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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL

Clinical Monitoring Form

5,233 Shared Subjects

N/A
Clinical Assessments
Questionnaire
12/15/2014
cmf01
03/22/2023
View Change History
01
Definition
Submission Template
Query Element Name Data Type Size Required Description Value Range Notes Aliases
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 stepid
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY
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.
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported gender
Query daysrz Integer Recommended days since randomization dayscons
Query certcode Integer Recommended stepbd certification code
Query depresd Float Recommended depressed most of the day
Query curdepr Integer Recommended current depression 0::3 0 = Inadequate information; 1=No; 2=Probable; 3= Definite
Query lessint Float Recommended less interest in activities
Query curenjoy Integer Recommended current enjoyment 1::3 1=No; 2=Probable; 3= Definite
Query moodelev Float Recommended abnormal mood elevation
Query curmania Integer Recommended current mania or hypomania 1::3 1=No; 2=Probable; 3= Definite
Query abnirrit Float Recommended abnormal irritability
Query curirrit Integer Recommended current irritability 1::3 1=No; 2=Probable; 3= Definite
Query abnanx Float Recommended abnormal anxiety
Query deprmd Float Recommended cmf depressed mood -2::2 -2=Much less; 0=Usual/none; 2=Much more
Query depsleep Float Recommended depression sleep -2::2 -2=Much less; 0=Usual/none; 2=Much more
Query depslmin Float Recommended depression sleep minimum hours
Query depslmax Float Recommended depression sleep maximum hours
Query depinter Float Recommended depression interest -2::2 -2=Much less; 0=Usual/none; 2=Much more
Query depguilt Float Recommended depression guilt -2::2 -2=Much less; 0=Usual/none; 2=Much more
Query depse Float Recommended depression self esteem -2::2 -2=Much less; 0=Usual/none; 2=Much more
Query depenerg Float Recommended depression energy -2.5::2 -2=Much less; 0=Usual/none; 2=Much more
Query depconcn Float Recommended depression concern -2::2 -2=Much less; 0=Usual/none; 2=Much more
Query depdist Float Recommended depression distractibility -2::2 -2=Much less; 0=Usual/none; 2=Much more
Query depappet Float Recommended depression appetite -2::2 -2=Much less; 0=Usual/none; 2=Much more
Query deppmr Float Recommended depression pmr -2::2 -2=Much less; 0=Usual/none; 2=Much more
Query deppma Float Recommended depression pma -2::2 -2=Much less; 0=Usual/none; 2=Much more
Query depsi Float Recommended depression suicidal ideations -7;-2::2 -7=Refused; -2=Much less; 0=Usual/none; 2=Much more
Query silnwl Integer Recommended suicidal life not worth living 0;1;-7 0=No; 1=Yes; -7=Refused
Query sipassiv Integer Recommended suicidal ideations passive 0;1;-7 0=No; 1=Yes; -7=Refused
Query siactive Integer Recommended suicidal ideations active 0;1;-7 0=No; 1=Yes; -7=Refused
Query elvselfe Float Recommended elevation self esteem -7;-2::2 -7=Refused; -2=Much less; 0=Usual/none; 2=Much more
Query elvsleep Float Recommended elevation need for sleep -2::2 -2=Much less; 0=Usual/none; 2=Much more
Query elvtalk Float Recommended elevation talking -2::2 -2=Much less; 0=Usual/none; 2=Much more
Query elvfoi Float Recommended elevation foi racing -2::2 -2=Much less; 0=Usual/none; 2=Much more
Query elvdistr Float Recommended elevation distractable -2::2 -2=Much less; 0=Usual/none; 2=Much more
Query elvgdact Float Recommended elevation goal directed activ -2::2 -2=Much less; 0=Usual/none; 2=Much more
Query elvpma Float Recommended elevation pma -2::2 -2=Much less; 0=Usual/none; 2=Much more
Query elvhrb Float Recommended elevation high risk behavior -2::2 -2=Much less; 0=Usual/none; 2=Much more
