Study Data Standardization Plan (SDSP)

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Project Overview

The development of a Study Data Standardization Plan (SDSP) was identified as a need in recent draft FDA Guidance on Providing Regulatory Submissions in Electronic Format - Standardized Study Data (Final FDA Guidance December 2014). In the Draft Study Data Technical Conformance Guide that accompanies the draft guidance the identification of a Study Data Standardization Plan was highlighted for both non-clinical and clinical studies. (see: UCM384744.pdf).

This team will work on a standardized approach to the development of a Study Data Standardization Plan (SDSP). The goals of the team are to provide a template, instruction, and some examples that may be utilized by sponsors to develop the SDSP. It is expected that the SDSP will support the Clinical Development and Non-Clinical development plans, as well as the Target Product Profile for a particular compound of device.

Project Deliverables

The Study Data Standardization Plan deliverables have been sent to FDA for the next level of review. They are attached.

Study Data Standardization Plan Template

Study Data Standardization Plan Template Updated 28March2017 - DO NOT USE THIS ONE FOR A NEW SDSP

The Study Data Standardization Plan was updated to correct a reference that is incorrect in the 28March2017. Please use the template below for a new SDSP or an update to a SDSP.

Study Data Standardization Plan Template Updated 15June2017

Study Data Standardization Plan Sponsor Implementation Guide

Study Data Standardization Plan Completion Guidelines

Study Data Standardization Plan Asthma Example Document

Study Data Standardization Plan Oncology Example Document

SDSP Deliverables Zipped

Project Leadership Team

Name Role Organization E-mail
Jane A Lozano Project Leader Eli Lilly lozano_jane_a (at) lilly.com
Nhi Beasley FDA Liaison FDA nhi.beasley (at) fda.hhs.gov

