? |
0;1
|
0=No; 1=Yes
|
|