|
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 |
|
|
CATIEID, bid, case_id, id, randid, record_id, stepid, subject_id |
|
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.
|
bslage, intvage |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
eosdt, intvdate, subsum_doa |
|
sex |
String |
20
|
Required |
Sex of subject at birth |
M;F; O; NR
|
M = Male; F = Female; O=Other; NR = Not reported
|
gender |
Query
|
visitid |
Integer |
|
Recommended |
MetaTrial Visit ID |
|
System variable: unique code for each type of visit -use to merge files
|
|
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
vtypdhs |
Query
|
truncvis |
Integer |
|
Recommended |
Truncated Visit Number |
|
Created variable: provides a numeric visit number for all visits, including unscheduled and end of phase
|
|
Query
|
phase_ct |
String |
20
|
Recommended |
Current Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase. |
Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase; Screening; Phase 1
|
|
|
Query
|
visday |
Integer |
|
Recommended |
Number of days from study baseline to date of visit |
|
|
date |
|
protocol |
String |
50
|
Recommended |
Protocol [Study] name |
|
|
|
Query
|
eos1 |
Integer |
|
Recommended |
Did the patient complete the medication portion |
0;1
|
0=No; 1=Yes
|
|
Query
|
eos1a |
Integer |
|
Recommended |
Day of study completion |
|
Number of days from study baseline to date of study completion
|
eos01a |
Query
|
eos1b |
Integer |
|
Recommended |
Day of medication withdrawal |
|
Number of days from study baseline to date of medication withdrawal
|
eos01b |
Query
|
eos2 |
String |
20
|
Recommended |
Patient's final medication phase? |
Phase 1 or 1a; Phase 1b; Phase 2; Phase 3; Open-choice
|
|
eos02 |
Query
|
eos3 |
Integer |
|
Recommended |
Indicate who initiated the discontinuation |
1::4
|
1=Investigator; 2=Patient; 3=Subject advocate; 4=caregiver
|
eos03 |
Query
|
eos4 |
Integer |
|
Recommended |
Primary reason for withdrawal |
1::19
|
1=Administrative reason, specify; 2=Patient refused to continue to next phase; 3=Adverse event precluding further study phase; 4=Other reason; 5=Caregiver/legal authorized representative; 6=Patient Death; 11= Completed; 12= Adverse Event-Subject Decision; 13= Adverse Event-Physician Decision; 14= Perceived Lack of Efficacy-Subject Decision; 15= Perceived Lack of Efficacy-Physician Decision; 16= Screen Fail / Did not Randomize; 17= Protocol Violation; 19= Subject is Moving or Has Moved
|
eos04 |
Query
|
eos5 |
Integer |
|
Recommended |
Investigator has signed end of study |
1; 0
|
1=yes; 0=no
|
eos05 |
Query
|
eos6 |
Integer |
|
Recommended |
Is the patient proceeding to the follow up phase? |
0;1
|
0=No; 1=Yes
|
|
Query
|
eos7 |
Integer |
|
Recommended |
Did the patient sign the follow up Informed Consnt? |
0::2
|
0=No; 1=Yes; 2=unable to contact
|
fuconsnt |
Query
|
eos8 |
Integer |
|
Recommended |
Day follow up Informed Consent was signed? |
|
Number of days from study baseline to date follow up informed consent was signed
|
consdate |
|
level |
String |
10
|
Recommended |
Treatment level |
|
|
|
Query
|
week |
Float |
|
Recommended |
Week in level/study |
|
99=week 10-week 14
|
|
|
crcid |
String |
40
|
Recommended |
CRC ID/ROA ID |
|
|
|
Query
|
update |
Integer |
|
Recommended |
Updated form |
0;1
|
1= yes; 0= no
|
|
Query
|
etlck |
Integer |
|
Recommended |
Lack of efficacy |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
eteff |
Integer |
|
Recommended |
Unacceptable side effects |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
etcmats |
Integer |
|
Recommended |
Committed/ suicide attempt |
0;1; -9
|
0=Not checked; 1=Checked; -9 =Unknown
|
|
Query
|
etmscdn |
Integer |
|
Recommended |
Generalized condition req prtcl stop |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
etdsym |
Integer |
|
Recommended |
Symptoms req nonprotocol treatment |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
etfret |
Integer |
|
Recommended |
Failed to return to clinic |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
etmvd |
Integer |
|
Recommended |
Moved from the area |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
etnapro |
Integer |
|
Recommended |
Non-adherence to study proc. |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
etnamed |
Integer |
|
Recommended |
Non-adherence to study medication |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
etrebur |
Integer |
|
Recommended |
Found research too burdensome |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
etwcnr |
Integer |
|
Recommended |
Patient withdrew with no reason |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
etpreg |
Integer |
|
Recommended |
Patient became pregnant |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
etnorandgen |
Integer |
|
Recommended |
Could not randomize due to gen. med cond. |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
etnorandmed |
Integer |
|
Recommended |
Could not randomize, PT is on concomitant med |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
duedate |
String |
30
|
Recommended |
Due date |
|
|
|
Query
|
dayscons |
Integer |
|
Recommended |
days since consent |
|
|
|
Query
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
site_no |
Query
|
certcode |
Integer |
|
Recommended |
stepbd certification code |
|
|
|
Query
|
pcsf |
Integer |
|
Recommended |
pcos screening form completed |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pcec |
Integer |
|
Recommended |
pcos eligibility completed |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pcexm |
Integer |
|
Recommended |
pcos exam form completed |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pcmhq |
Integer |
|
Recommended |
pcos menstrual hist completed |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
bloodsmp |
Integer |
|
Recommended |
blood samples collected |
0::4;-7
|
1 = Yes; 0 = No/Participant unable to complete; 2 = Not applicable; 3 = Participant refused; 4 = Not collected (other)
|
|
Query
|
bloodsuf |
Integer |
|
Recommended |
blood samples sufficient |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
ultsndcn |
Integer |
|
Recommended |
consented to ultrasound |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pcurf |
Integer |
|
Recommended |
pcos ultrasound form completed |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pccur |
Integer |
|
Recommended |
pcos central ultsnd completed |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pcosunab |
Integer |
|
Recommended |
pcos pt unable comp req assmts |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pcosnoas |
Integer |
|
Recommended |
pcos pt not return assessments |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pcosnoat |
Integer |
|
Recommended |
pcos pt did not attend eval |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pcoshosp |
Integer |
|
Recommended |
patient hospitalized |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pcosnocm |
Integer |
|
Recommended |
pcos assmts not compl in 6mo |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pcosothr |
Integer |
|
Recommended |
pcos missed other reason |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
rinact |
Integer |
|
Recommended |
reason for inactivation |
1::9
|
