|
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 |
|
|
CATIEID, id, pid, stepid, subjectid, subjid |
|
interview_date |
Date |
|
Required |
Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY |
|
|
visit_date |
|
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
|
hardcode |
String |
1,200
|
Recommended |
Significant Protocol Violation |
|
Textual description of the protocol violation
|
pdevdes |
Query
|
violate |
Integer |
|
Recommended |
Protocol Violation |
0;1
|
0=No; 1-Yes
|
|
Query
|
inc1 |
Integer |
|
Recommended |
If NO, which criteria have not been met: 18-65 years not met |
0;1
|
0=No; 1-Yes
|
|
Query
|
inc2 |
Integer |
|
Recommended |
If NO, which criteria have not been met: DSM-IV criteria for schizophrenia |
0;1
|
0=No; 1-Yes
|
|
Query
|
inc3 |
Integer |
|
Recommended |
If NO, which criteria have not been met: Appropriate for treatment with an oral drugs |
0;1
|
0=No; 1-Yes
|
|
Query
|
inc4 |
Integer |
|
Recommended |
If NO, which criteria have not been met: Demonstrated adequate decisional capability |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc1 |
Integer |
|
Recommended |
If YES, which criteria have been met: Other cog. Disorder not met |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc2 |
Integer |
|
Recommended |
If YES, which criteria have been met: Serious adverse reaction to even one of the proposed treatment arms? |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc3 |
Integer |
|
Recommended |
If YES, which criteria have been met: In first episode of schizophrenia |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc4 |
Integer |
|
Recommended |
If YES, which criteria have been met: Well-documented history of failure toto respond to even one of the proposed treatment arms? |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc5 |
Integer |
|
Recommended |
If YES, which criteria have been met: Treated with clozapine for treatment resistance? |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc6 |
Integer |
|
Recommended |
If YES, which criteria have been met: Currently stabilized on haloperidol decanoate or fluphenazine decanoate and clinically judged to require this for medication adherence? |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc7 |
Integer |
|
Recommended |
If YES, which criteria have been met: Pregnant or currently breastfeeding |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc9 |
Integer |
|
Recommended |
If YES, which criteria have been met: Contraindication to a study drug |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc10 |
Integer |
|
Recommended |
If YES, which criteria have been met: Serious and unstable medical condition |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc11 |
Integer |
|
Recommended |
If YES, which criteria have been met: Taken another investigational drug within 30 days of baseline? |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc12 |
Integer |
|
Recommended |
If YES, which criteria have been met: Recent myocardial infarction (<6 months)? |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc13 |
Integer |
|
Recommended |
If YES, which criteria have been met: QTc prolongation (screening ECG with QTc > 450 msec for men, QTc > 470 msec for women? |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc14 |
Integer |
|
Recommended |
If YES, which criteria have been met: History of congenital QTc prolongation? |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc15 |
Integer |
|
Recommended |
If YES, which criteria have been met: Sustained cardiac arrhythmia or history of sustained cardiac arrhythmia? |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc16 |
Integer |
|
Recommended |
If YES, which criteria have been met: Uncompensated congestive heart failure? |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc17 |
Integer |
|
Recommended |
If YES, which criteria have been met: Complete Left Bundle Branch Block (LBBB)? |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc18 |
Integer |
|
Recommended |
If YES, which criteria have been met: First-degree heart block with PR interval > or = .22 second? |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc19 |
Integer |
|
Recommended |
If YES, which criteria have been met: Concurrent treatment with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin..? |
0;1
|
0=No; 1-Yes
|
|
Query
|
exc8 |
Integer |
|
Recommended |
If YES, which criteria have been met: Tardive dyskinesia |
0;1
|
0=No; 1-Yes
|
|
Query
|
realtrt |
String |
50
|
Recommended |
Actual treatment received |
|
