Record the recreational product category, if not pre-printed on the CRF.
N/A
NOT SUBMITTED
(NY)
Yes; No
2
DVSPID
Were any recreational products used?
Any Recreational Product Used
Indicate if the subject had used any recreational products.
DVSPID
DVSPID
3
DVDECOD
What was the reason the recreational product use was not done?
Reason Not Done
Record the reason recreational product use was not done.
DVDECOD
DVDECOD
INFORMED CONSENT NOT OBTAINED; INCLUSION CRITERIA NOT MET; STUDY PRODUCT ASSIGNMENT DEVIATION; STUDY PRODUCT ADMINSTRATION DEVIATION; EXCLUDED CONCOMITANT MEDICATION; OTHER
4
SUTRT
What was the protocol deviation term?
What was the recreational product used?
Type of Recreational Product Used
Record each recreational product used on a new line.
DVTERM
5
SUNCF
What was the protocol deviation start date?
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.
DVSTDTC
6
SUDSTXT
What was the protocol deviation end date?
What was the amount of the recreational product used?
Amount
Indicate the amount of recreational drug the subject consumes on a regular basis.
DVENDTC
SUDOSU
What was the unit?
Unit
Record the unit. See the protocol for a list of units.
SUDOSFRQ
What was the frequency of recreational product use?
Frequency
Record how often the subject regularly uses the recreational product.