Sign In
|
Register
> Browse
all docs
DocStore
Legal
Business
Personal Finance
Technology
Education
Jobs & Careers
Tax
Real Estate
Current Events
Politics & History
Guides
Science
Entertainment
Health & Fitness
Medicine
Conferences
Art & Literature
Lifestyle
Travel
Templates
> Featured
> Browse
> Create
WILSON
Reviews
Shared by:
mike shinoda
Categories
Education
Tags
learn
,
learning
,
educational
Stats
views:
89
rating:
not rated
reviews:
0
posted:
11/20/2007
language:
English
pages:
0
Public Domain
The Standard Case Report Form: Another FDA Reviewer’s Perspective Stephen E. Wilson, DrPH Director (Acting) Office of Business Process Support (OBPS) CDER / FDA Creating Clinical Trial Efficiencies Through Standard Data Collection DIA Hot Topic – January 25, 2006 – Arlington, VA Company logo here www.diahome.org Disclaimer Views expressed in this presentation are those of the speaker and not, necessarily, of the Food and Drug Administration. www.diahome.org Assumption: Standards are Good • Improves efficiency of evaluation of safety and efficacy of investigational treatments – Communication between sponsor and agency – Development of efficient review environment • Improve efficiency for clinical research – Facilitates design and conduct of clinical trials – Facilitates communication between researchers and study sponsor – Integration with the electronic health record www.diahome.org “Generic” Data Collection Forms* • Patient Demographics • General Medical History • Specific Medical History (Therapeutic problem oriented) • Clinical Chemistry • Hematology and urinalysis • Urinary, fecal, or other samples • Radiology reports • ECGs • … • 32 examples Spilker, 1991 www.diahome.org “Pitfalls” to Avoid • Designing CRFs – – – – – – Request information without adequate instructions Using multiple pages that could be one page Requesting excessive amount of information on one page Using unfamiliar jargon Using a check-off system without all possibilities Using codes that are only relevant to data processors Not collecting sufficient data at baseline or post-treatment Not collecting data at the most relevant time points Not collecting adequate data at relevant time points Collecting unnecessary data www.diahome.org • Determining the amount of data – – – – Spilker, 1991 Standard Case Report Forms What do they mean to this statistical reviewer? www.diahome.org Motivation • “Critical Path” – continuous improvement • Science – 80/20 – Comments • Clinical trials • Review efficiency (clear, easy to use, understandable) • Data/information/tools standards • EHR – Public/Individual health www.diahome.org Statistical Review: A Few Considerations • • • • • • • • Reflection of endpoint – Protocol/Analysis plan Consistent definition of endpoint Annotated CRF Standard data & metadata – SDTM & ADaM Missing data Adequate data Comments – communication Too much data? Data quality. www.diahome.org Random Advice/Musings • • • • • • • • • • Full Model – “meta-enterprise” architecture Therapeutic area (sub-specialties) EDC EHR – patients HL7-CDISC Regulations/guidance Human factors/informatics Flexible standards – oxymoron? More than CRFs? Vision vs. next steps www.diahome.org THANK YOU wilsons@cder.fda.gov www.diahome.org
Shared by:
mike shinoda
mike shinoda
student
MR
IT specialist
contact me
In order to send a message you need to be logged in.
About
If u like these docs or they are helpful to you just say thanks, and if you want any document or any book + courses[actualtests.com] or from any other site just send me a message i will try my best to help you.
Other docs by
mike shinoda
The First Christian Historian
Views: 1008 | Downloads: 16
Learning to Teach History in the Primary School
Views: 879 | Downloads: 19
Celibacy and Religious Traditions
Views: 525 | Downloads: 9
10 ways to say i love u
Views: 1400 | Downloads: 113
O'Reilly - Core JSP _2000_
Views: 4603 | Downloads: 87
O'Reilly - C Programming
Views: 342 | Downloads: 50
O'Reilly - Advanced JAVA Networking
Views: 580 | Downloads: 60
Nokia_Xpress-on_Fun_shell_UG_en
Views: 202 | Downloads: 0
modphys[1]
Views: 845 | Downloads: 3
IPTELEPHONYCOOKBOOK[2]
Views: 703 | Downloads: 9
IEEE 2004 May 151[2]
Views: 166 | Downloads: 2
hackingguide3.1[1]
Views: 53 | Downloads: 7
Bodybuilding supplement Secrets Revealed[2]
Views: 482 | Downloads: 20
_ebook_ Mind Powers _How to Use and Control Your Unlimited Potential_[1]
Views: 256 | Downloads: 35
IPTELEPHONYCOOKBOOK[1]
Views: 134 | Downloads: 0
Related docs
Larry Wilson
Views: 1 | Downloads: 0
Wendi Wilson
Views: 1 | Downloads: 0
wilson
Views: 0 | Downloads: 0
Wilson
Views: 6 | Downloads: 0
Debra Wilson
Views: 208 | Downloads: 0
Cynthia Wilson
Views: 7 | Downloads: 0
Fawn Wilson
Views: 1 | Downloads: 0
Allan Wilson
Views: 9 | Downloads: 0
Bryant Wilson A
Views: 81 | Downloads: 0
Wilson Knerr
Views: 3 | Downloads: 0
Artist Pickett Wilson
Views: 1 | Downloads: 0
C T WILSON
Views: 3 | Downloads: 0
WILSON-v
Views: 5 | Downloads: 0