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Clinical Global Impression (CGI)

cgi

01

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Element NameData TypeSizeRequiredDescriptionValue RangeNotesAliases
subjectkeyGUIDRequiredThe NDAR Global Unique Identifier (GUID) for research subjectNDAR*guid
src_subject_idString20RequiredSubject ID how it's defined in lab/projectSUBJECT, abc_comm_src_subject, bid, case_id, catieid, id, newid, pid, randid, subject_id, subjectid, subjid
interview_dateDateRequiredDate on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYYRequired fieldCGIDate, abc_comm_interview_age, adate, cgiidt, datacollecteddate, intvdate, v2_cgii_date, v3_cgii_date, v4_cgii_date, v5_cgii_date, v6_cgii_date, v7_cgii_date, v8_cgii_date, v9_cgii_date, visit_date
interview_ageIntegerRequiredAge in months at the time of the interview/test/sampling/imaging.0 :: 1260Age 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, globage, intvage, v10_cgii_age, v2_cgii_age, v3_cgii_age, v4_cgii_age, v5_cgii_age, v6_cgii_age, v7_cgii_age, v8_cgii_age, v9_cgii_age
genderString20RequiredSex of the subjectM;FM = Male; F = Female
cgi_siIntegerRecommendedSeverity of Illness. Considering your total clinical experience with this particular population, how ill is the subject at this time?
0 :: 7; -7; -8; -9
CGI: 0 = Not assessed; 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. CPEA STAART CGI: All of the above, plus: -7 = Don't know; -8 = Refused to answer; -9 = Does not applyCGISI, bima_17, cgi1, cgi_01, cgi_1, cgi_2, cgi_s, cgi_severity, cgia1, cgis, cgis001, cgis_pdd, illness, severity_illness_si_score_si_row
cgi_si2IntegerRecommendedSeverity of Social Communication Impairment version 21::7Social communication scale:1 = Normal, no social communication impaired: In high levels of engagement with communication. 2 = Borderline social communication impairment: Easily enters coordinated joint engagement, occasionally slips into supported joint engagement. 3 = Mild social communication impairment: Can engage and communicate, but may be easily distracted, or need occasional adult support to re-engage. Communication attempts are difficult to understand, or predominantly about requests. 4 = Moderate social communication impairment: Needs consistent support to enter in to and/or maintain engagement, with inconsistent spontaneous communication; OR able to engage or communicate with ease but does not do both simultaneously. 5 = Marked social communication impairment: Can communicate about requests only, and does not comment. 6 = Severe social communication impairment: Rarely communicates, and is limited to requests. 7 = Most extreme social communication impairment: No engagement, no communication attemptsMental scale: 1 = Normal, not mentally ill 2 = Borderline mentally ill 3 = Mildly mentally ill 4 = Moderately mentally ill 5 = Markedly mentally ill 6 = Severely mentally ill 7 = Among the most extremely mentally ill
cgi_siiIntegerRecommendedGlobal Improvement. Rate the total improvement in the subject's overall function, whether or not, in your judgment, it is due entirely to treatment. Compared to the subject's condition at baseline, how much has the subject changed?
