|
subjectkey |
GUID |
|
Required |
The NDAR Global Unique Identifier (GUID) for research subject |
NDAR*
|
|
guid |
|
src_subject_id |
String |
20
|
Required |
Subject ID how it's defined in lab/project |
|
|
pid |
|
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.
|
|
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
|
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
gender |
Query
|
phase_cts |
Integer |
|
Recommended |
Phase I (12-weeks) Phase II (6-months) |
1;2
|
1 = Phase I - Participants were randomly assigned to receive sertraline (Zoloft), cognitive behavioral therapy, a combination of these treatments, or a placebo. 2 = Phase II - Maintenance period for participants who responded to any of the three active treatments.
|
phase, phase_ct, phase_p |
Query
|
change_s |
Integer |
|
Recommended |
Type of study status change |
1;2;3
|
1 = Study Dropout;2 = Treatment Dropout;3 = Pre-mature Termination
|
change |
|
stdate |
Date |
|
Recommended |
Study Treatment stop date |
|
|
daypmt, daytxdr |
Query
|
daydrop |
Integer |
|
Recommended |
Study Dropout - day of study drop |
|
|
|
Query
|
wkstdrop |
Integer |
|
Recommended |
Study week subject drops out of study |
0::36
|
0 = prior to Week 1;1 = Week 1;36 = Week 36
|
wkpmt, wktxdrop |
|
sd_othrs |
String |
80
|
Recommended |
Study Dropout - description of other reason |
|
|
|
|
erlrsmds |
String |
255
|
Recommended |
Describe reason for early termination |
|
|
tx_othrs, whatothr_p |
Query
|
trminatn |
Integer |
|
Recommended |
Premature Termination - Nature of the premature termination |
1;2
|
1 = Assigned study treatment discontinued all or in part;2 = Study treatment continued but out-of-protocol intervention added
|
|
Query
|
whatfx |
String |
60
|
Recommended |
Description of intolerable side-effects |
|
|
|
Query
|
daylasttx |
Integer |
|
Recommended |
Study day last regular treatment session was completed |
|
|
|
Query
|
daymstrecnt |
Integer |
|
Recommended |
Study day most recent scheduled assessment was completed |
|
|
|
Query
|
cssyorn |
Integer |
|
Recommended |
Was a change in study status assessment completed? |
0;1
|
0 = No;1 = Yes
|
|
Query
|
daycss |
Integer |
|
Recommended |
Study day change in study status form was completed |
|
|
|
Query
|
dayfinl |
Integer |
|
Recommended |
Study day final assessment was completed |
|
|
|
Query
|
asapform |
Integer |
|
Recommended |
Was an ASAP form completed? |
0;1
|
0 = No;1 = Yes
|
|
Query
|
dayasap_p |
Integer |
|
Recommended |
Study day ASAP initiated |
|
|
|
Query
|
asapanel |
Integer |
|
Recommended |
Presented to cross-site ASAP Panel? |
0;1
|
0 = No;1 = Yes
|
|
Query
|
daypanl |
Integer |
|
Recommended |
Study day of ASAP Panel |
|
|
|
Query
|
daychange |
Integer |
|
Recommended |
Study day of change in study status assessment |
|
|
|
Query
|
changewk |
Integer |
|
Recommended |
Study week of change in study status assessment |
|
|
|
Query
|
stdor1 |
Integer |
|
Recommended |
Dropout -subject moved and participation is no longer possible |
0;1
|
1 = Yes; 0=No
|
sd_moved |
Query
|
stdor2 |
Integer |
|
Recommended |
Dropout - lost to follow-up |
1;0
|
1 = Yes; 0=No
|
sd_lost |
Query
|
stdor3 |
Integer |
|
Recommended |
Dropout-consent withdrawn |
1;0
|
1 = Yes; 0-No
|
sd_wthdr |
Query
|
stdor5 |
Integer |
|
Recommended |