For patients who received incorrect study drug, this is the actual treatment they received
|
|
Query
|
rt_dur |
Integer |
|
Recommended |
Duration on incorrect study drug (days) |
|
For patients who received incorrect study drug, this is the number of days they received the incorrect study drug
|
|
Query
|
rt_day |
Integer |
|
Recommended |
Day incorrect study drug dispensed |
|
For patients who received incorrect study drug, this is the day (in relation to the baseline visit date) they received the incorrect study drug
|
firstdt1 |
Query
|
rtphase |
Integer |
|
Recommended |
Phase |
1::4
|
Phase in which patient received incorrect study drug; 1=1; 2=2; 1A=3; 1B=4
|
|
|
rtaction |
String |
100
|
Recommended |
Action taken |
|
For patients who received incorrect study drug, this is the action taken once it was discovered
|
|
Query
|
unbl_11a |
Integer |
|
Recommended |
Unblinded patients after successful completion of the phase 1/1A |
0;1
|
0=No; 1-Yes
|
|
Query
|
unbl_1b |
Integer |
|
Recommended |
Unblinded patients after successful completion of the phase 1B |
0;1
|
0=No; 1-Yes
|
|
Query
|
unbl_2 |
Integer |
|
Recommended |
Unblinded patients after successful completion of the phase 2 |
0;1
|
0=No; 1-Yes
|
notblind |
|
crcid |
String |
40
|
Recommended |
CRC ID/ROA ID |
|
|
|
|
level |
String |
10
|
Recommended |
Treatment level |
|
|
pphase |
Query
|
week |
Float |
|
Recommended |
Week in level/study |
|
99=week 10-week 14
|
intid, week_i |
Query
|
hand_date |
Integer |
|
Recommended |
reported date |
|
|
date |
Query
|
update |
Integer |
|
Recommended |
Updated form |
0;1
|
1= yes; 0= no
|
|
Query
|
inelg |
Integer |
|
Recommended |
Enrolled subject found to be ineligible |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
inelgs |
String |
250
|
Recommended |
Ineligible reason |
|
|
devenrol |
Query
|
exclmed |
Integer |
|
Recommended |
Concomitant use of excluded medications |
0;1
|
0=Not checked; 1=Checked
|
|
|
asispme |
String |
200
|
Recommended |
Specify medication by name |
|
|
exclmeds |
Query
|
prtclmed |
Integer |
|
Recommended |
Patient was noncompliant with protocol medications |
0;1
|
0=Not checked; 1=Checked
|
|
|
medication_name |
String |
255
|
Recommended |
Name of medication |
|
|
medname |
Query
|
q14_cd_s |
String |
100
|
Recommended |
Other medication: Specify |
|
|
medname_2 |
|
medexpl |
String |
250
|
Recommended |
Med explanation |
|
|
|
Query
|
no_roa |
Integer |
|
Recommended |
ROA assessment not completed |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
roacntct |
Integer |
|
Recommended |
ROA Contact |
1::3
|
1=Baseline; 2=Level exit; 3=Follow up
|
|
Query
|
roamnth |
Float |
|
Recommended |
ROA Month |
|
|
|
Query
|
roa |
Integer |
|
Recommended |
ROA |
0;1
|
0=No patient contact; 1=Form partially completed
|
|
Query
|
roarsns |
String |
250
|
Recommended |
ROA Form partially completed - Explain |
|
|
|
Query
|
raref |
Integer |
|
Recommended |
ROA - Patient refused |
|
|
|
Query
|
cvdr |
Integer |
|
Recommended |
Clinician cancelled scheduled visit |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
cvpt |
Integer |
|
Recommended |
Patient missed a scheduled clinic visit |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
incform |
Integer |
|
Recommended |
Visit took place, one or more forms missing or incomplete |
0;1
|
0=Not checked; 1=Checked
|
|
Query
|
cvoth |
Integer |
|
Recommended |
Missed visit - Other reason |
0;1
|
0=Not checked; 1=Checked
|
|
|
cvoths |
String |
250
|
Recommended |
Missed visit - Other reason explain |
|
|
|
Query
|
form_sc |
Integer |
|
Recommended |
SC form |
0;1
|
0=Missing; 1=Partially completed
|
sc |
Query
|
scrsns |
String |
250
|
Recommended |
SC form reason |
|
|
|
Query
|
form_el |
Integer |
|
Recommended |
EL form |
0;1
|
0=Missing; 1=Partially completed
|
el |
Query
|
elrsns |
String |
250
|
Recommended |
EL form reason |
|
|
|
Query
|
form_dm |
Integer |
|
Recommended |
DM form |
0;1
|
0=Missing; 1=Partially completed
|
dm |
Query
|
dmrsns |
String |
250
|
Recommended |
DM form reason |
|
|
|
Query
|
form_crs |
Integer |
|
Recommended |
CRS form |
0;1
|
0=Missing; 1=Partially completed
|
crs |
Query
|
crsrsns |
String |
250
|
Recommended |
CRS form reason |
|
|
|
Query
|
form_mhx |
Integer |
|
Recommended |
MHX form |
0;1
|
0=Missing; 1=Partially completed
|
mh, mhx |
Query
|
mhxrsns |
String |
250
|
Recommended |
MHX form reason |
|
|
|
Query
|
form_phx |
Integer |
|
Recommended |
PHX form |
0;1
|
0=Missing; 1=Partially completed
|
phx |
Query
|
phxrsns |
String |
250
|
Recommended |
PHX form reason |
|
|
|
Query
|
form_pds |
Integer |