0 :: 8; -7; -8; -9
CGI: 0 = Not assessed; 1 = Very much improved (at least 85% improvement); 2 = Much improved (at least 60% improvement); 3 = Improved (greater than 25% improvement); 4 = Minimally improved (at least 20-25% improvement); 5 = No change (between +/- 15% change); 6 = Minimally worse (at least 20-55% worse); 7 = Much worse (at least 60% worse); 8 = Very much worse (at least 80% worse). CPEA STAART CGI: 0 = Not assessed; 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse; -7 = Don't know; -8 = Refused to answer; -9 = Does not applybima_18, cgi2, cgi_3, cgi_global_imp, cgia2, cgia_s, cgii, cgii001, cgii_pdd, cgiiq, cgiiscal, global_improvement_gi_score_gi_row, improve, v2_cgii
cgi_siiiIntegerRecommendedSelect the terms which best describe the degrees of therapeutic effect and side effects1::160 = Not assessed; 1 = No Interference/Marked Improvement; 2 = Slight Interference/Marked Improvement; 3 = Significant Interference/Marked Improvement; 4 = Nullify Therapeutic Effect/Marked Improvement; 5 = No Interference/Moderate Improvement; 6 = Slight Interference/Moderate Improvement; 7 = Significant Interference/Moderate Improvement; 8 = Nullify Therapeutic Effect/Moderate Improvement; 9 = No Interference/Minimal Improvement; 10 = Slight Interference/Minimal Improvement; 11 = Significant Interference/Minimal Improvement; 12 = Nullify Therapeutic Effect/Minimal Improvement; 13 = No Interference/Unchanged or Worse; 14 = Slight Interference/Unchanged or Worse; 15 = Significant Interference/Unchanged or Worse; 16 = Nullify Therapeutic Effect/Unchanged or Worse
cgi_score_typeIntegerRecommendedCGI Score Type1::31 = Scoring range 0 to 7; 2 = Scoring range 0 to 8; 3 = Scoring range 0 to 6
cgi_sii_0_6IntegerRecommendedCGI SII 0 - 60::60 = Very much worse; 1 = Much worse; 2 = Minimally worse; 3 = No change; 4 = Minimally improved; 5 = Much improved; 6 = Very much improved
cgi_sii_0_7IntegerRecommendedCGI SII 0 - 7 Improvment/change0::7; 90 = Not assessed; 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse; 9=NAv10_cgii_change, v3_cgii_change, v4_cgii_change, v5_cgii_change, v6_cgii_change, v7_cgii_change, v8_cgii_change, v9_cgii_change
bafinfoIntegerRecommendedCheck if the Assessment was not done.0;10=No; 1=YesCGIINFO
comments_miscString4,000RecommendedMiscellaneous comments on study, interview, methodology relevant to this form dataCGICOM, cgi_si_comments, cgiicmt, cgiicmts, cgiscmts
visitString50RecommendedVisit nameCharacter description of each type of visitcgi_visit, int1, interval, timept, visit_name, visitlabel, visitnum, vistlabel, vtypbima, vtypbprs
aescodeIntegerRecommendedStaff code number of person completing this formCGICODE
visit_tadIntegerRecommendedSOFTAD visit Note: BSI-Adolescent Self-report missing for TADS assessments.1::71 = Visit 1; 2 = Visit 2; 3 = Visit 3; 4 = Visit 4; 5 = Visit 5; 6 = Visit 6; 7 = Visit 7
asstypIntegerRecommendedAssessment type1::201=TADS GATE A; 2=TADS GATE B; 3 = TADS Gate C; 4 = TADS Week 6; 5 = TADS Week 12; 6 = TADS Week 18; 7 = TADS Week 24; 8 = TADS Week 30; 9 = TADS Week 36; 10 = TADS F/U Mo 3; 11 = TADS F/U Mo 6; 12 = TADS F/U Mo 9; 13 = TADS F/U Mo 12; 14 = SOFTAD month 6; 15 = SOFTAD month 12; 16 = SOFTAD month 18; 17 = SOFTAD month 24; 18 = SOFTAD month 30; 19 = SOFTAD month 36; 20 = SOFTAD month 42
stageIntegerRecommendedStudy stage
0::5; 51::53; 67; -888; -999
0 = Pre-Randomization (TADS) 1 = Stage 1 (TADS) 2 = Stage 2 (TADS) 3 = Stage 3 (TADS) 4 = Stage 4 (TADS) 5 = Stage 5 (SOFTAD); 51=Treatmentas Usual; 52=Screening Alone; 53=Intervention; 67=Unknown; -888=Not Applicable; -999=Missing;
cgimoFloatRecommendedMonths from Time 0 to assessmentglobmo, monfol
cgistmFloatRecommendedMonths from SOFTAD enrollment to asst.globstm
cgiicatIntegerRecommendedCGI-I Treatment Response Indicator0;10 = CGI-I non-responder 1 = CGI-I responderresp
cgimIntegerRecommendedCGI. Improvement since the end of treatment1::71 = Very much improved 2 = Much improved 3 = Improved 4 = Unchanged 5 = Worse 6 = Much worse 7 = Very much worse
cgisuIntegerRecommendedClinical Global Imprsn.Subst. (CGI-SU)1::71 = Normal, not ill 2 = Borderline ill 3 = Mildly ill4 = Moderately ill 5 = Markedly ill 6 = Severely ill7 = Extremely ill
bsit0FloatRecommendedWeeks from Time 0/baseline to assessmentcgast0, cgastt0, cgi_week, cgiwksbtw, globt0
trttypIntegerRecommendedTreatment type1::31 = CBT; 2 = PT; 3 = PT and CBT
