The new domains are:

1. Device Disposition: links a specific device to a specific subject
2. Device Tracking: tracks the movement of the device between sponsor and site and, if necessary, the site and the subject.
3. Device Properties: describes the characteristics of a device at the generic or model level (possibly also each component of a device)
4. Device Malfunctions: records the malfunctions of a specific device

In addition, further device elements have been identified for the following domains: Device Identification, Demographics, Drug Accountability, Subject Exposure and Subject Disposition.  These domains will be included in Device Package-2 that will be developed later in 2010.

In parallel, the CDASH collection fields are being identified to accompany these 4 new SDTM domains. The goal is to focus on the basic device data collection fields that are seen in the majority of device clinical trials. To achieve this goal, a CRF-Analysis sub-team was formed.  This group collected and reviewed ~ 170 device CRFs from 42 device companies to identify areas where devices differ from or are the same as drug studies. Interestingly, the results of this analysis reveal that the current CDASH domains and collection fields developed for drug trials meet almost all the requirements of medical device trials. The team is also looking at existing Controlled Terminology to identify any gaps that may require the development of device specific terminology.  Once this gap analysis is completed new terms will be requested according the terminology change control process located on the NCI EVS webpage.

The Team is now working to prepare the “initial consensus version” (ICV) that will include both the new SDTM and CDASH device-related domains and to begin the first review period described in the CDISC consensus process. This consensus process includes an internal CDISC review and an external focused review followed by an open public review period. Comments from each of these review cycles will be addressed prior to the release of the final standard.

The overall goal is for the new CDASH and SDTM device domains to be incorporated into a device standard by Q2 2010.

For further information about what Device team is doing, please contact:

Rhonda Facile, Carey Smoak, Kit Howard or Fred Wood.

In addition, following a rigorous process of selection, CDISC is pleased to announce that two highly qualified individuals will be added to its Board of Directors for a three year term (2010-2012).  Dr. Steven Hirschfeld and Wayne R. Kubick will have now been welcomed to the CDISC Board.  Sincere appreciation goes to Dr. Christopher Chute, who served his three year term on the CDISC Board but did not run again since he assumed the role of Chair, ISO TC 215 (Healthcare Standards) as of January 2010.  We look forward to continuing to work with Dr. Chute within ISO.   Dr. Pierre-Yves Lastic completed two 3 year terms on the CDISC Board, but will remain on the Board in an ex-officio capacity through his role as Chair of the European CDISC Coordinating Committee (E3C), which officially begins in April 2010.  William Rosen will be staying for one more year to complete a second term on the Board.

Dr. Steven Hirschfeld has recently become the Acting Director for the National Children’s Study at the National Institutes for Health, in Bethesda, MD and he also holds the position of Associate Director for Clinical Research at the National Institute of Child Health and Human Development. Dr. Hirschfeld brings a thorough knowledge of and first-hand experience with CDISC standards and their implementation.  He has been FDA Liaison to CDISC for Data Analysis, Adverse Event Analysis and Protocol Representation, with additional work on the CDISC Glossary.  In addition, he is a co-lead for the CDISC Integrated Safety Data Pilot work with the FDA. After gaining his MD at Columbia University, he began a distinguished career as a pediatrician at the University of California. Dr. Hirschfeld joined the FDA Center for Drug Evaluation and Research as a Medical Officer working in the Division of Oncologic Drugs and the Pediatric Program.  He also worked for the FDA Center of Biologics Evaluation and Research as a medical officer in the Office of Cellular, Tissue and Gene Therapy. 

Wayne Kubick has over 25 years experience, primarily involving clinical research, drug development and product safety, including executive management, strategy development, consulting and software development. He is currently Sr. Vice President and Chief Quality Officer at Phase Forward Lincoln Technologies. Mr. Kubick has vast consulting experience in clinical data architectures, product safety, data mining and analysis technologies, electronic regulatory submissions, information technology strategies, and business processes for clinical research. In addition, he has made major contributions to CDISC over the last 10 years bringing his expert knowledge to CDISC.  Wayne generated the initial strawman SDTM model (with Dave Christiansen) before CDISC was incorporated and served as a team leader for the SDS team and also on the first CDISC Board.  Wayne has also worked with the HL7 standards, regulatory processes and quality systems, EDC, CDMS, electronic publishing, database and analysis software applications.  We are glad to have him back ‘on Board’.

The skillsets and experience that these two new Board members will bring is complementary to and augments that already within the CDISC Board of Directors and will no doubt prove invaluable during their coming terms.  

