Legacy Data Conversion Plan & Report Meeting Minutes 13 December 2017
From PhUSE Wiki
- Discuss example documents.
- Helena Sviglin
- Jane Lozano
- Kristin Kelly
- Lisa Brooks
- Sandra Minjoe
- Soumya Rajesh
- Tony Chang
- The first example document that Kristin created was updated to move the information into an appendix. The content did not change.
- The second example document was discussed (SDTM 3.1.1 data was converted to a standard supported by FDA). The example was updated to move the information into an appendix. The following changes were suggested:
- Include the SDTM and ADaM model and IG wherever they are referenced. This would apply to the first example document as well.
- Add a reference to the website that contains the Data Standards Catalog (similar to what is in the SDSP).
- Section 3 of the main part of the guide - change the word 'section' to 'appendix'. This would apply to the first example document as well.
- Remove the references to the MedDRA and WHODrug lookup tables.
- [Kristin] Update second cSDRG example documents.
- [Dave and his sub-group] Start on Completion Guidelines.