Loading...

National Institute of Mental Health Data Archive (NDA) Sign In
NDA

Enter the email address associated with your existing NDA Account and click Continue Linking Process.

If you do not have an existing NDA account, click Go Back.

Warning Notice This is a U.S. Government computer system, which may be accessed and used only for authorized Government business by authorized personnel. Unauthorized access or use of this computer system may subject violators to criminal, civil, and/or administrative action. All information on this computer system may be intercepted, recorded, read, copied, and disclosed by and to authorized personnel for official purposes, including criminal investigations. Such information includes sensitive data encrypted to comply with confidentiality and privacy requirements. Access or use of this computer system by any person, whether authorized or unauthorized, constitutes consent to these terms. There is no right of privacy in this system.
National Institute of Mental Health Data Archive (NDA) Sign In
NDA

Success! An email is on its way!

Please check your email to complete the linking process. The link you receive is only valid for 30 minutes.

Check your spam or junk folder if you do not receive the email in the next few minutes.

Warning Notice This is a U.S. Government computer system, which may be accessed and used only for authorized Government business by authorized personnel. Unauthorized access or use of this computer system may subject violators to criminal, civil, and/or administrative action. All information on this computer system may be intercepted, recorded, read, copied, and disclosed by and to authorized personnel for official purposes, including criminal investigations. Such information includes sensitive data encrypted to comply with confidentiality and privacy requirements. Access or use of this computer system by any person, whether authorized or unauthorized, constitutes consent to these terms. There is no right of privacy in this system.
Create or Link an Existing NDA Account

Warning Notice

This is a U.S. Government computer system, which may be accessed and used only for authorized Government business by authorized personnel. Unauthorized access or use of this computer system may subject violators to criminal, civil, and/or administrative action. All information on this computer system may be intercepted, recorded, read, copied, and disclosed by and to authorized personnel for official purposes, including criminal investigations. Such information includes sensitive data encrypted to comply with confidentiality and privacy requirements. Access or use of this computer system by any person, whether authorized or unauthorized, constitutes consent to these terms. There is no right of privacy in this system.

NIMH Data Archive (NDA) Sign In or Create An Account
Update Password

You have logged in with a temporary password. Please update your password. Passwords must contain 8 or more characters and must contain at least 3 of the following types of characters:

  • Uppercase
  • Lowercase
  • Numbers
  • Special Characters limited to: %,_,!,@,#,$,-,%,&,+,=,),(,*,^,:,;
Update Password

Subscribe to our mailing list

Mailing List(s)
Email Format

You are now leaving the NIMH Data Archive (NDA) web site to go to:

Click on the address above if the page does not change within 10 seconds.

Disclaimer

NDA is not responsible for the content of this external site and does not monitor other web sites for accuracy.

Accept Terms
Data Access Terms - Decline Terms

Are you sure you want to cancel? This will decline terms and you will not be authorized for access.

