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 PRODUCTS
Indicate if the subject had used any recreational drugs.	Were any recreational products used? SUYN SUSTAT = "NOT DONE" and SUTRT=Recreational Product where SUYN = "Not DoneE"	Yes No Not Done <NY codelist>
Record the reason recreational product use was not collected.	What was the reason the recreational drug product use was not done? SUREASND	_________________
Record each reactional product used on a new line.	What was the recreational product used? SUTRT
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 product 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 recreational product use (e.g., how long the subject has used the recreational product)	Duration SUCDUR SUDUR	_________________
Select the appropriate duration unit of the recreational product 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 PRODUCTS

SUYN

2

Were any recreational products used?

Any Recreational Product Used

Indicate if the subject had used any recreational drugs.

Text

N/A

SUSTAT = "NOT DONE" and SUTRT=Recreational Product where SUYN = "Not DoneE"

(NY)

Yes; No; Not Done

SUREASND

3

What was the reason the recreational drug product use was not done?

Reason Not Done

Record the reason recreational product use was not collected.

Text

SUREASND

SUTRT

4

What was the recreational product used?

Type of Recreational Product Used

Record each reactional product used on a new line.

Text

SUTRT

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

SUNCF

5

Does the subject currently or formerly used recreational products?

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 product 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 product 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 product use consumption?

Duration

Provide the duration of the recreational product use (e.g., how long the subject has used the recreational product)

Text

SUDUR

Prompt

SUCDURU

9

What was the unit of duration of recreational product use?

Unit

Select the appropriate duration unit of the recreational product 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.
Row 2:	Shows the subject uses marijuana starting in 2002 and stopped using it on the day of the baseline visit.
Row 3:	Subject 1234006 is a former smoker. The date this subject began smoking is unknown, but it was sometime before the assessment date; this is shown by the values of SUSTTPT and SUSTRTPT. The end date of smoking was collected, so SUENTPT and SUENRTPT are not populated. Instead, the end date is in SUENDTC.
Rows 4 & 5:	Show the subjects had missing data for the usage of recreational products; this is indicated by SUSTAT = "NOT DONE". The reason is in SUREASND.

Row Captions Debug Message

Please construct row caption labels as instructed in <ac:link><ri:page ri:content-title="Constructing labels for row captions" ri:space-key="TTD"/></ac:link>.

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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	MARIJUNA	RECREATIONAL PRODUCT	Y						2002	2006-01-01
3	1234	SU	1234006	1	CIGARETTES	RECREATIONAL PRODUCT	Y			1	PACK	QD		2003	2006-03-15	BEFORE
4	1234	SU	1234007	1	RECREATIONAL PRODUCT	RECREATIONAL PRODUCT		NOT DONE	Subject left office before CRF was completed
5	1234	SU	1234007	2	RECREATIONAL PRODUCT	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