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:9/19/2014)... 2014 Dublin ... has announced the addition of the  "Micro Market ... their offering.       (Logo: http://photos.prnewswire.com/prnh/20130307/600769) , ... the fastest-growing segments in the chromatography market. The ... and expected to reach $2.0 billion by 2019, ...
(Date:9/18/2014)... -- About POCT POCT, also ... laboratory. It helps in making fast clinical decisions, ... POCT is gaining popularity due to the increasing ... diabetes, heart disease, and obesity. It is generally ... minimize errors during the diagnosis of patients. POCT ...
(Date:9/18/2014)... September 18, 2014 Texas Governor ... Sharp, Texas A&M Health Science Center CEO Brett ... of Health and Human Services (HHS), State of ... national pandemic influenza vaccine manufacturing facility in Bryan, ... anchor for the Texas A&M Biocorridor – a ...
(Date:9/18/2014)... , Sept. 18, 2014 Research ... "Global Companion Diagnostics (Polymerase Chain Reaction, In-situ hybridization, ... report to their offering. The global ... CAGR of 22.7% from 2014 to 2019. Factors such ... growing adoption of companion diagnostics by the pharmaceutical industry, ...
Breaking Biology Technology:Micro Market Monitor : Global Pre-packed Chromatography Columns 2POCT Market in China 2014-2018 2Texas A&M Dedicates National Pandemic Influenza Vaccine Manufacturing Facility, on Track for 2016 Start-Up Phase 2Texas A&M Dedicates National Pandemic Influenza Vaccine Manufacturing Facility, on Track for 2016 Start-Up Phase 3Texas A&M Dedicates National Pandemic Influenza Vaccine Manufacturing Facility, on Track for 2016 Start-Up Phase 4Global Companion Diagnostics (Polymerase Chain Reaction, In-situ hybridization, Immunohistochemistry) Market - Trends & Forecasts to 2019 2Global Companion Diagnostics (Polymerase Chain Reaction, In-situ hybridization, Immunohistochemistry) Market - Trends & Forecasts to 2019 3
... LI-COR Biosciences has released a,new Technical ... the Odyssey Infrared,Imaging System. The E-PAGE 48- ... a high-throughput SDS-PAGE,method for processing protein samples. ... System, up to 96 different proteins samples can ...
... 19 PharmAthene, Inc.,(NYSE Alternext US: PIP), a ... threats, announced today that,it has signed an agreement ... in Israel. , ... combat the risk of,terrorist attacks with biological or ...
... Jazz Pharmaceuticals,Inc. (Nasdaq: JAZZ ) announced that it ... Capital Markets 5th Annual Healthcare,Conference due to the proximity of ... pivotal clinical trial of JZP-6 (sodium oxybate) for,the treatment of ... anticipates that it will release the preliminary top-line data,within the ...
Cached Biology Technology:Technical Note: E-PAGE(TM) 48- and 96-Well Gels on the Odyssey(R) Infrared Imaging System 2PharmAthene Signs Agreement with Medison Pharma Ltd. to Commercialize and Distribute Biodefense Medical Countermeasures in Israel 2PharmAthene Signs Agreement with Medison Pharma Ltd. to Commercialize and Distribute Biodefense Medical Countermeasures in Israel 3PharmAthene Signs Agreement with Medison Pharma Ltd. to Commercialize and Distribute Biodefense Medical Countermeasures in Israel 4
(Date:9/18/2014)... camouflage: you don,t just blend in, the background shows ... as you might think. Kathryn Feller, from the University ... life stages of many marine species are transparent. However, ... creatures cannot make transparent. Feller explains that the animals ... unit with an opaque pigment to prevent light leaking ...
(Date:9/18/2014)... protective tentacles of host anemones, but new research shows ... across the open ocean. Although the process of long-distance ... the first time that the high level exchange of ... Steve Simpson, Senior Lecturer in Marine Biology and Global ... the Australian Research Council Centre of Excellence for Coral ...
(Date:9/17/2014)... scientists were instrumental in the creation of the Santa ... classify the fire threat potential of the powerful, hot, ... into an inferno. The index was introduced Sept. 17 ... and San Diego Gas and Electric. , The index ... that will be used to help fire agencies and ...
Breaking Biology News(10 mins):Transparent larvae hide opaque eyes behind reflections 2Expedition finds Nemo can travel great distances to connect populations 2Expedition finds Nemo can travel great distances to connect populations 3UCLA scientists play key role in developing new Santa Ana Wildfire Threat Index 2
... of the brain, which scavenge pathogens and damaged neurons, are ... research by Duke neuroscientists. Earlier studies by Staci Bilbo, ... laboratory rats experiencing an infection at an early age have ... their learning and memory. In a study published ...
... Lake City Physicians preparing to deliver a baby look ... whether or not to perform a C- section. But a ... shows that those heart rate patterns may not be a ... lead to unnecessary interventions and higher costs. "We,re trying ...
... a class of theoretical concepts for manipulating the climate ... caused by greenhouse gasses. But its potential effectiveness and ... could help narrow these uncertainties. A team composed of ... and Harvard,s David Keith used modeling to determine the ...
Cached Biology News:Source found for immune system effects on learning, memory 2Source found for immune system effects on learning, memory 3New study finds fetal heart rate not a good indicator of a baby's health 2New study finds fetal heart rate not a good indicator of a baby's health 3Testing geoengineering 2
ANTI DIPHTH TOX A SU...
... Kit (E-22013) provides,researchers with a sensitive ... in solution. This fluorescence-based assay can ... (Figure 1). The assay,measures lysozyme activity ... labeled to such a degree that ...
... m7G(5')ppp(5')G (Cap Analog) is used for the ... in vitro transcription reactions. Substitution of cap ... GTP in an in vitro transcription reaction ... structure into a large fraction of the ...
The iEMS Incubator/Shaker is a high performance microplate incubator and orbital shaker. Its superior temperature control and efficient orbital shaking reduce incubation times. It can incubate up to ...
Biology Products: