The metadata/specification in the first section focus on the whether any recreational products were used. | Metadataspec |
|---|
| Order | Question Text | Prompt | CRF Case Report Form Completion Instructions | Type | CDASH Collection Variable Name | SDTMIG Target Variable | SDTM Target Mapping | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
|---|
| 1 | What is the category of the substance used? | Substance Use Category | Record the recreational product category, if not pre-printed on the CRF. | SUCAT | SUCAT |
|
|
| RECREATIONAL PRODUCT |
| | 2 | Were any recreational products used? | Any Recreational Product Used | Indicate if the subject had used any recreational products. | SUYN | N/A | SUSTAT = "NOT DONE" and SUTRT="RECREATIOAL PRODUCT" where SUYN = "Not Done" | (NY) | Yes; No; Not Done |
|
| | 3 | What was the reason the recreational product use was not done? | Reason Not Done | Record the reason recreational product use was not done. | SUREASND | SUREASND | SUREASND |
|
|
|
|
The metadata/specification in the second section focus on each recreational product used.
| Metadataspec |
|---|
| Order | CDASH Variable | Question Text | Prompt | CRF Case Report Form Completion Instructions | Type | SDTMIG Target Collection Variable | SDTMIG Target Mapping | | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
|---|
| 4 | SUTRT | What was the recreational product used? | Type of Recreational Product Used | Record each recreational product used on a new line. | SUTRT |
|
| Alcohol; Tobacco; Marijuana; Hallucinogen Drugs; Non-medical prescription drugs use; Stimulants; Other
|
|
| | 5 | SUNCF | Does the subject currently use or formerly used recreational products? | Usage | Check the appropriate box to indicate if the subject currently or formerly used recreational products. | SUOCCUR; SUSTRTPT; SUSTRF; SUENRTPT; SUENRF | SUOCCUR = "Y" WHEN SUNCF = "CURRENT". SUOCCUR = "Y" WHEN SUNCF = "FORMER". | (NCF) | Current; Former |
|
| | 6 | SUDSTXT | What was the amount of the recreational product used? | Amount | Indicate the amount of recreational drug the subject consumes on a regular basis. | SUDOSE; SUDOSTXT |
|
|
|
|
| | 7 | SUDOSU | What was the unit? | Unit | Record the unit. See the protocol for a list of units. | SUDOSU | SUDOSU | (UNIT) |
|
|
| | 6 | SUDOSFRQ | What was the frequency of recreational product use? | Frequency | Record how often the subject regularly uses the recreational product. | SUDOSFRQ |
| (FREQ) | Occasionally; Intermittent; Daily; PRN; Unknown |
|
|
|
|
|