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Clinical Trials: Other Medications Record

omr

01

Clinical Trials: Other Medications Record

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Element NameData TypeSizeRequiredDescriptionValue RangeNotesAliases
subjectkeyGUIDRequiredThe NDAR Global Unique Identifier (GUID) for research subjectNDAR*
src_subject_idString20RequiredSubject ID how it's defined in lab/projectSUBJECT, bid
interview_dateDateRequiredDate on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYYRequired field
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.dema1
genderString20RequiredSex of the subjectM;FM = Male; F = Femaledema2
aescodeIntegerRecommendedStaff code number of person completing this formOMRACODE
visitString50RecommendedVisit nameCharacter description of each type of visit
omrainfoIntegerRecommendedCheck if the Patient Takes no other medications0;10=No; 1= Yes
omramednameString150RecommendedName of Medicationamra1, omra1
omramedcodeIntegerRecommendedCode for Name of Medication
omramedotherString150RecommendedOther Medication name (not in list) specified
omrapriorIntegerRecommendedStarted prior to study entry? (If Yes, go to Primary Indication)0;10=No; 1= Yesamra5, omra2
omrastartDateRecommendedStart Date MM/YYYYomra3
omraprimindIntegerRecommendedPrimary Indication 01-14omra4
omraprimindoString150RecommendedPrimary Indication Other specified
omrav1FloatRecommendedAt the study visit V1, indicate the dose of antipsychotics and anticholinergics medication at each visit; -1= patient took other medications at that visit
omrav3FloatRecommendedAt the study visit V2 indicate the dose of antipsychotics and anticholinergics medication at each visit; -1= patient took other medications at that visit
omrav4FloatRecommendedAt the study visit V4 indicate the dose of antipsychotics and anticholinergics medication at each visit; -1= patient took other medications at that visit
amra2IntegerRecommendedRoute (1=PO/2=MI)1;2Record all adjunctive medications and oral antipsychotics
amra3aFloatRecommendedTotal Dose (include units)Record all adjunctive medications and oral antipsychotics
amra3bString20RecommendedTotal Dose (include units)Record all adjunctive medications and oral antipsychotics
amra4String20RecommendedFrequency (Daily/Weekly/Bi-Weekly/Monthly)Record all adjunctive medications and oral antipsychotics
medication_startDateRecommendedStart date of medication
medication_stopDateRecommendedStop date of medication
amra7IntegerRecommendedPrimary Indication1::151 = Psychosis; 4 = Agitation/excitement/mania; 2 = Anxiety; 5 = Aggression/violence; 3 = Depression; 6 = Insomnia; 7=Parkinsonism/rigidity/tremors; 8=Substance use disorder; 9=Akathisia; 10=Hyperglycemia/diabetes; 11=Hyperlipidemia; 12=High blood pressure; 13=Constipation; 14=Weight Gain; 15=Other (specify)
amr_m0IntegerRecommendedV2 (month 0 or baseline)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m0, omra5a
amr_m0_25IntegerRecommendedV3 (month .25 or week 1)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m0_25, omra5b
amr_m0_5IntegerRecommendedV4 (month .5 or week 2)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m0_5, omra5c
amr_m0_75IntegerRecommendedV5 (month .75 or week 3)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m0_75, omra5d
amr_m1IntegerRecommendedV6 (month 1 or week 4)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m1, omra5e
amr_m1_5IntegerRecommendedV7 (month 1.5 or week 6)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m1_5, omra5f
amr_m2IntegerRecommendedV8 (month 2 or week 8)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m2, omra5g
amr_m2_5IntegerRecommendedV9 (month 2.5 or week 10)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m2_5, omra5h
amr_m3IntegerRecommendedV10 (month 3 or week 12)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m3, omra5i
amr_m4IntegerRecommendedV11 (month 4 or week 16)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m4, omra5j
amr_m5IntegerRecommendedV12 (month 5 or week 20)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m5
amr_m6IntegerRecommendedV13 (month 6 or week 24)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m6
amr_m7IntegerRecommendedV14 (month 7 or week 28)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m7
amr_m8IntegerRecommendedV15 (month 8 or week 32)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m8
amr_m9IntegerRecommendedV16 (month 9 or week 36)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m9