sesstypIntegerRecommendedSession Type1;21 = Office; 2 = Phone
cgiitrloIntegerRecommendedITT Version of Clinical Global Impressions Improvement (LOCF) treatment responder indicatorDerivation Logic: If the patient was missing the Week 6 CGII data then the patient was assigned as a non-responder. If the patient was missing the Week 12 CGII data, the Week 6 CGII LOCF treatment response data was used as the Week 12 response.Similar logic was used to populate the remaining visits out to Month 12.1;01 = CGII treatment responder 0 = CGII treatment non-responder
cgiilocfIntegerRecommendedITT Version of Clinical Global Impressions -Improvement (LOCF)Derivation Logic: If the patient was missing the Week 6 CGII data then the patient was assigned with missing data. If the patient was missing the Week 12 CGII data, the Week 6 CGII LOCF data was used as the Week 12 response. Similar logic was used to populate the remaining visits out to Month 12.1::71 = Very much improved 2 = Much improved 3 = Minimally improved 4 = No change 5 = Slightly worse 6 = Much worse 7 = Very much worse
cgasratIntegerRecommendedCGAS Rating1::100; -91 - 10: Needs constant supervision (24-hour care); 11 -20: Needs considerable supervision; 21- 30: Unable to function in almost all areas; 31 - 40: Major impairment in functioning; 41 - 50: Moderate degree of interference in functioning; 51 - 60: Variable functioning with sporadic difficulties; 61-70: Some difficulty in a single area; 71- 80: No more than slight impairment in functioning; 81-90: Good functioning in all areas; 91-100: Superior functioning in all areas; -9=incompletecgas_score, cgastrat, functioning_score
cgascatIntegerRecommendedCGAS Rating categorized into functional groupings1::101 = 1 � 10; 2 = 11 � 20; 3 = 21 � 30; 4 = 31 � 40; 5 = 41 � 50; 6 = 51 � 60; 7 = 61 � 70; 8 = 71 � 80; 9 = 81 � 90; 10 = 91 � 100cgas1, cgastcat
pesqcritFloatRecommendedAdolescent age: 19-year criterion0;10 = Under 19.0; 1 = 19.0 or older
gafratFloatRecommendedGAF rating1::100Rating Notes: 1-10: Persistent danger of severely hurting self or others; 11-20: Some danger of hurting self or others; 21-30: Inability to function in almost all areas; 31-40: Major impairment in several areas; 41-50: Serious symptoms; 51-60: Moderate symptoms 61-70: Some mild symptoms; 71-80: No more than slight impairment; 81-90: Absent or minimal symptoms; 91 100: Superior functioning;gaf_01, gafc
gafcatIntegerRecommendedGAF category1::101 = 1-10; 2 = 11-20; 3 = 21-30; 4 = 31-40; 5 = 41-50; 6 = 51-60; 7 = 61-70; 8 = 71-80; 9 = 81-90; 10 = 91-100
glob_fmIntegerRecommendedGlobal functioning form1::31=CGAS; 2=GAF; 3=Both
globratFloatRecommendedGlobal functioning rating (CGAS/GAF)1::100cur1
globcatIntegerRecommendedGlobal functioning category (CGAS/GAF)1::101 = 1-10; 2 = 11-20; 3 = 21-30; 4 = 31-40; 5 = 41-50; 6 = 51-60; 7 = 61-70; 8 = 71-80; 9 = 81-90; 10 = 91-100
siteString100RecommendedSiteStudy Sitesite_no, site_uid, siteid
dsmversString10Recommendedversion/name of assessmentform_name
date_updatedDateRecommendedDate record updatededit_date
session_idString20Recommendedsession ID/screening IDscreeningid, session
completedIntegerRecommendedChecks if form is completed0::20=No; 1=Yes; 2=Yes, lostformcomp, frmcomp, tststfld
cgi_efficacy_teFloatRecommendedEfficacy Index - Therapeutic Effect: Rate this item on the basis of drug effect only. Select the terms that best describe the degrees of therapeutic effect and side effects0 :: 40=Not Assessed; 1=Marked - Vast improvement. Complete or nearly complete remission of all symptoms; 2=Moderate - Decided improvement. Partial remission of all symptoms; 3=Minimal - slight improvement which doesn't alter status of care of subject; 4=Unchanged or worse
cgi_efficacy_seIntegerRecommendedEfficacy Index - Side Effects: Rate this item on the basis of drug effect only. Select the terms that best describe the degrees of therapeutic effect and side effects0 :: 40=Not Assessed; 1=None; 2=Dos not significanly interfere with subject's functioning; 3=Significanly interfere with subject's functioning; 4=Outweighs therapeutic effect
trt_grpString10RecommendedTreatment Group Assignment1;1AO;1CT;2;31=Group 1 first 8 weeks; 1AO=Group 1 8 week add on; 1CT=Group 1 8 week cross taper; 2=Group 2; 3=Group 3
days_baselineIntegerRecommendedDays since baselinebsldays, cgidays, cgidaysbtw, gafdays
