Copy of spring05-nwsltr2 PUBLICATION OF THE SCDM Promoting Clinical Data Management Excellence SPRING 2005 DATA BASICSEditorial Policies EDITORIAL BOARD (also known as Publications

PromotingClinical DataManagementExcellenceDATA BASICSDATA BASICS

A PUBLICATION SUPPORTED BY AND FOR THE MEMBERS OF THE SOCIETY FOR CLINICAL DATA MANAGEMENT, INC.

Letter from the Editors This Issue1

Letter from the Editors

1The FDA Website: An On-Line Resource

for Clinical Data Managers

3Letter from the Chair

6CDISC, Regulations and You

7The World of Regulatory Myths

11Comparison of FDA Guidance for Clinical

Systems

12Taking a Behavioral Approach to

Reliability

15All In The Family

16SCDM Membership Survey 2004

18Special Addition: Sneak Peek Preview

Summary of the 2005 Spring Forum fromAtlanta GA

19Snapshots of the 2005 SCDM Spring

Forum

Volume 11Number 12005 Spring

Dear SCDM Members,

The role of Data Basics editor is a two yearappointed position for two co-editors. In January,Kit Howard’s term as co-editor was completed.We, the Publications Committee, want to thankKit for her contribution to Data Basics and thecommittee: championing the concept of themesfor Data Basics, encouraging submission andpublication of quality articles, researching theconcept of a SCDM journal and providing herexpertise to the committee. She will continue toserve on the committee as the Chair for next year.

We are happy to welcome Chandra Wooten as herreplacement for 2005/2006 term.

This Data Basics issue is devoted to the topic ofRegulatory Compliance and Quality Assurance.Quality assurance is the overarching principleguiding our daily practice of Clinical DataManagement activities and regulatory compli-ance. This concept is clearly demonstrated in theICH E6 definition of Quality Assurance: All thoseplanned and systematic actions that are established

Continued on page 4

The FDA Website: An On-Line Resource for Clinical Data ManagersBy: David Sabritt, Sabritt Solutions LLC

Clinical data management professionals – whether they work for trialsponsors, CROs or technology suppliers – are part of an enterprise built onthe expectation of compliance with requirements of the US Food and DrugAdministration and other regulatory authorities. Some of these regulatoryrequirements directly address how data from clinical trials are managed andreported. Other requirements – for example, those involving the conduct ofclinical trials – also have an impact on data managers’ roles. While theregulatory environment is complex and constantly evolving, it is not mysteri-ous. The FDA maintains a highly instructive website at www.fda.gov to serveprofessionals, consumers, patients and the general public. It can be a valuableresource in many ways for clinical data managers. Here are some examples.

Stay informed on regulatory issues and actions. The FDA’s home page contains up-to-date links toimportant news items and announcements: product approvals and safety actions; new regulations andguidances; meetings and press releases. From the home page, take advantage of the opportunity tosubscribe to free FDA e-mail newsletters that will help you stay abreast of regulatory issues where youhave an ongoing interest.

Find any FDA regulation. At the FDA home page, click on Code of Federal Regulations to launch asearch for any part of “CFR Title 21 - Food and Drugs” (for example, the much-discussed Part 11regulating electronic records and electronic signatures).

Review Good Clinical Practice-related regulations. Virtually every element of clinical data management isrequired to reflect Good Clinical Practice (GCP). FDA defines GCP as “ . . . a standard for the design,

Continued on page 6

PUBLICATION OF THE SCDM Promoting Clinical Data Management Excellence SPRING 20052

DATA BASICSDATA BASICS Editorial Policies

EDITORIAL

BOARD(also known as PublicationsCommittee)

Kit Howard, ChairKestrel Consultants, Inc.Phone: (734) 576-3031E-mail:[email protected]

Lynda Hunter, Co-editorPRA InternationalPhone: (913) 577-2972E-mail:[email protected]

Chandra Wooten, Co-editorCorus PharmaPhone: (206) 832-2016E-mail:[email protected]

Tamela BlackstoneAllos TherapeuticsPhone: (720) 540-5274E-mail: [email protected]

Felicia Ford-RiceAcambis, IncPhone: (781) 302-3007E-mail:[email protected]

Virginia NidoGenentech, Inc.Phone: (650) 225-3805E-mail:[email protected]

Christine Riley-WagenmannCephalon, Inc.Phone: (610) 558-2228E-mail: [email protected]

Kim TiefenbachOmniComm Systems, Inc.Phone: (610) 326-3249E-mail:[email protected]

SUBMISSION DEADLINES (Articles and Advertising Art Work)

Our quarterly publication schedule for the next four issues requires the following input deadlines:

Volume 11, #2 (Summer) 11 April 2005

Volume 11, #3 (Fall) 11 July 2005

Volume 11, #4 (Winter) 10 October 2005

Volume 12, #1 (Spring) 9 January 2006

PUBLICATION POLICYWe welcome submission of materials for publication in Data Basics. Materials should preferably be submitted in electronic form (MSWord). Acceptance of materials for publication will be at the sole discretion of the Editorial Board. The decision will be based primarilyupon professional merit and suitability (i.e. publication may be edited at the discretion of the Editorial Board.)

Neither SCDM nor the Data Basics Editorial Board endorses any commercial vendors or systems mentioned or discussed in anymaterials published in Data Basics.

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**Ads are net, non-commissionable.