|
Recommended |
PDS form |
0;1
|
0=Missing; 1=Partially completed
|
pds |
|
pdsrsns |
String |
250
|
Recommended |
PDS form reason |
|
|
|
Query
|
form_qh |
Integer |
|
Recommended |
QH form |
0;1
|
0=Missing; 1=Partially completed
|
qh |
|
qhrsns |
String |
250
|
Recommended |
QH form reason |
|
|
|
Query
|
form_qs |
Integer |
|
Recommended |
QS form |
0;1
|
0=Missing; 1=Partially completed
|
qs |
|
qsrsns |
String |
250
|
Recommended |
QS form reason |
|
|
|
Query
|
form_qc |
Integer |
|
Recommended |
QC form |
0;1
|
0=Missing; 1=Partially completed
|
qc, qids |
|
qcrsns |
String |
250
|
Recommended |
QC form reason |
|
|
|
Query
|
form_prs |
Integer |
|
Recommended |
PRS form |
0;1
|
0=Missing; 1=Partially completed
|
prs |
|
prsrsns |
String |
250
|
Recommended |
PRS form reason |
|
|
|
Query
|
form_fg |
Integer |
|
Recommended |
FG form |
0;1
|
0=Missing; 1=Partially completed
|
fg |
|
fgrsns |
String |
250
|
Recommended |
FG form reason |
|
|
|
Query
|
form_cc |
Integer |
|
Recommended |
CC form |
0;1
|
0=Missing; 1=Partially completed
|
cc |
|
ccrsns |
String |
250
|
Recommended |
CC form reason |
|
|
|
Query
|
form_ct |
Integer |
|
Recommended |
CT form |
0;1
|
0=Missing; 1=Partially completed
|
ct |
Query
|
ctrsns |
String |
250
|
Recommended |
CT form reason |
|
|
|
Query
|
form_tc |
Integer |
|
Recommended |
TC form |
0;1
|
0=Missing; 1=Partially completed
|
tc |
Query
|
tcrsns |
String |
250
|
Recommended |
TC form reason |
|
|
|
Query
|
other |
Integer |
|
Recommended |
Other prevent dose increase |
0;1;999
|
0 = No; 1 = Yes
|
pdevoth |
|
othersp |
String |
1,000
|
Recommended |
Other protocol deviation specify |
|
|
devother, pdvothtx |
|
firstdt |
Date |
|
Recommended |
Date of first use of excluded medication |
|
|
|
|
noncmpdt |
Date |
|
Recommended |
Date non compliance with protocol medication began |
|
|
|
|
reqdt |
Date |
|
Recommended |
Date contact requested or due |
|
|
|
|
cntctdt |
Date |
|
Recommended |
Date of contact |
|
|
|
|
rarefdt |
Date |
|
Recommended |
Date patient refused ROA |
|
|
|
|
vstdate |
Date |
|
Recommended |
Visit date |
|
|
|
|
cntctm |
String |
10
|
Recommended |
Time of contact |
|
|
|
|
rareftm |
String |
10
|
Recommended |
Time patient refused ROA |
|
|
|
Query
|
roanot |
Integer |
|
Recommended |
ROA Not |
|
|
|
|
date_reported |
Date |
|
Recommended |
Date reported |
|
|
|
Query
|
ivr_err |
Float |
|
Recommended |
IVR error |
|
|
|
Query
|
daysrz |
Integer |
|
Recommended |
days since randomization |
|
|
|
Query
|
visit |
String |
60
|
Recommended |
Visit name |
|
|
o3week, vstdev |
Query
|
rcpoff |
Integer |
|
Recommended |
rcp off protocol category |
1;2
|
1=Lost to RCP timepoint; 2=Protocol violation
|
|
Query
|
whymissd |
Integer |
|
Recommended |
reason missed timepoint |
1::6
|
1=Patient out of town; 2=Patient could not be located; 3=Patient could not be scheduled due to other commitments; 4=Patient too ill; 5=Hospitalization; 6=Other
|
|
Query
|
speclost |
String |
250
|
Recommended |
Spec lost |
|
|
|
Query
|
pv21days |
Integer |
|
Recommended |
protocol violation 21 days |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pv28days |
Integer |
|
Recommended |
protocol violation 28 days |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pvmissed |
Integer |
|
Recommended |
proto viol missed assessments |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
dqmissed |
Integer |
|
Recommended |
dietary questionairre missing |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
mhumiss |
Integer |
|
Recommended |
menstrual history update miss |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
cmfmiss |
Integer |
|
Recommended |
CMF missing |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
ymrs |
Integer |
|
Recommended |
YMRS missing |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
madrsmis |
Integer |
|
Recommended |
MADRS missing |
0;1;-7; -9999
|
0=No; 1=Yes; -7=Refused; -9999=NK/NA/Missing
|
|
Query
|
labmiss |
Integer |
|
Recommended |
lab form missed |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
tpnmiss |
Integer |
|
Recommended |
therarpy prog note missed |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pvout |
Integer |
|
Recommended |
protocol violation out of town |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pvnloc |
Integer |
|
Recommended |
protocol violation not located |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pvnsch |
Integer |
|
Recommended |
protocol violation not schedul |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pvtooill |
Integer |
|
Recommended |