The 2010 goals will be posted later this year due to an excellent opportunity to ensure that they are aligned with those of FDA CDER and CBER. In November and December 2009, FDA representatives met with the CDISC Board and Operations leaders;  others from FDA participated in the CDISC Interchange. Consequently, a key meeting with the CDISC Executive Committee and FDA representatives is scheduled for early February. We will be reporting more about this opportunity and the outcome of our coming discussions in future eNewsletters. In the interim, we already know some of the key drivers for 2010 and would like to outline those for you now.

Focus Area for CDISC 2010: 

This year, as a focus area, CDISC wants to encourage all organisations and their partners to adopt the CDISC standards at the “front end” of the medical research process i.e.-when a programme or study is being designed, “Use Standards from the Start”.  Why? Well it’s simple, by using standards from the start, you can gain the greatest benefits in terms of the time and cost savings and reap the highest quality data, an extremely valuable asset. Understandably, adoption of the Submission Data Standards has been the focus for many companies. However, CDISC now has a complete suite of standards that can be used right from the development of the protocol. Therefore, it seems sensible to collect standards the way we want to submit them, thus avoiding costly, time-consuming (and sometimes difficult mapping exercises) to do data conversions at the end of the process, prior to submission, when companies should be focusing on the science of their research.

With this in mind, below are current key drivers influencing the goals for CDISC in 2010:

• Drive adoption of and support new and existing standards (through technical, communications and education support) by emphasizing implementation at the ‘front end’ of the process (build in quality to reap the greatest benefits)
  • CDASH for case report forms as a path to reporting and submission
  • Protocol Representation for trial registration and study design
  • Retrieve Form for Data Capture (RFD) IHE Integration Profile (to capture data directly from electronic health records) and implementation of the HITSP Clinical Research Interoperability SpecificationSupport
• FDA needs for standards now:
  • New efficacy standards development
  • Refinement of SDTM (especially instructions for use) 

• Enable SHARE as a key goal of the CDISC Technical Roadmap

• Bind healthcare link with core CDISC standards development and support; integrate healthcare link roadmap with CDISC technical roadmap (same as 2009) and launch healthcare link opportunities

• Bring BRIDG to a global standard  

• Continue collaboration development and management on a global basis

• Identify new funding opportunities and manage operational tasks to the budget on a regular basis

As indicated previously, CDISC is working closely with the FDA representatives to address their current needs and in the coming weeks, we will be updating the overall CDISC Goals for 2010 to reflect those discussions. The 2010 Goals will be posted on the website thereafter.

CDISC Collaborations:

In 2010, CDISC will continue to represent your views and thoughts on a global basis in collaboration with a number of organizations. Over the next month, we will be developing a page for the website that will outline the organizations where your voice is being represented via CDISC and the value that is brought to you through your CDISC membership. These connections are vital to ensure that CDISC remains aligned with global developments, and they also ensure that the standards are being adopted as widely as possible. We’ll announce when the page goes live and you may be surprised at the number of organizations where you are represented.

CDISC Communications:

CDISC Communications continues to develop strategies to ensure all of you are receiving our messages; this year, in particular, we would like to hear more about your views on our digital strategy. In 2009, we launched the CDISC Primer to give everyone an overview of how the standards fit together, how to implement standards, the business case for standards and more. We launched a Twitter account, in order to microblog our activities and we recommend you follow this if you are not already doing so. Perhaps our major achievement last year was the launch of the new CDISC website, which has proved to be a popular move, judging by the number of hits we are getting and the great feedback we have received. The CDISC blog now resides on the CDISC website and has regular updates from our technical teams and communications on our activities.

So what next for CDISC Communications? In 2010 we plan to launch the CDISC journal, where we would like to encourage you to write articles or case studies about your implementation experiences. In the next few months, we will be asking you to submit articles for our first issue, which will be published to coincide with the CDISC Interchange in North America in October. We want all our community to share ideas and successes to support adoption and to help others just starting out on the standards road to implement successfully.

Finally, in 2010, please be sure you continue to support CDISC through membership. Whilst we keep our standards open and accessible to everyone, we need your membership to ensure that they continue to be supported and promoted on a global stage. We are grateful to those companies who have shown us continuous support and those individuals who give up valuable time and effort to ensure that we have an efficient and truly collaborative development process. 2010 will be as busy as ever and we look forward to you joining us on the journey.

AJ de Montjoie
CDISC Communications.

