CDISC Standards in the Regulatory Submission Process · CDISC Standards in the Regulatory...

© CDISC 2012 © CDISC 2011

CDISC Standards in the Regulatory Submission Process

CDISC © 2010

What’s New and What’s Ahead 26 January 2012

Moderator Frank Newby, CDISC COO


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

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Presenters and Panelists

  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

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SDTM Amendment 1 Wayne Kubick, CDISC CTO

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New SDTM Variables - DM

6 V3.5 Training Materials


New SDTM Variables - DM



SDTM IG - Demographics - DM



New SDTM Variables - Events



SDTM IG – Adverse Events - AE


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 –  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


•  Available publically at Study Data Standards for Submission to CDER web page

–  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm248635.htm


•  Version control


•  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:

[email protected]


•  All data standards questions submitted to [email protected] are answered by the CDER Data Standards Questions Team

•  Comprised of: – OB/Analysis File Working Group – OBI/eData Team – CSC Data Standards Team – CBER


•  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

•  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 –  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

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

•  ~ 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

Background

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

–  Randomly selected 20 studies (432 datasets) •  Identified correlation between dataset sizes and

allotted column variable length •  Columns lengths were being padded

–  i.e. actual length = 8, allotted length = 200 •  Impact on dataset size compounded by large

number of rows

Variable Name

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

Total 2718 283

Reduced to the width

needed

Totals bytes used ~ 1/10 the size

1. Waste of Space

•  Observed 70% file size reduction, on average, across 432 datasets

•  Collaborated with Phrma group –  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

•  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

–  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)

1. Waste of Space

•  CDISC IGs (SDTM and ADaM) specify standard domains and variables, but allow sponsor to create their own domains and variables

–  “If no existing model seems appropriate…” •  SUPP- domains contain unnecessary

information –  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

2. Extras (Domains, Variables, SUPPQUAL)

•  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”

3. Validation Errors

•  Submissions include codelists where variable values are not included in the codelist

•  Incorrect define.xml

4. Extended Codelists


Type Message N Rows

Error Invalid ISO 8601 value 384

Informa The source data for SV is missing an 1

Warning Value for VSTEST not found in VSTEST 2840

1/31/12 38

Not in codelist


1/31/12 39

Fixed with one xml line edit


Type Message N Rows

Error Invalid ISO 8601 value 384

Information The source data for SV is missing an 1

Warning Value for VSTEST not found in

VSTEST 2840

Common Problem

•  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

5. ISO Dates

•  YYYY-MM-DDThh:mm:ss (i.e. 2001-12-26T07:10:15)

Includes time element 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

5. ISO Dates

•  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

6. Traceability

CRF

Raw Data

SDTM

Analysis

•  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

•  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

7. Inadequate Documentation

Contact Information:

Please send CDER questions to: [email protected]. Please send CBER questions to: [email protected]

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.)

Summary

Methods

Interpreta>on

Data tabula>ons

pdf

Data tabula>ons

SEND xpt

Summary

Methods

Interpreta>on

pdf

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

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)

Submission timeline

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 [email protected]

•  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

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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)

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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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• 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 to regulatory authorities

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Device Domains

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Q2-4 2011 Q1 2012 Q3 2012

New SDTM Domains Development TLC Review

Public Review

Address Comments

Project Plan

*Device Standard

v. 1.0

CRF Analysis Elements

Address Comments

65

*May issue as a Draft Standard for Trial Use

2009 – Q2 2012

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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.

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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 •  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

•  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

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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

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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

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DMWG Activities

•  Inventory and Prioritize Projects •  Track Data Standards Work •  Educate DMWG Representatives •  Identify and Facilitate Subcommittees

– CDISC – Vocabulary – UDI

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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

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Contacts

CDISC Device Team •  Carey Smoak - [email protected] •  Kit Howard – [email protected] •  Fred Wood - [email protected]

•  Rhonda Facile – [email protected]

FDA CDRH •  Lynn Henley – [email protected]

•  Terrie Reed – [email protected]

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Webinar Q&A Moderator – Frank Newby

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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


CD I SC M E M B E R S H I P R AT E S

Number of GOLD PLATINUM First Year one-timeEmployees in Annual Fee Annual Fee (joining) Platinum Organization Contribution

1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000

Academic Institution $ 2,500 $ 5,000 Annual fee+$5,000Government ($ 1,200Non-pro!t if < 20)

Additional Support Opportunities Available Please Contact CDISC Membership

MembershipA PART OF CDISC

For more information contact the

CDISC Membership Team

Sheila Leaman [email protected]

Jyoti Pillay [email protected]

www.cdisc.org/membership-bene!ts-and-options

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1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000












1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000












1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000












1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000












1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000










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G O LD LE V E L B E N E FIT S

