myCSG © |Area: SDTM| Concept: FA : Findings About Events or Interventions | Lesson: LGE01 : FA-Gastroenteritis |

 

Background
  • In clinical trials, as per SDTM standard, the data collected is classified into three general observation classes.
    • Interventions
    • Events
    • Findings
  • Sometimes, we may need to collect additional information about the events or interventions
  • As per SDTM standard, we have to represent the additional information collected about events or interventions in a dataset classed as 'Findings About'
  • These 'Findings About' share the same list of variables as that of a SDTM 'Findings' domain but has an additional variable named 'FAOBJ' - objective of the observation or test presented on a record
  • Some examples:
    • Additional details about vomiting in a vaccine study: 
      • Occurrence of vomiting in a vaccine study is an event and we may want to collection additional information about this event in terms of 
        • Number of episodes
        • Volume of vomit
      • We do not have standard variables in events class to represent this information in AE
      • As per SDTM standard, as these are additional questions about an event, we need to use FA domain to present this data
    • Additional details about bone fractures in osteoporosis study
      • Bone fracture is considered an event and any additional information collected about this event has to be presented in FA domain
        • Reason for bone fracture
        • Activity being performed when bone fracture was supposed to have occurred
        • Any further complications occurred - yes/no

What type of information is typically collected or presented?

 

  • Objective for which the test is collected
  • Short name for the test 
  • Name of the test
  • Result
    • in collected units
    • in standard units
  • Date/time of collection
 
  • Complete Key programming of Findings About Domain:
    • Findings related to gastroenteritis (SDTM_CE_LGE01), a clinical event in a vaccine study
    • Occurrence and number of episodes of diarrhea over different days
    • Three collections within a day - Three 8-hour intervals
    • Additional details related to the event are also collected
      • Additional details include
      • Required healthcare visit and type of visit
      • Needed Oral rehydration
      • Needed IV hydration
      • Required hospitalization for the event

CEEVENT : Gastroenteritis Event Symptoms
Question Response
Start Date of the Event
[CEDAT_RAW]
Nominal day of assessment for this event
[GEDAY]
Date of assessment
[GEDAT_RAW]
Any Diarrhea episodes from 00:01 to 08:00?
[DIAOCCUR_1]

Yes
No
If Yes, Number of diarrhea episodes from 00:01 to 08:00?
[DIANUM_1]
Any Diarrhea episodes from 08:01 to 16:00?
[DIAOCCUR_2]

Yes
No
If Yes, Number of diarrhea episodes from 08:01 to 16:00?
[DIANUM_2]
Any Diarrhea episodes from 16:01 to 24:00?
[DIAOCCUR_3]

Yes
No
If Yes, Number of diarrhea episodes from 16:01 to 24:00?
[DIANUM_3]
Any vomiting episodes from 00:01 to 08:00?
[VOMOCCUR_1]

Yes
No
If Yes, Number of vomiting episodes from 00:01 to 08:00?
[VOMNUM_1]
Any vomiting episodes from 08:01 to 16:00?
[VOMOCCUR_2]

Yes
No
If Yes, Number of vomiting episodes from 08:01 to 16:00?
[VOMNUM_2]
Any vomiting episodes from 16:01 to 24:00?
[VOMOCCUR_3]

Yes
No
If Yes, Number of vomiting episodes from 16:01 to 24:00?
[VOMNUM_3]
Body Temperature (degree celsius)
[TEMP]




CEDETAILS : Event Details
Question Response
Start Date of the Event
[CEDAT_RAW]
Did this event require healthcare provided visit?
[HCARE]

Yes
No
If yes, healthcare visit type
[HCARE_TYPE]

Outpatient
Emergency Room
Required oral rehydration?
[OREHYD]

Yes
No
Required intravenous hydration?
[IVREHYD]

Yes
No
Did this event result in hospitalization of subject?
[HOSP]

