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: '/>"/>

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Page: 1 2

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:10/20/2014)... , Oct. 20, 2014  GenVec, Inc. (NASDAQ: ... Horovitz , Ph.D., from its board of directors effective on ... August 2003, and served as its chairman from June 2006 ... the Nominating and Corporate Governance and Audit Committees of the ... than a decade of dedicated service to GenVec, and its ...
(Date:10/20/2014)... 20, 2014 OncLive® ... Cancer Center at Thomas Jefferson University has joined ... the Strategic Alliance Partnership program, the Sidney Kimmel ... to raise awareness of the Center’s cutting-edge research ... projects. Clinicians and other health care professionals from ...
(Date:10/20/2014)... Local veterinary surgeon, Dr. Tim McCarthy is seeking ... stem cells for dogs with osteoarthritis. Dr. McCarthy has ... clinical stem cell therapy for 7 years. The ultimate ... single injection of donor stem cells into one or ... inflammation in the treated joints. , Candidates for ...
(Date:10/19/2014)... OCTOBER 20-22, 2014: The 9th ... will take place at the Congress Center ... is now available at http://www.abim.ch . ... organizations from all over the globe will ... latest products and developments on the world ...
Breaking Biology Technology:Zola P. Horovitz To Retire From GenVec Board 2Sidney Kimmel Cancer Center at Thomas Jefferson University Partners With OncLive 2Sidney Kimmel Cancer Center at Thomas Jefferson University Partners With OncLive 3Cascade Veterinary Referral Center Seeks Candidates for an Investigational Study of Stem Cells for Dogs with Arthritis 2
... 14 /PRNewswire-FirstCall/ - BioSyntech, Inc. (TSX: BSY), a ... today announced that it will conclude enrolment next ... cartilage repair device, BST-CarGel(R). To date, the Company ... clinical sites will be permitted to enrol additional ...
... Va., Jan. 14 CEL-SCI CORPORATION , ... reports financial results for the fiscal year ended September 30, 2008.CEL-SCI ... a net loss of $(9,629,657) in fiscal year 2007. The ... $(0.07) compared to a net loss per common share in fiscal ...
... Comprehensive tutorials on the publicly available PROSITE, InterPro, IntAct and UniProt ... , ... Seattle (PRWEB) January 15, 2009 -- ... PROSITE, InterPro and IntAct, in addition to a newly updated tutorial ...
Cached Biology Technology:BioSyntech to conclude enrolment for pivotal BST-CarGel(R) trial in February 2009 2BioSyntech to conclude enrolment for pivotal BST-CarGel(R) trial in February 2009 3BioSyntech to conclude enrolment for pivotal BST-CarGel(R) trial in February 2009 4CEL-SCI Corporation Announces 2008 Financial Results 2CEL-SCI Corporation Announces 2008 Financial Results 3New and Updated Online Tutorials for PROSITE, InterPro, IntAct and UniProt 2New and Updated Online Tutorials for PROSITE, InterPro, IntAct and UniProt 3
(Date:10/14/2014)... N.Y. – Scientists have sequenced the house fly genome ... one might expect from an insect that thrives in ... published Oct. 14 in the journal Genome Biology ... biology and of how flies quickly adapt to resist ... Adult house flies (Musca domestica) carry and transmit more ...
(Date:10/14/2014)... fish oil supplements, rich in omega-3 fatty acids, do not ... which the heart can beat as fast as 150 beats ... the Montreal Heart Institute were published in the Journal ... , For the trial, 337 patients with atrial fibrillation not ... of fish oil a day or to placebo for up ...
(Date:10/14/2014)... by the Chinese Academy of Agricultural Sciences in Beijing, ... brief genomic history of tomato breeding, based on sequencing ... C.M. Rick Tomato Genetics Resource Center at UC Davis ... seed of both cultivated tomato varieties and related wild ... tomato genome sequence completed just two years ago, shows ...
Breaking Biology News(10 mins):House fly genome reveals expanded immune system 2
... MA (July 27, 2011) SomaLogic, Inc. and New ... entered into an exclusive licensing agreement whereby SomaLogic will ... several current and future NEB nucleic acid amplification and ... specific protein binding reagents based on chemically modified "aptamers," ...
... each other plant and harvest, rural Chinese neighbors also ... likely to reenroll their land in a conservation program ... Scientists from the Center for Systems Integration and Sustainability ... study the amount of land farmers in the Wolong ...
... NEW YORK (July 27, 2011) ... increasingly sophisticated illegal trade in wildlife parts conducted by organized crime, coupled ... rhinos, tigers, and elephants on a scale never before seen. , ... paper, published June 7 on the online issue of the journal ...
Cached Biology News:Farmers more likely to be green if they talk to their neighbors, according to MSU research 2Organized crime is wiping out wildlife 2
Whole rabbit blood (any breed, either sex) is collected at the time of slaughter and processed immediately at 4C, bottled, frozen and stored at -70C....
GlutaMAX-I Supplement...
Chemically Defined Lipid Concentrate...
... are membrane-filtered isotonic and enzyme-free aqueous ... cell-conditioning agents in either Ca2+- and ... Ca2+- and Mg2+-free phosphate-buffered saline ... from support substrates and each other ...
Biology Products: