CDASH
...
In this example, a General Medical History CRF collected verbatim descriptions of any condition This is an example SDTM dataset used to represent the medical history collected on the above CRF. This CRF was designed to allow the applicant to use either MHENRF or MHENRTPT to represent an event that was ongoing. This SDTM dataset uses MHENRTPT. (For more information, see Section 2.8.7.6, Representing References and Relative Timing.)
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Rows 1Rows 1-32: | MHCAT indicates that these data were collected on the General Medical History CRF, and MHSCAT indicates the body system for which the event was collected. The reported events were coded using a standard dictionary. MHDECOD and MHBODSYS display the preferred term and body system assigned through the coding process. MHENRTPT was populated based on the response to the "Ongoing" question on the General Medical History CRF. MHENTPT displays the reference date for MHENRTPT , that is, (i.e., the date the information was collected). If "Yes" was specified for Ongoing, MHENRTPT = "ONGOING"; if "No" was checked, MHENRTPT = "BEFORE". See Section 4.4.7, Use of Relative Timing Variables, for further guidance. | Rows 4-5: | MHCAT indicates that these data were collected on the Cardiac Medical History CRF. Because 2 kinds of start date were collected for congestive heart failure, there are 2 records for this event, with start dates of MHEVDTYP = "SYMPTOM ONSET" and MHEVDTYP = "DIAGNOSIS". The sponsor grouped these 2 records using the MHGRPID value "CHF" | | Row 3: | Displays the start and end date of the reported event. | |
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | MHSEQ | MHGRPIDMHSPID | MHTERM | MHDECODMHEVDTYP | MHCAT | MHSCAT | MHBODSYS | MHSTDTC | MHENDTC | MHENRTPT | MHENTPT |
|---|
| 1 | ABC123 | MH | 123101 | 1 | 01 | ASTHMA | Asthma | GENERAL MEDICAL HISTORY | RESPIRATORY | Respiratory system disorders | 2003 |
| ONGOING | 2004-09-18 | | 2 | ABC123 | MH | 123101 | 2 | 02 | FREQUENT HEADACHES | Headache | GENERAL MEDICAL HISTORY | CNS | Central and peripheral nervous system disorders | 2004-07 |
| ONGOING | 2004-09-18 | | 3 | ABC123 | MH | 123101 | 3 | 03 | BROKEN LEG | Bone fracture | GENERAL MEDICAL HISTORY | OTHER | Musculoskeletal system disorders | BEFORE | 20042005-0907-18 | 4 | ABC123 | MH | 123101 | 4 | CHF | CONGESTIVE HEART FAILURE | Cardiac failure congestive | SYMPTOM ONSET | CARDIAC MEDICAL HISTORY | Cardiac disorders | 2004-09-17 | 15 | 2005-08-31 | 5 | ABC123 | MH | 123101 | 5 | CHF | CONGESTIVE HEART FAILURE | Cardiac failure congestive | DIAGNOSIS | CARDIAC MEDICAL HISTORY | Cardiac disorders | 2004-09-19 |
|
|
|
|