Subjects in this example were followed until death or the end of the study, whether or not they were still on the study treatment. The sponsor included only an end-of-study disposition CRF; no end-of-treatment form was used. Information on treatment exposure was reported only in the EX domain (not shown). A typical study disposition form was used to collect the data (per CDASH; https://www.cdisc.org/standards/foundational/cdash). This study disposition data was represented as a disposition event in the DS domain, as referenced in the SDTMIG (https://www.cdisc.org/standards/foundational/sdtmig). The sponsor created DSLNKID in the data management system.
|INFORMED CONSENT||PROTOCOL MILESTONE||2019-04-04|
|3||HF3||DS||HF3-002||1||Informed Consent||INFORMED CONSENT||PROTOCOL MILESTONE||2019-04-03|
The sponsor used a Death Detail CRF to collect additional information on the deaths. This data was represented in the Death Details (DD) domain. For any subject death, the DTHFL and DTHDTC variables in the DM domain are also populated.
|1||HF3||DD||HF3-001||1||DTH-1||PRCDTH||Primary Cause of Death||SUDDEN CARDIAC DEATH||SUDDEN CARDIAC DEATH||2019-08-01|
|2||HF3||DD||HF3-001||2||DTH-1||SECDTH||Secondary Cause of Death||HEART FAILURE||HEART FAILURE||2019-08-01|
|3||HF3||DD||HF3-001||3||DTH-1||LOCDTH||Location of Death||HOME||HOME||2019-08-01|
Death Witnessed Indicator
shows the relationship between the DS and DD domains. In this example, because death data were collected on a single CRF, the sponsor created a RELREC. A RELREC dataset is not necessary in all cases.