An Overview in Clinical Data Standardization in Electronic ...

An Overview in Clinical Data Standardization in Electronic

Submissions

Nicola Tambascia

Principal Statistical Programmer Nicola started programming SAS in 2010 for

Sanofi-Aventis in Frankfurt Nicola has worked with various project teams

and served statistical programming needs within all major indications Regular presenter at conferences like PhUSE Daily work at Clinipace includes:

hands-on application of CDISC standards for regulatory submission

consulting clients regarding the implementation of SDTM, ADaM and define.xml

? 2017 Clinipace Worldwide

Agenda

General Overview

Why is standardized data needed? Authority Guidelines

FDA PMDA Others

CDISC Overview

SDTM (SEND) ADaM Define.xml

? 2017 Clinipace Worldwide

Why is standardized data needed?

Global standards for clinical research data and metadata

from collection to submission

demo.xpt

patinfo.xpt

dm.xpt

PT

SEX

PATIENT

GENDER

USUBJID SEX

101

1

101

Male

01-101

M

102

2

102

Female

01-102

F

General benefits of standards

Improve communication Save time and resources Facilitate comparison across studies/projects/submissions Transparency Enhances data sharing / collaborations (e.g. after mergers, acquisitions) Eases the development of software / tools

Main reason: authorities request standardized clinical data

? 2017 Clinipace Worldwide

FDA

FDA Study Data Standards Resources andards/ucm2005545.htm

Deadlines: Sponsors whose studies started after December 17, 2016 must use the data standards listed in the FDA Data Standards Catalog for NDAs, BLAs and ANDAs. For Commercial INDs, the requirement starts after December 17, 2017.

eCTD Technical Rejection Criteria for Study Data were defined Process on how to request waivers defined

? 2017 Clinipace Worldwide

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