In this example, a General Medical History CRF collected verbatim descriptions of any medical conditions or events experiences by the subject.
| Xformpusher |
|---|
| CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Variable | SDTMIG Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value | Query Display | List Style | Hidden |
|---|
| MHYN | 1 | Has the subject had any medical conditions or events? | Any Medical History | Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF. | Text | N/A |
| (NY) | Yes; No |
|
| radio |
| | MHSPID | 3 | What is the medical condition or event identifier? | MH Number | Sponsor-Defined CRF Completion Instructions | Text | MHSPID |
|
|
|
|
|
|
| | MHTERM | 4 | What is the medical condition or event term? | Medical History Term | Record all relevant medical conditions or events, as defined in the protocol. Record only one medical condition or event per line. Ensure that the medical conditions or events listed on the Medical History page do not meet any of the exclusion criteria. | Text | MHTERM |
|
|
|
|
|
|
| | MHSTDAT | 5 | What was the medical condition or event start date? | Start Date | Record the start date of the medical event or condition using this format (DD-MON-YYYY). | Date | MHSTDTC |
|
|
|
| prompt |
|
| | MHONGO | 6 | Is the medical condition or event ongoing? | Ongoing | Record the medical condition or event as ongoing (Yes) if it has not ended at the time of data collection; the end date should be left blank. | Text | MHENRF/ MHENRTPT |
| (NY) | Yes; No |
|
| radio |
| | MHENDAT | 7 | What was the medical condition or event end date? | End Date | Record the end date of the medical event or condition using this format (DD-MON-YYYY). | Date | MHENDTC |
|
|
|
| prompt |
|
|
|
This is an examples of SDTM dataset used to represent the medical history collected on the above CRF.
| Dataset wrap |
|---|
|
| Rowcaps |
|---|
| Rows 1-2: | 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, 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. | | Row 3: | The start and end date of the reported event was displayed. | |
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | MHSEQ | MHTERM | MHDECOD | MHCAT | MHBODSYS | MHSTDTC | MHENDTC | MHENRTPT | MHENTPT |
|---|
| 1 | ABC123 | MH | 123101 | 1 | ASTHMA | Asthma | GENERAL MEDICAL HISTORY | Respiratory system disorders | 2003 |
| ONGOING | 2004-09-18 | | 2 | ABC123 | MH | 123101 | 2 | FREQUENT HEADACHES | Headache | GENERAL MEDICAL HISTORY | Central and peripheral nervous system disorders | 2004-07 |
| ONGOING | 2004-09-18 | | 3 | ABC123 | MH | 123101 | 3 | BROKEN LEG | Bone fracture | GENERAL MEDICAL HISTORY | Musculoskeletal system disorders | 2005-07-15 | 2005-08-31 |
|
| |
|