Advertisers purchasing multiple ad packages will have the option of placing those ads anytime within the 12-monthperiod following receipt of payment by SCDM.

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Half Page-horizontal = (7 ½ inches x 4 7/8 inches) Full page = (7 ½ inches X 10 inches)

MECHANICAL REQUIREMENTS: Do not send logo/photos/images from word processing software, presentation software,or Web sites. Files should be saved in the native application/file format in which they were created. Photos/images should be highresolution and received in the file size you wish to have it printed.

600 dpi or higher for black and white, 300 dpi or higher for color/grayscale

Acceptable file formats include AI, EPS, and high resolution PDF, PSD, JPEG, and/or TIFF

PAYMENT: Payment must be received with advertising. Space reservations cannot be made by telephone. There is NO agencydiscount. All ads must be paid in full.

CANCELLATIONS: Cancellations or changes in advertising requests by the advertiser or its agency 5 days or later after thesubmission deadline will not be accepted.

GENERAL INFORMATION: All ads must be pre-paid. Publisher is not liable for advertisement printed from faulty admaterials. Advertiser agrees to hold SCDM harmless from any and all claims or suits arising out of publication on any of his/heradvertising. SCDM assumes no liability, including but not limited to compensatory or consequential damages, for any errors oromissions in connection with any ad. The SCDM does not guarantee placement in specific locations or in a given issue. SCDM reservesthe right to refuse or pull ads for space or content.

Please submit all forms, artwork, and payments to:Society for Clinical Data Management Phone: 1 (414) 226-0362555 E. Wells St. Fax: 1 (414) 276-3349Suite 1100 E-mail: [email protected], WI 53202 Web site: www. scdm.org

SPRING 2005 PUBLICATION OF THE SCDM Promoting Clinical Data Management Excellence 3

SCDM Committees

The following are currentlyactive Committees within theSociety for Clinical DataManagement.

Certification CommitteeChair : Armelde PitrePhone: (860) 441-5642E-mail: [email protected]

GCDMP CommitteeChair : Christine LittlePhone: (919) 408-8000E-mail: [email protected]

Membership CommitteeChair : Brenda HoeperPhone: (513) 984-0450E-mail:[email protected]

Publications CommitteeChair: Kit HowardPhone: (734) 576-3031E-mail:[email protected]

Web Site CommitteeChair: David BorbasE-mail: [email protected]

Web Sites to Check OutACDM - www.acdm.org.ukCDISC - www.cdisc.orgFDA - www.fda.govICH - www.ich.org

There are more links to befound on our web site!SCDM - www.scdm.org

Please let the Web SiteCommittee know about anyother “hot” web sites that youfeel would be of interest to theSCDM membership.

Letter from the ChairBy: Sharon Miller, Lilly

Dear Colleagues:

I am writing this letter today as I return from ameeting of the Society’s Board of Trustees(BOT). My experience in the last two days hasserved to further remind me just how incrediblyprivileged I am to be a part of SCDM, and tohave the opportunity to work with such a greatgroup of dedicated and forward-thinkingvolunteers who invest countless hours to ensureSCDM’s continued success.

Having just spent time with this group, it isvery clear to me that each member of yourBoard takes his or her responsibilities veryseriously and is eager to make sure that they arerepresenting the best interests of the ClinicalData Management profession and you, themembers of the Society. On behalf of the Boardand the SCDM administrative office, I’d like toencourage you to share (or continue to share)your input and ideas about how the Society canbest promote the profession of data manage-ment and provide meaningful services to itsmembers. I assure you that your comments arebeing heard and are a key input into setting thedirection of the Society.

I’d also like to take this opportunity to eliminateany mystery that might exist regarding whathappens behind the doors of the SCDM BOTmeetings by sharing highlights of our recentannual planning meeting. Following is asummary of the key take-aways from the jam-packed two-day session.

Key focus areas for 2005 were identified:• Marketing & Finance - In the spirit of

ensuring the continued growth of thesociety and of providing members with thebest value for their membership dollars, aproactive plan for marketing and financingthe organization is vital. The BOTsanctioned a new Finance and Marketingcommittee to address this important area.A charter for this committee will bedeveloped over the next few months andwe’ll look forward to sharing moreinformation about the objectives andplanned activities of this group in the nearfuture.

• GCDMPs – The GCDMPs are quicklybecoming the gold standard for clinicaldata management best practices. TheGCDMPs represent a very important body

of work to which many of you havecontributed. The document is a centerpieceof SCDM of which you can be very proud.This year, emphasis will be on putting inplace a strategy for continuing to evolve theguidelines and to promote further distribu-tion and use of the document throughoutthe profession.

• Certification – As most of you know, thesociety reached a major milestone earlierthis year with the release of the certificationexam for Clinical Data Managers. We arenow committed to increasing awareness ofthe certification program and its value tothe profession and to the individuals whobecome certified. In addition, we will beturning our attention to ensuring thatopportunities and resources are available tosupport test candidates in preparing for theexam.

• Cross Committee & Board/CommitteeCommunications – SCDM’s all-volunteercommittees have managed to accomplishamazing things over the past years. TheBoard recognizes, however, that we have anopportunity to be even more effective if wecan increase the communication and thedegree to which we leverage informationand activities across the various commit-tees. Similarly, we’ll be looking at ways toincrease communication between theCommittees and the Board of Trustees.

