Recreational Drug Product Use Example

In this example, this CRF collects general history about recreational drug use.

CRF Instructions

Example CRF Completion Instructions

Record any recreation drug use in the past or currently. Sponsor may indicate how the amount used is collected. For example,

Alcohol: The amount of each type of alcohol consumed should be an integer. The following description should be used in determining the amount consumed:

1 Beer Unit = 12 oz or 360 ml

1 Wine Unit = 5 oz or 150 ml

1 Spirits Unit = 1.5 oz or 45 ml

	Substance Use Category SUCAT Pre-populated	Recreational Drugs
Indicate if the subject had used any recreational drugs.	Were any recreational drugs used? SUYN SUSTAT = "NOT DONE" where SUYN = "NOT DONE"	Yes No Not Done <NY codelist>
Record the reason recreation product use was not collected.	What was the reason the recreational drug use was NOT DONE. SUREASND Not Submitted	_________________
Record the name of the recreational drug used.	What was the recreational drug used? SUTRT	Alcohol Tobacco Marijuana. Hallucinogen Drugs Non-medical prescription drugs use Stimulants OTher
Check the appropriate box to indicate if the subject currently or formerly used recreational drugs.	Usage SUNCF SUOCCUR = "Y" WHEN SUNCF = "CURRENT". SUOCCUR = "Y" WHEN SUNCF = "FORMER".	Current Former <NCF codelist>
Indicate the amount of recreational drugs the subject consumes on a regular basis.	What was the amount of recreational drug used? SUDSTXT SUDOSE SUDOSTXT	_________________
Record how often the subject regularly uses recreational drugs.	Frequency SUDOSFRQ	QD EVERY WEEK QM PA <FREQ codelist>
Provide the duration of the substance use (e.g., how long the subject has smoked).	Duration SUCDUR SUDUR	_________________
Select the appropriate duration unit of the substance use.	Unit SUCDURU SUDUR	DAYS MONTHS YEARS <UNIT codelist>

CDASH Variable

Order

Question Text

Prompt

CRF Completion Instructions

Type

SDTMIG Target Variable

SDTMIG Target Mapping

Controlled Terminology Code List Name

Permissible Values

Pre-Populated Value

Query Display

List Style

Hidden

SUCAT

1

What is the category of the substance used?

Substance Use Category

Record the recreational product category, if not pre-printed on the CRF.

Text

SUCAT

Recreational Drugs

SUYN

2

Were any recreational drugs used?

Any Recreational Drugs Used

Indicate if the subject had used any recreational drugs.

Text

N/A

SUSTAT = "NOT DONE" where SUYN = "NOT DONE"

(NY)

Yes; No; Not Done

SUREASND

3

What was the reason the recreational drug use was NOT DONE.

Reason Not Done

Record the reason recreation product use was not collected.

SUTRT

4

What was the recreational drug used?

Type of Recreational Drug Used

Record the name of the recreational drug used.

Text

SUTRT

Alcohol; Tobacco; Marijuana. Hallucinogen Drugs; Non-medical prescription drugs use; Stimulants; OTher

SUNCF

5

Does subject use recreational drugs?

Usage

Check the appropriate box to indicate if the subject currently or formerly used recreational drugs.

Text

SUOCCUR; SUSTRTPT; SUSTRF; SUENRTPT; SUENRF

SUOCCUR = "Y" WHEN SUNCF = "CURRENT". SUOCCUR = "Y" WHEN SUNCF = "FORMER".

(NCF)

Current; Former

Prompt

SUDSTXT

6

What was the amount of recreational drug used?

Amount

Indicate the amount of recreational drugs the subject consumes on a regular basis.

Text

SUDOSE; SUDOSTXT

SUDOSFRQ

7

What was the frequency of recreational drug use?

Frequency

Record how often the subject regularly uses recreational drugs.

Text

SUDOSFRQ

(FREQ)

QD; EVERY WEEK; QM; PA

Prompt

SUCDUR

8

What was the duration of recreational drug use consumption?

Duration

Provide the duration of the substance use (e.g., how long the subject has smoked).

Text

SUDUR

Prompt

SUCDURU

9

What was the unit of duration of recreational drug use?

Unit

Select the appropriate duration unit of the substance use.

Text

SUDUR

(UNIT)

DAYS; MONTHS; YEARS

Prompt

This is the SDTM dataset used to represent the above collected data.

Row 1	Shows that the subject was using cigarettes before the baseline visit and was expected to continue to use cigarettes after the baseline visit, The baseline visit occurred on 2006-01-01 . This is represented using SUSTTPT, SUSTRTPT, SUENTPT and SUENRTPT
Rows 3-5:	Show 3 records for a subject who completed 3 stages of the study ("SCREENING", "TREATMENT", "FOLLOW-UP").

Row Captions Debug Message

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Row	STUDYID	DOMAIN	USUBJID	SUSEQ	SUTRT	SUCAT	SUOCCUR	SUSTAT	SUREASND	SUDOSE	SUDOSU	SUDOSFRQ	SUSTDTC	SUENDTC	SUSTTPT	SUSTRTPT	SUENTPT	SUENRTPT
1	1234	SU	1234005	1	CIGARETTES	RECREATIONAL PRODUCT	Y			2	PACK	QD			2006-01-01	BEFORE	2006-01-01	ONGOING
2	1234	SU	1234005	2	COFFEE	RECREATIONAL PRODUCT	Y			3	CUP	QD	2002	2006-01-01
3	1234	SU	1234006	1	CIGARETTES	RECREATIONAL PRODUCT	Y			1	PACK	QD		2003	2006-03-15	BEFORE
6	1234	SU	1234007	1		RECREATIONAL PRODUCT		NOT DONE	Subject left office before CRF was completed
7	1234	SU	1234007	2		RECREATIONAL PRODUCT		NOT DONE	Subject left office before CRF was completed

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

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Recreational Drug Product Use Example