Query cdcaf Float Recommended caffeine cups per day 999=DK; 77=Refused
Query ppd Float Recommended nicotine packs per day
Query mendays Integer Recommended onset menses days from o3 randomization
Query mensesti Integer Recommended time of menses 0;1;-7 0=Early; 1=Late; -7=Refused
Query alcabuse Integer Recommended alcohol abuse 0;1;-7 0=No; 1=Yes; -7=Refused
Query subabuse Integer Recommended curr substance abuse or depend 0;1;-7 0=No; 1=Yes; -7=Refused
Query headache Integer Recommended headaches 0;1;-7 0=No; 1=Yes; -7=Refused
Query migraine Integer Recommended migraine headaches 0;1;-7 0=No; 1=Yes; -7=Refused
Query bingpurg Integer Recommended binge purge 0;1;-7 0=No; 1=Yes; -7=Refused
Query panic Integer Recommended does participant meet for panic disorder? 0 = no; 1 = yes 0;1 0 = No; 1 = Yes
Query psychtx Integer Recommended psychiatric treatment 0;1;-7 0=No; 1=Yes; -7=Refused
Query genmedtx Integer Recommended general medical treatment 0;1;-7 0=No; 1=Yes; -7=Refused
Query sigilln Integer Recommended significant medical illness 0;1;-7;9 0=No; 1=Yes; -7=Refused; 9=NK
Query weight_std Float Recommended Weight - Standard Unit -1 = Not known; 999 = Missing weight
medication1_name String 500 Recommended Name first medication that the participant has taken 0 = No medication; 999= Legitimately skipped med1
medication1_dosage String 150 Recommended First medication dosage 0 = No medication; 999 = Missing dose1
Query miss1 Float Recommended current mg1 missed past 7 days
medsp1 String 50 Recommended other current treatment1
medication2_name String 500 Recommended Name second medication that the participant has taken 0 = No medication; 999= Legitimately skipped med2
medication2_dosage String 100 Recommended Second medication dosage 0 = No medication; 999 = Missing dose2
Query miss2 Float Recommended current mg2 missed past 7 days
medsp2 String 50 Recommended other current treatment2
medication3_name String 500 Recommended Name third medication that the participant has taken 0 = No medication; 999= Legitimately skipped med3
medication3_dosage String 100 Recommended Third medication dosage 0 = No medication; 999 = Missing dose3
Query miss3 Float Recommended current mg3 missed past 7 days
medsp3 String 50 Recommended other current treatment3
medication4_name String 500 Recommended Name fourth medication that the participant has taken 0 = No medication; 999= Legitimately skipped med4
medication4_dosage String 100 Recommended Fourth medication dosage 0 = No medication; 999 = Missing dose4
Query miss4 Float Recommended current mg4 missed past 7 days
medsp4 String 50 Recommended other current treatment4
medication5_name String 500 Recommended Name fifth medication that the participant has taken 0 = No medication; 999= Legitimately skipped med5
medication5_dosage String 100 Recommended Fifth medication dosage 0 = No medication; 999 = Missing dose5
Query miss5 Float Recommended current mg5 missed past
medsp5 String 50 Recommended other current treatment5
medication6_name String 500 Recommended Name sixth medication that the participant has taken 0 = No medication; 999= Legitimately skipped med6
medication6_dosage String 100 Recommended Sixth medication dosage 0 = No medication; 999 = Missing dose6
Query miss6 Float Recommended current mg6 missed past 7 days
medsp6 String 50 Recommended other current treatment6
medication7_name String 500 Recommended Name seventh medication that the participant has taken 0 = No medication; 999= Legitimately skipped med7
medication7_dosage String 100 Recommended Seventh medication dosage 0 = No medication; 999 = Missing dose7
Query miss7 Float Recommended current mg7 missed past 7 days
medsp7 String 50 Recommended other current treatment7