Dropout-adverse event |
1;0
|
1 = Yes; 0=No
|
sd_advev, tx_advev |
Query
|
stdor6 |
Integer |
|
Recommended |
Dropout-subject' death |
1;0
|
1 = Yes; 0=No
|
sd_died |
Query
|
stdor8 |
Integer |
|
Recommended |
Dropout-unknown reason |
1;0
|
1 = Yes; 0=No
|
sd_unkn, tx_unknw |
Query
|
stdor7 |
Integer |
|
Recommended |
Dropout-other reason |
1;0
|
1 = Yes; 0=No
|
sd_other, tx_other |
Query
|
tx_attnd |
Integer |
|
Recommended |
Unable to attend treatment sessions |
0;1
|
0 = No;1 = Yes
|
|
Query
|
tx_noint |
Integer |
|
Recommended |
No longer interested in participating |
0;1
|
0 = No;1 = Yes
|
|
Query
|
preg |
Integer |
|
Recommended |
patient become pregnant |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
TX_PREG |
Query
|
tx_cnsnt |
Integer |
|
Recommended |
Child/parent withdrew consent for treatment |
0;1
|
0 = No;1 = Yes
|
|
Query
|
tx_nocbt |
Integer |
|
Recommended |
Do not want to participate in CBT |
0;1
|
0 = No;1 = Yes
|
|
Query
|
tx_nopbo |
Integer |
|
Recommended |
Do not want to risk possibility of taking PLACEBO |
0;1
|
0 = No;1 = Yes
|
|
Query
|
tx_nomed |
Integer |
|
Recommended |
Do not want to risk possibility of taking meds |
0;1
|
0 = No;1 = Yes
|
|
Query
|
psycotic |
Integer |
|
Recommended |
Subject became psychotic |
0;1
|
0 = No;1 = Yes
|
|
Query
|
manic |
Integer |
|
Recommended |
Subject became manic |
0;1
|
0 = No;1 = Yes
|
|
Query
|
hypomanc |
Integer |
|
Recommended |
Subject became hypomanic |
0;1
|
0 = No;1 = Yes
|
|
Query
|
agitated |
Integer |
|
Recommended |
Subject displayed agitation/disinhibition |
0;1
|
0 = No;1 = Yes
|
|
Query
|
nosucont |
Integer |
|
Recommended |
Subject became suicidal |
0;1
|
0 = No;1 = Yes
|
|
Query
|
chrt_que2 |
Integer |
|
Recommended |
Patient made a suicide attempt |
0;1
|
0=No; 1=Yes
|
suiatmpt |
Query
|
chronill |
Integer |
|
Recommended |
Chronic medical illness |
0;1
|
0 = No;1 = Yes
|
illness |
Query
|
medintefere |
Integer |
|
Recommended |
Use of medications that interfere with study |
0;1
|
0 = No;1 = Yes
|
meds |
Query
|
subabuse |
Integer |
|
Recommended |
curr substance abuse or depend |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pregnant |
Integer |
|
Recommended |
Patient is currently pregnant |
0::2;-7; 999
|
0=No; 1=Yes;2=DK;-7= Refused; 999=Legimately skipped
|
|
Query
|
nocontct |
Integer |
|
Recommended |
Unable to contact |
0;1
|
0 = No;1 = Yes
|
|
Query
|
worscond |
Integer |
|
Recommended |
Condition substantially worse |
0;1
|
0 = No;1 = Yes
|
|
Query
|
norespns |
Integer |
|
Recommended |
Lack of clinical response |
0;1
|
0 = No;1 = Yes
|
|
Query
|
anclrytx |
Integer |
|
Recommended |
Subject requires ancillary treatment |
0;1
|
0 = No;1 = Yes
|
|
Query
|
sidefx |
Integer |
|
Recommended |
Intolerable side-effects |
0;1
|
0 = No;1 = Yes
|
|
Query
|
otherrsn |
Integer |
|
Recommended |
Premature termination. Other reason |
0;1
|
0 = No;1 = Yes
|
|
|
comments_misc |
String |
4,000
|
Recommended |
Miscellaneous comments on study, interview, methodology relevant to this form data |
|
|
|
|
study |
String |
100
|
Recommended |
Study; The code for each individual study |
|
|
|
Query
|
trtgroup |
String |
2
|
Recommended |
Treatment Group |
N1;N2;R1;R2;R3
|
N1=Non-Responder Entering Fluvoxamine; N2=Non-Responder Entering Fluoxetine; R1=Maintenance; R2=Responder Entering Fluvoxamine; R3=Responder Entering Fluoxetine