1=Death; 2=Too sick/unstable; 3=Relocated; 4=Untraceable; 5=Drop out; 6=Incomplete study entry; 7=Ineligible, specify; 8=Other, specify; 9=Completed 24 month follow up
|
|
Query
|
suicide |
Integer |
|
Recommended |
Was the death because of a suicide? |
0;1; 999
|
0 = No; 1 = Yes; 999 = Legitimately Skipped
|
dsuicide |
Query
|
inactcon |
Integer |
|
Recommended |
inact days since consent |
|
|
|
Query
|
lifedx1 |
String |
50
|
Recommended |
Lifetime diagnosis 1 |
|
|
|
Query
|
lifedxsp |
String |
50
|
Recommended |
Lifetime diagnosis specify |
|
|
|
Query
|
trt_grp |
String |
10
|
Recommended |
Treatment Group Assignment |
1;1AO;1CT;2; 3;4;5;6;7;8;9;10;11;12; O; P; CCA; GCT; TCT; TAU; CGC; ESDM; NA; EG
|
1=Group 1 first 8 weeks; 2=Group 2; 3=Group 3; 4 =active; 5=sham; 6=none; 7=ESDM High intensity; 8=ESDM Low intensity; 9=EIBI High intensity; 10=EIBI Low intensity; ESDM = Early Start Denver Model; EIBI = Early and Intensive Behavioral Intervention; 11 = Navigator; 12 = Care manager; 13=Waitlist Control; 14=Treatment; 1AO=Group 1 8 week add on; 1CT=Group 1 8 week cross taper; O=Oxytocin; P=Placebo; CCA=Community Control Arm; GCT=Generalized Cognitive Training; TCT=Targeted Cognitive Training; TAU=Treatment as Usual; CGC = Computer Games Control; NA=not assigned to treatment group; EG= Experimental Group
|
|
Query
|
days_baseline |
Integer |
|
Recommended |
Days since baseline |
|
|
bsldays |
Query
|
etype |
String |
10
|
Recommended |
Rating Period |
BSL;WK1;WK2;WK3;WK4;WK5;WK6;WK7;WK8;WK9;WK10;WK11;WK12;WK13;WK14;WK15;WK16
|
BSL=Baseline; WK1-WK16=Weeks 1-16
|
|
Query
|
respond_detail_oth_spec |
String |
255
|
Recommended |
Respondent details |
|
|
informnt |
Query
|
relationship |
Integer |
|
Recommended |
Relationship of respondent to individual |
|
1 = Biological mom; 2 = Biological dad; 3 = Grandparent; 4 = Special education (sped) teacher; 5 = General education teacher; 6 = Occupational therapist; 7 = Speech and language therapist; 8 = Behavioral therapist; 9 = Paraprofessional; 10 = Aide; 11 = Principal; 12 = Administrator; 14 = Content teacher; 15 = Parent center director; 16 = Self; 17=Adoptive mother; 18=Adoptive father; 19=Foster mother; 20 = Foster father; 21=Grandmother; 22=Grandfather; 23=Step-mother; 24 = Step-father; 25=Aunt; 26=Uncle; 28=Both parents;31= Grandmother from mother side; 32= Grandfather from mother side; 33= Grandmother from father side; 34= Grandfather from father side; 36= Brother; 37= Sister; 38= Cousin; 39= female caregiver; 40=male caregiver; 41=Female child; 42=Male child; 43=Spouse/Mate; 44=Friend; 45=Parent; 46=Significant other; 47=Sibling; 48=Son/Daughter; 49=Son-in-law/Daughter-in law; 50=Other Relative; 51=Paid caregiver; 52=Friends; 53=Roommate; 54=Supervisor; 55=mother's boyfriend; 56=other parental figure; 57=Summary; 58=counselor ; 59 = other female relative; 60 = other male relative; 61 = non-relative ; 62=Maternal Aunt; 63=Maternal Uncle; 64=Maternal Cousin; 65 = Paternal Aunt; 66=Paternal Uncle; 67=Paternal Cousin ; 68=Biological/Adoptive Mother and Grandmother; 69=Biological/Adoptive Mother and Stepmother and Grandmother; 70=Biological/Adoptive Mother and Grandmother and Foster Father; 71=Biological/Adoptive Mother and Stepmother and Foster Mother; 72=Biological/Adoptive Mother and Foster Mother; 73=Biological/Adoptive Mother and Biological/Adoptive Father; 74=Biological/Adoptive Mother and Stepmother and Biological/Adoptive Father; 75=Biological/Adoptive Mother and Other; 76=Biological/Adoptive Mother and Stepmother and Stepfather; 77=Biological/Adoptive Mother and Stepfather; 78=Biological/Adoptive Mother and Grandfather; 79=Biological/Adoptive Mother and Stepmother and Foster Father; 80=Biological/Adoptive Mother and Stepmother; 81=Guardian, female; 82=Other female; 83=Guardian, male; 84=Other male; 85=Other/Grandparent/Nanny; 86 = Mother, Father, Guardian; 87 = Daughter, son, grandchild; 88 = Professional (e.g., social worker, nurse, therapist, psychiatrist, or group home staff); -999=Missing; 89 = Biological parent; 90=Other; 91 = Stepparent; 92 = Adoptive parent; 93 = Foster parent; 94 = Co-worker
