myCSG © |Area: SDTM| Concept: RP : Reproductive System Findings | Lesson: L101 : Reproductive System Findings - Childbearing Potential and Menopause Status |

 

Background
  • In some clinical trials, we may have to collect data about physiological and morphological findings related to the male and female reproductive systems
  • Some example data points are:
    • Childbearing Potential
    • Menopause Status
    • Number of Pregnancies
    • Birth Control Method
  • SDTM standard has a standard domain for capturing these findings - "Reproductive System Findings (RP)"
  • RP dataset belongs to Findings class and has an expected record structure of 'One record per finding or result per time point per visit per subject'

What type of information is typically collected or presented?
  • Date of assessment
  • Test performed status
    • Yes
    • No 
      • Reason not performed
  • Short name of the test
  • Name of the test
  • Result
    • in original units
    • in standard units
  • Derived information
    • Baseline flag - when results of a test are collected over pre and post treatment period
 

In this lesson, we will see

  • How to create new rows for separate testcds from different variables present on a record
  • How to derive study day
  • How to derive epoch variable using subject elements dataset
  • How to create baseline flag
  • How to create seq variable

REPMEN : Reproductive and Menopause Status
Question Response
Assessment Performed?
[REPMEN_YN]

No
Yes
If Yes, date performed
[REPMENDAT]
Is the subject of childbearing potential?
[CHILDPOT]

No
Yes
Menopause Status
[MENOSTAT]

Pre-Menopause
Menopause



VARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_REPMEN
STUDYID Study Identifier Char Set to 'statschoice'
DOMAIN Domain Abbreviation Char Set to 'RP'
USUBJID Unique Subject Identifier Char Concatenate REPMEN.PROJECT and REPMEN.SUBJECT with a hyphen in between.
RPSEQ Sequence Number Num Sort the records by USUBJID, RPTESTCD, RPDTC and assign as 1 on the first record of each subject and increment by 1 for each subsequent record for that subject.
RPSPID Sponsor-Defined Identifier Char Populate using REPMEN.RECORDPOSITION in three digit format padding with leading 0's where applicable.
RPTESTCD Short Name of Reproductive Test Char Create one record for each test collected. Populate as 'CHILDPOT' when creating the record using 'CHILDPOT'. Populate as 'MENOSTAT' when creating the record using 'MENOSTAT'. Populate as 'RPALL' when creating the record where REPMEN.REPMEN_YN='No'.
RPTEST Name of Reproductive Test Char Populate as 'Childbearing Potential' when RPTESTCD='CHILDPOT'. Populate as 'Menopause Status' when RPTESTCD='MENOSTAT'. Populate as 'Reproductive System Findings' when RPTESTCD='RPALL'.
RPORRES Result or Finding in Original Units Char Populate using REPMEN.CHILDPOT, REPMEN.MENOSTAT
RPORRESU Original Units Char Set to null
RPSTRESC Character Result/Finding in Std Format Char Populate using SDTM.RP.RPORRES
RPSTRESU Standard Units Char Populate using SDTM.RP.RPORRESU
RPSTAT Completion Status Char Set to 'NOT DONE' when REPMEN.REPMEN_YN='No'.
RPREASND Reason Not Done Char Set to 'Not Collected' when SDTM.RP.RPSTAT='NOT DONE'
RPBLFL Baseline Flag Char Set to "Y" on the latest record with non-missing result on or prior to SDTM.DM.RFSTDTC per each test.
VISITNUM Visit Number Num Populate using FOLDERSEQ.
VISIT Visit Name Char Populate using FOLDERNAME.
EPOCH Epoch Char Populate using SDTM.SE.EPOCH by comparing RPDTC 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.
RPDTC Date/Time of Collection Char Populate using REPMEN.REPMENDAT in ISO 8601 format.
RPDY Study Day of Visit/Collection/Exam Num If the SDTM.RP.RPDTC is on or after reference start date then SDTM.RP.RPDTC-SDTM.DM.RFSTDTC +1. Else if date is before reference start date then assign as SDTM.RP.RPDTC-SDTM.DM.RFSTDTC.
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