myCSG © |Area: SDTM| Concept: MH : Medical History | Lesson: LCSG801 : MH dataset programming for study CSG801 |
Multiple raw datasets contributing to single dataset
End relative to a timepoint
ENRTPT
ENTPT
Lesson description will be added soon
End relative to a timepoint
ENRTPT
ENTPT
Lesson description will be added soon
| variable_name | variable_label | derivation |
|---|---|---|
| General | Medical History Data is collected on 3 crf pages: 1) Diabetes History - mh801_1 2) Diabetes Complications - mh801_2 3) General Medical History - mh801_3. Information from these datasets has to combined to create SDTM.MH | |
| STUDYID | Study Identifier | Equals to the value from STUDY variable of raw.mh801_1, raw.mh801_2 and raw.mh801_3 datasets |
| DOMAIN | Domain Abbreviation | Assign as "MH" |
| USUBJID | Unique Subject Identifier | Derive by concatenating the values from STUDY and PT variables from raw.mh801_1, raw.mh801_2 and raw.mh801_3 datasets |
| MHSEQ | Sequence Number | Sort the records by STUDYID,USUBJID,MHTERM, MHSTDTC and set to 1 on the first record of the subject, and increment by 1 on subsequent records of the subject. |
| MHREFID | Reference ID | Derive by concatenating the name of the input dataset in upper case and the value of REPEAT variable as three character wide digit with leading zeros where applicable, separated with a hyphen in between. For example, a record from mh801_1 with value of 1 in REPEAT will look like 'MH801_1-001' |
| MHTERM | Reported Term for the Medical History | raw.mh801_1.MHTERM converted to uppercase raw.mh801_2.MHTERM raw.mh801_3.MHTERM |
| MHCAT | Category for Medical History | For the records coming from raw.mh801_1 and raw.mh801_2, set to "DIABETES". For the records coming from raw.mh801_3, set to "GENERAL" |
| MHSCAT | Subcategory for Medical History | For the records coming from raw.mh801_2, set to "COMPLICATIONS" |
| MHPRESP | Medical History Event Pre-Specified | For the records coming from raw.mh801_1 and raw.mh801_2, set to "Y" |
| MHOCCUR | Medical History Occurrence | For the records coming from raw.mh801_1, assign as "Y". For the records coming from raw.mh801_2, set to the value from MHOCCUR. |
| MHDTC | Date/Time of History Collection | Equals to the value from MHDAT variable of raw.mh801_1, raw.mh801_2 and raw.mh801_3 datasets, after converting to ISO 8601 format |
| MHSTDTC | Start Date/Time of Medical History Event | Equals to the value from MHSTDAT variable of raw.mh801_1, raw.mh801_2 and raw.mh801_3 datasets, after converting to ISO 8601 format |
| MHENDTC | End Date/Time of Medical History Event | Equals to the value from MHENDAT raw.mh801_3 dataset, after converting to ISO 8601 format |
| MHDY | Study Day of History Collection | Difference between the date values from sdtm.mh.MHDTC and sdtm.dm.RFSTDTC. Add 1 to the difference if MHDTC is on or after RFSTDTC. |
| MHENRTPT | End Relative to Reference Time Point | Assign as "ONGOING" : 1) For all records coming from raw.mh801_1 2) For the records coming from raw.mh801_1 when MHOCCUR="Y" 3) For the records coming from raw.mh801_3 when raw.mh801_3.MHONGO="Yes" |
| MHENTPT | End Reference Time Point | Equals to the value from sdtm.mh.MHDTC when sdtm.MHENRTPT="ONGOING" |
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