protocol violation too ill |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pvhosp |
Integer |
|
Recommended |
protocol violation hospital |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
pvoth |
Integer |
|
Recommended |
protocol violation other |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
other_prot |
Query
|
incmasmt |
Integer |
|
Recommended |
patient unwill unable complete assessments |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
unable |
Query
|
noreturn |
Integer |
|
Recommended |
pt assessments not returned |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
notretrn |
Query
|
incmpcra |
Integer |
|
Recommended |
clinician rated incomplete |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
noattend |
Integer |
|
Recommended |
pt did not attend sched eval |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
miss_vis |
Query
|
incdthos |
Integer |
|
Recommended |
assessments incompl dt hosp |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
late |
Integer |
|
Recommended |
assessments after halfway pt |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
Query
|
othmiss |
Integer |
|
Recommended |
other reason assessment missed |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
missoth |
Query
|
site |
String |
101
|
Recommended |
Site |
|
Study Site
|
site_id, site_uid, siteid |
Query
|
certcode |
Integer |
|
Recommended |
stepbd certification code |
|
|
|
|
session_id |
String |
20
|
Recommended |
session ID/screening ID |
|
|
screeningid |
|
version_form |
String |
121
|
Recommended |
Form used/assessment name |
|
|
form_name |
Query
|
pdevid |
Integer |
|
Recommended |
Deviation number |
|
|
|
|
pdevdtds |
Date |
|
Recommended |
Date Deviation Discovered |
|
|
|
|
pdevdt |
Date |
|
Recommended |
Date Deviation Occurred |
|
|
|
|
pdevvsto |
String |
30
|
Recommended |
Other visit |
|
|
|
Query
|
pdevsev |
Integer |
|
Recommended |
Deviation Severity |
1;2
|
1=Minor; 2=Major
|
|
Query
|
pdevtyp |
Integer |
|
Recommended |
Deviation Type |
1::10
|
1. Eligibility deviation; 2. Informed Consent Violation; 3. Study drug not taken/dispensed per protocol; 4. Concomitant medication restriction violated; 5. Study procedure violated; 6. Visit deviation; 7. Safety; 8. Safety Labs deviation; 9. IRB Procedures; 10. Other
|
|
Query
|
pdevelig |
Integer |
|
Recommended |
Eligibility Deviation |
11
|
11=1a. Enrollment of a subject who did not meet inclusion or exclusion criteria
|
|
Query
|
pdevic |
Integer |
|
Recommended |
Informed Consent |
21::25
|
21=2a. No documentation of informed consent;22=2b. Informed consent obtained after initiation of procedures;23=2c. Informed consent obtained by someone other than authorized individuals; 24=2d. Missing/Inappropriate documentation of informed consent; 25=2e. Subject signed expired or incorrect version of the consent form
|
|
Query
|
pdevsdrg |
Integer |
|
Recommended |
Study Drug not per protocol |
31;32
|
31=3a. Dosing compliance; 32=3b. Dispensing error
|
|
Query
|
pdevcmed |
Integer |
|
Recommended |
Concomitant Medications |
41;42
|
41=4a. Patient started exclusionary medication during the study; 42=4b. Required supplemental medication discontinued or interrupted during the study per protocol
|
|
Query
|
pdevproc |
Integer |
|
Recommended |
Study Procedure |
51::56
|
51=5a. Study procedure performed that is not approved by the IRB and/or is not in the protocol; 52=5b. Study procedure not performed or not performed properly that in the opinion of the Site Investigator, may affect subject safety or data integrity; 53=5c. Study test/scale not performed or not performed properly that in the opinion of the Site Investigator, may affect subject safety or data integrity; 54=5d. Study procedure not performed or not performed properly that in the opinion of the Site Investigator, does not affect subject safety or data integrity; 55=5e. Study test/scale not performed or not performed properly that in the opinion of the Site Investigator, does not affect subject safety or data integrity; 56=5f. Study procedure conducted out of sequence
|
|
Query
|
pdevvst |
Integer |
|
Recommended |
Visit deviation |
61::63
|
61=6a. Visit not done; 62=6b. Study visit conducted outside of required timeframe that, in the opinion of the PI, may affect subject safety; 63=6c. Visit done out of window
|
|
Query
|
pdevsft |
Integer |
|
Recommended |
Safety |
71::73
|
71=7a. Failure to implement changes necessary to eliminate apparent immediate hazards to the subject; 72=7b. Failure to report serious adverse event (SAE) per protocol to the IRB or Coordination Center; 73=7c. Failure to follow safety (AE) management plan
