eDISH Tool Assessment Using the CDISC Data Built Into the Tool

eDISH Tool Assessment

This survey is designed to assess how well the eDish tool facilitates the workflow for assessing liver toxicity. The tool is limited to the eDish workflow described in “eDISH ISG User's Manual & Workflow”. This tool will be enhanced to meet additional requirements in the workflow in the future.

Types of Questions

Fill-in: capture comments or answers
Y/N: ‘Yes’ or ‘No’
Choice: Selection of responses

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* 1. Please provide your company e-mail.

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* 2. Were you able to identify any patient in this data set with lab values that meet the Hy’s Law criteria?

Yes

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* 3. Were you able to determine the treatment the patient was taking?

Yes

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* 4. Did that patient have more than 1 consecutive scheduled visit with an elevated lab value (> 3xULN) for Alanine Aminotransferase (U/L)?

Yes

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* 5. Were you able to assess how many Bilirubin lab values for that patient were above 2xULN?

Yes

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* 6. Were you able to assess if the increase Bilirubin lab values occurred after the elevation in Alanine Aminotransferase (U/L)?

Yes

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* 7. Were you able to determine if the peak increase in Bilirubin lab occurred within 15 days of the peak increase of ALT?

Yes

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* 8. Were you able to apply mDish criteria for the data for this patient?

Yes

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* 9. If you answered “No” to any of the above questions, please describe what you would suggest to make it easier to execute that task

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* 10. Did you require technical assistance to follow the workflow at any point?

Yes