|
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 |
|
|
SUBJECT, bid, id, randid, record_id, rsubjid, subject_id |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
RVDATE, date_of_interview_contact, intvdate |
|
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, dema1, intvage |
|
sex |
String |
20
|
Required |
Sex of subject at birth |
|
M = Male; F = Female; O=Other; NR = Not reported
|
dema2, gender, sex |
Query
|
aescode |
Integer |
|
Recommended |
Staff code number of person completing this form |
|
999= Missing Data
|
RDMCODE, interviewer_code |
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
int1, redcap_event_name |
Query
|
bafinfo |
Integer |
|
Recommended |
Check if the Assessment was not done. |
0::2
|
0=No; 1=Yes; 2=Unverified
|
RDMINFO |
Query
|
mtinc |
Integer |
|
Recommended |
Does the subject continue to meet the inclusion exclusion criteria? |
0;1; -9
|
0=No; 1=Yes; -9=unknown
|
ran001 |
Query
|
elrdm |
Integer |
|
Recommended |
Is the subject eligible for randomization? |
|
|
rdma3 |
|
rdmdate |
Date |
|
Recommended |
Date of Randomization |
|
|
ran003, rand_local_date |
|
prjdate6 |
Date |
|
Recommended |
6 week projection date |
|
|
|
|
prjdate12 |
Date |
|
Recommended |
12 week projection date |
|
|
|
Query
|
hlocondition |
Integer |
|
Recommended |
What condition is the patient randomized to? |
0;1
|
0=Control; 1=Posit Science
|
CONDITION |
Query
|
nrdmrsn |
Integer |
|
Recommended |
Primary reason not randomized |
0::5
|
1=Failed to meet inclusion criteria; 2=Withdrew consent; 3=Medical reason (AE, illness, etc); 4=Non-compliance with protocol treatment; 5=Subject requires prohibited medication; 0=Other
|
ran005 |
|
nrdmspc |
String |
500
|
Recommended |
Specify other reason not randomized |
|
|
ran006 |
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
siteid |
Query
|
ran001a |
Integer |
|
Recommended |
Was this subject a re-screen? |
0;1
|
0=No; 1=Yes
|
|
Query
|
ran001b |
Integer |
|
Recommended |
Were all re-screen assessments performed? |
0;1
|
0=No; 1=Yes
|
|
Query
|
ran002 |
Integer |
|
Recommended |
Was the subject randomized? |
0::3; -9
|
0=No; 1=Yes; -9=unknown; 2=No meds; 3=No community care
|
ran_q1b |
|
ran004 |
String |
10
|
Recommended |
Randomization number/coding |
|
|
cohort |
Query
|
visitid |
Integer |
|
Recommended |
MetaTrial Visit ID |
|
System variable: unique code for each type of visit -use to merge files
|
|
Query
|
fseqno |
Integer |
|
Recommended |
Sequence Number |
0::999
|
The FSEQNO variable in the ADJ form has a special interpretation compared to other forms.
For example, ADJ FSEQNO of '1' can be thought of as being '001', FSEQNO of '2' can be thought of as
being '002', and FSEQNO of '3' can be thought of as being '003'.
The first digit of FSEQNO relates to the corresponding ENF sequence number at that visit and the third
digit relates to the specific adjudicator who completed the adjudication form.
|
|
Query
|
rdma1 |
Integer |
|
Recommended |
Does the patient still give consent to participate in the study? |
0;1
|
0=No; 1=Yes
|
|
Query
|
rdma2 |
Integer |
|
Recommended |
Is the patient still considered eligible for study participation? |
0;1
|
0=No; 1=Yes
|
|
Query
|
rdma4 |
Integer |
|
Recommended |
Do you want to randomize this patient? |
0;1
|
0=No; 1=Yes
|
|
Query
|
rdma6 |
Integer |
|
Recommended |
Do you need a bottle code for the oral trial? |
0;1
|
0=No; 1=Yes
|
|
Query
|
version |
String |
20
|
Recommended |
Version/code of assessment |
|
|
|
Query
|
visday |
Integer |
|
Recommended |
Number of days from study baseline to date of visit |
|
|
|
|
version_form |
String |
121
|
Recommended |
Form used/assessment name |
|
|
|
Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
date, visitdt |
|
study |
String |
100
|
Recommended |
Study; The code for each individual study |
|
|
studyid |
Query
|
completed |
Integer |
|
Recommended |
Checks if completed |
0::3
|
0=No; 1=Yes; 2=Yes, lost; 3=Unverified
|
formcomp |
Query
|
subtrial_name |
Integer |
|
Recommended |
Name of subtrial |
1::3
|
1=Crossover; 2=Guanfacine; 3= Open Label MPH
|
|
Query
|
ran_q1 |
Integer |
|
Recommended |
Tolerate 4 lowest Doses |
0;1
|
0=No; 1=Yes
|
|
Query
|
ran_q1a |
Integer |
|
Recommended |
Tolerate highest dose |
0;1
|
0=No; 1=Yes
|
|
Query
|
ran_q4 |
Integer |
|
Recommended |
Primary reason not randomized |
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; 8 = Subject no longer eligible to participate; 9 = School unable/no longer willing to participate; 10 = Other
|
|
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
|
ranq5 |
Integer |
|
Recommended |
Reason not randomized |
1::7;-9
|
1=Failed to meet inclusion or exclusion criteria; 2=Declined study participation/Withdrew consent; 3=Failed to return to clinic; 4=Moved from area; 5=Incarceration; 6=Death; 7=Other; -9=Unknown
