Enhance your PharmaSUG experience by attending optional pre- and post-conference training seminars taught by seasoned experts. Half-day courses are only $125 and full-day courses are $250. You can sign up for classes when you register for the conference. Space is limited!

Be sure to review the seminar registration, attendance, and cancellation policy.

Saturday, May 16, 2015

Course Title (click for description) Instructor(s) (click for bio) Time
#1 SAS® DATA Step and Macro Language Debugging 101 Kirk Paul Lafler 8:00 AM - 12:00 PM
#2 The SDTMIG: Beyond the Modeled Domains and Other Implementation Challenges – Fred Wood and Jerry Salyers Fred Wood
& Jerry Salyers
8:00 AM - 12:00 PM
#3 XML in a SAS® and Pharma World Mike Molter 1:00 PM - 5:00 PM
#4 How (and Why) to Harmonize Data Collection with CDISC Submission Standards Mario Widel
& Steve Kirby
1:00 PM - 5:00 PM

Sunday, May 17, 2015

Course Title (click for description) Instructor(s) (click for bio) Time
#5 The Guidance Documents are No Longer Drafts… – REVISED FDA Data Submission Requirements Dave Izard 8:00 AM - 12:00 PM
#6 PROC SQL Programming: The Basics and Beyond Kirk Paul Lafler 8:00 AM - 12:00 PM
#7 Learning R for SAS® Users Arthur Li 8:00 AM - 5:00 PM
#8 CDISC and XML for SAS® Programmers Lex Jansen 1:00 PM - 5:00 PM
#9 Cleaning, Validating, and Reshaping Your Data:  Taking Advantage of SAS Tools Art Carpenter 1:00 PM - 5:00 PM

Wednesday, May 20, 2015

Course Title (click for description) Instructor(s) (click for bio) Time
#10 Innovative Tips and Techniques: Doing More in the DATA Step Art Carpenter 1:00 PM - 5:00 PM
#11 ADaM Datasets: Creation and Applications Sandra Minjoe
& Paul Slagle
& Mario Widel
1:00 PM - 5:00 PM
#12 Essential Clinical Graphs Using SG Procedures Sanjay Matange 1:00 PM - 5:00 PM

Thursday, May 21, 2015

Course Title (click for description) Instructor(s) (click for bio) Time
#13 Advanced Reporting and Analysis Techniques for the SAS® Power User: It's Not Just About the PROCs! Art Carpenter 8:00 AM - 5:00 PM

Seminar Registration, Attendance, and Cancellation Policy

  1. You must register for the conference in order to attend a seminar.
  2. You must register for a seminar via the PharmaSUG 2015 conference registration form either by postal mail, fax, or online (preferred).
  3. You may cancel a seminar on or before May 4, 2015, and receive a full refund minus a $25 administration fee per cancelled seminar.
  4. You may add a seminar on or before May 4, 2015 for no additional fee. To sign up for an additional seminar after you have already registered for the conference, please contact the This email address is being protected from spambots. You need JavaScript enabled to view it..
  5. On or before May 4, 2015, you may swap one seminar for another; however, this is considered a change in conference registration and will incur a $25 administration fee.
  6. After May 4, 2015, you MAY NOT SWAP seminars; however, a new seminar may be added depending on space and availability.
  7. There will be NO REFUNDS after May 4, 2015. However, if you are unable to attend, the seminar material will be provided to you (either by postal mail or email) without additional charge.
  8. Should a seminar be cancelled at any time for any reason, the sole liability of PharmaSUG and the instructor is a refund of the seminar fee, and they are NOT liable for any special or consequential damages arising from the cancellation of the seminar.
  9. On-site registration will be permitted based on space and availability, and payable by major credit card (MC, VISA, Discover, AMEX). However, seminar materials may not be available on-site but will be provided later to paid attendees.
  10. You may sign up for seminars occurring at the same time, i.e., you can attend one class and ask for material for another class, bearing in mind that tuition must be paid for both seminars.

For questions about the above seminar policy and availability, please contact Craig Brelage and Venky Chakravarthy, Seminar Coordinators, at This email address is being protected from spambots. You need JavaScript enabled to view it..

Course Descriptions

SAS® DATA Step and Macro Language Debugging 101
Kirk Paul Lafler
Saturday, May 16, 2015, 8:00 AM - 12:00 PM

Users are always surprised to discover their programs contain bugs. In fact, when asked SAS® users will emphatically stand by their programs and logic by saying they are bug free. But, the vast number of experiences along with the realities of writing code indicates otherwise. Bugs in software can appear anywhere; whether accidentally built into the software by developers, or introduced by programmers when writing code. No matter where the origins of bugs occur, the one thing that all SAS® users know is that debugging SAS program errors and warnings can be a daunting, and humbling, task. This seminar explores the world of SAS DATA step and Macro Language bugs, providing essential information about the different types of bugs, how bugs are created, the symptoms of bugs, how to locate bugs, and strategies and techniques on how to resolve bugs. Attendees learn how to apply effective techniques to better understand, identify, and repair bugs and enable program code to work as intended.

The SDTMIG: Beyond the Modeled Domains and Other Implementation Challenges – Fred Wood and Jerry Salyers
Fred Wood, Jerry Salyers
Saturday, May 16, 2015, 8:00 AM - 12:00 PM

This course will cover aspects of the SDTMIG that, in our experience, frequently present the greatest challenges to sponsors. These include the use of variables in the SDTM but not in domain models, when to create custom domains, and when to use Findings About rather than a custom Findings domain. In addition, considerations around when to create Supplemental Qualifiers and how to relate them back to parent domains via the most efficient IDVAR values will be presented.

Other problematic challenges include the use of relative Timing variables as updated in SDTMIG 3.2, the submission of legacy terms in addition to CDISC Controlled Terminology, misuse of variables, not following conventions established for modeled domains when creating custom domains, and the creation of Trial Design datasets. The course will also include examples and exercises that highlight some of the newer domains and concepts in SDTMIG 3.2, as well as some planned for SDTMIG v3.3. The exercises will be used 1) to generate discussion, and 2) so that attendees can assess their overall understanding of SDTM as well as the concepts presented in the course material. The exercises will not require the use of computers or the knowledge of SAS®.

XML in a SAS® and Pharma World
Mike Molter
Saturday, May 16, 2015, 1:00 PM - 5:00 PM

The introduction of standards to the clinical data life cycle has brought about significant changes to the job of a SAS programmer. Traditionally, SAS programmers who built data sets and statistical output for regulatory submission purposes had little need for technical knowledge beyond SAS programming and maybe some Microsoft or Adobe basics. In today’s world, collected data can be made available in an XML format produced by EDC systems (i.e. ODM.xml). Submissions are expected to be accompanied by metadata expressed through an XML extension of ODM (i.e. Define.xml). Right around the corner is Dataset-XML, another extension of ODM that will replace the traditional version 5 transport files for submission of domain data. The increased use of XML for transferring data and metadata has its advantages, but also imposes new requirements of a programmer’s skill set.

This seminar will cover three main areas. We’ll begin with an XML primer. Here students will learn the basic structural rules behind XML. We’ll also dive into the subjects of XML namespaces and schemas, and review common examples. In the second area we’ll discuss different ways in which SAS can interact with XML, in terms of both importing and exporting. With this background now behind us, we’ll then be ready to discuss how XML exists alongside SAS in the pharmaceutical and biotech industry. We’ll take a detailed look at the ODM structure, as well as how Define-XML and Dataset-XML extend it. We’ll see how tools such as SAS XML Maps and XSL stylesheets can help us to produce and view them. Finally, we’ll put all of this knowledge together to see how SAS supports the construction and maintenance of clinical standards through the Clinical Standards Toolkit.

Often times the easiest way to learn something new is by doing so using familiar tools. In the end, SAS programmers with a modest amount of SAS experience will have the opportunity to expand their horizons into new technologies and tools, but with familiar SAS tools holding their hand most of the way.

How (and Why) to Harmonize Data Collection with CDISC Submission Standards
Mario Widel, Steve Kirby
Saturday, May 16, 2015, 1:00 PM - 5:00 PM

In recent years the FDA have been seriously encouraging sponsors to provide study tabulations data in CDISC SDTM format and analysis data in CDISC ADaM format; they also released binding guidance for electronic submission of standardized study data late last year. Planning to provide CDISC data as you write the protocol or translate it into electronic CRF forms and associated output data sets saves money and avoids stress by providing a clear path from collection data to submission domains. As noted by the FDA: “The use of case report forms that incorporate SDTM standard data elements . . . allows for a simplified process for the creation of SDTM domains.” This half-day course will briefly explain the submission process and share how to create a traceable path from collection data to submission domains that is driven by communication and collaboration between groups. Strategies to keep your data processes current as CDISC standards and regulatory expectations evolve via FDA guidance and through initiatives such as CFAST and the FDA/PhUSE working groups will be discussed. Interaction and participation will be emphasized and questions based on local collection standards will be welcome. Attendees are expected to be familiar with CDISC data standards and have spent some quality time with protocols and CRFs.

