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

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  • Опубліковано 7 лис 2024

КОМЕНТАРІ • 26

  • @purnachandar7627
    @purnachandar7627 Рік тому +2

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

    • @mycsg
      @mycsg  Рік тому +1

      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
    @naveensai5730 Місяць тому

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

    • @mycsg
      @mycsg  Місяць тому +1

      Hope the below video helps.
      ua-cam.com/video/4HB2oWEpZvs/v-deo.html

  • @sripriyagujjula7881
    @sripriyagujjula7881 6 місяців тому

    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
      @mycsg  6 місяців тому

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

  • @asm_adam
    @asm_adam Рік тому

    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
      @mycsg  Рік тому +1

      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
    @arjunpandya93 Рік тому

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

    • @mycsg
      @mycsg  Рік тому

      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
      @sripriyagujjula7881 6 місяців тому

      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

  • @gowrik77
    @gowrik77 Рік тому

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

    • @mycsg
      @mycsg  Рік тому

      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
      @gowrik77 Рік тому

      thank you

  • @avlsramakrishna4219
    @avlsramakrishna4219 7 місяців тому

    Hi sir, how to validate define.xml?

    • @mycsg
      @mycsg  6 місяців тому

      We use Pinnacle 21 to validate define.xml.

  • @rishithab575
    @rishithab575 Рік тому

    How to convert a file into sdtm while using R program

    • @mycsg
      @mycsg  Рік тому

      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
      @rishithab575 Рік тому

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

    • @mycsg
      @mycsg  Рік тому

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

    • @rishithab575
      @rishithab575 Рік тому

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

    • @rishithab575
      @rishithab575 Рік тому

      @@mycsg Got it thanks

  • @Sai_g969
    @Sai_g969 Рік тому

    Hi dude please do video on kaplan meier survival analysis plot

    • @mycsg
      @mycsg  Рік тому

      Sure Somanath. Will do it in a few days.

  • @maheshgarlapati5429
    @maheshgarlapati5429 Рік тому

    Tq bro

    • @mycsg
      @mycsg  Рік тому

      You are welcome.