Slides - CDISC

CDISC © 2010
CDISC Standards in the Regulatory
Submission Process
What’s New and What’s Ahead
26 January 2012
Moderator
Frank Newby, CDISC COO
© CDISC 2011
2012
Webinar Agenda
•  SDTM Amendment 1 Wayne Kubick, CDISC
•  CDER Common Data Standards Issues
Document, Chuck Cooper, CDER
•  CDER/CBER’s Top 7 Standards Issues Dhananjay
Chhatre, CDER and Amy Malla, CBER
•  SEND Update - CDER Timothy Kropp, CDER
•  CDRH: CDISC Update, Terrie Reed, CDRH
•  Q&A CDISC and FDA Panel
© CDISC 2011
2012
3
Presenters and Panelists
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Amy Malla, CBER
Stephen E Wilson, CDER
Charles Cooper, CDER
Virginia Hussong, CDER
Douglas Warfield, CDER
Dhananjay Chhatre, CDER
Paul Okwesili , CDER
Terrie Reed, CDRH
Timothy Kropp, CDER
Wayne Kubick, CDISC
Frank Newby, CDISC
© CDISC 2011
2012
4
SDTM Amendment 1
Wayne Kubick, CDISC CTO
© CDISC 2011
2012
5
New SDTM Variables - DM
© CDISC 2011
2012
V3.5 Training Materials
6
New SDTM Variables - DM
© CDISC 2011
2012
V3.5 Training Materials
7
SDTM IG - Demographics - DM
© CDISC 2011
2012
V3.5 Training Materials
8
New SDTM Variables - Events
© CDISC 2011
2012
V3.5 Training Materials
9
New SDTM Variables - Events
© CDISC 2011
2012
V3.5 Training Materials
10
SDTM IG – Adverse Events - AE
© CDISC 2011
2012
V3.5 Training Materials
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CDISC Webinar
Update on Data Standards Activities
January 26,2012
Chuck Cooper, M.D.
Computational Science Meeting, OTS, CDER, FDA
Outline
•  CDER Data Standards Common Issues
Document, v.1.1
•  CDER Data Standards Questions Team
•  FAQ database
•  Ongoing Data Standards Development
Activities
•  PhUSE/FDA Conference
CDER Data Standards Common Issues
Document, v.1.1
•  Purpose of document
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Reduce variability in submissions containing cdisc-specified data standards
Provide direction to industry on how to submit study data to CDER
Comprised mainly of preferences, clarifications, and examples of errors
Not intended to be comprehensive
Instead- is focused on actual reviewer feedback, experience with submissions
containing standardized data
Initially posted (version 1.0) on website for sponsors to access in Spring 2011
First updated version (version 1.1) in December 2011
Intention is to update periodically, as needed
CDER Data Standards Common Issues
Document, v.1.1
•  Available publically at Study Data Standards for
Submission to CDER web page
–  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/
FormsSubmissionRequirements/ElectronicSubmissions/ucm248635.htm
CDER Data Standards Common Issues
Document, v.1.1
•  Version control
CDER Data Standards Common Issues
Document, v.1.1
•  Important new items:
–  Variable length issue
–  Updated info on SEND
•  no longer in pilot
•  Clarification of terminology issues
–  Additional ADaM information
•  General expectations
•  Repeated measures variable
CDER Data Standards Questions Team
Submit Questions to:
cder-edata@fda.hhs.gov
CDER Data Standards Questions Team
•  All data standards questions submitted to
cder-edata@fda.hhs.gov are answered by
the CDER Data Standards Questions Team
•  Comprised of:
–  OB/Analysis File Working Group
–  OBI/eData Team
–  CSC Data Standards Team
–  CBER
CDER Data Standards Questions Team
•  Questions entered into a FAQ Database
•  Goals of database:
–  Record of how questions were answered
–  Identify common questions
–  Ensure consistency of response
–  Serve as reference for others
•  Also included in database
–  Questions and answers generated from
periodic FDA data standards webinars
Data Standards Activities:
Some Ongoing SDTM Projects
• 
• 
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Virology Data Standards
Tuberculosis Data Standards
Trial Summary
Imaging/CV Imaging
Death Domain
Schizophrenia
Data Standards Activities:
FDA/PhUSE Annual Conference
•  FDA/PhUSE Annual Computational Science Symposium
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March 19-20, 2012
Silver Spring Civic Center
Re-designed conference focused on Working Groups
Register now at www.phuse.eu/css