The BOT also discussed other plans & initia-tives for this year such as:• Strategic Planning - The BOT is commit-

ted to ensuring that the society has aproactive plan to enable the continuedvibrancy of SCDM and the profession ofCDM well into the future. To this end, adedicated strategic planning session will beheld in July of this year to outline the plansfor evolving the society over the next severalyears. I’ll look forward to sharing theoutcome of that session in a future editionof Data Basics.

• Local Chapters – In response to memberfeedback, plans are currently underway toestablish a number of local chapters ofSCDM across North America. This willopen up a whole new world of opportunityfor meaningful involvement and develop-

Continued on page 4

Bring your expertise to

the SCDM Discussion

Forum, on the web at

http://www.scdm.org/.


ment of clinical data managers at a local level.You can expect to hear more details as theplans progress throughout this year with anexpected launch of the program at this year’sannual fall conference in San Diego, Califor-nia.

• External Relations & Awareness – Last year,SCDM launched an External RelationsCommittee charged with building relation-ships and identifying opportunities tosynergize activities with other organizationswith similar interests. Initially, those organi-zations have included CDISC, HL7, PhRMABiostats Committee, DIA, Data QualityResearch Institute (DQRI), and the Interna-tional Network of Clinical Data Manage-ment Associations (INCDMA). This year,we’d like to make sure that the learning wegain through these collaborations is mademore broadly available to the members of theSociety. The committee will also be launchinga process to ensure that all draft regulatoryguidance documents of interest to or directlyimpacting CDM are reviewed and that timelyfeedback is provided by the members of the

Letter from the ChairContinued from page 3SCDM Board

Sharon A. MillerChairEli Lilly and [email protected]

Jill VathVice-Chair/TrusteeGenentech, [email protected]

Judy PykeSecretaryKendle International [email protected]

Audra [email protected]

Jonathan AndrusTrusteePhoenix Data [email protected]

Anthony CostelloTrusteeNextrials, [email protected]

Charlene DarkTrusteeConstella Clinical [email protected]

Lisa FreemanTrusteeCorus Pharma, [email protected]

Jane HiattTrusteeSchering Plough [email protected]

Lynda HunterTrusteePRA [email protected]

Armelde PitreTrusteePfizer, [email protected]

Marianne R. PlauntPast ChairI3Statprobe, [email protected]

Continued on page 5

conduct, performance, monitoring, auditing,recording, analysis, and reporting of clinicaltrials.” At the home page’s list of FDA activities,click on Clinical Trial Professionals to reach thepage on GCP for FDA-regulated clinical trials.That page permits you to access a set of links toGCP-related regulations.

Review relevant guidances. FDA guidances, whilenot binding, provide valuable insight on theagency’s current thinking on how to satisfy therequirements of the applicable regulations andstatutes. These documents are critically importantfor industry. For a list of links to GCP-relatedguidance documents, click on Clinical TrialProfessionals at the FDA home page, and then onGuidances and Information Sheets. In addition toFDA guidances (such as the Guidance forIndustry clarifying the scope and application ofPart 11 for electronic records and signatures),you’ll also find important international harmoni-zation documents such as the ICH E6: Good

The FDA Website: An On-Line Resource for Clinical Data ManagersContinued from cover

SCDM. You will see an increased focus onbringing you leading edge issues, news andother information of interest to the professionof CDM. You can expect to see moreinformation in upcoming communicationsregarding activities of the External RelationsCommittee.

In addition to the above, other routine businessconducted during the BOT meeting includedapproving the budget for the year, reviewing thebylaws and policies and procedures of the Societyand reviewing reports from all standing commit-tees. One final item of business was the appoint-ment of Jonathon Andrus to fill a vacancy on theBoard that resulted when Abdel Oualim resignedhis elected position due to recent changes in hisjob responsibilities.

In closing, I’d like to encourage you get in touchwith any member of the BOT if you would like toknow more about the plans for the society or toshare your input and ideas. A roster of boardmembers along with their contact information canbe found on the SCDM website at www.scdm.org.We look forward to hearing from you.

Clinical Practice: Consolidated Guidance.

Anticipate proposed regulations and draft guidances.The FDA makes proposed regulations and draftguidances available for a period of public com-ment before issuing the final versions. Thiscomment period is an essential opportunity forcompanies (and other parties affected by theregulation or guidance) to provide input that theywould want the FDA to consider. The FDA takesthese comments very seriously, and there are manyinstances where this input has helped the FDA toissue more effective regulations and guidances. Fora list of links, go from the home page to ClinicalTrial Professionals, and then click on ProposedRegulations and Draft Guidances.

View comments submitted to the FDA on proposedregulations and draft guidances. The FDA main-tains and posts dockets that include the commentsit receives, and these dockets can be extremely


The FDA Website: An On-Line Resource for Clinical Data ManagersContinued from page 4

useful mirrors of the concerns of othercompanies and the industry as a whole. (Forexample, clinical data managers would findit instructive to view comments recentlysubmitted to the FDA on its Draft Guid-ance for Industry on Computerized SystemsUsed in Clinical Trials.) From the FDAwebsite’s home page, click on Dockets toview these valuable depositories.

View news and information within each ofthe FDA’s Centers. In addition to under-standing the FDA’s Center for DrugEvaluation and Research (CDER), clinicaldata managers may have specific interest inthe agency’s centers for regulating otherproducts such biologics (CBER) anddevices (CDRH). The FDA’s home pagecontains a link to each of these centers’websites.