|
|
Query
|
pdevslb |
Integer |
|
Recommended |
Other deviation |
81; 82
|
81=8a. Missing lab results; 82=8b. Missing Biomarker or Genetics Collection
|
|
Query
|
pdevirb |
Integer |
|
Recommended |
IRB Deviation |
91::94
|
91=9a. Implementation of unapproved recruitment procedures; 92=9b. Over-enrollment; 93=9c. Enrollment of subjects after IRB approval of the study has expired; 94=9d. Failure to submit a continuing review application to the IRB before study expiration
|
|
|
pdevcapa |
String |
1,200
|
Recommended |
Description of Corrective Action |
|
|
|
Query
|
q1_14a1 |
Integer |
|
Recommended |
Medication Code 1 |
1 :: 2099
|
|
medcode |
Query
|
q1_14b1 |
Integer |
|
Recommended |
Medication Code 2 |
1 :: 2099
|
|
medcode_2 |
Query
|
prtclwin |
Integer |
|
Recommended |
Visit took place outside of protocol window |
0;1
|
0=No;1=Yes
|
|
Query
|
uncert |
Integer |
|
Recommended |
Uncertified Rater |
0;1
|
0=No;1=Yes
|
|
Query
|
rateathf |
Integer |
|
Recommended |
Uncertified-ATHF/ATF |
0;1
|
0=No;1=Yes
|
|
Query
|
rateham |
Integer |
|
Recommended |
Uncertified- HAM |
0;1
|
0=No;1=Yes
|
|
Query
|
ratepsr |
Integer |
|
Recommended |
Uncertified- LIFE/PSR |
0;1
|
0=No;1=Yes; (Note: PSR (Follow-up LIFE);Although the LIFE RIFT(LR) is administered by a rater, there is no certification necessary for the REVAMP LR. )
|
|
Query
|
ratescid |
Integer |
|
Recommended |
Uncertified-SCID/FSCID |
0;1
|
0=No;1=Yes
|
|
Query
|
preg |
Integer |
|
Recommended |
patient become pregnant |
0;1;-7
|
0=No; 1=Yes; -7=Refused
|
|
|
duedate |
String |
30
|
Recommended |
Due date |
|
|
duedt |
Query
|
phase_discont |
Integer |
|
Recommended |
Phase of violation |
|
|
phase_i |
Query
|
form_ham |
Integer |
|
Recommended |
HAM form |
0;1
|
0=No;1=Yes
|
ham |
Query
|
form_ivc |
Integer |
|
Recommended |
IVC Form |
0;1
|
0=No;1=Yes
|
ivs |
Query
|
form_ml |
Integer |
|
Recommended |
ML Form |
0;1
|
0=No;1=Yes
|
ml |
Query
|
form_pe |
Integer |
|
Recommended |
PE form |
0;1
|
0=No;1=Yes
|
pe |
Query
|
form_po |
Integer |
|
Recommended |
PO form |
0;1
|
0=No;1=Yes
|
po |
Query
|
form_ased |
Integer |
|
Recommended |
ASED form |
0;1
|
0=No;1=Yes
|
asex |
Query
|
form_athf |
Integer |
|
Recommended |
ATHF form |
0;1
|
0=No;1=Yes
|
athf |
Query
|
form_das |
Integer |
|
Recommended |
DAS form |
0;1
|
0=No;1=Yes
|
das |
Query
|
form_deq |
Integer |
|
Recommended |
DEQ form |
0;1
|
0=No;1=Yes
|
deq |
Query
|
form_ewps |
Integer |
|
Recommended |
EWPS form |
0;1
|
0=No;1=Yes
|
ewps |
Query
|
form_fad |
Integer |
|
Recommended |
FAD form |
0;1
|
0=No;1=Yes
|
fad |
Query
|
form_idsc |
Integer |
|
Recommended |
IDSC form |
0;1
|
0=No;1=Yes
|
idsc |
Query
|
form_isr |
Integer |
|
Recommended |
ISR form |
0;1
|
0=No;1=Yes
|
idssr |
Query
|
form_lr |
Integer |
|
Recommended |
LR form |
0;1
|
0=No;1=Yes
|
lr |
Query
|
form_masq |
Integer |
|
Recommended |
MASQ form |
0;1
|
0=No;1=Yes
|
masq |
Query
|
form_mops |
Integer |
|
Recommended |
MOPS form |
0;1
|
0=No;1=Yes
|
mops |
Query
|
form_pabs |
Integer |
|
Recommended |
PABS form |
0;1
|
0=No;1=Yes
|
pabs |
Query
|
form_qmi |
Integer |
|
Recommended |
QMI form |
0;1
|
0=No;1=Yes
|
qmi |
Query
|
form_sas |
Integer |
|
Recommended |
SAS form |
0;1
|
0=No;1=Yes
|
sas |
Query
|
form_scid |
Integer |
|
Recommended |
SCID form |
0;1
|
0=No;1=Yes
|
scid |
Query
|
form_fscid |
Integer |
|
Recommended |
FSCID form |
0;1
|
0=No;1=Yes
|
fscid |
Query
|
form_sp36 |
Integer |
|
Recommended |
SF36 form |
0;1
|
0=No;1=Yes
|
sf36 |
Query
|
form_spsi |
Integer |
|
Recommended |
SPSI form |
0;1
|
0=No;1=Yes
|
spsi |
Query
|
form_teq1 |
Integer |
|
Recommended |
TEQ1 form |
0;1
|
0=No;1=Yes
|
teq1 |
Query
|
form_teq2 |
Integer |
|
Recommended |
TEQ2 form |
0;1
|
0=No;1=Yes
|
teq2 |
Query
|
form_waic |
Integer |
|
Recommended |
WAIC form |
0;1
|
0=No;1=Yes
|
waic |
Query
|
form_wait |
Integer |
|
Recommended |
WAIT form |
0;1
|
0=No;1=Yes
|
wait |
Query
|
form_bpt |
Integer |
|
Recommended |
BPT Form |
0;1
|
0=No;1=Yes
|
bpt |
Query
|
form_psr |
Integer |
|
Recommended |
PSR Form |
0;1
|
0=No;1=Yes
|
psr |
Query
|
rtda3 |
Integer |
|
Recommended |
Was study treatment discontinued for administrative reasons? |
0;1
|
1=Yes; 0=No;Note: This implies that both the patient and the clinical staff judge the assigned antipsychotic treatment to be a success (i.e. adequately effective, with tolerable or no side effects), and that treatment would have continued if not for the administrative reason independent of the study procedures.
