>20 Chars Error – Possible Discussion Topics: the WG1 discussions came up with a reasonable interpretation of FDA language, it was reasonable, and met with resistance in the industry. “arbitrarily” Is this more a communication challenge than issue with the logic rule? Given that sponsors need to address all rule violations with a severity of Warning and Error, is there benefit in distinguishing the severity between the two? Consider phased implementation (e.g., warning/error when above 20 for the first year, warning/error when above 5 after that)? ? Overall File/Dataset Size See Appendix B for a full accounting of the text from various documents related to this issue. References to file/dataset size and splitting decisions can be summarized as a whole: One GB is the target for maximum file size, with some flexibility. As noted under the variable length section, variable sizing issues need to be addressed prior to decisions on splitting datasets, and variable length should be consistent across split datasets. As with variable padding, a scale of severity is identified in some material, and is likely subject to the same considerations. CDISC references address splitting based on categorical variables (e.g., --CAT/--SCAT). FDA references note this, as well as other mechanisms such as grouping by subject number, but these other mechanisms are identified as inferior. Possible Discussion Topics: Is there a rationale/benefit to maintain references to splitting by less desirable methods? Per above, a scale of severity is identified in some material, and is likely subject to the same considerations as variable length severity. The FDA CDER Common Data Standards Issues Document mentions the use of a /SPLIT subdirectory, which is not identified in other material. That said, it is a critical piece of information, not only in providing a clear mechanism for
>20 Chars – Error Possible Discussion Topics: the WG1 discussions came up with a reasonable interpretation of FDA language, it was “arbitrarily” reasonable, and met with resistance in the industry. Is this more a communication challenge than issue with the logic rule? Given that sponsors need to address all rule violations with a severity of Warning and Error, is there benefit in distinguishing the severity between the two? Consider phased implementation (e.g., warning/error when above 20 for the first year, warning/error when above 5 after that)? ? Overall File/Dataset Size See Appendix B for a full accounting of the text from various documents related to this issue. References to file/dataset size and splitting decisions can be summarized as a whole: One GB is the target for maximum file size, with some flexibility. As noted under the variable length section, variable sizing issues need to be addressed prior to decisions on splitting datasets, and variable length should be consistent across split datasets. As with variable padding, a scale of severity is identified in some material, and is likely subject to the same considerations. CDISC references address splitting based on categorical variables (e.g., --CAT/--SCAT). FDA references note this, as well as other mechanisms such as grouping by subject number, but these other mechanisms are identified as inferior. Possible Discussion Topics: Is there a rationale/benefit to maintain references to splitting by less desirable methods? Per above, a scale of severity is identified in some material, and is likely subject to the same considerations as variable length severity. The FDA CDER Common Data Standards Issues Document mentions the use of a /SPLIT subdirectory, which is not identified in other material. That said, it is a critical piece of information, not only in providing a clear mechanism for
Sizing_Discussion_Document.docx