From CDER’s website, you can click onDrug Application Process for a detailed andwell-organized overview that includesrequirements for electronic submissions. Byclicking on CDERLearn, you can launchon-line tutorials by FDA faculty, includinga workshop on the drug development andreview process.

View Warning Letters issued to Pharmaceuti-cal Companies. One way of determiningwhat the issues of greatest current interest tothe agency is to view the Warning Lettersthat have been sent. While much of thecontent of the letters will not pertain todata management activities, they do outlinethe activities that have drawn agencyconcern, and may be useful to datamanagers in identifying where theircompany’s systems may need attention.

From CDER’s website, mouse over theRegulatory Guidance tab, and selectRegulatory and Scientific Guidances. Scrolldown to Compliance Activities, and clickon Warning Letters and Notice of ViolationLetters to Pharmaceutical Companies. A more general list ofwarning letters, including those issued to clinical investigators, canbe found in the Electronic Reading Room of the FDA, atwww.fda.gov/foi/warning.htm.

In summary, the clinical data management professional’s rolerequires an active understanding of the regulatory environment –how it affects data management responsibilities directly, and how it

shapes the entire clinical development enterprise. Clinical datamanagers always need to work closely with their company’s regula-tory affairs department, whose responsibilities typically includeestablishing and communicating the company’s regulatory strategy,and coordinating contacts with the FDA and other agencies. At thesame time, it is incumbent on data managers to maintain their ownprofessional knowledge. The FDA’s website is a valuable resource,and it is worth consulting often.


CDISC, Regulations and YouBy: Sally Cassells, Lincoln Technologies

2004 was an important year for theClinical Data Interchange StandardsConsortium (CDISC). Since its inceptionin 1997, the CDISC Submissions DataStandards (SDS) group has been workingdiligently at developing a standard forelectronic submission of clinical trials datato regulatory agencies. The first produc-tion ready version (Study Data TabulationModel (SDTM) version 3.1) was pub-lished in March of 2004. In July Dr. LesterCrawford, acting FDA commissionerspeaking at the Secretarial Summit onHealth Information in Washington DC,announced that the SDTM developed byCDISC will be the standard format forsponsors to use when submitting humandrug clinical trials data to the FDA.

According to Dr. Crawford, an importantgoal the FDA hopes to achieve by adopting the SDTM standard isto reduce the amount of time FDA reviewers spend simply reorga-nizing large amounts of data submitted in varying formats.

There is not yet any guidance or regulation mandating the use of theSDTM. Nonetheless, companies who wish to take advantage of thepotential efficiencies for the application review process by providing

Letter from the EditorsContinued from cover

to ensure that the trial is performed and the data regenerated,documented (recorded), and reported in compliance with GoodClinical Practice (GCP) and the applicable regulatoryrequirement(s).”

The topic for the Summer Data Basics will be Clinical DataManagement: Envisioning the Future, also the focus for the SCDMSpring Forum. CDM is poised at a threshold of enormous changeand opportunity. What will Clinical Data Management look like inthe future? What will be the effect of these influences:• emergence of CDM as a profession,• impact of certification,• necessity and implications for training,• effects of a changing regulatory environment,• role of new and changing technologies,• possibilities and outcomes of standardization, and• effects of the growing trend for off-shoring?

We encourage you to submit an article on this fascinating topic.

Lynda Hunter and Kit Howard Continued on page 7

SDTM submission datasets may do so. In August 2004, PfizerCorporation got the ball rolling by submitting SDTM datasets aspart of its Lasofoxefene submission. Because the standard is relativelynew, the FDA reviewers are still in the early adoption phase.Through the experience of this first submission they are starting tocome up to speed with the SDTM data structures and the tools theynow have in place for working with data in this format.

If you plan to send a submission in SDTM format, it is important tonotify the appropriate FDA reviewing division before the data is sent.That way, the agency can ensure that the reviewers receive training.

How will the adoption of the SDTM standard impact data manag-ers in pharmaceutical, biotechnology companies, CROs or academiccenters?

The SDTM has the most immediate affect on the study data that issent to the FDA. From a data manager’s point of view, this representsdata at the very end of the process. Typically clinical trials data isprocessed by a number of systems between its initial collection at astudy site through submission to the FDA.

While the details of how data flows through this process vary acrossorganizations, the general flow is that data is collected on CRFs(paper or electronic), validated and cleaned using a CDMS, analyzedusing SAS and then extracted for submission. This flow is illustratedin Figure 1.

A key question that arises when an organization decides to adopt theSDTM standard is where to start? Should the data be converted tothe SDTM as the final step in the submissions-preparation processor should the entire data collection and data management process bere-engineered to use SDTM variable naming conventions frombeginning to end?

Figure 1. Clinical Data Flow


Continued on page 8

The World of Regulatory MythsBy: Kit Howard, Kestrel Consultants

Converting to SDTM format at the end of the data preparationprocess has the advantage that it minimizes disruption to currentprocesses. For this reason, it may be a suitable approach to use for acompany’s first CDISC submission. On the other hand, because theSDTM has some features that are likely to be different from currentcompany submission standards, converting existing submissiondatasets to the SDTM format may be a complicated, time consum-ing process.

Re-engineering the data collection process to use SDTM variablenaming conventions from beginning to end is a daunting prospect.Even in the most straightforward case, all CRFs, edit checking andextraction programs would need to be changed to reflect SDTMvariable naming. Because the SDTM data structures have beendesigned to optimize data review and analysis, they will differ fromcurrent CDMS data structures. A significant amount of re-tooling willbe needed. Early experience with the SDTM structures suggests thatthe fixed structures for each of the 3 dataset domain types (Events,Interventions, Findings) do not accommodate all of the informationthat needs to be included in a submission and that additionalinformation must be mapped into the CDISC Supplemental Qualifi-ers (SUPPQUAL) domain. When redesigning CRFs and datastructures to work with SDTM, it will be important to consider whichinformation is mapped into a core domain and which will becomeSUPPQUAL variables.

Between these two extremes lie a wide range of SDTM conversionstrategy options. Except for the ‘convert at the end’ option, all willhave impact on Clinical Data Management. Even if your organiza-tion is not yet ready to undertake a pilot project or a full scaleadoption of the CDISC STDM, there are a number of steps you cantake:1) Download information on the SDTM model from the CDISC

web site (www.cdisc.org/models/sds/v3.1).2) Become familiar with the structure of the 3 core domain types

and the Supplemental Qualifiers Domain and how these datastructures differ from your current CDMS and Analysis andReporting systems.

3) Discuss the impact of the CDISC SDTM with colleagues inother departments – clinical, biostatistics, IT.

4) Continue to follow new CDISC developments. Although theSDTM Version 3.1 is stable, it will continue to evolve. Feed-back from early adopters both from pharma and from the FDAwill drive future changes.

Certification Committee Update

The certification committee is pleased to announce that thefinal certification exam is now available. For more informa-tion, please go to http://www.scdm.org/.

CDISC, Regulations and YouContinued from page 6

“We have to do it that way. The FDA requires it.”

How often have you heard someone in a study group meeting saythat? How often have you sat there and thought that they must beright, otherwise they wouldn’t have said it? And gone on to tellothers the same thing when the issue arose later? It is probable thatwe have all done it at one time or another.

Let’s do an experiment. Read the following and jot down youranswers.1. What is the FDA’s acceptable error rate for database audits?2. True or false: The FDA requires 100% source data verification

(SDV) and double data entry.3. True or false: The FDA requires that all data collected on a case

report form must be entered into the clinical database.4. True or false: The FDA requires that, if a central or local lab

sends lab data that was not requested in the protocol, thecompany must include the values in the study report and theNDA.

Are these statements reflective of beliefs at your company? Itwouldn’t be surprising – they are very widely held. In truth, forQuestion 1, not only does the FDA not publish an acceptable errorrate, but they don’t require database audits. They do require thatcompanies be able to demonstrate that they are in control of theirprocesses, and can show data integrity from start to finish1. Industrydecided that database auditing was the way to accomplish one partof that. Questions 2 through 4 are all false. The FDA does notrequire 100% source data verification (SDV) or double data entry,but as in Question 1, requires evidence of data integrity2. SourceData Verification (SDV) and double data entry are ways of provid-ing part of the evidence of data integrity. In Question 3, the FDArequires that companies be able to answer certain kinds of questionsabout their study population and their safety experience with thedrug, and companies also want to be able to answer questions aboutthe efficacy of the drug. Case Report Form (CRF) questions such as‘Was the patient asked about his or her AEs during the visit?’ can bevery useful in prompting study coordinators to complete requiredprocedures, but they do not have to be entered into the studydatabase. On the other hand, if a company decides not to capturequestions that may shed light on the safety or efficacy of the drug,they will need to have a good reason for their decision. Question 4 isa complex one. Companies are not required to send all lab data ifthey were not specified in the protocol. That said, if the labs weredone in response to an AE, or a serious AE, or were themselves anAE, then they become a relevant part of the patient’s care, andshould be reported.

All these examples share a confusion between a requirement (e.g.,data integrity) and a means of satisfying that requirement (e.g.,database audits). Over time, industry has evolved generally acceptedprocesses for satisfying the requirements, and those processes havebeen perceived to be the requirements. In fact, the agency rarely


specifies the process by which a requirement should be met, leavingit up to each company to identify the most efficient approach forthem. This is why we often hear the familiar cry “if the FDA wouldjust tell us exactly what they want, we’d give it to them.”

It is perhaps useful to examine the structure of the regulatory worldin which the FDA and industry operate. At the highest level, thereare laws and acts, such as the FDA Modernization Act of 1997(FDAMA). These represent legally enforceable mandates, and aregenerally quite clear. They are usually very broad and high-level, andmust be interpreted in order to be implemented. Regulations are thefirst step in that implementation, and are the rules that the FDAwrites to translate the spirit of the law into a workable framework.Finally, there are guidances, which are the agency’s interpretation ofregulations. In the agency’s own words, Guidance documentsrepresent the Agency’s current thinking on a particular subject. Theydo not create or confer any rights for or on any person and do notoperate to bind FDA or the public. An alternative approach may beused if such approach satisfies the requirements of the applicablestatute, regulations, or both.3

In other words, the agency deliberately won’t specify “exactly whatthey want” because they are interested in the result, and are generally

amenable to reasonable and defensible processes that get there.Industry has to look at the laws, regulations and guidances and usetheir judgment in determining the best way to satisfy them. Hereinlies the origin of many of the regulatory myths that flourish so well.Below, we’ll examine some more of those myths.