etypeString10RecommendedRating PeriodBSL;WK1;WK2;WK3;WK4;WK5;WK6;WK7;WK8;WK9;WK10;WK11;WK12;WK13;WK14;WK15;WK16BSL=Baseline; WK1-WK16=Weeks 1-16
respond_detail_oth_specString255RecommendedRespondent detailsinformnt
relationshipString255RecommendedRelationship of respondent to individual
1;2;3;4;5;6;7;8;9;10;11;12;13;14;15;16;17;18;19;20;21;22;23;24;25;26;27;28;29;30;31;32;33;34;35;36;37;38;39;40;41;42;43;44;45;46;47;48;49;50;51;52;53;54;55;56;57;58;59;60;61;62;63;64;65;66;67;68;69;70;71;72;73;74;75;76;77;78;79;80;81;82;83;84; -999
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; 13 = Other; 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; 27=Missing Data; 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; 90= Other, specify; -999= Missing; 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 maleinfrmnt2
cgimania1IntegerRecommendedSeverity of Mania during the past week1::71=normal-not ill; 2=minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=very severely ill
cgidepr1IntegerRecommendedSeverity of depression during the past week1::71=normal-not ill; 2=minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=very severely ill
cgioverall1IntegerRecommendedSeverity of overall bipolar illness during the past week1::71=normal-not ill; 2=minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=very severely ill
cgimania2IntegerRecommendedChange from baseline week - mania1::81=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse; 8=not applicable
cgidepr2IntegerRecommendedChange from baseline week - depression1::81=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse; 8=not applicable
cgioverall2IntegerRecommendedChange from baseline week - overall bipolar illness1::81=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse; 8=not applicable
fseqnoIntegerRecommendedSequence Number0::999The 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.
visdayIntegerRecommendedNumber of days from study baseline to date of visitcgia0b, daycgi
version_formString100RecommendedForm usedvers
subject_descriptionString4,000RecommendedSubject related information (e.g the affection, phenotype, disease information, etc.).
blcgisIntegerRecommendedbaseline clinical global impressions severity1;2;3;4;5;61=Normal, not ill; 2=minimally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill
chcgisIntegerRecommendedChange from baseline in Clinical Global Impressions Severity-10::10
cgicwIntegerRecommendedSubstantial deterioration on CGI scale0;10=No; 1=Yes
daysrzIntegerRecommendeddays since randomizationstudyday, visitdt
studyString100RecommendedStudystudyid
subtrial_nameIntegerRecommendedName of subtrial1::31=Crossover; 2=Guanfacine; 3= Open Label MPH
cgis_adhIntegerRecommendedSymptoms of ADHD significant0;10=No; 1=Yes
weekFloatRecommendedWeek in level/study99=week 10-week 14intid
visitidIntegerRecommendedMetaTrial Visit IDSystem variable: unique code for each type of visit -use to merge files
last1IntegerRecommendedFlag Last Phase 1/1A Visit1=Yes for all records meeting this criteria
last2IntegerRecommendedFlag Last Phase 2 Visit1=Yes for all records meeting this criteria
last3IntegerRecommendedFlag Last Phase 3 Visit1=Yes for all records meeting this criteria
lastocIntegerRecommendedFlag Last Open Choice Phase Visit11=Yes for all records meeting this criteria
base1IntegerRecommendedFlag Baseline Phase 1/1A Visit1=Yes for all records meeting this criteria
base2IntegerRecommendedFlag Baseline Phase 2 Visit1=Yes for all records meeting this criteria
base3IntegerRecommendedFlag Baseline Phase 3 Visit1=Yes for all records meeting this criteria
baseocIntegerRecommendedFlag Baseline Open Choice Phase Visit11=Yes for all records meeting this criteria
phase_ctString20RecommendedCurrent 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
cgicrespIntegerRecommendedCGIC Response0;11= when cgi_sii is 1, 2, or 4; 0= when cgi_sii is 5, 6, 7, or 8; blank= when cgi_sii is missing
visnumFloatRecommendedNumeric 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 visitsvisitnumber
b2_cgicIntegerRecommendedPhase 2 Baseline CGIC
b2_respIntegerRecommendedPhase 2 Baseline CGIC Response
boc_cgicIntegerRecommendedPhase 4 Baseline CGIC
boc_respIntegerRecommendedPhase 4 Baseline CGIC Response
b3_cgicIntegerRecommendedPhase 3 Baseline CGIC
b3_respIntegerRecommendedPhase 3 Baseline CGIC Response