|
infrmnt2 |
Query
|
esfref |
Integer |
|
Recommended |
Referral for clinical care given |
0::2
|
0=N/A; 1=no; 2=yes
|
|
Query
|
esfltr |
Integer |
|
Recommended |
End of study letter sent |
0::2
|
0=N/A; 1=no; 2=yes
|
|
Query
|
cmp001 |
Integer |
|
Recommended |
Did the subject complete the study? |
|
0=No; 1=Yes
|
eoscomp, subsum_all_complete |
Query
|
cmp003 |
Integer |
|
Recommended |
Reason for early termination (Use codes below. Select one, then describe in Q4.) |
|
1=Withdrew consent; 2=Medical reason (AE, abnormal lab, intercurrent illness, etc.); 3=Disease progression; 4=Non-compliance with protocol or treatment; 5=Subject requires prohibited medication; 6=Termination of study by sponsor; 7=Subject terminated at discretion of the investigator or sponsor; 8=Other; 9=Death; 10=Protocol violation; 11=Lost to follow up; 12=CGI-I>5; 13=Screen Failure; 15=Other; -9=Unknown; 14=Non compliance with study drug; 16=Dissatisfied with treatment setting; 17=Experiencing unsatisfactory side effects; 18 = Subject ineligible; 19= Study too burdensome; 20= Dissatisfied with clinical response to treatment; 21= Unable to follow procedures, visit schedule, etc.; 22=Significant adverse event; 23=Participant uncooperative; 24 = Participant request; 25=Provider/Family request; 26=Did not continue to meet study criteria
|
eosreas |
|
cmp004 |
String |
500
|
Recommended |
Describe reason for early termination |
|
|
eosother |
Query
|
eff_fail |
Integer |
|
Recommended |
Efficacy Failure based on 3 Criteria (psychiatric hospitalization, deterioration on CGI scale, PANSS change PANSS_C) |
0;1
|
0=No; 1=Yes
|
|
Query
|
iefffail |
Integer |
|
Recommended |
Subject Indicator for efficacy failure (3 criteria) |
0;1
|
0=Otherwise; 1=Subject had efficacy failure (4 criteria) at least once
|
|
Query
|
time2 |
Integer |
|
Recommended |
Time Trial 2 |
0 :: 999
|
|
|
Query
|
efffail2 |
Integer |
|
Recommended |
Efficacy Failure based on 4 Criteria (psychiatric hospitalization, deterioration on CGI scale, PANSS change PANSS_C,
or RTDA3 value of '01=positive symptoms', '02= Negative symptoms', '03 = mood symptoms', '04= other efficacy/inadequate therapeutic effect |
0;1
|
0=No; 1=Yes
|
|
Query
|
ieffail2 |
Integer |
|
Recommended |
Subject Indicator for efficacy failure (4 criteria) |
0;1
|
0=Otherwise; 1=Subject had efficacy failure (4 criteria) at least once
|
|
Query
|
time_ef2 |
Integer |
|
Recommended |
Time To Efficacy Failure (4 criteria), In Days |
0::260
|
|
|
Query
|
site_p |
String |
5
|
Recommended |
Pseudo Site: Pooled According To Size |
|
|
|
Query
|
site_pp |
String |
5
|
Recommended |
Pseudo Site: Pooled According to Size and Ethnicity |
pp1;pp2;pp3;pp4;pp5;pp6
|
|
|
Query
|
itt |
Integer |
|
Recommended |
Intent-To-Treat Population |
0;1
|
0=Not in Intent-to-treat population; 1=In intent-to-treat population
|
|
Query
|
ee |
Integer |
|
Recommended |
Efficacy Evaluable Population |
0;1
|
0=Not in Efficacy Evaluable population; 1=In Efficacy Evaluable population
|
|
Query
|
pp |
Integer |
|
Recommended |
Per Protocol Population |
0;1
|
0=Not in Per Protocol population; 1=In Per Protocol population