|
admin |
Query
|
noncmpdt1 |
Integer |
|
Recommended |
Date of non-compliance (in days) |
|
|
daydev |
Query
|
visday |
Integer |
|
Recommended |
Number of days from study baseline to date of visit |
|
|
date1, date_form |
Query
|
phase |
Integer |
|
Recommended |
Phase |
|
9 =follow up
|
|
Query
|
med2b |
Integer |
|
Recommended |
Visit Day |
|
Number of days from study baseline to date of visit
|
|
Query
|
scidrevw |
Integer |
|
Recommended |
SCID review |
1
|
1=Yes
|
|
Query
|
ad_inc1 |
Integer |
|
Recommended |
Clinical diagnosis of Dementia of the Alzheimers Type (DSM-IV) or NINCDS/
ADRDA criteria for possible or probable Alzheimers disease (McKhann et al.,
1984). |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_inc2 |
Integer |
|
Recommended |
Outpatient living at home, in residential care, or assisted living (not nursing
home). |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_inc3 |
Integer |
|
Recommended |
Ambulatory, able to ambulate independently or with a cane or 4-point walker, but
not bed- or wheelchair- bound. |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_inc4 |
Integer |
|
Recommended |
MMSE score between 5 and 26 inclusive |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_inc5 |
Integer |
|
Recommended |
Presence of delusions, hallucinations, or agitation/aggression, severe enough to
disrupt the patients functioning, and severe enough, in the opinion of the
investigator, to justify medication treatment. |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_inc6 |
Integer |
|
Recommended |
The delusions, hallucinations, or agitation/aggression have occurred nearly
everyday over the previous week, or at least intermittently over 4 weeks |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_inc7 |
Integer |
|
Recommended |
A score of moderate or higher (score of ? 3) on any one of the following BPRS
items: |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_inc8 |
Integer |
|
Recommended |
Onset of the psychotic or agitation/aggression must have been after the onset of
cognitive and functional signs or symptoms of dementia. |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_inc9 |
Integer |
|
Recommended |
Must have an informant who lives with, or visits the patient at least 8 hours per
week over at least 3-4 days per week. |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_inc10 |
Integer |
|
Recommended |
Informed consent from patient and legal representative, or assent from the
patient and informed consent from the representative according to relevant state
laws |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_inc11 |
Integer |
|
Recommended |
The results of laboratory screening studies (see below) are not inconsistent with
a psychosis of Alzheimers disease or agitation not due to a medical cause. |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_exc1 |
Integer |
|
Recommended |
Receiving and benefiting from psychotropic medication treatment |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_exc2 |
Integer |
|
Recommended |
Fulfills criteria for schizophrenia, schizoaffective disorder, delusional disorder,
or mood disorder with psychotic features |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_exc3 |
Integer |
|
Recommended |
Fulfills criteria for delirium |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_exc4 |
Integer |
|
Recommended |
Has a psychosis, agitation, or aggression that could be better accounted for by
another general medical condition or direct physiological effects of a substance |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_exc5 |
Integer |
|
Recommended |
Fulfills criteria for probable vascular dementia (AIRENS-NINDS criteria) |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_exc6 |
Integer |
|
Recommended |
Fulfills criteria for Lewy body variant of AD (McKeith criteria) |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_exc7 |
Integer |
|
Recommended |
Severe or unstable medical illness treatment |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_exc8 |
Integer |
|
Recommended |
In need of psychiatric admission in judgment of study site or local physicians |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_exc9 |
Integer |
|
Recommended |
Acutely suicidal or has persistent suicidal intent |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_exc10 |
Integer |
|
Recommended |
Previous or current treatment with any two of the three atypical antipsychotic
study medications or with citalopram |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_exc11 |
Integer |
|
Recommended |
Current use of antidepressants or anticonvulsants |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_exc12 |
Integer |
|
Recommended |
Current plans to start a cholinesterase inhibitor or antidepressant medication
during the subsequent 24 weeks ( patient may be currently receiving stable
doses of a cholinesterase inhibitor) |
0;1
|
0=No; 1=Yes
|
|
Query
|
ad_exc13 |
Integer |
|
Recommended |
Hypersensitivity or absolute contraindications to any of the study medications |
0;1
|
0=No; 1=Yes
|
|
Query
|