cgitherIntegerRecommendedRole of Therapist Completing Clinical Global Impressions0::20 = IE (Independent Evaluator);1 = PT (Pharmacotherapist);2 = CBT (Cognitive Behavioral Therapist)
cgi_exrespIntegerRecommendedExcellent Response0;10 = responder (CGI-I =1);1 = nonresponder (CGI-I > 1)
resp36IntegerRecommendedtreatment responder status based on CGI-I <=20;10 = non-responder; 1 = responder
imputationIntegerRecommendedIndicator noting imputed data set number1::20
gafyearIntegerRecommendedGAF score past year0::100Rating Notes: 1-10: Persistent danger of severely hurting self or others; 11-20: Some danger of hurting self or others; 21-30: Inability to function in almost all areas; 31-40: Major impairment in several areas; 41-50: Serious symptoms; 51-60: Moderate symptoms 61-70: Some mild symptoms; 71-80: No more than slight impairment; 81-90: Absent or minimal symptoms; 91 100: Superior functioning;gaf_02
dataqualityIntegerRecommendedData quality0::50=No data (cancelled); 1=Data entered but only once, has missing data; 2=Data entered but only once, no missing data; 3=Double entered; 4=Data frozen for cleaning; 5=Data clean/locked
elig_inclusion_checkIntegerRecommendedChecks for a pass/fail on Elig for Inclusion0::30=Failed (Ineligible); 1=Passed (Eligible); 2=In screening; 3=NA
subjecttypeString20RecommendedSubject TypeControl;Prodromal; Enhanced; Non-Enhanced
gaf1aIntegerRecommendedParticipant report-Symptom Scale Score
gaf1b1IntegerRecommendedParticipant report-Occupational Functioning Scale Score
gaf1b2IntegerRecommendedParticipant report-Occupation1::31 = Worker;2 = Student;3 = Homemaker
gaf1cIntegerRecommendedParticipant report-Social Functioning Scale Score
gaf2aIntegerRecommendedParticipant and clinician report-Symptom Scale Score
gaf2b1IntegerRecommendedParticipant and clinician report-Occupational Functioning Scale Score
gaf2b2IntegerRecommendedParticipant and clinician report-Occupation1::31 = Worker;2 = Student;3 = Homemaker
gaf2cIntegerRecommendedParticipant and clinician report-Social Functioning Scale Score
gaf3IntegerRecommendedCurrently in remission0;10=No; 1=Yes
gaf3aIntegerRecommendedDuration of remissionMonths
intrtIntegerRecommendedTreatment Status Code0::20=Baseline; 1=In Treatment; 2=In Follow-up
trtgrp_pIntegerRecommendedTreatment Group1;21=Long-Acting Injectable Risperidone Microspheres; 2=Second Generation Oral Antipsychotic Medication
days_visit1IntegerRecommendedDays from Visit 1dav1bima, dav1bprs
trtgroupString2RecommendedTreatment GroupN1;N2;R1;R2;R3N1=Non-Responder Entering Fluvoxamine; N2=Non-Responder Entering Fluoxetine; R1=Maintenance; R2=Responder Entering Fluvoxamine; R3=Responder Entering Fluoxetine
study_idIntegerRecommendedStudy ID number46=Acute Phase; 47=Stabilization Phase
sitedatasource_1IntegerRecommendedSource of Data: Site0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;infosrcr
sitedatasource_phoneIntegerRecommendedSource of Data: Telephone0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;infoscrct
sitedatasource_physicianIntegerRecommendedSource of Data: Physician0;1; -888; -9990=False; 1=True; -888=Not Applicable; -999=Missing;infoscrp
ci_enrolledIntegerRecommendedParticipant enrolled0;10=No; 1=Yesenrolled
confidence_lvlIntegerRecommendedConfidence Level1::41=Very Confident;2=Somewhat confident;3=Some reservations;4=Severe reservationscgiconf
commentsString4,000RecommendedComments about assessmentcgi_sii_comments
cgi_worstmaniaIntegerRecommendedCGI- Change from worst phase of illness, mania1::81=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse; 8=not applicable
cgi_worstdeprIntegerRecommendedCGI- Change from worst phase of illness, depression1::81=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse; 8=not applicable
cgi_worstoverallIntegerRecommendedCGI- Change from worst phase of illness, overall bipolar1::81=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse; 8=not applicable
sideeffectIntegerRecommendedSide effects1;21=Present; 2=Not present
medication_nameString255RecommendedName of medication
assessment_typeIntegerRecommendedAssessment Type1::31 = Admission; 2 = Acute; 3 = Prophylactic
mood_trialentryIntegerRecommendedMood State at Trial Entry1::51 = Depressed; 2 = Euthymic; 3 = Dysphoric Mania; 4 = Euphoric Mania; 5 = Cycling
moodstate_lengthString20RecommendedLength of time in mood state
saps_ad10IntegerRecommendedRater number
