Data Validation and Edits in Software Development
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Questions and Answers

What is the main responsibility of data management in preparing for DB go-live?

  • Programming the edits specified in the DVP document
  • Creating test patients in EDC testing environment
  • Re-checking the DVP for necessary changes and signing it off (correct)
  • Preparing the testing log during UAT

    • What is the purpose of the ECS document?

  • To define edits and draft the DVP document
  • To perform UAT on a guideline document
  • To specify data validations required in the EDC (correct)
  • To create test patients in the EDC testing environment

    • Who performs the task of programming the edits as specified in the DVP document?

  • Test patients in the EDC testing environment
  • Data Management
  • Clinical Research Form users
  • The programmer (correct)

    • What is the purpose of screen UAT based on the CCG guideline document?

    <p>Hyperlink forms/CRFs/pages for data entry in the EDC</p> Signup and view all the answers

    Which category of checks does DM identify when defining panel-wise edit checks for the DVP document?

    <p>Discrepancy in clinical data identification checks</p> Signup and view all the answers

    What is the final step before DB go-live as per the given text?

    <p>Re-check DVP for necessary edits</p> Signup and view all the answers

    Who is responsible for preparing and documenting the testing log during UAT?

    <p>Data Management</p> Signup and view all the answers

    What document is hyperlinked in the EDC as per the text?

    <p>CRF completion guidelines</p> Signup and view all the answers

    What should be focused on while performing UAT based on the text?

    <p>Documenting edits as per ECS.</p> Signup and view all the answers

    Which party segregates instructions form/CRF/page-wise based on the CCG guideline document?

    <p>Data Management.</p> Signup and view all the answers

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