medication8_name String 500 Recommended Name eighth medication that the participant has taken 0 = No medication; 999= Legitimately skipped med8
medication8_dosage String 100 Recommended Eighth medication dosage 0 = No medication; 999 = Missing dose8
Query miss8 Float Recommended current mg8 missed past 7 days
medsp8 String 50 Recommended other current treatment8
medication9_name String 500 Recommended Name ninth medication that the participant has taken med9
medication9_dosage String 100 Recommended Ninth medication dosage dose9
Query miss9 Float Recommended current mg9 missed past 7 days
medsp9 String 50 Recommended other current treatment9
medication10_name String 100 Recommended Name tenth medication that the participant has taken med10
medication10_dosage String 50 Recommended Tenth medication dosage dose10
Query miss10 Float Recommended current mg10 missed past 7 day
medsp10 String 50 Recommended other current treatment10
Query medication11_name String 500 Recommended Medication 11 name med11
Query medication11_dosage String 100 Recommended medication 11 dosage dose11
Query miss11 Float Recommended current mg11 missed past 7 day
medsp11 String 50 Recommended other med specify 11
Query medication12_name String 500 Recommended Med name12 med12
Query medication12_dosage String 100 Recommended medication 12 dosage dose12
Query miss12 Float Recommended current mg12 missed past 7 day
medsp12 String 50 Recommended other med specify 12
prnmed1 String 50 Recommended current PRN medication 1
Query prndose1 Float Recommended PRN 1 dose mg 24hr total
prnspec1 String 50 Recommended other current PRN treatment1
Query prnmed2 String 50 Recommended current PRN medication 2
Query prndose2 Float Recommended PRN 2 dose mg 24hr total
prnspec2 String 50 Recommended other current PRN treatment2
Query prnmed3 String 50 Recommended current PRN medication 3
Query prndose3 Float Recommended PRN 3 dose mg 24hr total
prnspec3 String 50 Recommended other current PRN treatment3
Query prnmed4 String 50 Recommended current PRN medication 4
Query prndose4 Float Recommended PRN 4 dose mg 24hr total
prnspec4 String 50 Recommended other current PRN treatment4
Query psimo Integer Recommended psychosocial interventions mth
Query ectmo Integer Recommended Electroconvulsive Therapy (ECT) per month
Query tremorsv Integer Recommended tremor severity 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
Query drymthsv Integer Recommended dry mouth severity 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
Query sedatnsv Integer Recommended sedation severity 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
Query constisv Integer Recommended constipation severity 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
Query diarrhsv Integer Recommended diarrhea severity 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
Query headacsv Integer Recommended headache severity 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
Query memsv Integer Recommended poor memory severity 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
Query sexdyssv Integer Recommended sexual dysfunction severity 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
Query incappsv Integer Recommended increase appetite severity 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
ae String 4,000 Recommended Adverse event Description
Query othrsv1 Integer Recommended other effect severity1 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
aes2 String 500 Recommended Description of Adverse Event2
Query othrsv2 Integer Recommended other effect severity2 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
aes3 String 500 Recommended Description of Adverse Event3
Query othrsv3 Integer Recommended other effect severity3 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
Query epssv Integer Recommended extrapyramidal symptoms [EPS] severity 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
Query smspi Integer Recommended selected mental status PI (paranoid ideation) 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
Query smsior Integer Recommended selected mental status IOR (ideas of reference) 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
Query smsocd Integer Recommended selected mental status OC (True Obsessions or compulsions (but criteria for OCD not required)) 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
Query smshallu Integer Recommended select mental stat Hallucination 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
Query smsdelus Integer Recommended select mental status Delusions 0::4;-7 0=none; 1= Mild; 2= Moderate; 3= Marked; 4= Severe; -7=Refused
Query clinstat Integer Recommended clinical status 1::13;-7 1=Depression; 2=Mania; 3=Mixed/Cycling; 4=Hypomania; 5=Continued SXs; 6=Roughening; 7=Recovering; 8=Recovered; 9=Other DX; -7=Refused;10=Remission; 11=Response; 12=Partial Response; 13=Minimal or no response
Query ondays Integer Recommended new episode days from omega 3 randomization
Query cgi_si Integer Recommended Severity 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 apply cgi
Query gafweek Integer Recommended global assess functioning week 0::90
Query gafmonth Integer Recommended global assess functioning month 0::90
Query path1 Integer Recommended standard or randomized path 1 1::22;-7 1=SAD; 2=RAD; 3=SRD; 4=RRD; 5=SRP; 6=RRP; 7=SPG; 8=SRM; 9=SME; 10=SRC; 11=SSA; 12=SHD; 13=SOC; 14=SPA; 15=SGA; 16=SPT; 17=SSP; 18=SBL; 19=SAM; 20=OM3; 21=LIM; 22=PAD; -7=Refused
Query path2 Integer Recommended standard or randomized path 2 1::22;-7 1=SAD; 2=RAD; 3=SRD; 4=RRD; 5=SRP; 6=RRP; 7=SPG; 8=SRM; 9=SME; 10=SRC; 11=SSA; 12=SHD; 13=SOC; 14=SPA; 15=SGA; 16=SPT; 17=SSP; 18=SBL; 19=SAM; 20=OM3; 21=LIM; 22=PAD; -7=Refused
Query path3 Integer Recommended standard or randomized path 3 1::22;-7 1=SAD; 2=RAD; 3=SRD; 4=RRD; 5=SRP; 6=RRP; 7=SPG; 8=SRM; 9=SME; 10=SRC; 11=SSA; 12=SHD; 13=SOC; 14=SPA; 15=SGA; 16=SPT; 17=SSP; 18=SBL; 19=SAM; 20=OM3; 21=LIM; 22=PAD; -7=Refused
Query path4 Integer Recommended standard or randomized path 4 1::22;-7 1=SAD; 2=RAD; 3=SRD; 4=RRD; 5=SRP; 6=RRP; 7=SPG; 8=SRM; 9=SME; 10=SRC; 11=SSA; 12=SHD; 13=SOC; 14=SPA; 15=SGA; 16=SPT; 17=SSP; 18=SBL; 19=SAM; 20=OM3; 21=LIM; 22=PAD; -7=Refused
Query phase4 Integer Recommended scp rcp phase 4 1::4;-7 1=Acute; 2=Continuation; 3=Maintenance; 4=Termination; -7=Refused
Query site String 101 Recommended Site Study Site site_id, siteid
Query sumd Float Recommended Sum D The Classified score is an indicator variable, and it is used to set the out of range scores into 0. cmfsumd
Query summ Float Recommended Sum M The Classified score is an indicator variable, and it is used to set the out of range scores into 0 cmfsumm
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 phase_2 Integer Recommended scp rcp phase 2 1::4;-7 1=Acute; 2=Continuation; 3=Maintenance; 4=Termination; -7=Refused
Query phase_3 Integer Recommended scp rcp phase 3 1::4;-7 1=Acute; 2=Continuation; 3=Maintenance; 4=Termination; -7=Refused
Query cmfyear Integer Recommended Year of CMF
Query cmfmhi Float Recommended Variables included in SumM (all on CMF): ELVSELFE, ELVTALK, ELVFOI, ELVDISTR, ELVGDACT, ELVPMA, ELVHRB - Call those variables Hi
Query cmfmlo Float Recommended Variables included in SumM (all on CMF): ELVSLEEP - Call this variable Lo
Query cmfdhi Float Recommended Variables included in SumD (all on CMF): DEPGUILT, DEPDIST, DEPPMR, DEPPMA, DEPSI - Call those variables Hi
Query cmfdlo Float Recommended Variables included in SumD (all on CMF): DEPINTER, DEPSE, DEPENERG, DEPCONC - Call those variables Lo