The Guidance Documents are No Longer Drafts… – REVISED FDA Data Submission Requirements
Dave Izard
Sunday, May 17, 2015, 8:00 AM - 12:00 PM

SAS® statistical and programming professionals work tirelessly contributing to CRF & clinical database design, protocol & SAP development, analysis dataset design & implementation and the generation of tables, figures and listings in support of clinical trials. If the compound under study successfully navigates clinical and regulatory hurdles, most of these items will make their way into a regulatory submission to the FDA. The FDA has now issued final versions of two guidance documents, a companion technical specifications document and the continued support for a data standards catalog. These documents have moved the needle with respect to Sponsor and CRO organization obligations in terms of how they plan and execute studies as well as prepare clinical assets for inclusion in a regulatory submission.

This highly interactive seminar will review each asset, its role in the submission and the impact that these final guidance documents have on how the asset is handled as it weaves its way through the drug development lifecycle on its way to the FDA. A portion of the seminar will be dedicated to a discussion of “hot off the press” topics, including a review of FDA behavior since these documents have been finalized including Sponsor feedback during the review period.

Audience Level: Beginner to Intermediate – individuals who are new to the Pharmaceutical industry would benefit greatly for the opportunity to put their hard work creating analysis datasets and TLFs into the context of a regulatory submission. Conversely, experienced professionals who have created submission assets in the past who are looking for a refresher on recent changes to FDA requirements, CDISC standards and the future outlook on submission data requirements for other global regulatory bodies would also enjoy this seminar.

PROC SQL Programming: The Basics and Beyond
Kirk Paul Lafler
Sunday, May 17, 2015, 8:00 AM - 12:00 PM

PROC SQL is a powerful database language that all SAS® users should be familiar with. This seminar presents SAS users with core concepts and programming techniques on how to access data stored in datasets; accomplish essential programming tasks including retrieving, subsetting, ordering, and grouping data; construct logic scenarios with case expressions; explore one-to-one, one-to-many, and many-to-many data relationships; understand the similarities and differences between DATA step merges and joins; create complex queries using inner and outer join constructs as well as with set operators; use summary (statistical) functions to aggregate data; create new tables; produce “quality” looking output using PROC SQL options with Output Delivery System (ODS); and interface PROC SQL with the macro facility to create single-value and multi-value (list) macro variables.

Learning R for SAS® Users
Arthur Li
Sunday, May 17, 2015, 8:00 AM - 5:00 PM

If you are a SAS programmer, have you ever thought of using an alternative language to validate your results that are generated from SAS? R will be the perfect choice for you because R is not only an open-source software but almost all the tools that you use in SAS to manage your data can also be found in R in similar methods.

The focus of this seminar will be on managing and manipulating data by using R software. The topics include arithmetical expressions of R objects, control structures, data input and output, subsetting objects, data manipulations and aggregation, and writing user-defined functions.

Although this is a lecture-based seminar, I would recommend that you bring your own laptop to the lecture and have R installed on your laptop (www.r-project.org) if you’ve never used R before. We can run some examples together during the break time.

CDISC and XML for SAS® Programmers
Lex Jansen
Sunday, May 17, 2015, 1:00 PM - 5:00 PM

Extensible Markup Language (XML) is a markup language that defines a set of rules for encoding documents in a format that is both human-readable and machine-readable. It is an open standard that was developed by the Worldwide Web Consortium (W3C) in order to provide a flexible way to create common information formats and share both the format and the data on the World Wide Web, intranets, and elsewhere.

The CDISC XML Technologies Team creates publishes several CDISC standards in an XML representation. These XML standards include:
  • Operational Data Model (ODM)
  • Define-XML
  • Controlled Terminology in XML (CT-XML)
  • Dataset-XML.
SAS® includes a number of useful generic tools for working with XML. These include:
  • The XML libname engine – Reading and writing XML documents, optionally with an XML Map.
  • The SAS XML Mapper – A Java-based, stand-alone application that analyzes the structure of an XML document or an XML schema and generates basic XML syntax for the XML Map.
  • The Output Delivery System - ODS MARKUP can use a TAGSET to create XML documents.
Furthermore, the SAS® Clinical Standards Toolkit is the platform used by SAS® to support Health and Life Sciences industry. It supports working with several XML based CDISC standards, such as ODM, Define-XML and CT-XML. SAS Clinical Standards Toolkit is under active development with continued releases planned in its product roadmap.

