Versions Compared

Old Version 2

changes.mady.by.user Kathleen Mellars

Saved on

compared with

New Version 3

changes.mady.by.user Kathleen Mellars

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Expand
titleCDASH DV Metadata Specifications
Metadataspec
OrderCDASH Variable Name Question TextPromptCRF Completion InstructionsSDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated Value
1DVYNSUCATWhat is the category of the substance used?Substance Use CategoryRecord the recreational product category, if not pre-printed on the CRF.N/ANOT SUBMITTED(NY)Yes; No
2DVSPIDSUYNWere any recreational products used?Any Recreational Product UsedIndicate if the subject had used any recreational products.DVSPIDDVSPID


3DVDECODSUREASNDWhat was the reason the recreational product use was not done?  Reason Not DoneRecord the reason recreational  product use was not done. DVDECODDVDECOD
INFORMED CONSENT NOT OBTAINED; INCLUSION CRITERIA NOT MET; STUDY PRODUCT ASSIGNMENT DEVIATION; STUDY PRODUCT ADMINSTRATION DEVIATION; EXCLUDED CONCOMITANT MEDICATION; OTHER
4SUTRTWhat was the protocol deviation term?What was the recreational product used?Type of Recreational Product UsedRecord each recreational product used on a new line. DVTERM


5SUNCFWhat was the protocol deviation start date?Does the subject currently use or formerly used recreational products?UsageCheck the appropriate box to indicate if the subject currently or formerly used recreational products.DVSTDTC


6SUDSTXTWhat was the protocol deviation end date?What was the amount of the  recreational product used?AmountIndicate the amount of recreational drug the subject consumes on a regular basis.DVENDTC



SUDOSU
What was the unit?UnitRecord the unit. See the protocol for a list of units.




SUDOSFRQ
What was the frequency of recreational product use?FrequencyRecord how often the subject regularly uses  the recreational product.



Expand
titleCDASH DV Metadata Specifications
Metadataspec
OrderCDASH Variable Name Question TextPromptCRF Completion InstructionsSDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated Value
1SUCATWere there any protocol deviations?Any DeviationsEnter 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/ANOT SUBMITTED(NY)Yes; No
2SUYNWhat is the protocol deviation identifier?DV NumberIf collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier.DVSPIDDVSPID


3SUREASNDWhat was the protocol deviation?Protocol DeviationRecord protocol deviations identified and/or select the appropriate code from the list of protocol deviation terms.DVDECODDVDECOD
INFORMED CONSENT NOT OBTAINED; INCLUSION CRITERIA NOT MET; STUDY PRODUCT ASSIGNMENT DEVIATION; STUDY PRODUCT ADMINSTRATION DEVIATION; EXCLUDED CONCOMITANT MEDICATION; OTHER
4SUTRTWhat was the protocol deviation term?Specify Protocol DeviationRecord the protocol deviation DVTERMDVTERM


5SUNCFWhat was the protocol deviation start date?Start DateRecord 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.DVSTDTCDVSTDTC


6SUDSTXTWhat was the protocol deviation end date?End DateRecord 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.DVENDTCDVENDTC



SUDOSU








SUDOSFRQ