amr_m10IntegerRecommendedV17 (month 10 or week 40)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m10
amr_m11IntegerRecommendedV18 (month 11 or week 44)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m11
amr_m12IntegerRecommendedV19 (month 12 or week 48)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m12
amr_m13IntegerRecommendedV20 (month 13 or week 52)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m13
amr_m14IntegerRecommendedV21 (month 14 or week 56)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m14
amr_m15IntegerRecommendedV22 (month 15 or week 60)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m15
amr_m16IntegerRecommendedV23 (month 16 or week 64)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m16
amr_m17IntegerRecommendedV24 (month 17 or week 68)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m17
amr_m18IntegerRecommendedV25 (month 18 or week 92)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m18
amr_m19IntegerRecommendedV26 (month 19 or week 96)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m19
amr_m20IntegerRecommendedV27 (month 20 or week 100)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m20
amr_m21IntegerRecommendedV28 (month 21 or week 104)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m21
amr_m22IntegerRecommendedV29 (month 22 or week 108)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m22
amr_m23IntegerRecommendedV30 (month 23 or week 112)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m23
amr_m24IntegerRecommendedV31 (month 24 or week 116)0;1At each study visit, indicate 1=Yes or 0=No if patient is taking medication. If 0, then record date stopped (6b). This completes data collection for this medication. If a medication is re-prescribed, please complete a new line with start date (6a).omr_m24
version_formString100RecommendedForm usedvers
visdayIntegerRecommendedNumber of days from study baseline to date of visit
omra3aIntegerRecommendedStart date of medication, calculated from randomization date-999::999
omra3bIntegerRecommendedStop date of medication, calculated from randomization date-999::999
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.
linenoIntegerRecommendedLine number (lines per participant)0::150
bpmedcatIntegerRecommendedAddition of or change in blood pressure medication based on OMRA form0;10=No; 1=Yes
ibpmedIntegerRecommendedIndicator for Addition or Change In Blood Pressure Meds0;10=Otherwise; 1=At least one addition of or change in blood pressure medication
llamedcIntegerRecommendedAddition of or change in lipid lowering medication based on LLA form0;10=No; 1=Yes
illamedIntegerRecommendedIndicator for Addition or Change In Lipid Lowering Meds0;10=Otherwise; 1=At least one addition of or change in blood pressure medication
glumedcIntegerRecommendedAddition of or change in glucose medication based on OMRA form0;10=No; 1=Yes
iglumedIntegerRecommendedIndicator for Addition or Change In Glucose Lowering Meds0;10=Otherwise; 1=At least one addition of or change in blood pressure medication
lla_okIntegerRecommendedNo Start/Stop/Change in lipid lowering agent dose (LLA)0;10=No; 1= Yes
lvt_okIntegerRecommendedNo Start/Stop/Change In Lithium/Topiramate/Valproate (LVT) Dose0;10=No; 1= Yes
mmrmIntegerRecommendedMixed model repeated measures0;10=No; 1= Yes
violString30RecommendedPrimary reason for the participant's protocol violation/deviationEarly 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; OtherEarly 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
llavioldIntegerRecommendedDate Of Visit for when LLA protocol violation occurred [converted to days from randomization]0::365
lvtvioldIntegerRecommendedDate Of Visit for when LVT protocol violation occurred [converted to days from randomization]0::365
kitdtDateRecommendedDate kit assigned
kitynIntegerRecommendedWas a kit number assigned?0;10=No; 1=Yes
kitnum1String10RecommendedMedication Kit Number 1
kitnum2String10RecommendedMedication Kit Number 2
comments_miscString4,000RecommendedMiscellaneous comments on study, interview, methodology relevant to this form datakitcmnts
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
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  • Description: A basic description
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Distribution for DataStructure: omr01 and Element:
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