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DM Processes - Have yours jumped the shark?

  • 1.  DM Processes - Have yours jumped the shark?

    Posted 10-01-2019 08:49
    At the SCDM US Conference, we are discussing old school DM Processes and ways we can do things better.
    Please post any thoughts or share your experiences on efficient ways to handle:

    • Protocol Deviations
    • System Implementation & Validation responsibilities
    • Data metrics and clean patient tracking
    • Standards implementation
    • SAE Reconciliation


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    Jennifer Price
    Senior Director, Clinical Data Management
    SCDM Board Member
    Paidion Research
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  • 2.  RE: DM Processes - Have yours jumped the shark?

    Posted 10-02-2019 10:26
    Hi Jennifer,

    Those are some good discussion topics! My comments are below:

    1. For Protocol Deviations, our EDC allows for email functionality and we now send out an email that is triggered when the critical is selected for the deviation type, this email can stop any further deviations at other sites  and speed up the process of reconciliation.

    2. For system implementation and validation, Our team uses a waterfall approach. Basically, the validation team (generally 4 or 5 members) will 1st attend a training on the new system functionality. Next, with the team members input, the test scripts are written by one member.  That is pushed to one or more testers. After testing of the functionality. the completed test script is then checked for completeness and quality.Then verified by the another user. i.e.retested.
    Our team does not use much technology when validating and would like what others are using or doing. I would also like to know if anyone else is using an agile approach to validation.

    3. Our team just started to run metrics on our trial building processes. We haven't applied an analysis of the metrics yet. but I do know that the LEAN approach is big in our company and we will most likely use these metrics  to determine where the bottlenecks are and try to mitigate them.

    4. For standards implementation, the database developer will work with the statistician to discuss the new variable names for each study. After testing, We then put the newly validated forms in out EDC library for future use, this greatly speeds up the build times for future studies. A  basic strait forward approach.
    We do not use the new CDASH Library software and , if there are any users on here, I would like to hear what they think about it. i.e pros and cons

    5. For SAE Reconciliation, I do not play a big part in the process, but like the PD form, we do send out an email as soon as an SAE is triggered in the EDC system.

    I would love to hear some responses and hope this discussion takes off :)

    Thank you!

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    Brandon Adkinson
    Data Manager Specialist
    GE Healthcare - WI
    Waukesha WI
    (262) 544-3755
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  • 3.  RE: DM Processes - Have yours jumped the shark?

    Posted 10-03-2019 11:35
    Hi Brandon,
       Thank you for your post.  ​
       Regarding #2 system implementation - there was talk at the conference about automated testing and using AI tools to help with this, but I don't know of anybody who has implemented any automation other than vendors who use regression testing.  I'd be interested in hearing what others are doing regarding automation.
       For #4 CDASH Library - We don't do enough study starts to warrant the resources needed to use the CDASH Library, so we still review things against the standard manually.

       I would love to see others post something similar to yours. 
    Thanks again!

    Jennifer
    ​​

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    Jennifer Price
    Senior Director, Clinical Data Management
    SCDM Board Member
    Paidion Research
    ------------------------------



  • 4.  RE: DM Processes - Have yours jumped the shark?

    Posted 10-03-2019 11:38
    Hi Jennifer,

    Thanks for the insights, I hope we hear more. I understand the group is still a bit small, but hopefully growing.

    -Brandon

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    Brandon Adkinson
    Waukesha WI
    GE Healthcare - WI
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