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 In the Draft Study Data Technical Conformance Guide that accompanies the draft guidance the identification of a Study Data Standardization Plan was highlighted for both non-clinical and clinical studies.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 published and are available on the site (

Project Leadership Team

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

Project Members

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

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