unbl_p1 |
Integer |
|
Recommended |
Phase 1 blind broken - doing well at com |
1
|
1=patients who were unblinded after successful completion of the phase
|
|
Query
|
unbl_p2 |
Integer |
|
Recommended |
Phase 2 blind broken - doing well at com |
1
|
1= patients who were unblinded after successful completion of the phase
|
|
Query
|
timept |
Integer |
|
Recommended |
Time Point |
|
888 = not applicable; 999 = missing
|
|
Query
|
daywaiver |
Integer |
|
Recommended |
Study Day of Waiver |
|
|
|
Query
|
dayasmnt |
Integer |
|
Recommended |
Study Day of Assessment |
|
|
|
Query
|
deviation |
Integer |
|
Recommended |
Deviation Category |
1::12
|
1= Ineligible subject enrolled;2= Concomitant use of excluded medication;3 = Concomitant use of excluded psycho-social treatment;4 = Assessment completed outside of protocol-designed window;5 = Assessment not completed;6 = Dosage outside of prescribed dosing schedule;7 = Inclusion / exclusion criterion waived;8 = Other; 9 = Safety issues; 10 = Consent issues; 11 = Enrollment issues; 12 = Protocol implementation issues
|
|
|
devconrx |
String |
60
|
Recommended |
Specify Excluded Medication |
|
|
|
Query
|
devcontx |
Integer |
|
Recommended |
Specify Excluded Psycho-social Treatment |
|
|
|
|
devvisit |
String |
50
|
Recommended |
Details of Out-of-Window Assessment |
|
|
|
Query
|
devdays |
Integer |
|
Recommended |
Days Out-Of-Window |
|
|
|
|
devvisitreason |
String |
50
|
Recommended |
Why was Assessment Out-Of-Window? |
|
|
|
Query
|
window |
Integer |
|
Recommended |
Which assessment window was violated |
|
-1 = Gate B to Gate C1 (28 days);0 = Gate C1 to Gate C2 (7 days);12 = Assessment 12 (+/- 5 days);24 = Assessment 24 (+/- 10 days);36 = Assessment 36 (+/- 10 days)
|
|
|
devmav |
String |
50
|
Recommended |
Reason Assessment was Missed |
|
|
|
|
devmavcode |
String |
100
|
Recommended |
Coded Reason for Missed Assessment |
|
|
|
Query
|
assesmnt |
Integer |
|
Recommended |
Which Assessment was Not Completed? |
0;4;8;12;24;36
|
0 = Gate C1 to Gate C2;4 = Week 4;8 = Week 8;12 = Week 12;24 = Week 24;36 = Week 36
|
|
|
devdosag |
String |
50
|
Recommended |
Describe Dosing Deviation |
|
|
|
|
devdosagetype |
String |
50
|
Recommended |
Type of Dosage Deviation |
|
|
|
|
devinex |
String |
50
|
Recommended |
Specify criterion waived |
|
|
|
Query
|
waiver |
Integer |
|
Recommended |
Patient did not meet all eligibility requirements but a waiver was granted during the caseness panel review |
0;1
|
0 = No 1 = Yes
|
|
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
|
phnphn |
String |
10
|
Recommended |
Two consecutive phone visits |
yes; no
|
|
|
Query
|
rand_med |
String |
10
|
Recommended |
Given med other than random assignment |
yes; no
|
|
|
Query
|
origarm |
String |
30
|
Recommended |
Assigned med |
bup+blue; ven+green; escit+orange
|
|
|
Query
|
givenarm |
String |
30
|
Recommended |
Med given |
bup+blue; ven+green; escit+orange
|
|
|
Query
|
nochron |
String |
10
|
Recommended |
No Chronic Depression at Baseline |
yes; no
|
|
|
|
missedform |
String |
250
|
Recommended |
Missed Form |
|
|
form |
|
missedvisit |
String |
10
|
Recommended |
Missed visit |
|
|
|
Query
|
trm_q3 |
Integer |
|
Recommended |
Date of study termination in days from the randomization/enrollment date (TRM_Q3 = Date of study termination - randomization/enrollment date) |
|
|
dateterm |
|
date_updated |
Date |
|
Recommended |
Date record updated |
|
|
edit_date |
Query
|
pdevnone |
Integer |
|
Recommended |
No deviations occurred for this subject |
|
1=Checked
|
|
Query
|
violationtype |
Integer |
|
Recommended |
Type of violation |
1::14
|
1 = Blind broken during trial to masked member of research team;2 = (Medication non-adherence: only applies if patient intends to stay in the study) Patient took less than 80% of prescribed medication during course of treatment;3 = (Medication non-adherence: as above) Patient has been off study medication longer than one week;4 = Patient took excluded medication during course of study;5 = Randomized patient did not meet study criteria;6 = Laboratory values for randomized patient were outside accepted parameters without documented justification;7 = Screening labs not completed (exception may be toxicology screens when subject has been inpatient for > 1 week);8 = Consent not signed;9 = Capacity not evaluated, or incorrectly evaluated;10=If in Lithium arm, discontinued Lithium; 11= If in OPT arm, started Lithium; 12= Medication recommendations by a non-LiTMUS physician; 13= Missed two consecutive study visits; 14= Other
|
|
Query
|
violationdays |
Integer |
|
Recommended |
Days from baseline violation occurred |
|
|
|
Query
|
study_id |
Integer |
|
Recommended |
Study ID number |
|
46=Acute Phase; 47=Stabilization Phase
|
|
Query
|
viol |
String |
30
|
Recommended |
Primary reason for the participant's protocol violation/deviation |
Early discont.; LLA; LVT; Non-Adherent; Rand. Err; Visit window; Sub Lack effic; Sub Side eff; Clin Lack effic; Clin Side eff; Treat site; Unwill proc; Unable cont; Interv ill; Other
|