NIMH Data Archive
NDA ABCD CCF OAI NIAAADA AMP SCZ HEAL

Clinical Trials: Other Medications Record

758 Shared Subjects

Clinical Trials: Other Medications Record
Clinical Assessments
Treatment
06/25/2014
omr01
06/25/2014
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 SUBJECT, bid
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. dema1
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported dema2, gender
Query aescode Integer Recommended Staff code number of person completing this form 999= Missing Data OMRACODE
Query visit String 60 Recommended Visit name
Query omrainfo Integer Recommended Check if the Patient Takes no other medications 0;1 0=No; 1= Yes
omramedname String 150 Recommended Name of Medication amra1, omra1
Query omramedcode Integer Recommended Code for Name of Medication
omramedother String 150 Recommended Other Medication name (not in list) specified
Query omraprior Integer Recommended Started prior to study entry? (If Yes, go to Primary Indication) 0;1 0=No; 1= Yes amra5, omra2
omrastart Date Recommended Start Date MM/YYYY omra3
Query omraprimind Integer Recommended Primary Indication 01-14 omra4
omraprimindo String 150 Recommended Primary Indication Other specified
Query omrav1 Float Recommended At the study visit V1, indicate the dose of antipsychotics and anticholinergics medication at each visit; -1= patient took other medications at that visit
Query omrav3 Float Recommended At the study visit V2 indicate the dose of antipsychotics and anticholinergics medication at each visit; -1= patient took other medications at that visit
Query omrav4 Float Recommended At the study visit V4 indicate the dose of antipsychotics and anticholinergics medication at each visit; -1= patient took other medications at that visit
Query amra2 Integer Recommended Route (1=PO/2=MI) 1;2 Record all adjunctive medications and oral antipsychotics
Query amra3a Float Recommended Total Dose (include units) Record all adjunctive medications and oral antipsychotics
amra3b String 20 Recommended Total Dose (include units) Record all adjunctive medications and oral antipsychotics
amra4 String 20 Recommended Frequency (Daily/Weekly/Bi-Weekly/Monthly) Record all adjunctive medications and oral antipsychotics
medication_start Date Recommended Start date of medication
medication_stop Date Recommended Stop date of medication
Query amra7 Integer Recommended Primary Indication 1::15 1 = 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)
Query amr_m0 Integer Recommended V2 (month 0 or baseline) 0;1 At 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
Query amr_m0_25 Integer Recommended V3 (month .25 or week 1) 0;1 At 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
Query amr_m0_5 Integer Recommended V4 (month .5 or week 2) 0;1 At 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
Query amr_m0_75 Integer Recommended V5 (month .75 or week 3) 0;1 At 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
Query amr_m1 Integer Recommended V6 (month 1 or week 4) 0;1 At 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
Query amr_m1_5 Integer Recommended V7 (month 1.5 or week 6) 0;1 At 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
Query amr_m2 Integer Recommended V8 (month 2 or week 8) 0;1 At 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
Query amr_m2_5 Integer Recommended V9 (month 2.5 or week 10) 0;1 At 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
Query amr_m3 Integer Recommended V10 (month 3 or week 12) 0;1 At 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
Query amr_m4 Integer Recommended V11 (month 4 or week 16) 0;1 At 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
Query amr_m5 Integer Recommended V12 (month 5 or week 20) 0;1 At 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
Query amr_m6 Integer Recommended V13 (month 6 or week 24) 0;1 At 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
Query amr_m7 Integer Recommended V14 (month 7 or week 28) 0;1 At 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
Query amr_m8 Integer Recommended V15 (month 8 or week 32) 0;1 At 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
Query amr_m9 Integer Recommended V16 (month 9 or week 36) 0;1 At 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
Query amr_m10 Integer Recommended V17 (month 10 or week 40) 0;1 At 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
Query amr_m11 Integer Recommended V18 (month 11 or week 44) 0;1 At 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
Query amr_m12 Integer Recommended V19 (month 12 or week 48) 0;1 At 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
Query amr_m13 Integer Recommended V20 (month 13 or week 52) 0;1 At 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
Query amr_m14 Integer Recommended V21 (month 14 or week 56) 0;1 At 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
Query amr_m15 Integer Recommended V22 (month 15 or week 60) 0;1 At 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
Query amr_m16 Integer Recommended V23 (month 16 or week 64) 0;1 At 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
Query amr_m17 Integer Recommended V24 (month 17 or week 68) 0;1 At 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
Query amr_m18 Integer Recommended V25 (month 18 or week 92) 0;1 At 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
Query amr_m19 Integer Recommended V26 (month 19 or week 96) 0;1 At 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
Query amr_m20 Integer Recommended V27 (month 20 or week 100) 0;1 At 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
Query amr_m21 Integer Recommended V28 (month 21 or week 104) 0;1 At 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
Query amr_m22 Integer Recommended V29 (month 22 or week 108) 0;1 At 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
Query amr_m23 Integer Recommended V30 (month 23 or week 112) 0;1 At 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
Query amr_m24 Integer Recommended V31 (month 24 or week 116) 0;1 At 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_form String 121 Recommended Form used/assessment name vers
Query visday Integer Recommended Number of days from study baseline to date of visit
Query omra3a Integer Recommended Start date of medication, calculated from randomization date -999::999
Query omra3b Integer Recommended Stop date of medication, calculated from randomization date -999::999
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 lineno Integer Recommended Line number (lines per participant) 0::150
Query bpmedcat Integer Recommended Addition of or change in blood pressure medication based on OMRA form 0;1 0=No; 1=Yes
Query ibpmed Integer Recommended Indicator for Addition or Change In Blood Pressure Meds 0;1 0=Otherwise; 1=At least one addition of or change in blood pressure medication
Query llamedc Integer Recommended Addition of or change in lipid lowering medication based on LLA form 0;1 0=No; 1=Yes
Query illamed Integer Recommended Indicator for Addition or Change In Lipid Lowering Meds 0;1 0=Otherwise; 1=At least one addition of or change in blood pressure medication
Query glumedc Integer Recommended Addition of or change in glucose medication based on OMRA form 0;1 0=No; 1=Yes
Query iglumed Integer Recommended Indicator for Addition or Change In Glucose Lowering Meds 0;1 0=Otherwise; 1=At least one addition of or change in blood pressure medication
Query lla_ok Integer Recommended No Start/Stop/Change in lipid lowering agent dose (LLA) 0;1 0=No; 1= Yes
Query lvt_ok Integer Recommended No Start/Stop/Change In Lithium/Topiramate/Valproate (LVT) Dose 0;1 0=No; 1= Yes
Query mmrm Integer Recommended Mixed model repeated measures 0;1 0=No; 1= Yes
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 llaviold Integer Recommended Date Of Visit for when LLA protocol violation occurred [converted to days from randomization] 0::365
Query lvtviold Integer Recommended Date Of Visit for when LVT protocol violation occurred [converted to days from randomization] 0::365
kitdt Date Recommended Date kit assigned
Query kityn Integer Recommended Was a kit number assigned?
0;1
0=No; 1=Yes
kitnum1 String 10 Recommended Medication Kit Number 1 cmd001, kitnum1x
kitnum2 String 10 Recommended Medication Kit Number 2 cmd002, kitnum2x
comments_misc String 4,000 Recommended Miscellaneous comments on study, interview, methodology relevant to this form data kitcmnts
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.

Additional Information
Training Privacy Policy Disclaimer Contact Us
External Resources
Accessibility FOIA OIG HHS Vulnerability Disclosure
NIH Logo HHS Logo USA Gov Logo
c725efb98f608e6bc0136950f08b0c3af2bde994