any information collected related to AE that cannot be mapped to standard variables will be stored in suppae... there is one standard qnam AETRTEM which is used in most studies..
Hi, the information on whether an adverse event is a dose limiting toxicity is generally captured on crf page itself. There is no standard variable in SDTM IG to indicate dose limiting toxicities. So, the information will be mapped to SUPPAE.
sure, will try to do it.. EC and EX belong to interventions class - some of the variables can be remembered using CM concpet map. Link to CM video is below. ru-vid.com/video/%D0%B2%D0%B8%D0%B4%D0%B5%D0%BE-SKTV9e65NTA.html
Hi Sir, I need a information on event and findings domain. Sorting data set on basis of USUBJID AETESTCD AESTDTC is correct or USUBJID AETESTCD AESTDTC is correct ?
There is no standard sorting requirement, you can choose it based on your requirement. I am assuming you have inadvertently specified AE as a findings domain here. AE is an events domain and you dont have 'AETESTCD'.