Poster presentations now being accepted
Data Standards Activities:
PhUSE/CSC Annual Conference
•  Working Groups:
–  WG 1: Data Validation
–  WG 2: Standardizing data within the
Inspection Site Selection Process
–  WG3: Challenges in Integration and
conversion of data
–  WG4: Standards Implementation Issues
–  WG5: Development of standard scripts
–  WG6: Non-clinical roadmap
END
CDER/CBER’s Top 7 CDISC
Standards Issues
Dhananjay Chhatre, MS, RAC
eData Management Solutions Team
Office of Business Informatics
CDER, U.S. FDA
Amy Malla
Review Management
CBER, U.S. FDA
Background
•  ~ 30% of unique NDAs received by CDER in 2011 submitted
CDISC/SDTM data
• 
~ 20% of the BLA’s received by CBER in 2011 submitted CDISC/
SDTM data
•  Although standardization has allowed for use of additional
data analysis tools, issues with either the implementation of
the standard, or the standard itself, have proven to be
inhibitive to the regulatory review process
Top 7 Issues
1
Waste of Space
2
Extras
3
Validation Errors
4
Extended Codelists
5
ISO Dates
6
Traceability
7
Inadequate Documentation
1.
Waste of Space
• 
eData team performed research on cause of
large dataset sizes
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• 
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Identified correlation between dataset sizes and
allotted column variable length
Columns lengths were being padded
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Randomly selected 20 studies (432 datasets)
i.e. actual length = 8, allotted length = 200
Impact on dataset size compounded by large
number of rows
Variable
Name
1.
Waste of Space
Reduced
to the width
needed
Totals bytes used
~ 1/10 the size
Variable Type
Previous Variable
Length
Modified Variable
Length
DOMAIN
Character
2
2
LBBLFL
Character
2
2
LBCAT
Character
200
20
LBDTC
Character
50
20
LBNRIND
Character
8
8
LBORNRHI
Character
200
10
LBORNRLO
Character
200
10
LBORRES
Character
200
15
LBORRESU
Character
200
10
LBREFID
Character
200
15
LBSEQ
Numeric
8
8
LBSPID
Character
200
5
LBSTAT
Character
8
8
LBSTNRHI
Numeric
8
8
LBSTNRLO
Numeric
8
8
LBSTRESC
Character
200
15
LBSTRESN
Numeric
8
8
LBSTRESU
Character
200
10
LBTEST
Character
200
30
LBTESTCD
Character
8
8
STUDYID
Character
200
10
USUBJID
Character
200
20
VISIT
Character
200
25
VISITNUM
Numeric
8
8
2718
283
Total
1.
Waste of Space
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Observed 70% file size reduction, on average,
across 432 datasets
Collaborated with Phrma group
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14 participants (15 studies, 545 datasets)
68% file size reduction, on average
But why is this phenomenon being seen in
CDISC/SDTM datasets, and not legacy data?
1.
Waste of Space
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SAS transport version 5 specifications allocate space
within every row and column (cell) based on the overall
column’s defined variable length
In the CDISC IG, an example references a column
length of 200
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It appears this example was taken to heart by industry
Added wording in CDER Common Data Standards
Issues Document and worked with CDISC to add similar
wording in the recent update to clarify that column
lengths should not be set to an arbitrary limit of 200
This requirement text will also be added to the Data
Standards Specifications next revision (in progress)
2.
Extras (Domains, Variables, SUPPQUAL)
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CDISC IGs (SDTM and ADaM) specify standard
domains and variables, but allow sponsor to
create their own domains and variables
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“If no existing model seems appropriate…”
SUPP- domains contain unnecessary
information
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Use common sense and discuss with review team
on whether all information in supp- datasets are
necessary.
For example, do not create a SUPPQUAL domain
just to include the initials of the subject.
2.
Extras (Domains, Variables, SUPPQUAL)
• 
The findings, events and interventions domain
classes list variables that are allowable.