* Access to “Members Only” area on the CDISC website for all of the organization, including access to :

New documentation that supports implementation of CDISC standards (eg. CDASH User Guide)

CDISC Case Studies

CDISC Business Case

Archived webinars

Tools, Presentations and Team Information

Other useful information (e.g. Pharmacogenomics Domains, ADaM validation checks, FDA-CDISC pilot reports)

* HL7 Member rates to HL7 Working Group Meetings

* Invaluable partnership prospects and networking opportunities with peers and visionaries

* 20% Discounts for CDISC Training Courses and CDISC sponsored events, e.g. Interchanges

* Opportunity to be a CDISC Registered Solution Provider

* Opportunity for discounted prices to participate in CDISC licensed training programs

* Receipt of personalized Gold Member plaque

PL ATI N U M LE V E L B E N E FIT S

All of the bene!ts of the Gold Level PLUS the following:

* Representation on the CDISC Advisory Board (CAB), through which the following bene!ts accrue:

Opportunity to provide strategic advice to CDISC leadership

Teleconferences that include implementation experiences from peers and CDISC updates from Operations sta"

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 the CAB area of the CDISC Portals

* Access to Team area of CDISC Portals

* Additional 20% discounts (i.e. 40% total) on CDISC Training Courses and CDISC Sponsored Events, e.g. Interchanges

* Personal Onsite Delivery of the New “CDISC Global Approach to Accelerating Medical Research” upon Member’s Request subject to instructor availability and coverage of travel expenses

* Receipt of personalized Platinum Member plaque





CDISC Case Studies

CDISC Business Case

Archived webinars









PL AT I N UM LE V E L B E N E FIT S


















CDISC Case Studies

CDISC Business Case

Archived webinars









PL ATI N UM LE V E L B E N E FIT S


















CDISC Case Studies

CDISC Business Case

Archived webinars









PL ATI N U M LE V E L B E N E FIT S


















CDISC Case Studies

CDISC Business Case

Archived webinars









PL AT I N UM LE V E L B E N E FIT S


















CDISC Case Studies

CDISC Business Case

Archived webinars









PL ATI N UM LE V E L B E N E FIT S














��

*Access to ‘Members Only’ area on the CDISCwebsite ��

� Access to new documentation for CDISCstandards

� CDISC Case Studies� CDISC Business Case� Tools, Presentations and Team Information� Access to new data standards and useful

information (e.g. Pharmacogenomics Domains,ADaM validation checks, FDA-CDISC pilotreports)

* 20% Discounts for CDISC Training Courses andCDISC sponsored events, e.g. Interchanges

* Opportunity be a CDISC Registered SolutionProvider

*HL7 Member rates to HL7 Working GroupMeetings

* Invaluable partnership prospects and networkingopportunities with peers and visionaries

* Receipt of personalized plaque

* All of the benefits of the Gold Level PLUS thefollowing:

* Representation on the CDISC Advisory Board(CAB), through which the following benefitsaccrue:� Opportunity to provide strategic advice to

CDISC leadership� Teleconferences that include implementation

experiences from peers and CDISC updatesfrom Operations staff

� Opportunity to be on Board Committees(Strategy, Technical, Financial)

� Opportunity to vote a Board Member onto theCDISC Board of Directors

� Opportunity to participate in Town Hallmeetings with regulators

� Networking at face to face meetings* Access to the Board area of the CDISC Portals* Access to Team area of the CDISC Portals* Additional 20% discounts (i.e. 40% total) on

CDISC Training Courses and CDISC SponsoredEvents, e.g. Interchanges

* Personal Onsite Delivery of the New “CDISCGlobal Approach to Accelerating MedicalResearch” at Members’ Request

Platinum LevelGold Level




1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000












1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000












1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000












1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000












1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000












1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000










CD I SC M E M B E R S H I P R ATE S


1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000












1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000












1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000












1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000












1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000












1-19 $ 1,200 $ 3,500 Annual fee+$3,500

20-99 $ 3,000 $ 5,500 Annual fee+$5,000

100-999 $ 7,000 $ 8,500 Annual fee+$8,500

1,000-9,999 $ 18,000 $ 20,000 Annual fee+$20,000

10,000-24,999 $ 21,000 $ 23,000 Annual fee+$23,000

>25,000 $ 25,000 $ 30,000 Annual fee+$30,000











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

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! 83


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

87


Thank you for attending.

Please complete the Course Evaluation that you will receive via email following today’s webinar.


Strength through collaboration.

CDISC’s vision is to Inform Patient Care & Safety Through Higher Quality Medical Research

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CDISC Standards in the Regulatory Submission Process · CDISC Standards in the Regulatory...

Documents

Transcript of CDISC Standards in the Regulatory Submission Process · CDISC Standards in the Regulatory...