Online Course - CRF Design

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Module 2 Case Study

  • 1.  Module 2 Case Study

    Posted 05-21-2019 09:34
    Edited by Estelle Denion 07-29-2019 11:50



    Dear participants,

    Here is the discussion forum for the case study.

    Feel free to discuss and exchange about your opinions, your suggestions and your comments.

    Best regards,

    SCDM Learning team

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    Annemarie Weise
    EDUCATIONAL PROJECTS MANAGER
    Society for Clinical Data Management Inc.
    B-1160 Brussels
    32-23202529
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  • 2.  RE: Module 2 Case Study

    Posted 08-02-2019 23:30
      |   view attached
    I chose #2 for this case study Module 2.​

    Thanks!

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    Jonathan Lim
    Singapore
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    Attachment(s)



  • 3.  RE: Module 2 Case Study

    Posted 08-13-2019 12:14
    Hi Jonathan:

    You have defined concisely the differences between Source and CRF.  Thanks for your submission and example of your comprehension.................Denise

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    Denise Redkar-Brown
    Principal
    Sunburst Clinical Solutions - PA
    Elkton MD
    (701) 219-4810
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  • 4.  RE: Module 2 Case Study

    Posted 08-03-2019 19:17
      |   view attached
    Hi,

    I have taken below case study for Module 2:

    • #2 You have been asked to help lead a workshop for prospective CRAs. Your part is to explain the difference between a "source document" and a "case report form." Your supervisor has asked you to develop a detailed outline of your presentation prior to the workshop and has suggested you use the ICH E6 Guidance to help develop it.

    Please find attached the document with details of difference between Source document and Case report form.

    Thanks and regards,
    Ujala Bhardwaj

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    Ujala Bhardwaj
    Stockholm
    (072) 220-0386
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    Attachment(s)



  • 5.  RE: Module 2 Case Study

    Posted 08-13-2019 12:18
    Hi Ujala!
    Thank you for this submission of your case study choice.  I can tell that you have utilized the ICH E6 (R2) for your descriptions which are quite comprehensive.

    Regards,
    Denise

    ------------------------------
    Denise Redkar-Brown
    Principal
    Sunburst Clinical Solutions - PA
    Elkton MD
    (701) 219-4810
    ------------------------------



  • 6.  RE: Module 2 Case Study

    Posted 08-07-2019 17:17
      |   view attached
    I choose: 

    • #4 Your group's most recent hire is new to CRF design. Your supervisor has asked that you review and suggest changes to his/her work to help him/her develop in this new role. S/he has developed three CRFs - CRF 1, CRF 2, CRF 3. Your supervisor has asked you to review the three CRFs your new colleague has developed and make any changes to the CRF you see necessary. Print out the CRFs, then write your changes on the hard copy. Finally, scan the hard copy with the suggested changes and submit it using the link below.


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    Dr Emma Callegari
    Lead Database Design and Development Manager, BaCT
    Peter MacCallum Cancer Centre - Australia
    ------------------------------

    Attachment(s)

    pdf
    Scan08-08-2019-070529.pdf   1.24MB 1 version


  • 7.  RE: Module 2 Case Study

    Posted 08-13-2019 12:22
    Thank you Emma for the annotations for corrections to the sample CRFs.  You have correctly noted inconsistencies in format of Date collections as well as noting the lack of CRF completion instructions which we would expect to be included in a paper CRF.

    Great job!

    Denise

    ------------------------------
    Denise Redkar-Brown
    Principal
    Sunburst Clinical Solutions - PA
    Elkton MD
    (701) 219-4810
    ------------------------------



  • 8.  RE: Module 2 Case Study

    Posted 08-10-2019 02:18
      |   view attached
    I chose the first option, working on the new database specification. 
    Thank you!


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    Samantha Carrington
    Loxo Oncology Inc.
    So. San Francisco CA
    (310) 995-0123
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  • 9.  RE: Module 2 Case Study

    Posted 08-13-2019 12:33
      |   view attached
    Hi Samantha!

    Thank you for this submission--this took a lot of work :-).  I have added a few comments................Denise

    ------------------------------
    Denise Redkar-Brown
    Principal
    Sunburst Clinical Solutions - PA
    Elkton MD
    (701) 219-4810
    ------------------------------



  • 10.  RE: Module 2 Case Study

    Posted 08-10-2019 12:17
      |   view attached
    For this case study I chose #1 the database specifications.​

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    James Koch
    Scientific Application Data Specialist
    Fujirebio Diagnostics, Inc.
    Malvern, PA
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  • 11.  RE: Module 2 Case Study

    Posted 08-13-2019 12:39
      |   view attached
    Hi James! 

    Thanks for this submission for the database specs.  I add a comment which may not be relevant to the DB specs per se, but there is no consequence to your work.........Denise

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    Denise Redkar-Brown
    Principal
    Sunburst Clinical Solutions - PA
    Elkton MD
    (701) 219-4810
    ------------------------------



  • 12.  RE: Module 2 Case Study

    Posted 08-11-2019 18:27
      |   view attached
    I chose option #1.


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    Eveline Niedermayr
    Peter MacCallum Cancer Centre - Australia
    Melbourbe
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  • 13.  RE: Module 2 Case Study

    Posted 08-13-2019 12:46
      |   view attached
    Thank you, Evaline for this submission.  I have added just a comment in the attached.

    Nice work!
    Denise

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    Denise Redkar-Brown
    Principal
    Sunburst Clinical Solutions - PA
    Elkton MD
    (701) 219-4810
    ------------------------------