–  Many of these variables are not in the published
parent domain but instead placed in the
SUPPQUAL.
–  In compliance with the standard, the variables
should be added to the parent domain and
eliminated from SUPPQUAL
• 
If “important” variables (support key analyses) are
placed in SUPPQUAL, discuss with the review
team
3.
Validation Errors
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CDER and CBER currently use OpenCDISC
v1.2
Validation process results in error log -> read it!
Errors and warnings that CAN be fixed,
SHOULD be fixed
–  Some errors/warnings will inherently exist because
of your study design
– i.e. no baseline result, no exposure record
–  Others won’t
– Don’t simply address and dismiss these errors in
a “Reviewer’s Guide”
3.
Validation Errors
Common Errors
a)  Codelist mis-match for extensible codelists
b)  End date is prior to start date
c)  Required and expected variables should be
present in the dataset
d)  Variable labels in the dataset should match
CDISC naming conventions
e)  AE set to serious but no qualifier exists that
has been set to “Y”
4.
Extended Codelists
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Submissions include codelists where variable
values are not included in the codelist
Incorrect define.xml
4.
Extended Codelists
Type
Message
Error
Invalid ISO 8601 value
Informa
The source data for SV is missing an
Warning
Value for VSTEST not found in VSTEST
N Rows
384
1
2840
4.
Extended Codelists
Not in codelist
1/31/12
38
4.
Extended Codelists
Fixed with one xml line edit
1/31/12
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5.
ISO Dates
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SDTM IG allows for partial dates
Date issues can arise from invalid ISO 8601 partial dates
Start date and end date should contain similar length and
characteristics
Type
Error
Message
Invalid ISO 8601 value
Informati
on
The source data for SV is missing an
Warning
Value for VSTEST not found in
VSTEST
Common Problem
N Rows
384
1
2840
5.
ISO Dates
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YYYY-MM-DDThh:mm:ss (i.e. 2001-12-26T07:10:15)
Includes time element
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Only day (no time)
Results in “Invalid ISO 8601 value” error
Since time indicated in one column, standard time of midnight is assumed
for 2nd, which occurs before start date, causing the error
Clarification needs to occur in CDISC IGs regarding when to input times
and when to omit
If time was captured in CRFs, include in tabulations data
Similar issue even when hour and minutes are captured (assumes
seconds of “:00” and triggers the error
6.
Traceability
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No traceability between source data and datasets
Need linkage: CRF -> SDTM -> ADaM -> CSR
SDTM datasets should be created from CRFs
If instead CRFs -> Raw -> SDTM, your analysis
(and hopefully ADaM) datasets should be created
from those same SDTM datasets, not the raw
datasets
Features exist in the ADaM standard that allow
for traceability of analyses to ADaM to SDTM
6.
Traceability
• 
Creating SDTM and Analysis data from
the raw data is incorrect (especially when
submitting only SDTM and analysis data
• 
Raw data should create SDTM, and
SDTM should then create Analysis
CRF
Raw Data
SDTM
Analysis
7.
Inadequate Documentation
• 
• 
Often times not all aspects of the standard apply
to your study/submission
Submit supporting documentation in the form of a
“Reviewer’s Guide” to explain how the data
standard was implemented:
–  What is in the custom domains?
–  What is in the suppqual’s?
–  Insufficient codelists?
–  Unfixable errors/warnings and why?
–  Derivation of key analysis variables
Contact Information:
Please send CDER questions to: edata@fda.hhs.gov.
Please send CBER questions to: cber.cdisc@fda.hhs.gov
URLs:
Study Data Standards for Submission to CDER
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/
FormsSubmissionRequirements/ElectronicSubmissions/ucm248635.htm
Study Data Standards for Submission to CBER
http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/
ucm209137.htm
Study Data Resources
http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm
SEND Update - CDER
Timothy Kropp, Ph.D. FDA/CDER/OTS Background on standard (SEND) •  What is SEND? –  SEND is an implementation of the CDISC Study Data Tabulation Model (SDTM) for nonclinical toxicology studies •  SEND is developed and maintained by the CDISC SEND team –  Nonclinical studies refer to nonhuman studies that are conducted during drug development to address safety issues. •  e.g. Tox studies to open clinical trials in humans •  e.g. Carcinogenicity studies to support product approval & labeling –  Generally, these studies are reviewed by Pharm/Tox reviewers in CDER •  What does SEND do? –  Provides a standardized presentation of toxicology study data in a electronic format. –  Enables the development and use of visualization and analytical tools for these types of data –  Enables more effective and efPicient review of nonclinical tox data. What is SEND not? •  SEND does not change data, or impose new study requirements. •  SEND will not replace summary, interpre>ve, or other informa>on in study reports. Only data tabula>ons. –  No requirement that summary, interpre>ve, or other informa>on ‘validate’ against tool generated summaries (e.g. handling of sig. figs.) pdf pdf Summary Methods Interpreta>on Summary Methods Interpreta>on Data tabula>ons SEND xpt Data tabula>ons Why? BenePits of Building Electronic Submission Infrastructure •  BenePits: Aligned with CDER’s goal of rapid acquisition, analysis, storage and reporting of regulatory data –  Improve efPiciency •  Highly educated and experienced people are spending their time manually transcribing numbers into spreadsheets. –  Improve review science •  Pharmacologists and toxicologists can determine the nonclinical parameters that best predict adverse events in humans –  Improve quality of reviews: •  Improve information in written review to demonstrate basis for decisions SEND History SEND Pilot •  Participants have submitted 20+ full, real submissions •  Many additional test submissions •  Most errors are simple and would be non-­‐existent if participants had a validator.* •  No errors of content were seen. •  Learning was applied to the SEND standard to improve ability to visualize data. *  Open source validator should be available early 2012. Implementation •  SEND is now a CDER preferred, supported standard –  “supported” means CDER has established processes and technology infrastructure to support the receipt, processing, review, and archive of study data using SDTM/SEND 1.  Receipt and processing: validation of datasets* occurs upon receipt from electronic gateway before routing to division. 2.  Automated loading of study data, associated metadata into repository (Nonclinical Information Management System -­‐ NIMS) 3.  Review -­‐ NIMS provides search platform and visualization. FDA has additional tools that can be used for visualization and graphing *Validation rules – both conformance to standard and CDER business rules will be published by CDER in early CY 2012. Aligned with CDER Data Standards Plan •  Ensure that useful, publicly available data standards exist •  Ensure that regulatory data is submitted according to those standards •  Ensure that regulatory review processes can fully-­‐
leverage the standardized data PDUFA V •  Agreement letter –  http://www.fda.gov/downloads/forindustry/userfees/
prescriptiondruguserfee/ucm270412.pdf • 
• 
• 
XII. IMPROVING THE EFFICIENCY OF HUMAN DRUG REVIEW THROUGH REQUIRED ELECTRONIC SUBMISSIONS AND STANDARDIZATION OF ELECTRONIC DRUG APPLICATION DATA A. To enhance the quality and efPiciency of FDA’s review of NDAs, BLAs, and INDs, FDA shall consult with stakeholders, including pharmaceutical manufacturers and other research sponsors, to issue draft guidance on the standards and format of electronic submission of applications by December 31, 2012. C. Requirements for electronic submission shall be phased in according to the following schedule: –  Twenty-­‐four (24) months after publication of the Pinal guidance: All new original NDA and BLA submissions, all new NDA and BLA efPicacy supplements and amendments, all new NDA and BLA labeling supplements and amendments, all new manufacturing supplements and amendments, and all other new NDA submissions. –  Thirty-­‐six (36) months after publication of the Pinal guidance: All original commercial INDs and amendments, except for submissions described in section 561 of the Federal Food, Drug, and Cosmetic Act. PDUFA V •  Agreement letter –  http://www.fda.gov/downloads/forindustry/userfees/
prescriptiondruguserfee/ucm270412.pdf • 
XII. IMPROVING THE EFFICIENCY OF HUMAN DRUG REVIEW THROUGH REQUIRED ELECTRONIC SUBMISSIONS AND STANDARDIZATION OF ELECTRONIC DRUG APPLICATION DATA • 
D. Because of the signiPicant investments required to change regulatory submission and review software, initial FDA guidance shall specify the format of electronic submission of applications using eCTD version 3.2.2 unless, after notice and an opportunity for stakeholder comment, FDA determines that another version will provide for more efPicient and effective applicant submission or FDA review. In general, when FDA revises Pinal guidance requiring submission using a new version of electronic standards or formats, FDA shall also accept submissions using the previous version for no less than twenty-­‐four (24) months. F. Development of terminology standards for data other than clinical data: To address FDA-­‐identiPied nonclinical data standards needs, FDA will request public input on the use of relevant already-­‐existing data standards and the involvement of existing standards development organizations to develop new standards or rePine existing standards. FDA will obtain this input via publication of a Federal Register notice that speciPies a 60-­‐day comment period. • 
• 
G. FDA shall periodically publish Pinal guidance specifying the completed data standards, formats, and terminologies that sponsors must use to submit data in applications. In the case of standards for study data, new data standards and terminology shall be applicable prospectively and only required for studies that begin 12 months after issuance of FDA's Pinal guidance on the applicable data standards and terminology. PDUFA Timeline per agreement leQer – Submission and Collec>on Submission timeline
What is a relevant study (from >meline above)? –  A study that is found in the guidance specifica>ons and is started aSer the relevant collec>on start date (see next) Collection timeline
to meet submission
Timeline – FDA preferences SEND is the preferred, supported standard for general tox and carcinogenicity studies. We are ready now! Communications •  Let us help you with this important transition: •  Send questions regarding submissions of electronic , standardized data to edata@fda.hhs.gov •  Division meetings / mtg acknowledgements –  Reminder: “Study data” is inclusive of clinical and nonclinical data. •  Test submissions for validation. –  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/
FormsSubmissionRequirements/ElectronicSubmissions/
ucm174459.htm Important Plug •  FDA/PhUSE Computational Science Symposium (CSS) –  FDA still has many nonclinical informatics needs to be tackled. We want to work with others in a public forum to… •  determine the best and most efPicient ways forward •  maximize benePits for everyone •  minimize negative impacts –  Be part of the solution; bring your ideas needs and challenges to the FDA/PhUSE CSS. –  http://www.phuse.eu/css –  Working Group 6: Non-­‐clinical road-­‐map and impacts on standards implementation. Resources •  SEND Implementation guide –  http://www.cdisc.org/send •  Study Data Standards for Submission to CDER webpage: –  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/
FormsSubmissionRequirements/ElectronicSubmissions/ucm248635.htm •  Study Data SpeciPications v1.6 –  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/
FormsSubmissionRequirements/ElectronicSubmissions/UCM199759.pdf •  Study Data Standards Catalog Instructions: –  http://www.fda.gov/downloads/ForIndustry/DataStandards/
StudyDataStandards/UCM261514.pdf •  Study Data Standards Catalog: –  http://www.fda.gov/downloads/ForIndustry/DataStandards/
StudyDataStandards/UCM261512.pdf CDRH: CDISC Update
Terrie L. Reed, MSIE
Chair, CDRH Data Management
Working Group
CDRH CDISC Efforts
•  CDRH Representatives on CDISC Device Team
•  No Center Policy requiring CDISC Submissions
but…
–  CDISC submissions received facilitated a more
efficient review and inspection
•  CDRH collaborating on eStudy Guidance and
standards website
•  CDISC Subcommittee under CDRH Data
Management Working Group (DMWG)
62
CDISC Device Team - Background
•  Purpose: develop collection & submission
standards to support electronic submission
of PMAs, 510K and Biological License
Applications (BLAs)
•  Cooperative effort between:
–  CDRH and CBER (FDA)
–  Industry experts
–  Members of the CDISC CDASH/SDS teams
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63
Device Domains
•  Six new Study Data Tabulation Model
(SDTM) data submission domains for key
data shared by most types of devices
•  One new unique identifier variable –
potential future map to UDI
•  Intended to guide the organization,
structure, and format of standard device
clinical trial tabulation datasets submitted
64
to regulatory authorities
64
Project Plan
Q2-4 2011
Q1 2012
Q3 2012
CRF Analysis
Elements
2009 – Q2 2012
New SDTM Domains Development
TLC
Review
Address
Comments
Public
Review
Address
Comments
*Device
Standard
v. 1.0
*May issue as a Draft Standard for Trial Use
65
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Next Steps
•  Post Draft Device Addendum to the SDTM V
3.1.2 on CDISC.org for 30-day public review in
January
•  Address comments from Public Review
•  Publish Device Addendum to the SDTM V 3.1.2
on CDISC.org
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Next Steps (cont’d)
•  Complete CDASH data collection field gap
analysis and draft metadata tables
•  Controlled Terminology gap analysis, develop
needed terms
–  FDA CDRH DMWG project to look at AE Coding for
patients
–  Device Problem codes
•  Complete SHARE Content Template to ensure
all metadata is developed to facilitate integration
with all CDISC standards.
