The CDASHIG DD domain is used to collect the additional data that are typically collected when a death occurs (e.g., official cause of death, when the death occurred, whether it was witnessed). This domain is not intended to replace or collate data collected on designated CRF pages (e.g., severe adverse event details in the AE domain) or details of disposition in the DS domain. Data on the DD domain may be linked to other domains that relate to death using the appropriate identifier variables and the related records (RELREC) dataset as described in the SDTMIG.
Additional tests are listed in controlled terminology, and more information can be found in the CDASHIG.
Package(s)
DD_eCRF_Package.zip
DD_eCRF_Package.zip