English Speaking User Group Face to Face Meeting

Implementing CDISC Standards from Protocol to P-Value

10 December 2009

Hosted by Medidata Solutions at Brunel University Conference Centre, Uxbridge

The day saw 53 delegates attend from across UK, Germany, Switzerland and Ireland.  There was variety amongst those in attendance in their working disciplines, from Data Managers, Statistical Programmers and Medical Writers.  There were also Software Vendors in attendance and also presenting.

In comfortable facilities, attendees were greeted by Donald Paterson (Amgen) who had co-ordinated the day’s programme, and outlined the agenda.

The first talk was presented by Mark LeBlanc (Eisai) and Michael Auld (Eisai), “Fast Tracking multiple studies using SDTM and ADaM”, which was an honest assessment of the practicalities involved in delivering multiple studies and the benefits and disadvantages of preparing submission-ready data at an early stage of development.  This encouraged a lot of questions from the floor which carried over into tea/coffee and into the afternoon.

Second to speak was Lauren Shinaberry (PRA International), who expanded the issues raised in the first talk, “A CRO perspective on implementation of SDTM across multiple sponsors”.  She talked about the difficulties in understanding the needs of the client, explaining that they could be grouped into 3 types: CDISC-naive, CDISC-expert, and those that were somewhere in between these two groups (the majority).  Also there were often subtle differences between clients’ interpretations of the CDISC standards – which could present confusion internally when repeating the same tasks to different clients.

Next was Darren Weston (Novartis) who presented, “CDISC – Mapping new pathways for Novartis”.  The challenges of organising data for a submission using Oracle Life Sciences Hub and a suite of existing SAS macros was detailed but also it was shown that understanding and clarifying what is required from regulatory authorities was the most revealing.

Following lunch was a live demonstration from our hosts Medidata - and the theme of the day, “From protocol to p-value: ODM along the critical path”, presented by Vaishali Patel (Medidata), Doug Bain (Medidata) and David Smith (SAS Institute).  They demonstrated an integrated end-to-end system incorporating Medidata Rave, Medidata Designer and SAS Data Integration Studio.  They showed that by entering protocol design information into the system (e.g. schedule of assessments, CDASH terminology) this could create metadata and help automate the setup for data capture and constraint checking, and that the heart of the exchange was data in the CDISC ODM format.  A strategy of integrating standards at all stages of the process was promoted, and the idea of multi-skilling across disciplines using the various software packages also emerged.

The final part of the day was an informal round-table “Birds of a Feather” session, in which delegates could discuss further the presentations with the authors.

Presentations can be found in the CDISC Portal under the English Speaking User Group.

At the time of the Intrachange in February we had already seen the annual release of the CDISC glossary with Version 7 being published both on the CDISC website and in Applied Clinical Trials. The month of March saw the publication of SDTM V1.2 and the associated Implementation Guide (IG) V3.1.2 and in the same month SEND V3.0 Draft A was released for use as part of the FDA/CDISC/Industry SEND pilot.

In April and May we saw a flurry of activity as the first version of the new Protocol standard V1.0 was released for public review, work started on support for Devices in SDTM and CDASH as work commenced on the HITSP EHR and Clinical Research interoperability specification.

The ADaM team released V2.1 of the standard and the first version V1.0 of the IG for public comment in the summer and as we approached the CDISC interchange in November BRIDG R3.0, ODM V1.3.1 and a substantial terminology package were all released for public comment. Around the same time the FDA announced the inclusion of SDTM V3.1.2 in their Study Data Specification and their acceptance of V3.1.2 submissions, while HITSP released the draft of IS/158, the  Clinical Research Interoperability Specification for public comment.

Within the last week the XML Technology team have released a guidance document on XML schema validation for define.xml to assist industry with issues in submitting define.xml to the FDA. This document was written in response to some issues uncovered during testing on SDTM data submissions being undertaken by CBER.

In parallel, CDISC has continued to work with Health Level 7 (HL7), ISO Technical Committee (TC) 215 and with Integrating the Healthcare Enterprise (IHE) on developing standards applicable to the clinical research domain and supporting the terminology needs of those projects. CDISC has also been starting to look at therapeutic area standards with partnerships in the areas of Cardiovascular, Diabetes, Parkinson & Alzheimer and Polycystic Kidney Disease.

In the next few weeks, we will see the CDASH V1.1 and the new CDASH User Guide (UG) V1.0 come out for public review and the formal release of the ADaM specification and the associated IG will take place before the end of the year.
And just to round off what is a pretty busy year the SHARE project has been proceeding with a significant amount of pilot work leading to a CDISC board decision to advance the project.

Looking back through the words, I see something like a dozen major items that CDISC will have posted for public comment or released at production status during 2009. This is an average of one a month. Given that the vast majority of the work within CDISC is undertaken by volunteers, this is a great achievement.

