Getting Ready for Successful Submissions

Converting legacy data to a CDISC compliant format for submission is a growing need for sponsors. The “Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Standardized Study Data” [10] states that studies initiated (earliest date a subject signed informed consent for that study) on or after December 17, 2016 must utilise data standards for collection and analysis as detailed in the Data Standards Catalog. PMDA requires that study data be submitted in CDISC standards for all submissions after April 1, 2020 as documented in “Basic Principles on Electronic Submission of Study Data for New Drug Applications”, published June, 2014. 

With these two requirements, conversion of studies analysed in a legacy format as part of a submission is a clear focal point of effective submission planning.

Getting ready for a submission at a later date

Proactively preparing legacy data into SDTM submission packages and confirming primary / key analyses will support upcoming submissions.  Traceability is important and if the original CSRs were written from the legacy format data, you will need to verify that the same analysis results are obtained from the newly formatted SDTM data.  The best way to do this is to create the necessary ADaM datasets and associated analysis outputs from the newly mapped SDTM data to confirm the same results are obtained.  Any data discrepancies between the legacy data and SDTM / ADaM data should be documented in the SDRG or ADRG, respectively.

Selecting the right studies for legacy conversion

Converting all legacy studies in a program may not be necessary and could impact your budget excessively.  We recommend that you consult with the applicable regulatory agency early in the process (for example end of Phase II meeting) to determine the scope of the submission to determine which studies would require legacy conversion and be included in the submission. This will help you to decide which studies should be converted to adequately prepare for upcoming submissions without putting the conversions under an aggressive and risky timeline.   

ICON Data Management and Statistical Programming experts provide advice and guidance on legacy conversion processes and what you need to implement to remain compliant.   

Contact us today to arrange a consultation with one of our experienced specialists and find out more about legacy data conversion to an SDTM compliant format.

By: Debra Anderson, Director of Clinical Data Services, ICON