Clinical Legacy Data Conversion Plan & Report
The submission of standardized study data was identified as a need in FDA Guidance on Providing Regulatory Submissions in Electronic Format - Standardized Study Data (FDA Guidance December 2014). In the Study Data Technical Conformance Guide that accompanies the guidance the identification of a Legacy Data Conversion Plan was highlighted for clinical studies. (Technical Conformance Guide v3.3 March 2017).
This team will update the cSDRG to include a Clinical Legacy Data Conversion Plan & Report section. There are 3 scenarios in which the Example Documents will be updated: 1) Conversion of clinical legacy tabulation data to SDTM after legacy analysis has been created 2) Conversion of SDTM IG 3.1.1 clinical data to a version of SDTM that is supported in the Data Standards Catalog 4) No conversion was done. The ADRG will also be updated for the scenarios in which converted clinical SDTM data is the source used to create ADaM and clinical legacy analysis is the source used to create ADaM.
The goal of the team is to provide an updated templates, completion guidelines, and example documents within the cSDRG and ADRG.
The clinical LDCP is being incorporated into various sections of the cSDRG and ADRG. Draft versions of the cSDRG and ADRG containing a LDCP appendix are below:
|Jane Lozano||Clinical Pharmacology Data Solutions Consultant||Eli Lilly & Companyfirstname.lastname@example.org|
The draft version of an Example Document describing the conversion from legacy data to SDTM is shown in the following document
Initial meeting was held on June 3, 2014. The team will meet every 2-3 weeks.
At the CSS in March 2016, the update to the SDRG for the Legacy Data Conversion Plan & Report, was discussed. The definition of 'legacy' came up as it could be applied to all data since it is converted to SDTM. The definition of legacy that is in the SDSP was added along with a few questions at the beginning of the section to identify if it should be completed. Meetings in 2016 and 2017 will alternate between Tuesday and Thursday every 2 weeks at 10:00 am EST.
During 2016 and early 2017 (prior to CSS), a decision tree was created to help sponsors determine when a Legacy Data Conversion Plan & Report should be created. Also, the discussion of where this information belongs (stand-alone document or part of a reviewer's guide) will be discussed with FDA at CSS in March 2017. The decision tree is attached with the current template above.
There is a gap in meeting minutes as a template was created last year. However, this team was not sure where the plan belonged (separate document, part of the SDRG, part of the SDSP). Subsequent releases of the Technical Conformance Guide and webinars provided the direction needed to continue with this project.