67
Leadership Team
•  Carey Smoak - Roche
Molecular Systems, Inc.
•  Kit Howard - Kestrel
Consultants, Inc.
•  Fred Wood - Octagon
Research Solutions
•  Rhonda Facile – NCI-EVS,
CDISC, LM
•  Bob Pearsall – Sensors for
Medicine and Science, Inc.
•  Maureen Lyden - BioStat
International, Inc.
•  Paul Franson - Medtronic
•  Jennifer Duggan - St. Jude
Medical
•  Marc Mucatel – W. L. Gore
•  Parag Shiralkar -eClinical
•  Jennie Tedrow - Boston
Scientific
•  Amy Malla - FDA-CBER
•  Lynn Henley - FDA-CDRH
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Additional Participating Companies
• 
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Abbott
AdvaMed
Alcon Labs
Allergan
Bayer
Becton Dickinson
BioClinica
Biomet
Emergo Group
Buckler Biomedical Sciences
Business Bridge
Edwards Lifesciences
CDISC
Cleveland Clinic
Covidien
eClinical Solutions
• 
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Dexcom
FDA-CBER
FDA-CDER
FDA-CDRH
Genprobe
Harvard Clinical Research Institute
Innoventz
Johnson & Johnson
National Cancer Institute
PRA International
Premier Research
Smith & Nephew
Stryker
Syneract
Trireme Medical
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CDRH Data Management Working Group
•  Informatics Team
–  Created in 2010
–  Focused on UDI, Health Informatics Plan,
Master Data
•  Data Management Working Group (DMWG)
–  Project Management Support/Leadership by
Informatics Team
–  Coordination of Data Standards Submissions
Work at CDRH
70
DMWG Vision
Promote awareness of and a managed
process for adoption of recognized data
standards into total product lifecycle
data in order to improve the efficiency and
timeliness for exchanging, storing,
analyzing and creating device information
relevant to FDA CDRH and our
stakeholders
71
DMWG Objectives
•  Prioritize projects to ensure that resources are
assigned to those standards-related projects that
align with Center priorities.
•  Develop and incorporate data management best
practices into identified projects.
•  Establish formal processes to increase
education, participation, and coordination on the
development of data standards.
•  Align with a CDRH Master Data Management
Plan and overall Agency, and Federal priorities
72
DMWG Activities
• 
• 
• 
• 
Inventory and Prioritize Projects
Track Data Standards Work
Educate DMWG Representatives
Identify and Facilitate Subcommittees
–  CDISC
–  Vocabulary
–  UDI
73
DMWG Subcommittees
CDISC
•  Increase CDISC Device Team Participation
•  Pilot Standard Submission of Pre-market clinical trial
data into CDRH
•  eStudy Guidance
Vocabulary/Terminology
•  Adverse Event Coding in Pre-Market
•  Master Data Management Strategy
UDI
•  Development of UDI Database
•  Master Data Management
•  Integration of UDI into EHR
74
Contacts
CDISC Device Team
•  Carey Smoak - carey.smoak@roche.com
•  Kit Howard – kit@kestrelconsultants.com
•  Fred Wood - fwood@octagonresearch.com
•  Rhonda Facile – rfacile@cdisc.org
FDA CDRH
•  Lynn Henley – lynn.henley@fda.hhs.gov
•  Terrie Reed – terrie.reed@fda.hhs.gov
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Webinar Q&A
Moderator – Frank Newby
© CDISC 2011
2012
76
How can YOU get involved
•  Join CDISC as a Member
•  Volunteer to contribute content
  Therapeutic area
  Lead a team
  Join a team as a member
• 
• 
• 
• 
Contribute Financial Support
Be a key collaborator
Adopt the standards – ask partners to do so
