Record the recreational product category, if not pre-printed on the CRF.
N/A
NOT SUBMITTED
(NY)
Yes; No
2
SUYN
Were any recreational products used?
Any Recreational Product Used
Indicate if the subject had used any recreational products.
DVSPID
DVSPID
3
SUREASND
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.
Order
CDASH Variable Name
Question Text
Prompt
CRF Completion Instructions
SDTMIG Target Variable
SDTM Target Mapping
Controlled Terminology Code List Name
Permissible Values
Pre-Populated Value
1
SUCAT
Were there any protocol deviations?
Any Deviations
Enter Yes if a protocol deviation occurred and No if none occurred. Ensure that any adverse event which triggers a protocol deviation (e.g., concomitant medication use, newly discovered medical history) is noted on the respective CRF.
N/A
NOT SUBMITTED
(NY)
Yes; No
2
SUYN
What is the protocol deviation identifier?
DV Number
If collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier.
DVSPID
DVSPID
3
SUREASND
What was the protocol deviation?
Protocol Deviation
Record protocol deviations identified and/or select the appropriate code from the list of protocol deviation terms.
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?
Specify Protocol Deviation
Record the protocol deviation
DVTERM
DVTERM
5
SUNCF
What was the protocol deviation start date?
Start Date
Record the start date for the protocol deviation using this format (DD-MON-YYYY). This should be the start or occurrence of the protocol deviation, not the date it was discovered or reported.
DVSTDTC
DVSTDTC
6
SUDSTXT
What was the protocol deviation end date?
End Date
Record the end date of the protocol deviation using this format (DD-MON-YYYY). This should be the date the protocol deviation stopped, not the date it was discovered or reported.