The FDA is monolithic, and speaks with one voice.Insofar as the entire agency is following the same laws, this is true.However, each division is made up of individuals, each of whomapproaches the interpretation of the regulations in a more or lessconservative fashion, resulting from differing scientific opinions.Thus, different companies will have different experiences and drawdifferent conclusions about the ‘right’ way to do things.

The FDA cannot change its mind about study design after thefact.Companies often conduct end-of-phase meetings with the agencywith the goal of agreeing upon the best approach to assess drug effectduring the next phase. This is an effort to ensure that, when theFDA receives the NDA, they agree with the scientific design. Thereis a common belief that agreements made with the agency arebinding, and the Agency cannot later change its opinion. This isfalse. If new information becomes available, in the interests ofprotecting public health the Agency may decide that a new method-ology is more appropriate.

There is only one right way to analyze data.As any statistician can tell you, there are many ways to analyze anytype of data. Some are more appropriate than others, and thejudgment of what is appropriate will depend in part upon thecircumstances of the study. Regardless of what approach is taken, thecompany should be prepared to explain why it chose that particularone. A corollary of this myth is that the FDA will not accepttransformed data, particularly log-transformed data. This is one ofthose myths that has a kernel of truth, but is greatly exaggerated. If asimple transformation allows for the application of a more appropri-ate statistical method, and the transformation is well documented,and the relationship between the original data and the transforma-tion is apparent, there is generally not a problem. What will be aproblem is if a whole series of transformations are performed to getthe data to fit a particular model. The farther the final data are fromthe original, the harder it is to make the case that there is any clinicalrelevance to the analysis, and the more likely it is to be labeled afishing expedition.

If part or all of a study is contracted out to a CRO, the CRO islegally accountable for the quality of the work.In fact, everyone involved in the interaction becomes accountable.The regulations specify that a sponsor may transfer responsibility toa CRO, if done in writing, and any responsibility not specificallytransferred is understood to have remained with the sponsor.4 Thatsaid, the CRO is held to the same regulatory standards as thesponsor, and if an issue arises, both will be investigated and held

The World of Regulatory MythsContinued from page 7

Continued on page 9



liable. In a DIA presentation in 2000, Dr. Stan Woolen, thenDeputy Director of CDER’s Division of Scientific Investigation,made it very clear that the agency will not play the ‘blame game’,and will hold all parties accountable.5

All materials submitted to the FDA in an NDA must be inEnglish, and translations from other languages must be done bya certified translator.This statement has two parts. The first part, that all materials mustbe in English, is correct. 21 CFR 314.50 specifies that “Theapplicant shall submit an accurate and complete English translation ofeach part of the application that is not in English. The applicant shallsubmit a copy of each original literature publication for which anEnglish translation is submitted.”6

The second part of the statement is incorrect. According to EllenBoyar, a professional translator with Thomson Scientific whopresented on this topic at the SCDM Fall Conference in Toronto in2004, there is no such thing as a “certified translator.” There areaccredited translators, but these accreditations are awarded byindependent organizations, and there is no oversight that determineswhat the accreditation signifies. One can obtain a certified transla-tion, but that just means that the translation is guaranteed to beaccurate and complete to the best of the translators’ knowledge. Oneway of attempting to ensure accuracy is to do a “back translation,”where the translated document is translated back into the originallanguage, and then compared to the original document. While thismay help in ensuring quality, it is not a definition of “certifiedtranslation.”

Now, here’s a different one for you.An individual can be held legally responsible for actions performedusing their electronic signature.

This is a trick question! This one is not a myth,but is, in fact, true. In 21 CFR Part 11, itclearly states that such an individual is indeedresponsible7. If Person B signs using Person A’selectronic signature (i.e., using their user nameand password), it is Person A’s responsibility toprove that it wasn’t them. It is parallel tohandwritten signatures, which are legallybinding and can be forged. This is anotherreason why it’s a bad idea to write your pass-word on a sticky and attach it to your monitor.Incidentally, according to the most recentIndustry Guidance on this topic, this is not oneof the sections of 21 CFR Part 11 that theAgency will use discretion in its enforcement. 8

ConclusionsCDM-related activities have a great many ofthese myths, especially in companies where thereis great longevity of employees and muchinstitutional history and knowledge. The myths

grow along with the real information. There are many ways thatmyths can arise. We may not have the time or resources to researchthe question ourselves, and given how complex regulations are, maynot even know where to begin looking. We rely on the priorexperiences of others in the group to know what should be done, andthis is very much the most efficient way to proceed, but it does haveits risks. Sometimes myths arise when a generalization is made froma specific situation, or when a regulation or guideline changes butthe implications of the change are not understood. An old system ordatabase may have had requirements that were thought to beregulatory requirements, but were in fact system limitations.Alternatively, a particular individual in a workgroup might beuncomfortable with a request, or isn’t sure how to do it, and maystate a belief that regulations require/forbid them to comply with therequest. There are also many cases of a company having been burnedin the past on a particular topic and now being ultra-conservative inthat area.

Part of the challenge with documenting the falseness of some mythsis that they assume the truth of something that doesn’t exist. Onecan quote a regulation that specifies how one is to do something, orwhat one is to do, but it is impossible to document the absence of aregulation or guidance specifying something. For example, one canstate 100% source data verification is not required, but one can’tpoint to a regulation that says it isn’t, because it doesn’t exist. Inother words, one cannot prove a negative.

