define.xml - Basic introduction on how SDTM define.xml looks like and key components

[@purnachandar7627]

Thank you for videos and very clear explaination. Can you explain different versions of Sdtm, Adam IG, added domains and variables?

[@mycsg]

Sure, I will try to do a video on this. The best place to check all the changes in a specific IG version is to go through the 'Relationship to Prior CDISC Documents ' section of the implementation guide document.

[@naveensai5730]

How do we creare define.xml? If possible can you explain breief steps

[@mycsg]

Hope the below video helps. kzbin.info/www/bejne/anmlY6KNetWNrNU

[@sripriyagujjula7881]

Hi, incase one variable haveing more than 200 char present in sdtm domain approx 1000 char, how to do split one variable into multiple variables?

[@mycsg]

www.mycsg.in/tasks.php?area=TASKS&concept=SDTMGEN&lesson=TASKS_SDTMGEN_L160

[@gowrik77]

hi can you tell me how to hyper link specific pages of crf to the variable metadata

[@mycsg]

Hi Gowri, I am not aware of any simple process of doing it. You may find the below link helpful. www.extendoffice.com/documents/excel/4349-excel-hyperlink-to-pdf-page.html

[@gowrik77]

thank you

[@asm_adam]

The SDTM IG version in the video is 3.1.2;But the latest one available is version 3.4.So,which version is the most used one currently?

[@mycsg]

The version I showed is an example file from CDISC. SDTM IG 3.2 and 3.3 are most widely used. The IG versions used also depends on the stage of the drug being tested, if some of the already conducted studies used an earlier version of IG (for example 3.2), further studies may also based on same IG version to support data pooling for Integrated analysis of safety/efficacy.

[@arjunpandya93]

what about dual bookmarking of aCRF..is it new requirement by FDA?

[@mycsg]

Hi Arjun, dual bookmarking is not very new, it has been there for some time. I think this was first part of the define.xml v2 release package, way back in 2014. (define_xml_2_0_releasepackage20140424)

[@sripriyagujjula7881]

Hi , incase one variable haveinh more than 200 char present in sdtm domain approx 1000 char, how to do split the one variable into multiple variables​@@mycsg

[@avlsramakrishna4219]

Hi sir, how to validate define.xml?

[@mycsg]

We use Pinnacle 21 to validate define.xml.

[@Sai_g969]

Hi dude please do video on kaplan meier survival analysis plot

[@mycsg]

Sure Somanath. Will do it in a few days.

[@rishithab575]

How to convert a file into sdtm while using R program

[@mycsg]

Hi Rishitha, this channel is currently focused on creation of sdtms using SAS. Plan is to create videos on R usage for SDTMs, but it will take time.

[@rishithab575]

@@mycsg thanks for your reply. Can I have your email or phone number to contact you. I need some help please

[@mycsg]

you can find it on the website www.mycsg.in

[@rishithab575]

@@mycsg perfect I emailed you, waiting for reply thanks

[@rishithab575]

@@mycsg Got it thanks

[@maheshgarlapati5429]

Tq bro

[@mycsg]

You are welcome.