Project Members

Name Organization E-mail
Alyssa Wittle Chiltern alyssa.wittle [at] chiltern.com
Amanda Brooke Hinkson Merck amanda.hinkson [at] merck.com
Andrea Baker Novartis andrea.baker [at] novartis.com
Anjelica Hoch Janssen Pharmaceutical Companies of Johnson & Johnson ahoch [at] its.jnj.com
Angelo Tinazzi Cytel Inc. angelo.tinazzi [at] cytel.com
Anne Russotto Industry annebrussotto [at] verizon.net
Aparna Kulkarni Novartis aparna.kulkarni [at] novartis.com
Beate Hientzsch PhUSE beate.hientzsch [at] phuse.eu
Bhavin Busa Softworld Life Sciences bbusa [at] softworldinc.com
Bhupendra Mistry Genentech mistry.bhupendra [at] gene.com
Cathy Bezek Astellas Pharma Cathy.Bezek [at] astellas.com
Chris Williams Alexion Pharmaceuticals williamsc [at] alxn.com
Dave Borbas EBA Inc. dave [at] borbas.com
Dave Izard Chiltern david.izard [at] chiltern.com
David Brega PharmaStat dbrega [at] pharmastat.com
David Fielding PRA Health Sciences FieldingDavid [at] prahs.com
Elizabeth Langevin Takeda elizabeth.langevin [at] takeda.com
Ellen Asam Merck ellen_asam [at] merck.com
Erica Davis Industry ericabdavis [at] gmail.com
Gitte Frausing Data Standards Decisions gfrausing [at] datastandardsdecisions.com
Helena Sviglin FDA helena.sviglin [at] fda.hhs.gov
Himaja Surapaneni Chiltern himaja.surapaneni [at] chiltern.com
Hiroshi Sakayucki PMDA sakayuchi-hiroshi [at] pmda.gp.jp
Hongli Wang BMS hongli.wang [at] bms.com
Hui Song PRA Health Sciences songhui [at] prahs.com
Jade Chen FDA huanyu.chen [at] fda.hhs.gov
Janet Low Merck janet_low [at] merck.com
Janie Ma FDA janie.ma [at] fda.hhs.gov
Jiaan Illidge Cara Therapeutics jiaanh [at] yahoo.com
John Brega PharmaStat jbrega [at] pharmastat.com
John Franchino Roche john.franchino [at] roche.com
Kajal Tahiliani GSK kajal.x.tahiliano [at] gsk.com
Kelly Mewes Roche kelly.mewes [at] roche.com
Kiran Bonda inVentiv Health Clinical kiran.bonda [at] inventivhealth.com
Koichi Yamaguchi Eli Lilly yamaguchi_koichi [at] lilly.com
Kristin Kelly Pinnacle21 kristin.kelly [at] pinnacle21.com
Laura Kaufman PDS, Inc. laura.kaufman [at] pds-america.com
Lauren Shinaberry AbbVie lauren.shinaberry [at] abbvie.com
Lei Zhao Roche zhao.lei [at] roche.com
Lili Garrard FDA lili.garrard [at] fda.hhs.gov
Linda Simonsson I-Mind linda.simonsson [at] i-mind.se
Lisa Brooks Iris Stat Computing lisa [at] irisstatcomp.com
Mike Hamidi PRA Health Sciences hamidimike[at] prahs.com
Lisa Lin FDA wei.lin [at] fda.hhs.gov
Lou Ann Kramer CDISC lkramer [at] cdisc.org
Maggie Lo Lung Biotechnology mlo [at] lungbiotechnology.com
Mary Beth Blauwet Astellas Pharma MaryBeth.Blauwet [at] astellas.com
Mathew Bryant inVentiv Health Clinical mathew.bryant [at] inventivhealth.com
Micky Salgado-Gomez PharmaStat mgomez [at] pharmastat.com
Nalin Tikoo Genentech tikoo.nalin [at] gene.com
Nick Naro Pfizer Nicholas.Naro [at] pfizer.com
Pam Ryley Takeda Pamela.Ryley [at] takeda.com
Peggy Zorn MMS Holdings pzorn [at] mmsholdings.com
Peng Yang Clindata Insight, Inc. pyang [at] clindatainsight.com
Pia Jellinggaard NovoNordisk pjel [at] novonordisk.com
Pritesh Solanki Merck pritesh_solanki [at] merck.com
Rama Kudaravalli Chiltern rama.kudaravalli [at] Chiltern.com
Ramakanth Kanukolanu Celgenen rkanukolanu [at] celgene.com
Ravi Chikkala GSK ravi.2.chillala [at] gsk.com
Sangeeta Bhattlacharya Novartis sangeeta.bhattacharya [at] novartis.com
Sara Pauwels Janssen R&D spauwel2 [at] its.jnj.com
Steven Kirby Industry skirbyne [at] gmail.com
Susan Kenny Maximum Likelihood susankenny [at]maxlikelihood.com
Terek Peterson Chiltern Terek.Peterson [at] Chiltern.com
Tony Chang Amgen tochang [at] amgen.com
Trevor Mankus PRA Health Sciences trevor.mankus [at] gmail.com
Veena Nataraj Shire vnatarag [at] shire.com
Vanessa Sarrechia Janssen R&D vsarrech [at] its.jnj.com
Vidhya Dandi FDA vidhya.dandi [at] fda.hhs.gov
Vineet Sharma Sunovion Pharmaceuticals vineet.sharma [at] sunovion.com
Weiya Zhang FDA weiya.zhang [at] fda.hhs.gov
Yi-ting Lin Gilead Science yi-ting.lin [at] gilead.com

Project Updates

  • The SDSP deliverables have been sent to the FDA Champion, Helena Sviglin, who will ensure they are reviewed at the next level. They were received by FDA on March 31, 2016. The team will not meet until the comments have been received from the public review, which is scheduled to occur via a Federal Registry notice after the review period is over for the SEND SDRG.

Objectives and Timelines

Objective Timeline
Template Finalized (Ready for CSS Steering Committee Reviw) End of June, 2015
First draft completion guidelines September 1, 2015


Project Content and Activities

  • The following presentation documents sub-groups and who is currently assigned to the sub-group.

Study Data Standardization Plan Sub Groups

  • The following link is to the Lab Units White Paper

Lab Test Plan White Paper


Meeting Minutes


SDSP Sponsor Implementation Plan Sub-Team Meeting Minutes

SDSP Example Sub-Team Meeting Minutes

Archived Content