临床试验：ADaM阅读材料 - ADaM IG Section

最近，为加深组里同事对ADaM的理解，给大家分享一些ADaM相关的阅读材料，附上一些总结性问题，方便回顾。

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阅读材料 ADaM IG v1.3 Section 4.3, Inclusion of All Observed and Derived Records for a Parameter Versus the Subset of Records Used for Analysis。

对于ADaM单个参数的衍生，建议包含所有收集的观测以及衍生的观测。

以下是总结性问题：

1. When selecting records from SDTM to create an ADaM parameter, how to deal with the subjects' records who are not included in analysis?

   • The ADaM methodology is to include all observed and derived rows for a given analysis parameter, in other word, also include those not used in the analysis.

2. When selecting records from SDTM to create an ADaM parameter, how to deal with the visits' records which are not analyzed?

   • The ADaM methodology is to include all observed and derived rows for a given analysis parameter, in other word, also include those not used in the analysis.

3. What are the advantages of including all observed and derived records?

   • Providing useful traceability to verify that the selection and derived timepoint processing was done correctly.
   • The complete data are available to enable other analyses, including sensitivity analyses.

4. What are the disadvantages of including all observed and derived records?

   • Increases the size of the dataset;
   • Possibly use wrong selection criteria to produce incorrect analysis results.

5. Which way do regulatory reviewers prefer to create and/or select analysis rows?

   • Include all observed and derived records as much as possible.

6. When SDTM QS dataset contains data for several different questionnaires, how to select records for one analysis topic questionnaire?

   • No need to include the data from the other questionnaires that is not analyzed.

7. What are the advantages of only including the rows that are actually used in the analysis?

   • Simplify the analysis , as no selection clause would need to be used.

8. What are the disadvantages of only including the rows that are actually used in the analysis?

   • The loss of traceability and the loss of flexibility for testing the robustness of the analysis.
   • Because of these disadvantages, this approach was not chosen.

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