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 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:



Project Lead

Jane Lozano Clinical Pharmacology Data Solutions Consultant Eli Lilly & Company

Project Members

Name Organization E-mail
Adrienne Bonwick EISAI adrienne_bonwick [at]
Anne Russotto Nth Analytics annebrussotto [at]
Anne-Sophie Bekx Janssen R&D abex1 [at]
Aparna Kilkarni Novartis aparna.kulkarni [at]
Bhanu Kannan FDA bhanu.kannan [at]
Claudia Meurer Merck Claudia.Meurer [at]
Dan Potenta PDS Life Sciences dan.potenta [at]
Dave Borbas EBA Inc. dave [at]
Dave Izard Chiltern david.izard [at]
Dirk Spruck EISAI dspruck [at]
Elizabeth Langevin Takeda elizabeth.langevin [at]
Ellen Asam Merck ellen_asam [at]
Erica Davis ericabdavis [at]
Harsha Anantaneni Pfizer harshawardhan.anantaneni [at]
Helena Sviglin FDA helena.sviglin [at]
Hui Song PRA Health Sciences songhui [at]
Jade Chen FDA huanyu.chen [at]
James Zuazo Chiltern James.Zuazo [at]
Janet Low Merck janet_low [at]
Jerry Salyers Accenture jerry.j.salyers [at]
Jinesh Shah Statistics Collaborative, Inc. jcs222 [at]
Joyce Hernandez Eliassen Group. joyce.hernandez_0029 [at]
Kajal Tahiliani Cytel kajal.tahiliani [at]
Kannan Nagureddi Amgen knagured [at]
Ken Stoltzfus Accenture kenneth.m.stoltzfus [at]
Kiran Bonda inVentiv Health Clinical kiran.bonda [at]
Kirk Prutzman FDA kirk.prutzman [at]
Koichi Yamaguchi Eli Lilly yamaguchi_koichi [at]
Kristin Kelly Pinnacle21 kristin.kelly [at]
Lauren Shinaberry AbbVie lauren.shinaberry [at]
Linda Cong FDA linda.cong [at]
Lisa Brooks Iris Statistical Computing lisa [at]
Maggie Lo Lung Biotechnology mlo [at]
Melissa Binz Pfizer melissa.a.binz [at]
Michael Johnson FDA michael.johnson [at]
Mikael Sacco Novartis mikael.sacco [at]
Micky Salgado-Gomez PharmaStat mgomez [at]
Natalia Smelyanski EMD Serono natalia.smeljanski [at]
Parag Shiralkar Independent Consultant pcshiralkar[at]
Patty Hegarty Bayer patricia.hegarty [at]
Proma Debnath Chiltern proma.debnath [at]
Ramakanth Kanukolanu Celgene rkanukolan [at]
Ron Fitzmartin FDA ronald.fitzmartin [at]
Roopali Lakhe Bayer roopali.lakhe [at]
Sandra Minjoe Accenture Sandra.Minjoe[at]
Sanket Sinojia Quintiles IMS ssinojia[at]
Simon Walsh Novartis simon.walsh[at]
Soumya Rajesh Inventiv Health soumya.rajesh [at]
Tejas Patel FDA Tejaskumar.Patel[at]
Terek Peterson Chiltern Terek.Peterson [at]
Todd Mailey GSK todd.a.mailey [at]
Tony Chang Amgen tochang [at]
Unnat Patel Pfizer unnat.patel [at]
Victoria Holloway Chiltern victoria.holloway [at]
Virginia Hussong FDA virginia.hussong [at]
Weiya Zhang FDA weiya.zhang [at]
Zhongwei Zhou Pfizer zhongwei.zhou [at]

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.

Archived Content