|
|
Query
|
version_form |
String |
121
|
Recommended |
Form used/assessment name |
|
|
vers |
Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
days |
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
|
phase |
Integer |
|
Recommended |
Phase |
|
9 =follow up
|
|
Query
|
enddy_2 |
Integer |
|
Recommended |
Number of days from study baseline to end date of phase 2 |
|
|
fupdate |
Query
|
eos01 |
Integer |
|
Recommended |
Did the patient
complete the study? (e.g.:attended all visits up to week 36) |
0;1
|
0=No; 1=Yes
|
fhx10a |
Query
|
eos06 |
Integer |
|
Recommended |
Day Signed |
|
Number of days from study baseline to date of signed End of Study form
|
fhx10b |
Query
|
eos04d |
Integer |
|
Recommended |
Day of patient death: |
|
Number of days from study baseline to date of death
|
|
Query
|
completed |
Integer |
|
Recommended |
Checks if completed |
0::3
|
0=No; 1=Yes; 2=Yes, lost; 3=Unverified
|
|
|
tcdate |
Date |
|
Recommended |
Date of study treatment completion |
|
|
cmp002 |
Query
|
possvisit |
Integer |
|
Recommended |
Possible number of visits |
|
|
|
Query
|
trtexcod |
Integer |
|
Recommended |
Treatment Exit Code |
1;2;3;4;5;6;7;8;9;10;11;12;13
|
1=End of Study � Completed ALL Months of Study Treatment; 2=Patient decision � Lack of Efficacy; 3=Patient decision � Side Effects; 4=Patient decision � Refusal of Study Treatment � Part of Illness; 5=Patient decision � Refusal of Study Treatment � No Further Reason; 6=Patient decision � Wants Different Treatment or Treatment Elsewhere; 7=Unwilling/Unable to Comply with Study Treatment Demands; 8=Doctor decision � Lack of Efficacy; 9=Doctor decision � Side Effects; 10=Intervening Illness or Treatment; 11=Moved or Other Administrative Reason; 12=Lost to Follow-Up � No Further Reason; 13=Deceased
|
|
Query
|
trtexday |
Integer |
|
Recommended |
Treatment Exit Days from Visit 1 |
|
|
|
Query
|
stexcod |
Integer |
|
Recommended |
Study Exit Code |
21;22;23;24;25;26;27
|
21=End of Study � Completed ALL Months of Assessment; 22=Lost to Follow-Up; 23=Patient Refused to Continue in Treatment and Study; 24=Patient Refused to Continue in Study; 25=Intervening Illness Interferes w/ Continuing; 26=Moved or Other Administrative; 27=Deceased
|
|
Query
|
stexday |
Integer |
|
Recommended |
Study Exit Days from Visit 1 |
|
|
|
Query
|
intrt |
Integer |
|
Recommended |
Treatment Status Code |
0::2
|
0=Baseline; 1=In Treatment; 2=In Follow-up
|
|
Query
|
trtgrp_p |
Integer |
|
Recommended |
Treatment Group |
1;2
|
1=Long-Acting Injectable Risperidone Microspheres; 2=Second Generation Oral Antipsychotic Medication
|
|
Query
|
days_visit1 |
Integer |
|
Recommended |
Days from Visit 1 |
|
|
dav1dhs |
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
|
|
|
dthdate |
String |
30
|
Recommended |
Date of death |
|
|
eosdthdt |
|
lstalvdt |
Date |
|
Recommended |
Date subject was last known to be alive |
|
|
eosalvdt |
Query
|
aef001 |
Integer |
|
Recommended |
Adverse Event number |
|
-9=unknown
|
eosaeref |
|
icfwddt |
Date |
|
Recommended |
Date subject withdrew consent |
|
|
eoswthdt |
Query
|
eosunbl |
String |
2
|
Recommended |
Was the subjects treatment assignment unblinded? |
Y;N
|
Y=Yes; N=No
|
|
|
eosrunbl |
String |
200
|
Recommended |
Reason for unblinding |
|
|
|
Query
|
subsum_mri |
Integer |
|
Recommended |
Did the participant have the MRI scan indicated in the protocol? |
0;1
|
0=No; 1=Yes
|
|
Query
|
subsum_socog_test |
Integer |
|
Recommended |
Did the participant have the social cognition and neuropsychological assessments completed as indicated in the protocol? |
0;1
|
0=No; 1=Yes
|
|
Query
|