|
|
Query
|
arm |
Integer |
|
Recommended |
Assigned Randomization Arm |
1::3
|
1=Escitalopram plus Orange capsule-Lexapro; 2=Bupropion-SR plus Blue capsule-Wellbutrin; 3=Venlafaxine XR plus Green capsule-Effexor
|
|
Query
|
vis_type |
Integer |
|
Recommended |
Visit type |
0::2
|
1=Phone/remote; 0=doctor's office/In person; 2=No, not phone interview
|
phone |
Query
|
ran004a |
Integer |
|
Recommended |
Treatment Group |
1;2;-9
|
1=start treatment with ketamine; 2= start treatment with saline; -9 =unknown
|
q4a |
|
inelgs |
String |
250
|
Recommended |
Ineligible reason |
|
|
rdma2a |
Query
|
iec16 |
Integer |
|
Recommended |
Eligibility status |
1::3
|
1=Eligible; 2= Ineligible; 3=Pending
|
rdma3a |
Query
|
iec003a |
Integer |
|
Recommended |
Is the subject eligible to participate in the study? |
|
0=No; 1=Yes; -9=Unknown
|
rndqual |
|
trtarm |
String |
200
|
Recommended |
Treatment arm |
|
|
treatment |
|
datetime |
String |
25
|
Recommended |
Date on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYY and __:__ |
|
|
sitedtm |
Query
|
resubmit |
Integer |
|
Recommended |
Randomization error- resubmit |
|
0=No; 1=Yes; -9=Unknown
|
|
Query
|
ad_exc11 |
Integer |
|
Recommended |
Current use of antidepressants or anticonvulsants |
0;1
|
0=No; 1=Yes
|
|
|
treatment_name |
String |
200
|
Recommended |
treatment name |
|
|
|
Query
|
randomization |
Integer |
|
Recommended |
Randomization Field |
2;3
|
2=Blue; 3=White
|
|
Query
|
ca6_1 |
Integer |
|
Recommended |
Chronic depression |
0;1
|
0=No; 1=Yes
|
|
Query
|
bdi_stw |
Integer |
|
Recommended |
Suicidal thoughts or wishes |
0;1;2;3;-7; -9
|
0=I don't have any thoughts of killing myself; 1= I have thoughts of killing myself, but I would not carry them out; 2=I would like to kill myself; 3=I would kill myself if I had the chance"; -7=Refused; -9=incomplete
|
|
|
psmd1 |
String |
250
|
Recommended |
Psych med code 1 |
|
|
|
|
refothers |
String |
50
|
Recommended |
Referral source: specify |
|
|
|
Query
|
med_group |
Integer |
|
Recommended |
Randomly Assigned Medication Group |
0;1
|
(0=Changed to Second SSRI, 1=Changed to VENLAFAXINE)
|
|
Query
|
cbt_group |
Integer |
|
Recommended |
Randomly Assigned to Clinical Behavior Therapy? |
0;1
|
(0=No, 1=Yes)
|
|
|
ssricat |
String |
50
|
Recommended |
Randomly Assigned SSRI |
|
|
|
|
cameon |
String |
50
|
Recommended |
Current SSRI |
|
|
|
Query
|
noparox |
Integer |
|
Recommended |
Constrain paroxetine? |
1
|
1 = YES for all patients; YES for all patients became active when study stopped using paroxetine.
|
|
Query
|
refflu |
Integer |
|
Recommended |
Did patient refuse fluoxetine?(Prozac) |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
refcit |
Integer |
|
Recommended |
Did patient refuse citalopram?(Celexa) |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
refpar |
Integer |
|
Recommended |
Did patient refuse paroxetine? |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
comanx |
Integer |
|
Recommended |
COMORBID ANXIETY |
0;1
|
0=No; 1=Yes
|
|
Query
|
rnd_5 |
Integer |
|
Recommended |
Randomized provider number |
|
|
|
Query
|
lithever |
Integer |
|
Recommended |
ever taken lithium |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
week |
Float |
|
Recommended |
Week in level/study |
|
99=week 10-week 14
|
|
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
|
iecsig |
Integer |
|
Recommended |
Investigator signature on form. |
0;1
|
0=No; 1= Yes
|
|
|
lab020 |
Date |
|
Recommended |
Date of PI/clinician signature |
|
|
|
Query
|
sigd1 |
Integer |
|
Recommended |
Physician/PI signature date (days since randomization) |
|
|
|
|
general_2 |
String |
4,000
|
Recommended |
How have you been since I last saw you? |
|
|
|
|
general_3 |
String |
4,000
|
Recommended |
Do you have any specific worries or complaints about your health in general? |
|
|
|
|
general_4a |
Integer |
|
Recommended |
Have you missed taking any of your trial medicines? |
|
0=No; 1=Yes
|
|
|
general_4b |
Float |
|
Recommended |
Have you missed taking any of your trial medicines? If yes, how many days? |
|
2 decimal place
|
|
|
general_4c |
String |
4,000
|
Recommended |
Have you missed taking any of your trial medicines? Any why? |
|
|
|
|
general_5 |
String |
4,000
|
Recommended |
Have you had any problems relating to the trial capsules? |
|
|
|
|
general_6 |
String |
4,000
|
Recommended |
Do you have any other problems or worries in relation to the trial? |
|
|
|
|
comments_misc |
String |
4,000
|
Recommended |
Miscellaneous comments on study, interview, methodology relevant to this form data |
|
|
clinician_notes |
|
rand_treat |
String |
20
|
Recommended |
Randomized treatment |
|
MST;ECT
|
|
|
rand_call_date |
Date |
|
Recommended |
Date of telephone call |
|
|
|