Early discont.=Early treatment discontinuation; LLA=Start/stop/change LLA; LVT=Start/stop/change LVT ; Non-Adherent=Was not at least 50% adherent with taking study meds over the 5 months of follow-up (V7 ? V11) AND at least 50% adherent with taking study medsover the last month of the study (V11) ; Rand. Err=Randomization error ; Visit window=Outside visit window; Sub Lack effic=Subject's decision: Lack of efficacy of study medication; Sub Side eff=Subject's decision: Side effects of study medication; Clin Lack effic=Clinician's decision: Lack of efficacy of study medication; Clin Side eff=Clinician's decision: Side effects of study medication; Treat site=No longer wants to be treated at study site (or seeking treatment elsewhere); Unwill proc=Unwilling/unable to comply with study procedures; Unable cont=Unable to be contacted/schedule a follow-up; Interv ill=Intervening medical illness that precludes continued participaation in the study
|
|
Query
|
op_2 |
Integer |
|
Recommended |
Last study visit number the subject was still on protocol |
0;2;4;6;8;12;16;20;24
|
0=Baseline; 2=Week2; 4=Week4; 6=Week6; 8=Week8; 12=Week12; 16=Week16; 20=Week20; 24=Week24
|
|
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
|
op_stop |
Integer |
|
Recommended |
Days from date of subject went back on protocol to baseline visit date |
|
|
|
Query
|
signspt |
Integer |
|
Recommended |
Are there clinically significant Complaints or Signs Present? |
0;1
|
Yes=1; No=0
|
|
Query
|
exgrant |
Integer |
|
Recommended |
If protocol violation, was an exception granted? (Was patient allowed to continue with the study?) |
0;1
|
0 = No; 1 = Yes
|
|
Query
|
pv_irboff |
Integer |
|
Recommended |
Offset from randomization of IRB notification |
|
|
|
Query
|
rand_num |
Integer |
|
Recommended |
Randomization Number |
0::2
|
|
|
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
|
lineno |
Integer |
|
Recommended |
Line number (lines per participant) |
0::150
|
|
|
Query
|
irbrprt |
Integer |
|
Recommended |
Report to IRB |
1;2
|
1=Yes; 2=Doesn't fit criteria for IRB reporting
|
|
|
irbrptdt |
Date |
|
Recommended |
IRB report date |
|
|
|
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
|
pdcode |
Integer |
|
Recommended |
Deviation code number |
1::26
|
1. Not reporting a serious complication within 24 hours; 2. Appropriate labs not obtained for individuals on anticonvulsants; 3. Pregnancy test not performed for female of childbearing potential; 4. Reportable safety events not reported to IRB; 5. Abnormal lab values at entry not reviewed by Steering Committee; 7. Failure to obtain informed consent; 8. Consent form used was not current IRB-approved version; 9. Consent form does not include updates or information required by IRB; 10. Consent form missing; 11. Consent form not signed and dated by subject parent/guardian; 12. Consent form does not contain all required signatures; 13. Videotape consent not obtained prior to Baseline Visit; 15. Randomization of an ineligible child; 16. Subject is randomized prior to Baseline Diagnosis, Baseline Assessment, etc.; 17. Randomization and/or treatment of subject prior to IRB approval; 19. Failure to keep IRB approval up to date; 20. Subject receives wrong treatment; 21. Subject seen outside window of normal follow-up visits; 22. Subject did not meet response criteria but continued in study; 23. Use of unallowable concomitant treatments; 24. Prescribed dosing outside protocol guidelines; 25. Patient exceeded allowable weight gain and not exited from study; 26. Other, specify in table
|
|
|
scapv01 |
Date |
|
Recommended |
Date of Deviation (DD/MM/YYYY) |
|
|
|
|
scapv02 |
Integer |
|
Recommended |
Protocol Violation/Deviation Visit |
0::6
|
0=Screening ; 1=Baseline; 2=6 months; 3=Year 2; 4=Year 3; 5=Year 4; 6=Year 5
|
|
|
scapv03 |
Integer |
|
Recommended |
Date Deviation was Identified(DD/MM/YYYY |
|
|
|
|
scapv04 |
Integer |
|
Recommended |
Deviation Type: |
0::6
|
0=Informed Consent; 1=Eligibility criteria; 2=Laboratory Assesments/Procedures; 3=Study Procedures; 4=Serious Adverse Event Reporting; 5=Visit Schedule/Interval; 6=Other
|
|
|
scapv05 |
String |
150
|
Recommended |
Deviation Type: If other please describe |
|
|
|
|
scapv06 |
String |
250
|
Recommended |
Brief description of violation/deviation identified above: |
|
|
|
|
scapv07 |
Integer |
|
Recommended |
Meets International Review Board(IRB) reporting Requirements? |
0;1
|
0=No; 1=Yes
|
|
|
scapv08 |
Date |
|
Recommended |
If yes, International Review Boardf(IRB) Reporting Date: (DD/MM/YYYY) |
|
|
|
|
scapv09 |
String |
250
|
Recommended |
Action taken by the International Review Board(IRB): if any |
|
|
|
|
deviation_age |
Integer |
|
Recommended |
AGE IN MONTHS AT PROTOCOL DEVIATION |
|
|
|
|
devidentified_age |
Integer |
|
Recommended |
AGE IN MONTHS WHEN DEVIATION IDENTIFIED |
|
|
|
|
pinotified_age |
Integer |
|
Recommended |
AGE IN MONTHS WHEN PI NOTIFIED |
|
|
|
|
irbnotified_age |
Integer |
|
Recommended |
AGE IN MONTHS WHEN IRB NOTIFIED |
|
|
|
|
scapv02_a |
Integer |
|
Recommended |
Protocol Violation/Deviation Visit: Clinic/MR |
1;2
|
1=Clinic; 2=MR
|
|