Clinical Legacy Data Conversion Plan & Report

From PhUSE Wiki
Jump to: navigation, search


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 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:

cSDRG with LDCP

cSDRG Completion Guidelines

ADRG with LDCP


Project Lead

Jane Lozano Clinical Pharmacology Data Solutions Consultant Eli Lilly & Company lozano_jane_a@lilly.com

Project Members

Name Organization E-mail
Amy Palmer CDISC apalmer@cdisc.org
Anne Russotto Nth Analytics annebrussotto@verizon.net
Anne-Sophie Bekx Janssen R&D abex1@its.jnj.com
Bess LeRoy CDISC bleroy@cdisc.org
Bhanu Kannan FDA bhanu.kannan@fda.hhs.gov
Catherine Munera Cara Therapeutics cmunera@caratherapeutics.com
Charity Quick Rho charity_quick@rhoworld.com
Christine Wang FDA christine.wang@fda.hhs.gov
Claudia Meurer Merck Claudia.Meurer@merckgroup.com
Dan Potenta PDS Life Sciences dan.potenta@pdslifesciences.com
Dave Borbas EBA Inc. dave@borbas.net
Dave Izard GSK david.x.izard@gsk.com
David Bobbitt CDISC dbobbitt@cdisc.org
Dirk Spruck EISAI dspruck@clinipace.com
Elizabeth Langevin Takeda elizabeth.langevin@takeda.com
Ellen Asam Merck ellen_asam@merck.com
Erica Davis ericabdavis@gmail.com
Harsha Anantaneni Pfizer harshawardhan.anantaneni@pfizer.com
Helena Sviglin FDA helena.sviglin@fda.hhs.gov
Hiroshi Sakaguchi PMDA sakaguchi-hiroshi@pmda.go.jp
Hui Song PRA Health Sciences songhui@prahs.com
Jade Chen FDA huanyu.chen@fda.hhs.gov
James Zuazo Chiltern James.Zuazo@chiltern.com
Janet Low Merck janet_low@merck.com
Jerry Salyers Independent jerry.salyers@datastandardsconsulting.com
Jinesh Shah Statistics Collaborative, Inc. jcs222@georgetown.edu
John Franchino Roche john.franchino@roche.com
Jon Neville CDISC jneville@cdisc.org
Joyce Hernandez Eliassen Group. joyce.hernandez_0029@yahoo.com
Kajal Tahiliani Cytel kajal.tahiliani@gmail.com
Kannan Nagureddi Amgen knagured@amgen.com
Kiran Bonda inVentiv Health Clinical kiran.bonda@inventivhealth.com
Kirk Prutzman FDA kirk.prutzman@fda.hhs.gov
Koichi Yamaguchi Eli Lilly yamaguchi_koichi@lilly.com
Kristin Kelly Pinnacle21 kristin.kelly@pinnacle21.com
Lauren Shinaberry AbbVie lauren.shinaberry@abbvie.com
Linda Cong FDA linda.cong@fda.hhs.gov
Lisa Brooks Iris Statistical Computing lisa@irisstatcomp.com
Lori Sandhu Commonwealth Informatics lsandhu@commoninf.com
Mark Wheeldon Formedix markwheeldon@formedix.com
Maggie Lo Lung Biotechnology mlo@lungbiotechnology.com
Melissa Binz Pfizer melissa.a.binz@pfizer.com
Michael Johnson FDA michael.johnson@fda.hhs.gov
Mikael Sacco Novartis mikael.sacco@novartis.com
Micky Salgado-Gomez PharmaStat mgomez@pharmastat.com
Natalia Smelyanski Merck natalia.smeljanski@merckgroup.com
Parag Shiralkar Independent Consultant pcshiralkar@gmail.com
Patty Hegarty Bayer patricia.hegarty@bayer.com
Proma Debnath Chiltern proma.debnath@chiltern.com
Ramakanth Kanukolanu Celgene rkanukolan@celgene.com
Ron Fitzmartin FDA ronald.fitzmartin@fda.hhs.gov
Roopali Lakhe Bayer roopali.lakhe@bayer.com
Sanket Sinojia Cytel ssinojia@gmail.com
Simon Walsh Novartis simon.walsh@novartis.com
Siwei Cheng PPD siwei.cheng@ppd.com
Soumya Rajesh Syneos Health soumya.rajesh@syneoshealth.com
Tanvir Ahmed FDA tanvir.ahmed@fda.hhs.gov
Tejas Patel FDA Tejaskumar.Patel@fda.hhs.gov
Terek Peterson Chiltern Terek.Peterson@Chiltern.com
Tessa Brown FDA tessa.brown@fda.hhs.gov
Todd Mailey GSK todd.a.mailey@gsk.com
Tony Chang Amgen tochang@amgen.com
Unnat Patel Pfizer unnat.patel@pfizer.com
Victoria Holloway Chiltern victoria.holloway@chiltern.com
Vincent Guo Novartis vincent.guo@novartis.com
Virginia Hussong FDA virginia.hussong@fda.hhs.gov
Weiya Zhang FDA weiya.zhang@fda.hhs.gov
Zhongwei Zhou Pfizer zhongwei.zhou@pfizer.com

Sub-Team Lead - ADRG Example

Lisa Brooks Independent Consultant Iris Statistical Computing Lisa@IrisStatComp.com]

ADRG Example Sub-Team Members

Name Organization E-mail
Albert Chau Datacision albert@datacision.co.uk
Cindy Stroupe UCB cynthia.stroupe@ucb.com
Deb Goodfellow Chiltern deborah.goodfellow@chiltern.com
Jiaan Illidge Cara Therapeutics jillidge@caratherapeutics.com
Sandra Minjoe PRA minjoesandra@prahs.com
Ting-Yuan Liu Gilead Ting-Yuan.Liu@gilead.com
Zhihai Zhang Gilead zhzhang22@gmail.com
Jane Lozano Eli Lilly & Company lozano_jane_a@lilly.com

Project Updates

The draft version of an Example Document describing the conversion from legacy data to SDTM is shown in the following document

Legacy data to SDTM Example1 Document

Legacy data to SDTM Example2 Document



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

All Conversion and Traceability Data Flows

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