This seminar will introduce XML and give examples of the way SAS supports XML, specifically in the context of CDISC. A goal of the seminar will be to gain a better technical understanding of CDISC based XML standards and what the ways are in SAS to efficiently support those XML standards.

Cleaning, Validating, and Reshaping Your Data:  Taking Advantage of SAS Tools
Art Carpenter
Sunday, May 17, 2015, 1:00 PM - 5:00 PM

The procedures of SAS® along with the DATA step provide the programmer and data analyst access to flexible programming power unavailable in any other programming language. Along with that power comes the complexity of multiple solutions to many common programming tasks. This class covers a number of Intermediate and Advanced SAS programming topics that offer solutions that take advantage of techniques that are not employed by a majority of SAS programmers. Based on Art’s latest book, Carpenter’s Guide to Innovative SAS Techniques, published in the spring of 2012, this course will extend the knowledge and tool set of SAS programmers that work with data.

Innovative Tips and Techniques: Doing More in the DATA Step
Art Carpenter
Wednesday, May 20, 2015, 1:00 PM - 5:00 PM

In order for you to write innovative DATA step solutions to complex coding problems, it is necessary for you to have more than a basic understanding of the individual statements. You need to understand how the various statements interact with each other and how their options can be leveraged to provide the kind of DATA step code that will provide innovative solutions to the toughest of problems. Based on Art’s latest book, Carpenter’s Guide to Innovative SAS® Techniques, published in the spring of 2012, this class is a must for the DATA step programmer that wants to take his or her programs to the ‘next’ level.

Topics include:
  • Data set options with impact
  • New functions and old functions with new options
  • Evaluating expressions
  • Working with Data Component Objects - Hash Tables
  • Transposing the data using arrays
  • Using the DOW loop
  • Using double SET statements effectively
  • Look-ahead and Look-back techniques
  • Using Multi-label formats to create running averages
  • Table look-ups in the DATA step
  • and much more
This course is designed to be taken by a student who has a basic understanding of the DATA step, its primary statements, and its basic operation. The seminar will provide a short refresher of these basics, but will concentrate on topics that will allow the user to take full advantage of the power of the DATA step.

The student will leave the seminar with a deeper understanding of the operation of the DATA step and a number of its primary statements. The student will be exposed to a number of advanced techniques that solve difficult programming problems in innovative ways. The relative efficiencies of a number of competing techniques will be discussed along with the methodologies for their implementation.

ADaM Datasets: Creation and Applications
Sandra Minjoe, Paul Slagle, Mario Widel
Wednesday, May 20, 2015, 1:00 PM - 5:00 PM

This half-day course shows you how to develop your CDISC ADaM datasets to meet your specific statistical analysis needs, such as t-tests, proportions, time to events, occurrence data (adverse events, concomitant medications) and ANOVA. Students will learn specifics of the published ADaM dataset structures and how to apply them to their own clinical study data. Additionally, we will examine situations that don’t fit the published structures, like multivariate analyses, and describe options for handling them.

Essential Clinical Graphs Using SG Procedures
Sanjay Matange
Wednesday, May 20, 2015, 1:00 PM - 5:00 PM

Graphs used in the Health and Life Sciences domain and Clinical Research have special requirements. It is necessary to display large amounts of data in a clear and concise manner including raw data and derived statistics. The data needs to be displayed by treatment, visit and other classifiers along with related information correctly aligned with the horizontal or vertical axis.

This half-day presentation will show you in detail how to create such graphs using SG Procedures. In this presentation we will review the basic features of the SG Procedures, and quickly pivot to creating clinical graphs used commonly in the Pharmaceutical and Life Sciences industry using SAS® 9.3 and SAS 9.4 features. These include, Distribution of Maximum LFT by Value and Treatment, Hazard Function Plot, Box Plots of Change from Baseline, Forest plots, Adverse Event Timeline with Concomitant Medications Graph, and more.

