Navigation Links
FDA/PhUSE Collaboration: Study Data Reviewer’s Guide Work Package v1.1 Available
Date:5/16/2013

Silver Spring, MD (PRWEB) May 16, 2013

PhUSE announces the availability of the Study Data Reviewer’s Guide (SDRG) Template. The FDA is currently reviewing the implementation/utility of this document and encourages sponsors to provide feedback. The Study Data Reviewer’s Guide is a proposed addition to module 5 of the eCTD which is submitted to the FDA for any drug, biologic or device application. Along with the define.xml the Study Data Reviewer’s Guide documents, in a human-readable way, decisions made during the data life-cycle like SDTM mapping decisions, sponsor-defined domains, sponsor-defined controlled terminology, and sponsor extensions to CDISC controlled terminology. A standardized Data Guide will provide the regulators with needed documentation to more thoroughly understand the submitted data.

The SDRG was created out of an industry/FDA collaboration initiated through PhUSE. PhUSE supports five working groups which provide the pharmaceutical industry with a platform to collaborate with experts, regulators, and other parties to create efficiencies in drug development. PhUSE Working Groups are focused on five crucial topics: Improving Data Quality, Optimizing the Use of Data Standards, Development of Standard Scripts for Analysis and Programming, Non-Clinical Roadmap and Impacts on Implementation, and Emerging Technologies.

“The SDRG demonstrates the power of volunteer collaboration; out of the efforts of a small but dedicated group an industry-wide change can be implemented,” Daniel Boisvert, Chair PhUSE Board of Directors.

The SDRG core team was led by Helena Sviglin, FDA; Douglas Warfield, FDA; Gail Stoner, J&J; Joanna Koft, Biogen Idec; Scott Bahlavooni, Genentech; and John Brega, Pharmastat.

The SDRG package can be downloaded from the PhUSE wiki: http://www.phusewiki.org/wiki/index.php?title=Study_Data_Reviewer%27s_Guide.

An Analysis Data Reviewer's Guide (ADRG) will be handled as a future project.

PhUSE, Share – Contribute – Advance, provides the industry with the premier platform for creating and sharing ideas, tools and standards around data, statistical and reporting technologies; PhUSE is a non-profit, volunteer-supported, community of professionals who are passionate about advancement of clinical information. Since its inception, PhUSE has expanded from its roots as a conference for European Statistical Programmers, to a global platform for the discussion of topics encompassing the work of Data Managers, Biostatisticians, Statistical Programmers and eClinical IT professionals.

Read the full story at http://www.prweb.com/releases/2013/5/prweb10714295.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Positive Clinical Study Results for BSPs HyperQ Technology
2. 15-Minute Data From Phase 3 Study of Avanafil Featured as a Late Breaking Abstract at SMSNA Annual Meeting
3. DermTechs Non-invasive Melanoma Detection Assay Poised to Enter Clinical Validation Study
4. Marshall study shows nanoparticles used as additives in diesel fuels can travel from lungs to liver
5. Clionsky Neuro Systems (CNS-Neuro) Announces Publication of Study Finding Elderly Patients Unable to Recognize Their Memory Loss
6. Convergence Pharmaceuticals Initiates Phase I Multiple Ascending Dose Study for CNV2197944
7. AtheroNova Inc. Preclinical Study Demonstrates 95% Reduction in Arterial Plaque Formation
8. Singapore scientists lead human embryonic stem cell study
9. GeneTex Antibody Company to Launch New Line of Primary Antibodies for the Study of Spindle Assembly
10. Nutra Pharma Announces Publication of a New Mechanism Study of Alpha-Cobratoxin in the Treatment of Pain
11. Metabolex Announces Positive Results From its Clinical Study of Arhalofenate in Combination With Febuxostat
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/21/2017)... COLORADO (PRWEB) , ... April 21, 2017 , ... ... Awards recognized outstanding manufactures in 10 categories with over 30 nominees and well ... in Manufacturing presented the new award and the event was hosted by CompanyWeek ...
(Date:4/21/2017)... ... 21, 2017 , ... Frederick Innovative Technology Center, Inc. (FITCI), ... and technology start-ups, is hosting “Celebration Friday” (a festive gathering highlighting client success ... libations and networking at 3:30 p.m. at FITCI’s 4539 Metropolitan Court location, off ...
(Date:4/20/2017)... ... ... USDM Life Sciences , the leading risk management, technological innovation and ... announce Holger Braemer as Vice President of its Europe division and Managing ... , Braemer is an integral part of USDM’s expansion of services and solutions for ...
(Date:4/20/2017)... ... April 20, 2017 , ... Parallel6™ , the leader in ... today that they were named one of the 2017 Top 10 eClinical Trial ... in the pharmaceutical industry. , “We take pride in honoring Parallel6 as one of ...
Breaking Biology Technology:
(Date:4/4/2017)...   EyeLock LLC , a leader of iris-based ... Patent and Trademark Office (USPTO) has issued U.S. Patent ... an iris image with a face image acquired in ... 45 th issued patent. "The ... the multi-modal biometric capabilities that have recently come to ...
(Date:3/29/2017)... the health IT company that operates the largest health ... today announced a Series B investment from BlueCross BlueShield ... investment and acquisition accelerates higi,s strategy to create the ... activities through the collection and workflow integration of ambient ... secures data today on behalf of over 36 million ...
(Date:3/23/2017)... March 23, 2017 The report "Gesture Recognition and Touchless ... and Geography - Global Forecast to 2022", published by MarketsandMarkets, the market is ... of 29.63% between 2017 and 2022. Continue Reading ... ... ...
Breaking Biology News(10 mins):