ayen |
Integer |
|
Recommended |
Has the subject had any adverse events during this study? |
0;1;-9
|
0 = No; 1 = Yes; -9 = Did not inquire
|
subsum_any_ae |
Query
|
ae |
String |
4,000
|
Recommended |
Adverse event Description |
|
|
subsum_ae_notes |
|
comments |
String |
4,000
|
Recommended |
Comments about assessment |
|
|
subsum_notes |
|
doa_futdt |
String |
20
|
Recommended |
Future date entered (Assessment) |
|
|
|
|
dode |
String |
10
|
Recommended |
Date of Data Entry |
|
|
subsum_dode |
|
dode_futdt |
String |
20
|
Recommended |
Future date entered (Data Entry) |
|
|
subsum_dode_futdt |
Query
|
form_completed |
Integer |
|
Recommended |
Was the form completed? |
1::4
|
1=Yes; 2=No; 3=Unverified; 4 = N/A-Not in age range
|
subsum_form_completed |
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
|
subsum_explain |
|
other_reason_nc |
String |
100
|
Recommended |
Other reason form was not completed |
|
|
subsum_other_reason_nc |
Query
|
assessment_complete |
Integer |
|
Recommended |
Complete? |
0::2
|
0=Incomplete; 1=Unverified; 2=Complete
|
participant_checklist_complete |
Query
|
stdor7 |
Integer |
|
Recommended |
Dropout-other reason |
1;0
|
1 = Yes; 0=No
|
|
Query
|
stdor7_s |
String |
255
|
Recommended |
Stage V: Dropout-other reason, spec. |
|
|
|
|
stdor3_s |
String |
100
|
Recommended |
Stage V: Dropout-consent withdrawn, sp. |
|
|
|
Query
|
stdor3 |
Integer |
|
Recommended |
Dropout-consent withdrawn |
1;0
|
1 = Yes; 0-No
|
|
Query
|
termin_day |
Integer |
|
Recommended |
Days since baseline that clinic officially terminated the subject |
|
|
|
Query
|
eterm_03 |
Integer |
|
Recommended |
Lost to follow up |
0;1
|
0=No; 1=Yes
|
|
Query
|
aescode |
Integer |
|
Recommended |
Staff code number of person completing this form |
|
999= Missing Data
|
|
Query
|
hardcode |
String |
1,200
|
Recommended |
Significant Protocol Violation |
|
Textual description of the protocol violation
|
|
Query
|
cmp004_screen |
Integer |
|
Recommended |
Was the subject a screen failure |
0;1
|
0=No; 1=Yes
|
|
Query
|
failreas |
Integer |
|
Recommended |
Reason for Screen Failure |
1::16
|
1=Patient did not want to change current typical antipsychitic med; 2 = Patient did not want to change current atypical antipsychitic med; 3 = Patient did not meet inclusion or exclusion criteria; 4 = Patient not able to make informed consent; 5 = Patient refusal - other reason; 6 = Other; 7=NA; 8=Did not meet diagnostic criteria; 9= Clinical or unstable medical disorder; 10= Moderate or severe substance use;11 =Pregnant, breastfeeding or planning on becoming pregnant; 12=Currently taking broccoli supplement; 13 = Substance- or medically-induced mood symptoms; 14 = Celiac disease; 15 = Receipt of ECT within 30 days prior to Visit 1/Baseline; 16 = Participation in any drug trial in the 30 days prior to Visit 1/Baseline
|
|
|
cmp005_desc |
String |
100
|
Recommended |
Other reason for screen failure |
|
|
|
|
cmp005_date |
Date |
|
Recommended |
Date of screen failure |
|
|
|
Query
|
cmp003_date |
String |
30
|
Recommended |
Date of early withdrawal |
|
|
|
|
cmp003_time |
String |
25
|
Recommended |
The participant was withdrawn prematurely from the study closest to |
|
visit/week
|
|
Query
|
cmp006_et |
Integer |
|
Recommended |
Did the subject complete an Early Termination Visit |
0;1
|
0=No; 1=Yes
|
|
|
cmp006_date |
Date |
|
Recommended |
Date of Early Termination Visit |
|
|
|
Query
|
phasescompleted |
String |
15
|
Recommended |
Phase completed |
|
|
|
Query
|
lastvisit |
Integer |
|
Recommended |