Advanced Reporting and Analysis Techniques for the SAS® Power User: It's Not Just About the PROCs!
Art Carpenter
Thursday, May 21, 2015, 8:00 AM - 5:00 PM

There are literally hundreds of techniques used on a daily basis by the users of SAS® software as they perform analyses and generate reports. Although often obscure, most of these techniques are relatively easy to learn and generally do not require specialized training before they can be implemented. Unfortunately a majority of these techniques are used by only a very small minority of the analysts and programmers. They are not used more frequently, because a majority of SAS users have simply not been exposed to them. Left to ourselves it is often very difficult to ‘discover’ the intricacies of these techniques and then to sift through them for the nuggets that have immediate value.

This one day course presents a series of those nuggets. It covers a broad range of SAS topics that have proven to be useful to the intermediate and advanced SAS programmer who is involved with the analysis and reporting of data. The intended audience is expected to have a firm grounding in Base SAS. For most of the covered topics, the course will introduce useful techniques and options, but will not ‘teach the procedure’. No matter how experienced we are, no matter how well we know a procedure or a technique, there is still more that we do not yet know.

The course includes options and techniques associated with:
  • New, powerful, and little used options in MEANS/SUMMARY
  • Reporting procedures including TABLULATE and REPORT
  • Understanding more about the REPORT compute block
  • In the DATA step (functions, options, statements)
  • Working with data
  • Taking full advantage of formats
  • Interfacing with the Macro Language
  • Output Delivery System, ODS, extras
  • Operating System Interfaces and how you can take advantage of them
  • Advanced Table look-up techniques
  • Importing and exporting data
Students attending this seminar will be exposed to a broad range of techniques, procedures, options, and statements. Throughout the seminar the discussion will include comparisons of coding and operating efficiencies. Even the most advanced students will come away from the training with a broader appreciation for the SAS System, its depth and its flexibility, and the programmer’s ability to tap into those capabilities.

Instructor Biographies

Art Carpenter

Art’s publications list includes five books, and numerous papers and posters presented at SAS Global Forum, SUGI, and other user group conferences. Art has been using SAS® since 1977 and has served in various leadership positions in local, regional, national, and international user groups. He is a SAS Certified Advanced ProgrammerTM and through California Occidental Consultants he teaches SAS courses and provides contract SAS programming support nationwide.

David Izard

Dave frequently finds himself at the intersection of clinical data standards, regulatory expectations and sponsor organization needs and desires. A SAS user since 1994 and pharmaceutical professional since 1997, he currently serves as the Clinical Data Consulting Lead for Accenture’s Accelerated Research & Development Shared Services after leading Octagon Research Solutions / Accenture’s SDTM practice for 6 years. Prior to joining Octagon / Accenture he served in a variety of Clinical Programming leadership roles at both GSK and Shire. He has been participating at PharmaSUG since 1990, supporting the conference as a presenter / seminar instructor as well serving in a number of leadership roles. He holds Bachelors and Masters of Science Degrees in Computer Science from Bucknell and West Chester University respectively.

Lex Jansen

Lex is a Principal Software Developer at SAS Institute, Health and Life sciences R&D. In this role he develops software that supports clinical data standards. Currently he is one of the developers working on the SAS Clinical Standards Toolkit. Since 2008 Lex has been an active member of the CDISC XML Technologies Team and was one of the developers of the Define-XML 2.0 specification. He was also involved in developing the Dataset-XML 1.0.0 specification. Lex holds an MSc in Mathematics from the Eindhoven University of Technology in the Netherlands. He maintains the SAS Proceedings library at www.lexjansen.com, which is well-known in the SAS community and contains more than 26,000 links to papers that were presented at all major SAS User Group conferences.

Steve Kirby

Steve, Sr. Manager of Statistical Programming at Theorem Clinical Research, has over a decade of industry experience in clinical and statistical programming. His primary focus is (and for a long time has been) on optimizing the delivery of submission data and documentation that comply with CDISC standards. Steve holds a JD, an MS in Biometry, is a member of the CDISC ADaM team and ADaM PK subteam and is involved with the FDA/CSS working group focused on optimizing the use of data standards.