Consequently, it is very important to seek verification whensomeone states that the FDA requires this or that, and ask for thereference or the wording that states the requirement. The regulations

Continued on page 10


are very seldom black and white, and it is more useful to migrate thediscussion from the black and white to a recognition that regulationsand guidances are grey, and require reasoned interpretation and theapplication of the judgment of all involved in clinical research.There is almost always more than one way to satisfy the require-ments, and some ways may be far more efficient than others. Oneway to address this is to become familiar with the parts of theregulations and guidances that cover our field. We can do this byreading the regulations and guidances ourselves (see elsewhere in thisissue for a guide to the FDA’s website), and we can also consult withour Regulatory colleagues and other members of our study teams.Talk to people from other companies, and find out how theyapproach the issue. If you hear more than one answer, chances areyou are working with a regulation that can be satisfied in differentways, and you’ve uncovered another myth.

Acknowledgements: Many thanks to Bill Sollecito, DRPh, Univer-sity of North Carolina, for his assistance with this article.

Author’s Note: the information in this article was compiled using thebest resources currently available. If a reader is aware of relevantinformation that contradicts statements made here, please alert theauthor at [email protected].


Be sure to renew your SCDM

membership, or this is your

last issue of Data Basics!

Endnotes1 ICH Guidelines, E6 – Good Clinical Practice Consolidated Guideline, Section 5.1.1.

and 5.1.3.2 Ibid.3 FDA CDER Web page index to guidances, http://www.fda.gov/cder/guidance/index.htm4 21 CFR 312.52, Transfer of obligations to a contract research organization.5 “Who’s In Charge, Anyway? Responsibility in Today’s Clinical Trial Environment”, Stan

Woolen. Presented at the Drug Information Association Annual Meeting, 12 June2000. http://www.fda.gov/cder/present/dia-62000/woolen2/

6 21 CFR 314.50 (g) (2)7 21 CFR 11.10(j), Controls for Closed Systems8 Part 11 Electronic Records: Electronic Signatures - Scope and Application, Section III A.

http://www.fda.gov/cder/guidance/5667fnl.htm


Comparison of FDA Guidance for Clinical SystemsBy: Steve Griggs, Explore Consulting

BackgroundThe FDA issued 21 CFR Part 11, Electronic Records; ElectronicSignature; Final Rule in March of 1997. Then the Guidance onComputerized Systems Used in Clinical Trials was issued in April of1999.

In August of 2003, the FDA reduced the Part 11 enforcement byissuing Guidance for Industry on Part 11, Electronic Records; ElectronicSignatures – Scope and Application. In September of 2004, the FDAissued a draft of a new computerized system guidance to bring it inline with the Part 11 guidance. Comments on the draft wereaccepted by the FDA until January 3, 2005.

As of January 6, 2005 the FDA web site lists 17 comments on thedraft from individuals and companies. You can view the commentsat http://www.fda.gov/ohrms/dockets/dockets/04d0440/04d0440.htm. The FDA will respond to all comments but may ormay not incorporate the comments in the final guidance. The draftguidance does not contain binding recommendations and the finalguidance may differ from the draft.

PurposeIn order to better understand the direction the FDA is moving andclarify issues for comment, this summary and comparison highlightthe changes between the version issued April 1999 and draft issuedSeptember 2004.

Summary of Additions1. Definition of “Original Data”2. Definition of “Predicate Rule”3. SOP for Alternative Recording Methods (in the case of system

unavailability).4. Automatic time adjustments for daylight savings need not be

documented.5. Documentation should explain time zone references, acronyms,

and naming conventions.6. Legacy systems (operational before August 20, 1997 and

unchanged since that date) need not comply with 21 CFR Part11.

7. System development and maintenance staff must have theeducation, training, and experience to perform their assignedtasks.

Summary of Deletions1. Definition of “Commit”2. Definition of “Electronic Case Report Form”3. Definition of “Electronic Patient Diary”4. Changes to records should not obscure the original informa-

tion.5. Electronic diaries and Case Report Forms do not require

annotation functionality.

6. System access control enforcement will include operationalsystem checks, authority checks, device checks, and theestablishment of and adherence to written policies that holdindividuals accountable for actions initiated under theirelectronic signatures.

Summary of Changes1. The need for an audit trail should be based on a risk assessment

and is not limited to predicate rules.2. The procedure for authenticating an electronic signature does

not require that the user name appear on the screen.3. Audit trails will come under “enforcement discretion.”4. It is not necessary to reprocess data from a study that can be

fully reconstructed from available documentation. Therefore,actual application software, operation systems, and softwaredevelopment tools do not need to be retained.

5. Paper and electronic (hybrid) record and signature componentscan co-exist.

6. The extent of system validation should depend on the ability tomeet predicate rule requirements, criticality and risk in generalto ensure the accuracy, reliability, integrity, availability andauthenticity of required records and signatures.

7. Security and performance patches should be covered by writtenchange control procedures.

8. Backup and recovery procedures should be based on the need tomeet predicate rule requirements, a justified and documentedrisk assessment, and a determination of the potential effect ondata quality and record integrity.

For the complete list of specific changes, please see the SCDM website inthe Members section, under Publications. The link to the list is underthe link for this issue of Data Basics.

Journal for Clinical Data Management

Fear Not! The Journal is not dead!It is merely hibernating. We hope torestart activities later in 2005 on thisexciting project.