Spread the Word
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2012
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for$ 1,200
CDISC
$ 3,500 Annual fee+$3,500
1-19
$ 3,500 Annual fee+$3,500
standards
20-99
$ 3,000
$ 5,500 Annual fee+$5,000
20-99
$ 3,000
$ 5,500 Annual fee+$5,000
Case
Studies 100-999
100-999
$ 7,000 CDISC
$ 8,500 Annual
fee+$8,500
$ 7,000
$ 8,500 Annual fee+$8,500
1,000-9,999
$ 18,000 $ 20,000 Annual fee+$20,000
$ 18,000 $ 20,000 Annual fee+$20,000
CDISC Business Case 1,000-9,999
10,000-24,999
$ 21,000 $ 23,000 Annual fee+$23,000
10,000-24,999
$ 21,000 $ 23,000 Annual fee+$23,000
Tools,
Presentations
and
Team
Information
>25,000
$ 25,000 $ 30,000 Annual fee+$30,000
>25,000
$ 25,000 $ 30,000 Annual fee+$30,000
tofee+$5,000
new data standards
and$ 2,500
useful
Academic Institution
$ 2,500 Access
$ 5,000 Annual
Academic Institution
$ 5,000 Annual fee+$5,000
Government
($ 1,200
Government
($ 1,200
information
(e.g.
Pharmacogenomics
Domains,
Non-profit
if < 20)
Non-profit
if < 20)
ADaM validation checks, FDA-CDISC pilot
Additional Support Opportunities Available
Additional Support Opportunities Available
Please Contact CDISC Membership reports)
Please Contact CDISC Membership
Platinum Level
* All of the benefits of the Gold Level PLUS the
following:
* Representation on the CDISC Advisory Board
(CAB), through which the following benefits
accrue:
G O LD LE V E L B E N E FI T S
$ 1,200
Opportunity to provide strategic advice to
CDISC leadership
Teleconferences that include implementation
experiences from peers and CDISC updates
from Operations staff
Opportunity to be on Board Committees
(Strategy, Technical, Financial)
Opportunity to vote a Board Member onto the
CDISC Board of Directors
Opportunity to participate in Town Hall
meetings with regulators
Networking at face to face meetings
* Access to “Members Only” area on the CDISC website for all of the
organization, including access to :
t
* 20% Discounts for CDISC Training Courses and
New
documentation
that supports implementation of CDISC
CDISC
sponsored
events, e.g. Interchanges
Opportunity
be athe
CDISC(eg.
Registered
Solution
For*more
information
contact
For
more information
contact the
standards
CDASH
User
Guide)
CDISCProvider
Membership Team
CDISC Membership Team
Sheila Leaman
sleaman@cdisc.org
Sheila Group
Leaman
sleaman@cdisc.org
*HL7
Member
rates to HL7 Working
Jyoti Pillay CDISC
jpillay@cdisc.org Case Studies
Jyoti Pillay
jpillay@cdisc.org
Meetings
* Access to the Board area of the CDISC Portals
www.cdisc.org/membership-benefits-and-options
www.cdisc.org/membership-benefits-and-options
* Invaluable partnership prospects and networking
* Access to Team area of the CDISC Portals
CDISC Business
opportunities
with peers andCase
visionaries
* Additional 20% discounts (i.e. 40% total) on
* Receipt of personalized plaque
CDISC Training Courses and CDISC Sponsored
Events, e.g. Interchanges
Archived webinars
* Personal Onsite Delivery of the New “CDISC
Global Approach to Accelerating Medical
Tools, Presentations and Team Information
Research” at Members’ Request
be
be
t
t
t
t rship Mem rship
Mem
A PARTOther
A PART OF CDISC
(e.g. Pharmacogenomics Domains,
t OF CDISCuseful information
© CDISC 2011
2012
ADaM validation checks, FDA-CDISC pilot reports)
*
Additional Support Opportunities Available
Please Contact CDISC Membership
p
Membership
Membership
C
A PART OF CDISC
