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NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL

Medication Logs by Phase

703 Shared Subjects

N/A
Clinical Assessments
Med History
10/11/2016
amed01
10/25/2016
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
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.
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported gender
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 aescode Integer Recommended Staff code number of person completing this form 999= Missing Data
Query visit String 60 Recommended Visit name
Query days_baseline Integer Recommended Days since baseline
Query amed02 Integer Recommended Dose level 1::4 cmed02
Query amed03 Integer Recommended Number of blister card(s) issued cmed03
Query amed04 Integer Recommended For dose level 1, was patient instructed to skip pills in rows 4, 5, and 6, due to side effects? 0;1 0 = No; 1 = Yes
Query am4ada Integer Recommended If told to skip rows 4, 5, and 6, date (days since baseline) instructed to reduce dosage:
Query am5da Integer Recommended Date (days since baseline) blistercard(s) returned cm4da, rm1da
Query am6da Integer Recommended Date (days since baseline) of first dose cm5da, rm2da
Query amed06am Integer Recommended First dose: time of day 1::3 1 = AM; 2 = noon; 3 = PM cmed05am, rmed02am
Query ldosedy Integer Recommended Day of last dose Number of days from study baseline to date of last dose cm6da, rm3da
Query amed07am Integer Recommended Last dose: time of day 1::3 1 = AM; 2 = noon; 3 = PM cmed06am, rmed03am
Query bottle1_disp Float Recommended Bottle 1 tablets dispensed 0::999 cmed7ds1, rmed4ds1
Query bottle1_actual Float Recommended Bottle 1 Actual number tablets returned 0::999 cmed7rt1, rmed4rt1
Query amed7tk1 Float Recommended Card 1: Total Tablets Taken cmed7tk1, rmed4tk1
Query amed7ms1 Float Recommended Card 1: Number Tablets Missing cmed7ms1, rmed4ms1
amed7re1 String 100 Recommended Card 1: Reason Missing cmed7re1, rmed4re1
Query bottle2_disp Float Recommended Bottle 2 tablets dispensed 0::999 cmed7ds2, rmed4ds2
Query bottle2_actual Float Recommended Bottle 2 Actual number returned 0::999 cmed7rt2, rmed4rt2
Query amed7tk2 Float Recommended Card 2: Total Tablets Taken cmed7tk2, rmed4tk2
Query amed7ms2 Float Recommended Card 2: Number Tablets Missing cmed7ms2, rmed4ms2
amed7re2 String 100 Recommended Card 2: Reason Missing cmed7re2, rmed4re2
Query bottle3_disp Integer Recommended Bottle 3 tablets dispensed 0::999 cmed7ds3, rmed4ds3
Query bottle3_actual Integer Recommended Bottle 3 Actual number tablets returned 0::999 cmed7rt3, rmed4rt3
Query amed7tk3 Integer Recommended Card 3: Total Tablets Taken cmed7tk3, rmed4tk3
Query amed7ms3 Integer Recommended Card 3: Number Tablets Missing cmed7ms3, rmed4ms3
amed7re3 String 100 Recommended Card 3: Reason Missing cmed7re3, rmed4re3
Query bottle4_disp Integer Recommended Bottle 4 tablets dispensed 0::999 cmed7ds4, rmed4ds4
Query bottle4_actual Integer Recommended Bottle 4 Actual number tablets returned 0::999 cmed7rt4, rmed4rt4
Query amed7tk4 Integer Recommended Card 4: Total Tablets Taken cmed7tk4, rmed4tk4
Query amed7ms4 Integer Recommended Card 4: Number Tablets Missing cmed7ms4, rmed4ms4
amed7re4 String 100 Recommended Card 4: Reason Missing cmed7re4, rmed4re4
Query bottle5_disp Integer Recommended Bottle 5 tablets dispensed 0::999 cmed7ds5, rmed4ds5
Query bottle5_actual Integer Recommended Bottle 5 Actual number tablets returned 0::999 cmed7rt5, rmed4rt5
Query amed7tk5 Integer Recommended Card 5: Total Tablets Taken cmed7tk5, rmed4tk5
Query amed7ms5 Integer Recommended Card 5: Number Tablets Missing cmed7ms5, rmed4ms5
amed7re5 String 100 Recommended Card 5: Reason Missing cmed7re5, rmed4re5
Query bottle6_disp Integer Recommended Bottle 6 tablets dispensed 0::999 cmed7ds6, rmed4ds6
Query bottle6_actual Integer Recommended Bottle 6 Actual number tablets returned 0::999 cmed7rt6, rmed4rt6
Query amed7tk6 Integer Recommended Card 6: Total Tablets Taken cmed7tk6, rmed4tk6
Query amed7ms6 Integer Recommended Card 6: Number Tablets Missing cmed7ms6, rmed4ms6
amed7re6 String 100 Recommended Card 6: Reason Missing cmed7re6, rmed4re6
Query capsdisp Integer Recommended Number of Capsules Dispensed: cmed7ds7, rmed4ds7
Query npillret Integer Recommended Number of pills returned 999=Legitimately skipped cmed7rt7, rmed4rt7
Query amed7tk7 Integer Recommended Card 7: Total Tablets Taken cmed7tk7, rmed4tk7
Query amed7ms7 Integer Recommended Card 7: Number Tablets Missing cmed7ms7, rmed4ms7
amed7re7 String 100 Recommended Card 7: Reason Missing cmed7re7, rmed4re7
Query asap13b Float Recommended If medication dispensed, quantity dispensed (tablet) cmed7ds8, rmed4ds8
Query asap14b Float Recommended If medication returned, quantity returned (tablet) cmed7rt8, rmed4rt8
Query amed7tk8 Integer Recommended Card 8: Total Tablets Taken cmed7tk8, rmed4tk8
Query amed7ms8 Integer Recommended Card 8: Number Tablets Missing cmed7ms8, rmed4ms8
amed7re8 String 100 Recommended Card 8: Reason Missing cmed7re8, rmed4re8
Query compprot Integer Recommended Completed treatment protocol 0;1;-7 0=No; 1=Yes; -7=Refused
Query compl3wk Integer Recommended Active at Week 3 0;1 0=No; 1=Yes
Query visday Integer Recommended Number of days from study baseline to date of visit
Query exitrz Integer Recommended exit days from randomization
Query days_discharge Integer Recommended Days from baseline to program discharge
Query study_drug_team String 30 Recommended Study drug Baseline; Risperidone; Valproate; Lithium; Blinded Therapy; Hypericum; Placebo; Sertraline; Aripiprazole; NA
