Clinical Legacy Data Conversion Plan & Report

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Project Overview

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.

Project Deliverables

The clinical LDCPR is being incorporated into various sections of the cSDRG and ADRG. Draft versions of the deliverables are below:

Applicable to cSDRG and ADRG: All Conversion and Traceability Data Flows



cSDRG with LDCP Summary of Changes

cSDRG Completion Guidelines

Legacy data to SDTM Example1 Document

Legacy data to SDTM Example2 Document



Project Lead

Jane Lozano Clinical Pharmacology Data Solutions Consultant Eli Lilly & Company

Project Members

Name Organization E-mail
Amy Palmer CDISC
Anne Russotto Nth Analytics
Anne-Sophie Bekx Janssen R&D
Bess LeRoy CDISC
Bhanu Kannan FDA
Catherine Munera Cara Therapeutics
Charity Quick Rho
Christine Wang FDA
Claudia Meurer Merck
Dan Potenta PDS Life Sciences
Dave Borbas EBA Inc.
Dave Izard GSK
David Bobbitt CDISC
Dirk Spruck EISAI
Elizabeth Langevin Takeda
Ellen Asam Merck
Erica Davis
Harsha Anantaneni Pfizer
Helena Sviglin FDA
Hiroshi Sakaguchi PMDA
Hui Song PRA Health Sciences
Jade Chen FDA
James Zuazo Chiltern
Janet Low Merck
Jerry Salyers Independent
Jinesh Shah Statistics Collaborative, Inc.
John Franchino Roche
Jon Neville CDISC
Joyce Hernandez Eliassen Group.
Kajal Tahiliani Cytel
Kannan Nagureddi Amgen
Kiran Bonda inVentiv Health Clinical
Kirk Prutzman FDA
Koichi Yamaguchi Eli Lilly
Kristin Kelly Pinnacle21
Lauren Shinaberry AbbVie
Linda Cong FDA
Lisa Brooks Iris Statistical Computing
Lori Sandhu Commonwealth Informatics
Mark Wheeldon Formedix
Maggie Lo Lung Biotechnology
Melissa Binz Pfizer
Michael Johnson FDA
Mikael Sacco Novartis
Micky Salgado-Gomez PharmaStat
Natalia Smelyanski Merck
Parag Shiralkar Independent Consultant
Patty Hegarty Bayer
Proma Debnath Chiltern
Ramakanth Kanukolanu Celgene
Ron Fitzmartin FDA
Roopali Lakhe Bayer
Sanket Sinojia IQVIA
Simon Walsh Novartis
Siwei Cheng PPD
Soumya Rajesh Syneos Health
Tanvir Ahmed FDA
Tejas Patel FDA
Terek Peterson Chiltern
Tessa Brown FDA
Todd Mailey GSK
Tony Chang Amgen
Unnat Patel Pfizer
Vincent Guo Novartis
Virginia Hussong FDA
Weiya Zhang FDA
Zhongwei Zhou Pfizer

Sub-Team Lead - ADRG Example

Lisa Brooks Independent Consultant Iris Statistical Computing]

ADRG Example Sub-Team Members

Name Organization E-mail
Albert Chau Datacision
Cindy Stroupe UCB
Deb Goodfellow Chiltern
Jiaan Illidge Cara Therapeutics
Sandra Minjoe PRA
Ting-Yuan Liu Gilead
Zhihai Zhang Gilead
Jane Lozano Eli Lilly & Company

Project Activities

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.

ADRG & SDRG Completion Guidelines and Example Document working groups

Legacy Data Flow Stages and Characteristics

Meeting Minutes

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.

ADRG Meeting Minutes

Archived Content