A PART OF CDISC
CD I S C M E M B E R S H I P R AT E S
CD I S C M E M B E R S H I P R AT E S
GOLD
PLATINUM First Year one-time
Annual Fee Annual Fee (joining) Platinum
Contribution
GOLD
PLATINUM First Year one-time
Annual Fee Annual Fee (joining) Platinum
Contribution
-time
num
Number of
Employees in
Organization
3,500
1-19
$ 1,200
$ 3,500
Annual fee+$3,500
1-19
$ 1,200
$ 3,500
Annual fee+$3,500
5,000
20-99
$ 3,000
$ 5,500
Annual fee+$5,000
20-99
$ 3,000
$ 5,500
Annual fee+$5,000
8,500
100-999
$ 7,000
$ 8,500
Annual fee+$8,500
100-999
$ 7,000
$ 8,500
Annual fee+$8,500
20,000
1,000-9,999
$ 18,000
$ 20,000
Annual fee+$20,000
1,000-9,999
$ 18,000
$ 20,000
Annual fee+$20,000
23,000
10,000-24,999
$ 21,000
$ 23,000
Annual fee+$23,000
10,000-24,999
$ 21,000
$ 23,000
Annual fee+$23,000
30,000
>25,000
$ 25,000
$ 30,000
Annual fee+$30,000
>25,000
$ 25,000
$ 30,000
Annual fee+$30,000
5,000
Academic Institution
Government
Non-profit
$ 2,500
($ 1,200
if < 20)
$ 5,000
Annual fee+$5,000
Academic Institution
Government
Non-profit
$ 2,500
($ 1,200
if < 20)
$ 5,000
Annual fee+$5,000
e
ns
p
C
Number of
Employees in
Organization
For more information contact the
CDISC Membership Team
Additional Support Opportunities Available
Please Contact CDISC Membership
Additional Support Opportunities Available
Please Contact CDISC Membership
Sheila Leaman
For more information contact the
CDISC Membership Team
Sheila Leaman
Jyoti Pillay
sleaman@cdisc.org
jpillay@cdisc.org
For more information contact the
CDISC Membership Team
Jyoti Pillay
Sheila Leaman
Jyoti Pillay
sleaman@cdisc.org
sleaman@cdisc.org
jpillay@cdisc.org
jpillay@cdisc.org
www.cdisc.org/membership-benefits-and-options
www.cdisc.org/membership-benefits-and-options
Membership
© CDISC 2011
2012
A PART OF CDISC
www.cdisc.org/membership-benefits-and-options
Membership
A PART OF CDISC
© CDISC 2012
Join us for Upcoming Webinars
Planned topics include:
•  Updates from the CDISC teams
•  Special webinars with FDA presenters invited
•  Communications and Resources from CDISC
http://www.cdisc.org/webinars
© CDISC 2011
2012
82
Join us for Public Training in 2012
• 
• 
• 
• 
• 
• 
• 
• 
• 
Hosted by Synteract in Carlsbad, CA in February
Hosted by PPD in Austin, TX in April
European Interchange in Stockholm, Sweden in April
Hosted by BioClinica in Audubon, PA in May
Hosted by Jazz Pharmaceuticals in Palo Alto, CA in June
CDISC Interchange in Japan in July
Hosted by Synteract in RTP, North Carolina in August
Hosted by Business & Decision in Brussels, Belgium in September
International Interchange in Baltimore, MD in October
Information and Registration at
http://www.cdisc.org/public-training-courses
**NEW** Early registration discounts available!
© CDISC 2011
2012
83
© CDISC 2012
© CDISC 2012
CDISC Interchange Japan
10 - 13 July 2012
Toyko, Japan
CDISC Interchange Asia
2013
© CDISC 2012
Request Private Training in 2012
Visit our website to learn more about having
authorized CDISC standards training
on-site at your location.
Information and Request form at
http://www.cdisc.org/private-training
© CDISC 2011
2012
87
© CDISC 2012
© CDISC 2012
Thank you for attending.
Please complete the Course Evaluation that you will
receive via email following today’s webinar.
© CDISC 2011
2012
CDISC’s vision is to
Inform Patient Care & Safety Through Higher Quality Medical Research
Strength through collaboration.
Sponsored by
© CDISC 2011
2012