vis_scale_changeIntegerRecommendedVisual Scale of Participant Change90=Very much better: Pt is very much more interactive or is much less inappropriate, may have many fewer or less concerning problem behaviors, functioning is much better than at week 0, usually in multiple settings.; 75=Much better: Pt is markedly more interactive or less socially inappropriate, problem behaviors may be clearly better, functioning in at least one setting is significantly better than at week 0. May consider reducing supports or increasing demands.; 50=Somewhat better: Pt is somewhat more interactive or less inappropriate on multiple occasions, problem behaviors may be modestly better in some settings, & functioning at times is clearly better than at week 0.; 25=Slightly better: Pt is sometimes slightly more interactive or less inappropriate or clearly better on 1 or 2 minor occasions, problem behaviors might be slightly better on a few occasions. Overall functioning is not meaningfully different from week 0.; 0=No meaningful changes: Variations in interaction and problem behaviors are within typical range for pt.; -25=Slightly worse: Pt is sometimes slightly less interactive or more inappropriate or notably worse on 1 or 2 occasions, problem behaviors might be slightly worse infrequently. Overall functioning is not meaningfully different from week 0.; -50=Somewhat worse: Pt is somewhat less interactive or more inappropriately interactive on multiple occasions, problem behaviors may be more frequent or intense in some settings, & functioning at times is clearly less good than at week 0. ; -75=Much worse: Pt is markedly less interactive or more inappropriately interactive, problem behaviors may be significantly worse , more support would be helpful, functioning in at least one setting is significantly worse than at week 0; -90=Very much worse: Pt is very much less interactive or extremely more inappropriately interactive, may have significantly worse problem behaviors, and urgently needs higher levels of support to function as at week 0participant_change_value_mm
rand_numIntegerRecommendedRandomization Number0::2
cgi_3sIntegerRecommendedDomain: Occupation/Education CGI-Severity0::7; -9990 = Not assessed; 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients; -999=missing
cgi_3iIntegerRecommendedDomain: Occupation/Education CGI-Improvement0::7;-9990= Not assessed; 1=Very much improved; 2= Much improved; 3=Minimally improved; 4= No change; 5= Minimally worse; 6=Much worse; 7= Very much worse; -999=missing
cgi_4sIntegerRecommendedDomain: Social/Peer CGI-Severity0::7; -9990 = Not assessed; 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients; -999=missing
cgi_4iIntegerRecommendedDomain: Social/Peer CGI-Improvement0::7;-9990= Not assessed; 1=Very much improved; 2= Much improved; 3=Minimally improved; 4= No change; 5= Minimally worse; 6=Much worse; 7= Very much worse; -999=missing
cgi_5sIntegerRecommendedDomain: Independent Living/Daily Functioning CGI-Severity0::7; -9990 = Not assessed; 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients; -999=missing
cgi_5iIntegerRecommendedDomain: Independent Living/Daily Functioning CGI-Improvement0::7;-9990= Not assessed; 1=Very much improved; 2= Much improved; 3=Minimally improved; 4= No change; 5= Minimally worse; 6=Much worse; 7= Very much worse; -999=missing
monthsblFloatRecommendedActual number of months from Baseline
gafhighIntegerRecommendedGAF Highest past level since last follow-up1::100; 9991-10 = Persistent danger of severely hurting self or others (e.g., recurrent violence) OR persistent inability to maintain minimal personal hygiene OR serious suicidal act with clear expectation of death.; 11-20 = Some danger of hurting self or others (e.g., suicide attempts without clear expectiation of death; frequently violent; manic excitement) OR occasionally fails to maintain minimal personal hygiene (e.g., smears feces) OR gross impairment in communication (e.g., largely incoherent or mute).; 21-30 = Behavior is considerably influenced by delusions or hallucinations OR serious impairment in communication or judgment (e.g., sometimes incoherent, acts grossly inappropriately, suicidal preoccupation) OR inability to function in almost all areas (e.g., stays in bed all day, no job, home, or friends).; 31-40 = Some impairment in reality testing or communication (e.g., speech is at times illogical, obscure, or