Yes
No



SUPPVARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_CEEVENTSFORM_CEDETAILS
_ STUDYID Study Identifier Char Populate as 'statschoice'
_ DOMAIN Domain Abbreviation Char Populate as 'FA'
_ USUBJID Unique Subject Identifier Char Populate using SUBJECT variable
_ FASEQ Sequence Number Num Sort the records by USUBJID, FAGRPID, FAOBJ, FATESTCD, FADTC, FAEVINTX and set to 1 on the first record for each subject, and increment by 1 for each subsequent record within the subject
_ FAGRPID Group ID Char Populate using CEDAT_RAW after converting to ISO8601 format Populate using CEDAT_RAW after converting to ISO8601 format
_ FATESTCD Findings About Test Short Name Char Tests corresponding to occurrence of diarrhea and vomiting :
1) Create a record with FATESTCD=OCCUR to store the information from DIAOCCUR_1 with FAOBJ=Diarrhea, FAEVINTX=Episodes from 00:01 to 08:00
2)Create a record with FATESTCD=OCCUR to store the information from DIAOCCUR_2 with FAOBJ=Diarrhea, FAEVINTX=Episodes from 08:01 to 16:00
3) Create a record with FATESTCD=OCCUR to store the information from DIAOCCUR_3 with FAOBJ=Diarrhea, FAEVINTX=Episodes from 16:01 to 24:00

Repeat the same process for VOMOCCUR_1, VOMOCCUR_2, VOMOCCUR_3 and use FAOBJ=Vomiting.
Tests corresponding to number of episodes of diarrhea and vomiting :
1) Create a record with FATESTCD=EPSDNUM to store the information from DIANUM_1 with FAOBJ=Diarrhea, FAEVINTX=Episodes from 00:01 to 08:00
2) Create a record with FATESTCD=EPSDNUM to store the information from DIANUM_2 with FAOBJ=Diarrhea, FAEVINTX=Episodes from 08:01 to 16:00
3) Create a record with FATESTCD=EPSDNUM to store the information from DIANUM_3 with FAOBJ=Diarrhea, FAEVINTX=Episodes from 16:01 to 24:00

Repeat the same process for VOMNUM_1, VOMNUM_2, VOMNUM_3 and use FAOBJ=Vomiting.		 1) Create a record with FATESTCD=OCCUR to store the information from HCARE with FAOBJ=Healthcare provided visit
2) Create a record with FATESTCD=HOSVISTYP to store the information from HCARE_TYPE with FAOBJ=Healthcare provided visit. Create this record only when HCARE is 'Yes'.
3) Create a record with FATESTCD=OCCUR to store the information from OREHYD with FAOBJ=Oral Rehydration
4) Create a record with FATESTCD=OCCUR to store the information from IVREHYD with FAOBJ=Intravenous hydration
5) Create a record with FATESTCD=OCCUR to store the information from HOSP with FAOBJ=Resulted in hospitalization
_ FATEST Findings About Test Name Char Populate as 'Number of Episodes" when FATESTCD=EPSDNUM
Populate as "Occurrence" when FATESTCD="OCCUR"
Populate as "Healthcare visit type" when FATESTCD="HOVISTYP".
_ FAOBJ Object of the Observation Char See FATESTCD variable for details. See FATESTCD variable for details.
_ FACAT Category for Findings About Char Populate as 'Gastroenteritis' Populate as 'Gastroenteritis Details'
_ FAORRES Result or Finding in Original Units Char See FATESTCD variable for details. See FATESTCD variable for details.
_ FAORRESU Original Units Char Leave null Leave null
_ FASTRESC Character Result/Finding in Std Format Char Populate using FAORRES.
Populate as "Y" when FAORRES="Yes".
Else populate as "N" when FAORRES="No".
_ FASTRESN Numeric Result/Finding in Standard Units Num Populate using FAORRES when the result is numeric.
_ FASTRESU Standard Units Char Populate using FAORRESU.
_ FAEVAL Evaluator Char Populate as 'INVESTIGATOR' Populate as 'INVESTIGATOR'
_ FADTC Date/Time of Collection Char Populate using GEDAT_RAW
_ FAEVINTX Evaluation Interval Text Char See FATESTCD variable for details. See FATESTCD variable for details.
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