|
|
Query
|
q18_8d |
Integer |
|
Recommended |
Result of contact: Blind broken |
0; 1; -7; -8; -9
|
Complete only if q18_8 = 1
|
|
Query
|
medication1_name |
String |
500
|
Recommended |
Name first medication that the participant has taken |
|
0 = No medication; 999= Legitimately skipped
|
|
Query
|
medication2_name |
String |
500
|
Recommended |
Name second medication that the participant has taken |
|
0 = No medication; 999= Legitimately skipped
|
|
Query
|
medication3_name |
String |
500
|
Recommended |
Name third medication that the participant has taken |
|
0 = No medication; 999= Legitimately skipped
|
|
|
medication4_name |
String |
500
|
Recommended |
Name fourth medication that the participant has taken |
|
0 = No medication; 999= Legitimately skipped
|
|
Query
|
week |
Float |
|
Recommended |
Week in level/study |
|
99=week 10-week 14
|
|
Query
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
|
|
ancitx1 |
String |
100
|
Recommended |
description of treatment |
|
|
|
Query
|
ncpill |
Integer |
|
Recommended |
Non-compliance - Pill count |
0;1
|
0=No; 1=Yes
|
|
Query
|
schprb |
Integer |
|
Recommended |
Subject has scheduling problems |
0;1
|
0=No; 1=Yes
|
|
Query
|
lengass |
Integer |
|
Recommended |
Subject has problems with length of assessment |
0;1
|
0=No; 1=Yes
|
|
Query
|
moved |
Integer |
|
Recommended |
Patient has moved away |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
personn |
Integer |
|
Recommended |
Subject doesn't like research staff |
0;1
|
0=No; 1=Yes
|
|
Query
|
nrespd |
Integer |
|
Recommended |
Subject is a non-responder |
0;1
|
0=No; 1=Yes
|
|
Query
|
ieeval |
Integer |
|
Recommended |
Subject agreed to IE evaluation? |
0;1
|
0=No; 1=Yes
|
|
Query
|
nc3ses |
Integer |
|
Recommended |
Subject missed 3 sessions without rescheduling |
0;1
|
0=No; 1=Yes
|
|
Query
|
aescode |
Integer |
|
Recommended |
Staff code number of person completing this form |
|
999= Missing Data
|
|
Query
|
ctf_1 |
Integer |
|
Recommended |
Subject received extension phase packet |
0;1
|
0=No; 1=Yes
|
|
Query
|
compprot |
Integer |
|
Recommended |
Completed treatment protocol |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
violate |
Integer |
|
Recommended |
Protocol Violation |
0;1
|
0=No; 1-Yes
|
|
Query
|
hardcode |
String |
1,200
|
Recommended |
Significant Protocol Violation |
|
Textual description of the protocol violation
|
|
Query
|
stdor3_s |
String |
100
|
Recommended |
Stage V: Dropout-consent withdrawn, sp. |
|
|
|
Query
|
termin_day |
Integer |
|
Recommended |
Days since baseline that clinic officially terminated the subject |
|
|
|
Query
|
ae |
String |
4,000
|
Recommended |
Adverse event Description |
|
|
|
|
study_status |
Integer |
|
Recommended |
What is the participant''s study status? Select the option that is the last appointment the participant completed. |
1::13
|
1 = Completed all follow-ups; 2 = Completed baseline appointment; 3 = Completed session 1; 4 = Completed session 2; 5 = Completed extra session 1; 6 = Completed extra session 2; 7 = Completed session 3; 8 = Completed session 4; 9 = Completed session 5; 10 = Completed post-assessment; 11 = Completed one-month follow-up; 12 = Completed three-month follow-up; 13 = Did not collect data
|
|