I want to finish by paying tribute to the volunteers, the team members and the team leads for their hours of dedication and effort. I would also like to thank their respective line managers and their organizations who allow them to be involved, who help CDISC by funding their time and their travel to such events as the Intrachange. Without them we could not deliver a product a month.

Dave Iberson-Hurst   
VP Technical Strategy

This year, many thanks to its wonderful volunteers, CDISC made significant progress in completing and ‘teeing up’ certain standards such that we will be going into 2010 with a complete suite of standards for biomedical research, from protocol representation through reporting and analysis.  This standards suite is augmented with interoperability specifications and integration profiles to enable the use of EHRs for research, while adhering to applicable regulations.   We are poised to benefit from the implementation of these transformational initiatives and products.

Specific accomplishments include (but are not limited to):

• The interoperability specification developed through HITSP, which identifies the CDISC IHE Retrieve Form for Data Capture (RFD) integration profile and CDISC CDASH to exchange a core set of research data from EHRs to clinical research systems
• The CDASH Implementation Guide and harmonization of CDASH elements with the NCI standard CRFs and CDEs
• BRIDG Release 3, which is targeted towards not only technology developers and modelers but also domain experts
• The Protocol Representation Model based on BRIDG, which includes the Trial Design Model (TDM) as in SDTM; the Clinical Trial Registration elements; Eligibility Criteria and other elements that are found in all protocols for research studies
• The application of the RFD to improve adverse event reporting (ASTER)
• Genomics augmentations for the LAB model (and coming for SDTM)
• And numerous terminology elements to enhance the interoperability and refinement of the CDISC standards

Additional progress was made in 2009 to pilot and determine how to build and implement SHARE to make the CDISC standards more accessible and identify terminology and value sets for the BRIDG model.  We have enjoyed strength through collaborations, in particular with the NCI and Mayo Clinic who enabled the SHARE pilot and those who contributed content for it (Mayo, MD Anderson, GSK, Lilly and Genzyme).

As this year draws to a close, we are excited to be working with CDER and CBER on a plan focusing on standards implementation, specifically to ‘tighten up’ SDTM and ADaM and to develop the efficacy data elements (which will also be in SHARE).

And, on the global front, we continue to grow, with 60 countries in our participant database and interest from Korea, India and China in solidifying CDISC Coordinating Committees and building Local Expert Groups.   We also continue to participate in the Joint Initiative Council (JIC) for International Harmonization (ISO, HL7, CEN, CDISC and IHTSDO) through which we will be balloting BRIDG in 2010.

On behalf of CDISC, its Board of Directors and Operations, we wish you all a joyous and peaceful holiday season and all the best for the coming New Year 2010.

Dr. Rebecca Kush
CDISC CEO and President

The conference was privileged to have several keynote speeches on the first day:  Dr. Frank Rockhold, GSK and Dr. Christopher Chute, Mayo Clinic College of Medicine. Key highlights from those opening speeches can be read on the CDISC Blog. The main thrust of Frank Rockhold’s presentation was to ensure that a global audience understood the imperative to implement the CDISC standards and how that message is conveyed to those outside of data management. As those of you who have tried to convey this message to senior managers will know, this is not always a simple task. We would recommend that you start by handing them a copy of the CDISC book: Introducing the CDISC Standards: New Efficiencies for Medical Research. Christopher Chute continued the broad theme of interoperability and also reinforced the message of working with healthcare to ensure that there is a close connection with research.  Both the keynotes emphasised a patient centred focus, something that is important to all of us. 

The CDISC Updates session has become an integral part of the Interchange and keeps our community abreast of the latest developments. Dr. Rebecca Kush began with her extensive roundup of the global activities that have taken place across 2009. You can read a summary of her presentation here on the Blog. She was followed by a summary from the CDISC Coordinating Committees in Europe, Japan and China who have all been busy with events and expounding the CDISC message. Concluding with the CDISC Team updates, it’s evident that CDISC is busier than ever working on the standards on behalf of its members.

Of course, our conference would not have been complete without the input from the FDA and this year we were honoured to have the new Principal Deputy Commissioner, Dr. Joshua Sharfstein, join us on the second day of the conference for his first meeting with the CDISC community. He was welcomed by Rebecca Kush and spent some time looking at the Healthcare Link demonstration in the lobby before taking to the podium to address an eager audience.  After an introduction by CDISC Board Chair, Dr. Edward Helton, he began with a lovely anecdote citing that he had been accepting every invitation to speak at conferences, including one to a cake manufacturers’ panel, at which point his assistant asked him politely to stop accepting everything that landed on his desk from Baltimore! He cancelled the cake speech, but he felt that CDISC was an opportunity too important to cancel and for that we are grateful.  

