myCSG © |Area: SDTM| Concept: RELREC : Related Records | Lesson: L101 : SDTM RELREC dataset - Relationship creation using raw datasets |

 

Background
  • As per CDISC SDTM standard, RELREC dataset has to be used to represent relationship between records across different SDTM datasets
  • Some commonly seen examples where relationships exist between different SDTM domains
    • Concomitant medications used for a specific adverse event
    • Discontinued study or treatment due to a specific treatment
    • Laboratory evaluations performed due to an adverse event

What do we learn in this lesson?
  • We will see how to programmatically create RELREC dataset using raw datasets
  • We will see a relationship between CM and AE domains
  • We will see a scenario where relationship exists between data that gets mapped to SDTM DS and AE domains

ADVERSE : Adverse Events
Question Response
Line number
[aespid]
Adverse Event Term
[aeterm]




EOS : End of study
Question Response
Line number
[dsspid]
Reason for end of study disposition
[dsterm]
If reason is 'Adverse Event', then AE number
[DSAENO]




CONMEDS : Concomitant Medications
Question Response
Line number
[cmspid]
Medication/Treatment
[cmtrt]
If this medication is used for an 'Adverse Event', then AE numb
[cmaeno]



SUPPVARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_EOSFORM_CONMEDS
_ General _isb When the subject discontinued a study due to an adverse event, the event line number is captured on EOS form to indicate the relationship between the discontinuation and a specific adverse event.
The line number of each adverse event in adverse event is mapped to SDTM variable AESPID.
Each row on EOS form is uniquely identified within a subject using line number and it is mapped to SDTM variable DSSPID
A link is established between DSSPID and AESPID using eos.dsaeno.		 When the subject took a medication for an adverse event, the event line number is captured on CONMEDS form to indicate the relationship between the treatment used and a specific adverse event.
The line number of each adverse event in adverse event is mapped to SDTM variable AESPID.
Each row on CONMEDS form is uniquely identified within a subject using line number and it is mapped to SDTM variable CMSPID
A link is established between CMSPID and AESPID using conmeds.cmaeno.
_ STUDYID Study Identifier Char Populate as 'statschoice'
_ RDOMAIN Related Domain Abbreviation Char Create two records for each non-missing value of eos.dsaeno (where eos.SUBJECT = adverse.SUBJECT and eos.dsaeno = adverse.aespid ) and set to 'DS' and 'AE' Create two records for each non-missing value of conmeds.cmaeno (where conmeds.SUBJECT = adverse.SUBJECT and conmeds.cmaeno = adverse.aespid ) and set to 'CM' and 'AE'
_ USUBJID Unique Subject Identifier Char Concatenate sdtm.relrec.STUDYID to SUBJECT with a hyphen in between. Concatenate sdtm.relrec.STUDYID to SUBJECT with a hyphen in between.
_ IDVAR Identifying Variable Char Set to DSSPID when RDOMAIN = DS and 'AESPID' when RDOMAIN = AE Set to CMSPID when RDOMAIN = CM and 'AESPID' when RDOMAIN = AE
_ IDVARVAL Identifying Variable Value Char Set to eos.dsspid when RDOMAIN = DS and adverse.aespid when RDOMAIN = AE Set to conmeds.cmspid when RDOMAIN = CM and adverse.aespid when RDOMAIN = AE
_ RELTYPE Relationship Type Char Leave null Leave null
_ RELID Relationship Identifier Char Concatenate "DSAE" as a prefix to eos.dsspid. Concatenate "CMAE" as a prefix to conmeds.cmspid.
Complete SAS code to generate the output is available for registered users!

Already registered! Login
Not registered, you can signup here! Signup

Dont want to register?
You can directly purchase this lesson (code+input data) here


You can purchase this lesson (code+input data) here

If you are looking to purchase subscription for full access to data and programs for all lessons (TASKS+SDTM+ADaM+TFLs), you can send us a message on +91-7330--77--66--49-- on Whatsapp.
R data is available only for R subscribers.
You can contact us on +91-7330--77--66---49 for purchasing subscription to R programs and data
R codes are available only for R subscribers.
You can contact us on +91-7330--77--66---49 for purchasing subscription to R programs and data