最近儿惫，為加深組里同事對ADaM的理解，給大家分享一些ADaM相關(guān)的閱讀材料伸但，附上一些總結(jié)性問題肾请，方便回顧。
歡迎關(guān)注砌烁，SAS茶談筐喳，后臺回復(fù)：ADaMIG，獲取相關(guān)資料函喉。
閱讀材料 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避归。
對于ADaM單個參數(shù)的衍生，建議包含所有收集的觀測以及衍生的觀測管呵。
以下是總結(jié)性問題：
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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.
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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.
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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.
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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.
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Which way do regulatory reviewers prefer to create and/or select analysis rows?
- Include all observed and derived records as much as possible.
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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.
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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.
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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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