medication_name String 255 Recommended Name of medication
Query npilltaken Float Recommended Number of pills taken
Query datedose Integer Recommended When the last dose was given in days from the randomization date (DATEDOSE = last dose date - randomization date)
Query high_dose Integer Recommended Experimental higher dose of medication
Query maxdosedays Integer Recommended Days to Maximum Dose 0::61 Number of days between Randomization and first time the Maximum dose of study medication was reached (0-61). Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
Query mettarget_daysbl Integer Recommended Days from Baseline to Target Met 7::76 Met Target Days from Baseline (7-76). Number of days from baseline when target concentration was first met. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
Query targ1st_days Integer Recommended Days to Reach Target 4::64 Number of days between Randomization and first time the Target Concentration was met. (4-64). Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
Query bloodlv Integer Recommended Blood level
Query maxlevel_days Integer Recommended Days to Maximum Study Blood Level 3::70 Number of days between Randomization and first time the Maximum serum level was met. (3-70). Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
Query risptmt String 10 Recommended RISP:No,RescueOnly,Adjunct Text: Risperidone treatment category. NO=No, ADJ=Adjunct, RES=Rescue without Adjunct. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
Query rispadj Integer Recommended Adjunct Risp 0;1 1=Risperidone used 3 weeks or later. 0=Not used 3 weeks+. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
Query risprescue Integer Recommended Rescue Risp 0;1 1=Risperidone used prior to 3 weeks. 0=Not used. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
Query seg_r String 10 Recommended Valpro+RispAdj Category variable: Study drug+Adjunct Risperidone. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
Query rispactive Integer Recommended Risp while active pt 0;1 1= Risperidone used while in protocol. 0= not used while active. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
Query loraz_tmt String 10 Recommended Lorazapam Treatment Text Category of Lorazepam treatment. No, Adjunct, Rescue without Adjunct. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
Query loraz_3wk Integer Recommended Loraz Adj 21days+ 0;1 Patient treated with Lorazapam 3 weeks or later into the protocol (1=y/0=n). Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
Query loraz_rescue Integer Recommended Loraz Resc <21 days 0;1 1= Lorazepam used prior to 3 weeks. 0=Not used. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
Query rescue_rl Integer Recommended Rescue: Risp or Loraz 0;1 1= Risperidol and/or Lorazepam used prior to 3 weeks. 0=Not used prior to 3 weeks. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
Query adjunct_rl Integer Recommended Adjunt Risp or Loraz 0;1 1=Risperidone and/or Lorazepam used in treatment 3 weeks or later. 0=Risperidone and Lorazepam not used post 3 weeks. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
Query actbdic Integer Recommended Active status 0::5 0=Inactive-Data collected after the 14 month treatment phase/after early termination from treatment phase/prior to treatment phase; 1=Active-Data collected during the 14 month treatment phase while subject received originally assigned treatment regardless of degree of compliance; 2=Active-This is the last active assessment for subjects who were about to violate treatment arm by receiving alternate treatment; 3=Active-This is the last active assessment for subjects who were about to leave the study by moving away;4=Yes, Active; 5=No, Not Active
Query btarget Integer Recommended Ever Met Target Concentration On or before this visit Y/N 0;1 Metadata = Visit Information Prefix = B; Visit = Day 0; DAYWK = D0; VISITN = 1; Number of Days in Protocol After Randomization 0; Variables are given a one-letter prefix to denote the time point of the data. Seq 51 - 61. The letter �I� is skipped. 0 = No. TARGET CONCENTRATION: Lithium:0.80-0.99 mEq/L Valpro: 80-99 mcg/ml.; 1 = Yes if target was met on or before this visit. This is a cumulative measure. If a subject met the target concentration at Week 4, for example, then these variables also =1 GTARGET, H ARGET, JTARGET, K TARGET, LTARGET, M TARGET
Query site String 101 Recommended Site Study Site
Query me2 Integer Recommended Status 0;1 0 = Past [Inactive]; 1 = Active
Query finaldose Integer Recommended Final Dose (number of Pills) 0::12 Final Dose as number of pills per day (0 - 12). Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
Query maxlevel Integer Recommended Maximum Study Blood Level 5::208 Maximum serum blood level brought to common units used in Valproate blood levels. To report Lithium serum blood levels, divide by 100. (Lithium: mEq/L & Valproate: mcg/ml) (5-208). Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
Query targetmet Integer Recommended Target met ever? 0;1 0=Target NOT met; 1=Target met within course of treatment; Target Concentration: Lithium:0.80-0.99 mEq/L Valpro: 80-99 mcg/ml. Element of analysis created from entries in the RUNNING LOGS pertaining to Study Medication doses and drug levels.
Query status String 50 Recommended Status
Query rreltrt Integer Recommended Past treatment 0::3 0 = none;1 = outpatient;2 = inpatient;3 = both
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

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