Query cmfdz Float Recommended Variables included in SumD (all on CMF): DEPSLEEP, DEPAPPET - Call those variables Nozero
Query conthour Integer Recommended Contact time hour
Query contmins Integer Recommended Contact time minutes
Query cschange Integer Recommended Change in clinical status 0;1;-7 0=No; 1=Yes; -7=Refused
Query newcs Integer Recommended New clinical status 1::9;-4;-5;-6;-7 1=Depression; 2=Mania; 3=Mixed/Cycling; 4=Hypomania; 5=Continued SXs; 6=Roughening; 7=Recovering; 8=Recovered; 9=Other Dx; -4=Missing; -5=N/A; -6=Unknown; -7=Refused
Query worsenep Integer Recommended Worsening of current episode 0;1;-7 0=No; 1=Yes; -7=Refused
Query specwors Integer Recommended Specify worsening episode 1::4;-4;-5;-6 1=Depression; 2=Hypomania; 3=Mixed; 4=Other, specify; -4=Missing; -5=N/A; -6=Unknown
Query specepi String 250 Recommended Specify current episode
Query aes Integer Recommended Have you had any physical or mental health problems since your last visit? 0;1 0 = No; 1 = Yes
Query newaes Integer Recommended New adverse effects 0;1;-7 0=No; 1=Yes; -7=Refused
newae1 String 250 Recommended Specify new adverse effect 1
newae2 String 250 Recommended Specify new adverse effect 2
Query newae3 String 250 Recommended Specify new adverse effect 3
Query worseaes Integer Recommended Worsening adverse effects 0;1;-7 0=No; 1=Yes; -7=Refused
worseae1 String 250 Recommended Specify worsening adverse effect 1
Query worseae2 String 250 Recommended Specify worsening adverse effect 2
Query worseae3 String 250 Recommended Specify worsening adverse effect 3
Query newcomor Integer Recommended New comorbid condition 0;1;-7 0=No; 1=Yes; -7=Refused
Query comorpsy Integer Recommended New comorbid psych condition 0;1;-7 0=No; 1=Yes; -7=Refused
specpsy String 250 Recommended Specify psych comorbidity
Query comormed Integer Recommended New comorbid general medical condition 0;1;-7 0=No; 1=Yes; -7=Refused
specmed String 250 Recommended Specify general medical comorbity
Query newstres Integer Recommended New stressors 0;1;-7 0=No; 1=Yes; -7=Refused
newstrs1 String 250 Recommended Specify new stressor 1
newstrs2 String 250 Recommended Specify new stressor 2
Query newstrs3 String 250 Recommended Specify new stressor 3
Query pcoshosp Integer Recommended patient hospitalized 0;1;-7 0=No; 1=Yes; -7=Refused
Query arrest Integer Recommended If you had any contacts with the police in the past month, how many resulted in your being picked up or arrested for any criminal activity in the past month?
Query txothpro Integer Recommended Treatment by another provider 0;1;-7 0=No; 1=Yes; -7=Refused
Query othconrs Integer Recommended Other reason for contact 0;1;-7 0=No; 1=Yes; -7=Refused
specreas String 250 Recommended Specify other contact reason
Query contobs Integer Recommended Continued observation 0;1;-7 0=No; 1=Yes; -7=Refused
Query refprov Integer Recommended Refer to other care provider 0;1;-7 0=No; 1=Yes; -7=Refused
Query othprov String 250 Recommended Other care provider
Query specprov String 250 Recommended Specify other care provider
Query fuvisit Integer Recommended New followup visit 0;1;-7 0=No; 1=Yes; -7=Refused
Query fudays Integer Recommended Followup visit days since RZ
Query helddose Integer Recommended Held medication dose 0;1;-7 0=No; 1=Yes; -7=Refused
Query medchng Integer Recommended Changes made to meds 0;1;-7 0=No; 1=Yes; -7=Refused
Query othinter Integer Recommended Other intervention 0;1;-7 0=No; 1=Yes; -7=Refused
specint String 250 Recommended Specify other intervention
Query medadd Integer Recommended Medications added 0;1;-7 0=No; 1=Yes; -7=Refused
medadd1 String 250 Recommended Medication added 1
othmeda1 String 250 Recommended Other medication added 1
Query adddose1 Float Recommended Added medication dosage 1
Query medadd2 String 250 Recommended Medication added 2
Query othmeda2 String 250 Recommended Other added medication 2 dast0
Query adddose2 Float Recommended Added MED2 dose mg 24hr TOTAL
Query prnadd1 String 250 Recommended Added PRN med 1
othprna1 String 250 Recommended Other added PRN 1
prnadd2 String 250 Recommended Added PRN med 2
othprna2 String 250 Recommended Other added PRN med 2
Query meddisc Integer Recommended Medication discontinued
0;1;-7
0=No; 1=Yes; -7=Refused
meddisc1 String 250 Recommended Medication discontinued 1
Query othmedd1 String 250 Recommended Other discontinued med 1
Query disdose1 Float Recommended Discontinued med 1 dose 24 hr
Query meddisc2 String 250 Recommended Medication discontinued 2
Query othmedd2 String 250 Recommended Other discontinued med 2
Query disdose2 Float Recommended Discontinued med 2 dose 24 hr
Query prndisc1 String 250 Recommended Discontinued PRN med 1
Query othprnd1 String 250 Recommended Other discontinued PRN med 1
Query prnddos1 Float Recommended Discontinued PRN 1 dose mg 24 hr total
Query prndisc2 String 250 Recommended Discontinued PRN med 2
othprnd2 String 250 Recommended Other discontinued PRN med 2
Query prnddos2 Float Recommended Discontinued PRN 2 dose mg 24 hr total
Query medadj Integer Recommended Medication adjustment 0;1;-7 0=No; 1=Yes; -7=Refused
medadj1 String 250 Recommended Medication 1 adjusted
Query othmedj1 String 250 Recommended Other adjusted med 1
Query adjdose1 Float Recommended Adjusted med 1 new dose 24 hr
Query med1ch Integer Recommended Adjusted med 1 increase/decrease 1;2 1=Increase; 2=Decrease
Query medadj2 String 250 Recommended Medication 2 adjusted
Query othmedj2 String 250 Recommended Other adjusted med 2
Query adjdose2 Float Recommended Adjusted med 2 new dose 24 hr
Query med2ch Integer Recommended Adjusted med 2 increase/decrease 1;2 1=Increase; 2=Decrease
Query prnadj1 String 250 Recommended Adjusted PRN med 1
othprnj1 String 250 Recommended Other adjusted PRN med 1
Query prnadjd1 Float Recommended Adjusted PRN 1 dose mg 24 hr
Query prn1ch Integer Recommended Adjusted PRN med 1 direction 1;2 1=Increase; 2=Decrease
Query prnadj2 String 250 Recommended Adjusted PRN med 2
othprnj2 String 250 Recommended Other adjusted PRN med 2
Query prnadjd2 Float Recommended Adjusted PRN 2 dose mg 24 hr
Query prn2ch Integer Recommended Adjusted PRN med 2 direction 1;2 1=Increase; 2=Decrease
othrae1 String 50 Recommended Other adverse effect 1
othrae2 String 50 Recommended Other adverse effect 2
othrae3 String 50 Recommended Other adverse effect 3
Query cgi_sii_0_7 Integer Recommended CGI SII 0 - 7 Improvment/change 0::7; 9 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; 9=NA
Query phase1 Integer Recommended SAE Emerged Phase 1 1= Yes if the SAE has a start date either during the phase or within 30 days of ending the phase; missing otherwise
Query phase2 Integer Recommended SAE Emerged Phase 2 1= Yes if the SAE has a start date either during the phase or within 30 days of ending the phase; missing otherwise
Query phase3 Integer Recommended SAE Emerged Phase 3 1=Yes if the SAE has a start date either during the phase or within 30 days of ending the phase; missing otherwise
Query se_b1 Integer Recommended Irritable, easily annoyed, touchy, (emotionally over-reactive) 0::4; -9 0=Absent, 1=Mild, 2=Moderate, 3=Severe'; 4= not done; -9=unknown
Query tdi_q4e Integer Recommended Trouble sleeping 0::3 0=Absent 1=Mild 2=Moderate 3=Severe
Query se_b19 Integer Recommended 19. Restless, high activity level 0::3; -9 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
Query se_b20 Integer Recommended 20. Easily excited 0::3; -9 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
Query aer035a Integer Recommended Disinhibited Behavior 0::3; -9 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
Query version_form String 121 Recommended Form used/assessment name
Query visit String 60 Recommended Visit name
Query week Float Recommended Week in level/study 99=week 10-week 14
Query cwm4c Integer Recommended Hostility. Becoming angry, argumentative. 0::3 0 = NOT PRESENT; 1 = MILD (no interference with functioning; 2 = MODERATE (interference in at least one area of functioning); 3 = SEVERE (prevents functioning in at least one area, or is a major threat to health)
Query cwm5c Integer Recommended Aggression. Verbal threats or physical aggression directed towards others. 0::3 0 = NOT PRESENT; 1 = MILD (no interference with functioning; 2 = MODERATE (interference in at least one area of functioning); 3 = SEVERE (prevents functioning in at least one area, or is a major threat to health)
Query cwm9c Integer Recommended Emotional lability. Mood swings, extreme changes in mood from neutral to strong emotions, either up or down. 0::3 0 = NOT PRESENT; 1 = MILD (no interference with functioning; 2 = MODERATE (interference in at least one area of functioning); 3 = SEVERE (prevents functioning in at least one area, or is a major threat to health)
Query cwm12c Integer Recommended Non-suicidal self injurious behavior. 0::3 0 = NOT PRESENT; 1 = MILD (no interference with functioning; 2 = MODERATE (interference in at least one area of functioning); 3 = SEVERE (prevents functioning in at least one area, or is a major threat to health)
Query cwm2i Integer Recommended Improvement: Problems Sleeping 0::3 0 = Improved; 1 = Worsened; 2 = Same; 3 = Don't know
Query cwm3i Integer Recommended Improvement: Irritability 0::3 0 = Improved; 1 = Worsened; 2 = Same; 3 = Don't know
Query cwm4i Integer Recommended Improvement: Hostility 0::3 0 = Improved; 1 = Worsened; 2 = Same; 3 = Don't know
Query cwm5i Integer Recommended Improvement: Aggression 0::3 0 = Improved; 1 = Worsened; 2 = Same; 3 = Don't know
Query cwm6i Integer Recommended Improvement: Restlessness 0::3 0 = Improved; 1 = Worsened; 2 = Same; 3 = Don't know
Query cwm7i Integer Recommended Improvement: Tremors. Shaking. 0::3 0 = Improved; 1 = Worsened; 2 = Same; 3 = Don't know
Query cwm8i Integer Recommended Improvement: Overexcitement 0::3 0 = Improved; 1 = Worsened; 2 = Same; 3 = Don't know
Query cwm9i Integer Recommended Improvement: Emotional lability. Mood swings. 0::3 0 = Improved; 1 = Worsened; 2 = Same; 3 = Don't know
Query cwm10i Integer Recommended Improvement: Disinhibition. Lack of Self Control 0::3 0 = Improved; 1 = Worsened; 2 = Same; 3 = Don't know
Query cwm11i Integer Recommended Improvement: Altered thinking. Trouble with memory, concentration, or motivation. 0::3 0 = Improved; 1 = Worsened; 2 = Same; 3 = Don't know
Query cwm12i Integer Recommended Improvement: Non-suicidal self injurious 0::3 0 = Improved; 1 = Worsened; 2 = Same; 3 = Don't know
Query days_baseline Integer Recommended Days since baseline
Query se_b18 Integer Recommended 18. Anxiety, fear, nervousness 0::4; -9 0=Absent, 1=Mild, 2=Moderate, 3=Severe'; 4= not done; -9=unknown
Query aesa18 Integer Recommended Akathisia/activation: Have you had any problems with a sense of inner restlessness, or a feeling that you need tomove? Have you had difficulty sitting or standing still due to this restless feeling? (Severe = individual is unable to maintain any position for more than a few seconds) 0;1;2;3 0=Absent; 1=Mild; 2=Moderate; 3=Severe
Query exambat220 Integer Recommended Agitation 0::3 0=None;1=Mild;2=Moderate;3=Severe
Query aer030a Integer Recommended Confusion 0::3; -9 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown
Query impulsvn Integer Recommended Impulsiveness 0::3 0=Absent; 1=Mild; 2=Moderate; 3=Severe
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.

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