                                                                                                                            
If you have been reading our Blog, then you will be aware of the flurry of activity and discussion at the FDA Panel session.  Clearly, for most of the attendees this was one of the highlights of the event and you can read both Rebecca Kush’s views of the presentations by the panel and Dr. Sharfstein’s speech and Dave Iberson-Hurst’s impressions of that session on our Blog. We would welcome your comments and thoughts about the interesting discussions that took place. Feel free to add them to our blogs.

The sessions and the training revealed the growing implementation of the CDISC standards and greater understanding of the benefits of the standards. CDISC SHARE was presented for the first time at this interchange and interested audiences listened closely to the benefits of an industry wide shared metadata repository for health and research. The increased pressure on CDISC to develop efficacy (therapeutic area) standards will benefit considerably from CDISC SHARE and you can read more about SHARE on the website. The standard specific sessions were as busy as ever with presenters explaining their implementation successes and offering advice to audiences hungry for information. However, there is an ever-present need to encourage implementation of the standards and one of the focuses for this year has been to broaden our communication channels. With this in mind, Tweets were sent directly from the Interchange and Blogs were posted frequently on the website. If you haven’t already done so make sure you follow us on Twitter and subscribe to our RSS feed on the blog.

As usual our exhibitors were a fundamental part of the wonderful atmosphere at the conference, supplying expertise and, new this year, some of the vendors took part in the SDTM validation tools demonstration. These demonstrations are vital to support understanding of the Model and to ensure SDTM is implemented correctly. On Thursday, Landen Bain had the Healthcare Link participants demonstrating how information from EHRs can be successfully utilised for research purposes. The Retrieve Form for Data capture profile is part of the work that Landen has been involved with at IHE and this solution can be used now.

Of course, it goes without saying that the evening social event at the National Aquarium was a memorable experience for everyone. Starting with drinks and food at the Shark tank was wonderful, as everyone was treated to the sight of huge rays and some very impressive sharks swimming beneath them.  Attendees chatted informally as they wandered through the various displays and eventually found themselves at the spectacular jellyfish exhibition, where they were also greeted with some rather delicious cakes and pastries. It was a truly unique event and we thank the Aquarium for our private viewing. I am assured that no-one went missing and there were no particularly fat sharks after everyone had left!

Once again, CDISC would like to thank all those who contributed to the success of this event particularly the CDISC Advisory Board who developed an excellent program, the many speakers who had prepared excellent presentations, the exhibitors and of course all the attendees who bring so much to CDISC, both as volunteers and as part of our collaborative community.  We look forward to you joining us in 2010!

Interchange Europe, Lancaster Hotel, London, United Kingdom
26 – 30 April 2010 (Call for abstracts now open)

Interchange Japan, Tokyo, 27 – 30 July 2010

AJ de Montjoie

Over the last decade, the Clinical Data Interchange Standards Consortium (CDISC) has acted as the catalyst for productive collaboration to develop and encourage adoption of standards through a consensus-based approach. The collective efforts of more than 250 CDISC member organizations, representing biopharmaceutical companies, academic research, CROs, government, service and technology provider organizations, has enabled robust standards development.

The result of this collaboration--CDISC Standards are named in regulatory guidance as the recommended standard for submission of electronic safety and efficacy data to the US Food and Drug Administration and in Health Information Technology Standards Panel (HITSP) interoperability specifications for use of EHRs for medical research.

CDISC members enjoy these benefits and more...

• Receive significant discounts on CDISC events, training and publications
• Stay informed and make a difference: provide your input and directly impact the standards development process, while connecting with peers and keeping abreast of industry trends and best practices 
• Leadership through participation on the CDISC Advisory Board 
• Access to CDISC Members (Only) Area on www.cdisc.org for information on implementation best practices, tips and tools 
• Ensure, through your financial support, that the standard data needs of medical research are incorporated in the fabric of global healthcare infrastructure reform

Join the collaborative efforts of 250 CDISC members!

To become a CDISC member complete the on-line application.  For further information on membership fees and benefits, or questions contact Tanyss Mason by email or call:  +1 919 419 7100. 

As members and/or supporters of the Clinical Data Interchange Standards Consortium (CDISC) Global Expert Group, we wish to encourage the advocacy and adoption, along with continued collaborative development, harmonization and support of the CDISC global clinical data standards that facilitate the clinical research process while integrating it into the healthcare arena...

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