Kirk Paul Lafler

Kirk is consultant and founder of Software Intelligence Corporation and has been programming in SAS® since 1979. He is a SAS Certified Professional, application developer, programmer, data scientist and provider of IT consulting services and training to SAS users around the world. As the author of six books including Google® Search Complete! (Odyssey Press. 2014), PROC SQL: Beyond the Basics Using SAS, Second Edition (SAS Institute. 2013) and PROC SQL: Beyond the Basics Using SAS (SAS Institute. 2004), he has written more than five hundred papers and articles, been an Invited speaker at four hundred-plus SAS International, regional, special-interest, local, and in-house user group conferences/meetings, and is the recipient of 23 “Best” contributed paper, hands-on workshop (HOW), and poster awards.

Arthur Li

Arthur holds an M.S. in Biostatistics from the University of Southern California. Currently, he is a Biostatistician at the City of Hope National Medical Center. In addition, Arthur developed and taught an introductory SAS course at U.S.C. for the past seven years, as well teaching the Clinical Biostatistics Course at U.C.S.D. extension. As well as teaching and working on cancer-related research, Arthur has written a book titled “Handbook of SAS® DATA Step Programming.”

Sanjay Matange

Sanjay is R & D Director in the Data Visualization Division at SAS, responsible for the development and support of ODS Graphics. This includes the Graph Template Language (GTL), Statistical Graphics (SG) procedures, ODS Graphics Designer and other related graphics applications. Sanjay has been with SAS for over 20 years, co-author of two patents and author of two SAS Press books.

Sandra Minjoe

Sandra is a Senior ADaM Consultant at Accenture Life Sciences. She has been part of the ADaM team since 2001, is on the ADaM Leadership Team, reviews all ADaM drafts with particular focus on the fundamental principle of traceability, and is a CDISC ADaM trainer. Sandra is also a co-lead of the Computational Sciences Symposium project on Traceability & Data Flow, and part of the PharmaSUG Executive Committee.

Mike Molter

Mike is a Life Sciences Consultant with d-Wise in Raleigh, North Carolina. Mike began working with SAS software in 1999 in the healthcare industry before moving to statistical programming in clinical trials in 2003. In his current role, Mike helps clients develop and implement technical and process solutions around clinical data standards such as CDISC SDTM and ADaM, using a variety of SAS tools. Mike volunteers with CDISC’s XML Technologies team as well as the Data Optimization FDA/PhUSE working groups. He has presented at various local, regional, and national SAS and CDISC user group conferences. Personal interests include reading, triathlon, and the Detroit Tigers.

Jerry Salyers

After a career in Data Management at Procter and Gamble Pharmaceuticals, Jerry joined Fred Wood’s Data Standards Consulting group within Accenture Life Sciences providing internal consulting services while also working one-on-one directly with clients in review of legacy-data mapping to SDTM-based datasets.. He also creates and delivers training classes on both CDASH and the SDTM to internal functions, and custom training to external clients. Jerry is also a certified CDISC instructor for both CDASH and SDTM.

Paul Slagle

Paul is Director of Data Standards for InVentiv Health Clinical and leads a team of SDTM and ADaM consultants and programmers. Paul is active in CDISC and is currently participating in the ADaM team the oncology sub team. He is also working on the CFAST team providing ADaM guidance to the Breast Cancer therapeutic area guide. Paul has been active in the using of CDISC since 2004 implementing SDTM followed by ADaM standards in clinical trials. He is SAS programmer with over 30 years’ experience.

Mario Widel

Mario is a Research Scientist at Eli Lilly and Company. He has been involved in CDISC related activities since 2007. In his current role Mario oversees and participates in the metadata definition for SDTM and ADaM datasets, the design, creation and validation of TFL’s. He is a regular presenter at conferences like JSM, PharmaSUG, SAS Global Forum, PhUSE and CDISC. Mario is an authorized CDISC instructor.

Fred Wood

Fred is Senior Manager and Lead of the Data Standards Consulting Group within Accelerated R&D Services, a group he has led since 2007. He has been active in leading the development of CDISC standards since 1999. He is one of the principal contributors to the CDISC Study Data Tabulation Model (SDTM). Fred is a founding member of the SDS Team (1999), the SEND Team (2002), and the Devices Team (2007), and has led or co-led these for many years; he currently serves on the Leadership Teams of all three. Fred is currently a member of the CDISC Standards Review Council (SRC), the CDISC SDTM Governance Committee (SGC), and the CDISC Technical Leadership Committee (TLC). He has been a member of many other CDISC SDTM-related teams since 1999, and is providing SDTM expertise to therapeutic-area projects conducted as part of the CFAST initiative.