myCSG © |Area: SDTM| Concept: EC : Exposure as Collected | Lesson: LCSG001 : EC dataset Programming for study CSG001 |

Background
  • In clinical trials, we administer 'study treatments' to the subjects over time as per study requirement
  • We need to report the data as collected for these study drug administrations
  • SDTM standard has standard data structure for reporting such data - "Exposure as Collected (EC)"
  • EC domains falls under interventions class of the SDTM domains
  • In some studies, we collect both planned doses to be given and actual dose given. We report both planned and actual dosages in EC domain
    • We use the variable ECMOOD to distinguish between planned and actual dose records 
      • On the record where planned dose is reported we populate ECMOOD as 'SCHEDULED'
      • On the record where actual dose is reported we populate ECMOOD as 'PERFORMED'
  • EC domain is expected to have a record structure of "One record per protocol-specified study treatment, collected-dosing interval, per subject, per mood".
  • Any treatments other than study treatments must be reported in CM domain.
  • 'Study treatments' include
    • Investigational drug
    • Control 
      • Existing marketed product
      • Placebo
    • Any other medications specified in protocol like co-therapies

What type of information is typically collected or presented?
  • Treatment name
  • Treatment administered
    • Yes
    • No
      • Reason when not administered
  • Start date/time of the treatment
  • End date/time of the treatment
  • Dose and dosing unit of the treatment
  • Frequency of administration (once daily/twice daily etc.)
  • Route of administration (oral/intravenous/intramuscular etc.)
  • Dosage form (tablet/capsule/injection etc.)
  • Location of administration (Hand/Thigh etc.)
  • Laterality (Left/Right etc.)
  • Was the dose adjusted for any reason?
    • Reason for adjustment
  • Lot number of the treatment package

In this lesson,

  • We will see how to create EC domain, for an example CRF where the volume of injection administered is collected.
  • We will also how to fetch the treatment content based on kit identification number
variable_namevariable_labelderivation
General Exposure to study drug is collected in ipadmin dataset. Volume of injection administered is captured in the raw data, we present this information in Exposure as Collected (EC) dataset.
STUDYID Study Identifier Equals to the value from raw.ipadmin.STUDY
DOMAIN Domain Abbreviation Assign as "EC"
USUBJID Unique Subject Identifier Derive by concatenating raw.ipadmin.STUDY and raw.ipadmin.PT with a hyphen in between
ECSEQ Sequence Number Sort the records by USUBJID,ECTRT,ECSTDTC and set to 1 on the first record of the subject and increment by 1 on subsequent records within the subject
ECTRT Name of Treatment Derive by fetching raw.box.CONTENT by joining raw.ipadmin and raw.box datasets based on raw.ipadmin.IPBOXID and raw.box.KITID. If CONTENT="PBO" then assign as 'PLACEBO", else if CONTENT="ACTIVE" then assign as "ACTIVE".
ECDOSE Dose Equals to the value from raw.ipadmin.IPQTY_RAW after converting to numeric value
ECDOSU Dose Units Equals to the value from raw.ipadmin.IPQTYU
ECDOSFRM Dose Form Assign as "INJECTION"
ECDOSFRQ Dosing Frequency per Interval Assign as "EVERY WEEK"
ECROUTE Route of Administration Assign as "INTRAVENOUS"
ECLOT Lot Number Derive by fetching raw.lot.LOTNUM by joining raw.ipadmin and raw.lot datasets based on raw.ipadmin.IPBOXID and raw.lot.KITID. Assign the value of LOTNUM to ECLOT.
ECPSTRG Pharmaceutical Strength Equals to the value from raw.ipadmin.IPCONC
ECPSTRGU Pharmaceutical Strength Units Assign as "ug/mL"
ECADJ Reason for Dose Adjustment Equals to the value from raw.ipadmin.IPADJ after converting to upper case
EPOCH Epoch Assign as "TREATMENT"
ECSTDTC Start Date/Time of Treatment Derive the datetime value in ISO 8601 format by obtaining the information from raw.ipadmin.IPSTDT_RAW and raw.ipadmin.IPSTTM_RAW variables.
ECENDTC End Date/Time of Treatment Equals to the value from sdtm.EC.ECSTDTC
ECSTDY Study Day of Start of Treatment If the administration date is on or after reference start date then sdtm.ec.ECSTDTC-sdtm.dm.RFSTDTC +1. Else if date is before reference start date then assign as sdtm.ec.ECSTDTC-sdtm.dm.RFSTDTC.
ECENDY Study Day of End of Treatment If the administration date is on or after reference start date then sdtm.ec.ECENDTC - sdtm.dm.RFSTDTC +1. Else if date is before reference start date then assign as sdtm.ec.ECENDTC-sdtm.dm.RFSTDTC.
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