This variable indicates whether the assessment was the last for the subject. For the acute phase, this is generally at week 12, but the last weekly visit will vary for early terminators. |
0;1
|
0 = no; 1 = yes
|
|
Query
|
term_consent_withdraw |
String |
200
|
Recommended |
Participant Withdrew Consent - Please Specify |
|
|
|
Query
|
reason_for_rejection |
String |
250
|
Recommended |
Please, specify reason for rejection or disapproval: |
|
|
|
Query
|
ptaef |
Integer |
|
Recommended |
AEF Completed? |
0;1
|
(Yes=1; No=0)
|
|
Query
|
trmssrsn |
String |
250
|
Recommended |
Termination of participation by sponsor Reason |
|
|
|
Query
|
iecsig |
Integer |
|
Recommended |
Investigator signature on form. |
0;1
|
0=No; 1= Yes
|
|
Query
|
sigd1 |
Integer |
|
Recommended |
Physician/PI signature date (days since randomization) |
|
|
|
Query
|
enroll_not |
Integer |
|
Recommended |
Reason for not being in study |
1::7
|
1= Not eligible;2= Not interested;3= Withdrawn -- Participant choice;4= Withdrawn -- Investigator choice;5= Withdrawn -- Lost to follow-up;6= Death; 7 = Withdrawn -- Patient/Family choice
|
|
Query
|
phase_1 |
Integer |
|
Recommended |
scp rcp phase 1 |
1::6;-7
|
1=Acute; 2=Continuation; 3=Maintenance; 4=Termination; 5 = Extension; 6 = Discontinuation/Tapering -7=Refused
|
|
Query
|
argcont |
Integer |
|
Recommended |
Has the subject agreed to continue to come in for scheduled visits even thought he/she is no longer following the study protocol? |
0;1
|
0 = No; 1 = Yes
|
|
|
ptdrief1 |
String |
400
|
Recommended |
How do you think the treatment sessions worked? |
|
|
|
Query
|
ptdrief2 |
Integer |
|
Recommended |
During treatment sessions, did you notice a pattern of when the music would start and stop? |
0;1
|
0 = No; 1 = Yes
|
|
|
tms7 |
String |
20
|
Recommended |
If yes, session 2 start time |
|
|
|
|
tms16 |
String |
20
|
Recommended |
If yes, session 2 end time |
|
|
|
|
tms14 |
String |
20
|
Recommended |
Start time of MRI (after session 2) |
|
|
|
|
tms9 |
Integer |
|
Recommended |
Was session 3 completed? |
|
1 = yes, 0=no
|
|
|
tms10 |
Date |
|
Recommended |
If yes, session 3 date |
|
|
|
|
tms11 |
String |
20
|
Recommended |
If yes, session 3 start time |
|
|
|
|
tms17 |
String |
20
|
Recommended |
If yes, session 3 end time |
|
|
|
|
tms15 |
String |
20
|
Recommended |
Start time of MRI (after session 3) |
|
|
|
|
tms1 |
Integer |
|
Recommended |
Was session 1 completed? |
|
1 = yes, 0=no
|
|
|
tms2 |
Date |
|
Recommended |
If yes, session 1 date |
|
|
|
|
tms3 |
String |
20
|
Recommended |
If yes, session 1 start time |
|
|
|
|
tms12 |
String |
20
|
Recommended |
If yes, session 1 end time |
|
|
|
|
tms13 |
String |
20
|
Recommended |
Start time of MRI (after session 1) |
|
|
|
|
tms5 |
Integer |
|
Recommended |
Was session 2 completed? |
|
1 = yes, 0=no
|
|
|
tms6 |
Date |
|
Recommended |
If yes, session 2 date |
|
|
|
|
comp_s |
Integer |
|
Recommended |
Completed Study |
0;1
|
0=No; 1=Yes
|
|
|
csop01 |
Integer |
|
Recommended |
Participant withdrawn from study prior to end: |
0;1
|
0=No; 1=Yes
|
|
|
csop02 |
Integer |
|
Recommended |
Reason for early withdrawal: |
0::6
|
0=Death; 1=Intercurrent illness of a nature requiring withdrawal; 2=Lost to follow-up/exclusion criteria; 3=PI removed participant from study; 4=Participant/Parent Request; 5=Study stopped by DSMB/IRB/sponsor; 6=Other
|
|
|
csop03 |
String |
225
|
Recommended |
Other: Specify |
|
|
|
|
csop04 |
Date |
|
Recommended |
Date investigator determined participant withdrew |
|
|
|
|
completedstudy_age |
Integer |
|
Recommended |
age in months at study completion |
|
|
|
|
withdrawn_age |
Integer |
|
Recommended |
age in months at study rejoining |
|
|
|