irrelevant) OR major impairment in several areas, such as work or school, family relations, judgment, thinking, or mood (e.g., depressed man avoids friends, neglects family, and is unable to work; child frequently beats up younger children, is defiant at home, and is failing at school).; 41-50 = Serious symptoms (e.g., suicidal ideation, severe obsessional rituals, frequent shoplifting) OR any serious impairment in social, occupational, or school functioning (e.g., no friends, unable to keep a job).; 51-60 = Moderate symptoms (e.g., flat affect and circumstantial speech, occasional panic attacks) OR moderate difficulty in social, occupational, or school functioning (e.g., few friends, conflicts with peers or co-workers).; 61-70 = Some mild symptoms (e.g., depressed mood and mild insomnia) OR some difficulty in social, occupational, or school functioning (e.g., occasional truancy, or theft within the household), but generally functioning pretty well, has some meaningful interpersonal relationships.; 71-80 = If symptoms are present, they are transient and expectable reactions to psychosocial stressors (e.g., difficulty concentrating after family argument); no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork).; 81-90 = Absent or minimal symptoms (e.g., mild anxiety before an exam), good functioning in all areas, interested and involved in a wide range of activities, socially effective, generally satisfied with life, no more than everyday problems or concerns (e.g., an occasional argument with family members.; 91-100 = Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. No symptoms.; 999 = Missing
me2IntegerRecommendedStatus0;10 = Past [Inactive]; 1 = Active
cgi_parentIntegerRecommendedGlobal Severity: Considering your total experience with this child, how much difficulty is he or she experiencing at this time?0::70=Not Assessed; 1=No Difficulties; 2=Minimal Difficulties; 3=Mild Difficulties; 4=Moderate Difficulties; 5=Marked Difficulties; 6=Severe Difficulties; 7=Very Severe Difficulties
Data Structure

This page displays the data structure defined for the measure identified in the title and structure short name. The table below displays a list of data elements in this structure (also called variables) and the following information:

  • Element Name: This is the standard element name
  • Data Type: Which type of data this element is, e.g. String, Float, File location.
  • Size: If applicable, the character limit of this element
  • Required: This column displays whether the element is Required for valid submissions, Recommended for valid submissions, Conditional on other elements, or Optional
  • Description: A basic description
  • Value Range: Which values can appear validly in this element (case sensitive for strings)
  • Notes: Expanded description or notes on coding of values
  • Aliases: A list of currently supported Aliases (alternate element names)
  • For valid elements with shared data, on the far left is a Filter button you can use to view a summary of shared data for that element and apply a query filter to your Cart based on selected value ranges

At the top of this page you can also:

  • Use the search bar to filter the elements displayed. This will not filter on the Size of Required columns
  • Download a copy of this definition in CSV format
  • Download a blank CSV submission template prepopulated with the correct structure header rows ready to fill with subject records and upload

Please email the The NDA Help Desk with any questions.

Distribution for DataStructure: cgi01 and Element:
Chart Help

Filters enable researchers to view the data shared in NDA before applying for access or for selecting specific data for download or NDA Study assignment. For those with access to NDA shared data, you may select specific values to be included by selecting an individual bar chart item or by selecting a range of values (e.g. interview_age) using the "Add Range" button. Note that not all elements have appropriately distinct values like comments and subjectkey and are not available for filtering. Additionally, item level detail is not always provided by the research community as indicated by the number of null values given.

Filters for multiple data elements within a structure are supported. Selections across multiple data structures will be supported in a future version of NDA.