myCSG © |Area: SDTM| Concept: PR : Procedures | Lesson: L101 : Procedures - transfusions - date, type, volume and reason |

Background
  • In clinical trials, subjects would be the given the investigational drug or a matching control and we call these as 'study treatments' and relevant information for these medications is captured as part of EC/EX domains
  • Any other medications taken prior or concurrent with the study or during the follow-up phase of study are reported in CM domain
  • Like the concomitant medications, patients may undergo some procedures which may have diagnostic, preventive, therapeutic, or palliative effects
  • Some example procedures:
    • CT Scan of body
    • Biopsy
    • Wisdom teeth extraction
    • Eye examination
    • Endoscopy
    • Radiotherapy
    • Echocardiogram
  • SDTM standard has the domain named "Procedures (PR)" to capture the occurrence of these procedures
  • Any results coming out of these procedures should be captured in their own individual findings or findings about domains
    • Example, the occurrence of echocardiogram procedure is captured in PR and the resulting findings like left ventricular ejection fraction and right ventricular ejection fraction are to be reported in CV domain

What type of information is typically collected or presented?
  • Procedure name
  • Is the procedure prespecified?
  • If prespecified
    • Performed
    • Did not perform
      • Reason not performed
  • Date or start date of the procedure
  • Status of the procedure - ongoing or ended?
    • If ended, end date/time of the medication
  • Dose and dosing unit where applicable (e.g. radiotherapy intensity)
  • Frequency of administration (once daily/twice daily etc.)
  • Route of administration 
  • Location and laterality of the procedure (Hand/Leg - right/left)
  • Indication for which the procedure is performed

In this lesson we will see,

  • How to create ISO dates
  • How to create study day variables
  • How to create --SEQ variable
  • How to derive epoch variable

TRANFUSN :
Question Response
Start date of transfusion
[PRSTDAT]
Start time of transfusion
[PRSTTIM]
End date of transfusion
[PRENDAT]
End time of transfusion
[PRENTIM]
Transfusion type
[PRTRT]

Whole blood
Platelets
Packed red blood cells
Total volume transfused
[PRVOL]
Total volume unit
[PRVOLU]
Reason for transfusion
[PRREAS]



SUPPVARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_TRANSFUSN
_ STUDYID Study Identifier Char Set to 'statschoice'
_ DOMAIN Domain Abbreviation Char Set to 'PR'
_ USUBJID Unique Subject Identifier Char Concatenate transfusn.PROJECT and transfusn.SUBJECT with a hyphen in between.
_ PRSEQ Sequence Number Num Sort the records by USUBJID, PRCAT, PRTRT, PRSTDTC,PRENDTC and assign as 1 on the first record of each subject and increment by 1 for each subsequent record for that subject.
_ PRSPID Sponsor-Defined Identifier Char Populate using transfusn.RECORDPOSITION in three digit format padding with leading 0's where applicable.
_ PRTRT Reported Name of Procedure Char Populate using transfusn.PRTRT
_ PRCAT Category Char Populate as 'TRANSFUSIONS'
_ PRINDC Indication Char Populate using transfusn.PRREAS
_ PRDOSE Dose Num Populate using transfusn.PRVOL
_ PRDOSU Dose Units Char Populate using transfusn.PRVOLU
_ EPOCH Epoch Char Populate using SDTM.SE.EPOCH by comparing PRSTDTC with SESTDTC and SEENDTC of each element of the subject. Populate as 'TREATMENT' when the record falls on the boundary of SCREENING and TREATMENT elements. Populate as 'TREATMENT' when the record falls on the boundary of TREATMENT and FOLLOW-UP.
_ PRSTDTC Start Date/Time of Procedure Char Populate using transfusn.PRSTDAT and transfusn.PRSTTIM in ISO 8601 format.
_ PRENDTC End Date/Time of Procedure Char Populate using transfusn.PRENDAT and transfusn.PRENTIM in ISO 8601 format.
_ PRSTDY Study Day of Start of Procedure Num If the SDTM.PR.PRSTDTC is on or after reference start date then SDTM.PR.PRSTDTC-SDTM.DM.RFSTDTC +1. Else if date is before reference start date then assign as SDTM.PR.PRSTDTC-SDTM.DM.RFSTDTC.
_ PRENDY Study Day of End of Procedure Num If the SDTM.PR.PRENDTC is on or after reference start date then SDTM.PR.PRENDTC-SDTM.DM.RFSTDTC +1. Else if date is before reference start date then assign as SDTM.PR.PRENDTC-SDTM.DM.RFSTDTC.
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