03-02-2017 minutes

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  1. Discussed the change of approach by Optimization of Data Standards Team for Legacy Data Conversion Plan & Report project – changing to separate document from incorporation in SDRG. This is a clinical focused group and we think the needs are different (less) for nonclinical. Proposal to meet with them at CSS to align our thinking with theirs and assure the TCG is influenced appropriately considering nonclinical perspective. Message sent to Jane Lozano with request for satellite meeting at CSS. Link to LDCP&R Wiki: http://www.phusewiki.org/wiki/index.php?title=Legacy_Data_Conversion_Plan_%26_Report
  2. Reviewed CRL proposal for changes to nSDRG table of contents
  • Sections 1-3 had no changes recommended.
  • Section 4:
- Exclusion of original section 4.2 “Data Set Explanation” – we recommend this be kept as a useful section that addresses some of the other additions suggested by CRL.
- Addition of a section “Datasets that SEND cannot generate” - Either this is related to modeling gaps or system limitations – we feel both can be addressed in [original] Section 4.2 explaining datasets, and/or 6.2 as differences between SEND and Report (i.e data in report that does not have a data set or has a custom data set…) We will beef up the guide on these sections and the examples to show how these topics can be addressed in existing sections. ( Team members have lots more experience in creating these things now…)
  • Section 5
- Addition of a section for LB variables…. – we had discussed this in the past within the team and feel that this is part of explaining warnings in section 5.4, as for any other warning. A separate table for LB is not necessary. Depending on the validator you are using, this result can vary. Adding sub-bullets by an author is an option in any section, but we don’t feel it is needed in the template.
- Addition of a new high level section for Define validation – we agree this content needs to be added, but we will incorporate it within section 5. So 5.1 will be “Data Standards Validation Outcome” and 5.2 will be “Define.xml Validation Outcome”. Both 5.1 and 5.2 will have subsections as originally seen in section 5. This is a good learning from Test Submissions.
  • Section 6 (as Section 7 on CRL email)
- Addition of sub-bullets under 7.2. - It is an SDRG Authors option to use these sub-bullets to organize the content of 6.2, but aren’t necessary for the templates and are not universal. We suggest that some of these may be better commucated in « Dataset Explanation » under the relevant domain.
- Change in Legacy Data Conversion section - The TCG specifically mentions Legacy for this section and describes the importance of explaining things that improve traceability. We don’t (yet) recommend dropping the legacy word. Agreed more exploration of FDA expectations for this section is needed!