Data Structure
IVR Form
Version 014041 Shared Subjects
Short Name: ivra01
Data Type: Clinical Assessments
Categories: Questionnaire
No description.
Name, Type, Required, Description, Value Range, Notes
Name | Type | Required | Description | Value Range | Notes |
|---|---|---|---|---|---|
| subjectkey | GUID | Required | The NDAR Global Unique Identifier (GUID) for research subject | NDAR* | |
| src_subject_id | String | Required | Subject ID how it's defined in lab/project | ||
| interview_date | Date | Required | Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY | ||
| interview_age | Integer | Required | Age in months at the time of the interview/test/sampling/imaging. | 0::1440 | Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month. |
| sex | String | Required | Sex of subject at birth | M;F; O; NR | M = Male; F = Female; O=Other; NR = Not reported |
| days_baseline | Integer | Recommended | Days since baseline | ||
| level | String | Recommended | Treatment level | ||
| week | Float | Recommended | Week in level/study | 99=week 10-week 14 | |
| crcid | String | Recommended | CRC ID/ROA ID | ||
| update | Integer | Recommended | Updated form | 0;1 | 1= yes; 0= no |
| sae | Integer | Recommended | Was this an SAE (severe adverse event) | 0;1 | 0=No; 1=Yes |
| reason | Integer | Recommended | Primary reason for alert | 1::5 | 1=Suicide attempt within week prior to IVR call; 2=Suicide plan within week prior to IVR call but not at time of IVR call; 3=Suicidal plan at time of IVR call; 4=Misunderstanding of IVR questions; 5=Other reason |
| action_ia | Integer | Recommended | Action taken | 0;1 | 0=No; 1=Yes |
| er_ref | Integer | Recommended | Referred to ER | 0;1 | 0=Not checked; 1=Checked |
| clinvis | Integer | Recommended | Clinic visit scheduled | 0;1 | 0=Not checked; 1=Checked |
| contract | Integer | Recommended | Safety contract negotiated | 0;1 | 0=Not checked; 1=Checked |
| other | Integer | Required | Other prevent dose increase | 0;1;999 | 0 = No; 1 = Yes |
| contact_date | Integer | Recommended | Date patient contacted | ||
| pat_status | Integer | Recommended | Patient status at contact | 1::3 | 1=Suicidal ideation with plan - AT RISK; 2=Suicidal ideation but no plan; 3=Suicidal ideation |
| action_call | Integer | Recommended | Call Action | 0::5 | 0=Level exit; 1=New Level; 2=Follow-up; 3=Study exit; 4=Reactivation; 5=Interim month follow-up |
| txassign | String | Recommended | Treatment to which Pt was assigned | ||
| medswl2 | Integer | Recommended | Level: Medication Switch | 1::3 | 1=Yes; 2=No; 3= definitely time of day |
| medaugl2 | Integer | Recommended | Level: Medication Augmentation | 1::3 | 1=Yes; 2=No; 3= definitely time of day |
| cogswl2 | Integer | Recommended | Level: Cognitive Switch | 1::3 | 1=Yes; 2=No; 3= definitely time of day |
| cogaugl2 | Integer | Recommended | Level: Cognitive Augmentation | 1::3 | 1=Yes; 2=No; 3= definitely time of day |
| nextlev | Integer | Recommended | Next level |