Taking a Behavioral Approach to Reliabilityby Don Groover, Behavioral Science Technology

In environments where failure can have serious consequences fordownstream results, creating sustainable quality performance iscritical. Successful outcomes depend on meeting rigorous regula-tions, protocols, and best practices. Yet as any leader can tell you,defining the best way to do the work doesn’t always ensure that itwill happen. That’s why many forward-thinking organizations areturning to a behavioral approach to improving quality and reliabilityin their performance. Interestingly, as organizations engage employ-ees at the “front-line” levels, they are also recognizing a need forcomprehensive engagement that extends to the senior-most leaders.The reason is that while behaviors of themselves are a useful focusarea, they are strongly influenced by the systems and culture of theorganization as established and supported by leaders at every level.

Why Focus on Behavior?Years of experience in performance improvement initiatives haveshown us that the chain of causation is more complex than a simple“either/or” dichotomy. In the great majority of cases the cause of theerror lays not simply with just the employee or just the systems, butin the interaction between the employee and the facility, procedures,and systems within which he or she works. The interaction of these

factors—conditions, management systems, and what people do—iscalled the working interface.

A behavior-based performance improvement (BBPI) approach isconcerned with assessing the working interface by using what peopledo—behavior—as the starting point for improving the whole systemin which people work. These approaches identify and define, inoperational terms, the critical interfaces associated with how systemsare used or how procedures affect risk for error. Improvementactivities that focus on the working interface allow organizations topinpoint where they need to direct improvement resources inadvance of any incident. Successfully using this approach requiresunderstanding what influences behavior, how behaviors fit withinthe context of the whole organizational system, and finally, the roleof leadership in generating improvement.

Understanding Behavior: Applied Behavior AnalysisOne of the most powerful tools in the BBPI approach is appliedbehavioral analysis, also known as ABC Analysis. ABC Analysisworks on the principle that behaviors are influenced by two basicfactors. Antecedents (triggers) set the stage for behavior andconsequences (outcomes) encourage or discourage the repetition ofthe behavior. A simple example is the behavior of answering a phone.Does a person answer the phone because it is ringing (antecedent) orbecause there is someone on the line she wishes to talk to (conse-quence)? Consider what would happen if every time the phone ringsthere is no one there. No doubt, the person would soon stopanswering the phone, even if it continues to ring. Antecedents, itturns out, influence behavior only to the degree that they predictconsequences. Unfortunately, many organizations spend consider-able time and other resources on antecedents (signs, posters,training, etc.) instead of identifying and fixing the consequencesthat support or discourage quality-critical behavior. Appliedbehavior analysis helps organizations understand the data theycollect on the working interface—and map out how best to improveit.

The Role of Attitudes, Behavior and CultureBehaviors don’t occur in a vacuum. Within an individual there arebeliefs and values, (called attitudes) that influence how the indi-vidual behaves. Attitude has long been a popular focus area forimprovement efforts. While they are important in the whole picture,by themselves they present serious limitations: attitudes are internaland therefore difficult to measure and consequently manage.

Another powerful influencer of behavior is the organizational culture(defined as “how we do things around here”) that individual workswithin. Culture dictates what behaviors are tolerated, what behaviorsare valued, and what the organization expresses as critical versusincidental. Culture, while measurable and manageable, is usually anenormous undertaking and slow to change. It is at the level ofbehavior, from the front office to the boardroom, that change can be

Continued on page 13


affected quickly and can have positive influences both for attitude andfor culture generally.

The Role of Leadership in Generating Reliable PerformanceThe final piece of a comprehensive improvement system is the role ofleadership itself.

While behavioral initiatives rely heavily on the involvement of “front-line” level employees, where the exposure to incidents is the greatest,these employees also have the least amount of power to affect change.Generating sustainable improvement requires addressing the barriers toquality-critical behaviors that exist in systems and procedures as well asin the organizational culture itself. Middle managers and supervisorsplay an important role in day-to-day feedback and activities thatunderscore the stated goals of the organization. Senior leaders have themost direct and powerful influence on the direction of the culture.Through what they choose to focus on, and how they go about doingthe things they do, leaders establish what is important in the organiza-tion and ultimately, “how we do things here.”

ConclusionBehavior is hard to change and long-lasting culture change is evenharder. However, a multi-level approach (attitudes, culture and leader-ship) forms a cord of three strands that is not easily broken and thatprovides a foundation for overall organizational excellence.

Taking a Behavioral Approach to ReliabilityContinued from page 12

Future SCDM ConferenceDates and Locations

2005 Fall ConferenceOctober 9-12, 2005

Sheraton San Diego Hotel & MarinaSan Diego, California

•

2006 Fall ConferenceOctober 8-11, 2006

Wyndham Palace Resort & SpaOrlando, Florida

•

2007 Fall ConferenceSeptember 16-19, 2007

Hyatt Regency Chicago on the RiverwalkChicago, IL


All In The FamilyBy: Paul Wilds, Genentech

Many of us in data managementview our industry as a small,well-connected community andoften tend to think of our workcolleagues as “family.” Personally,I have had the opportunity towork with some of the samepeople at different pharmaceuti-cal and biotech companies overthe past several years. Organiza-tions like SCDM have providedme the chance to connect andnetwork with colleagues withwhom I have established closerelationships. And I discoveredjust how important it is tonurture these relationships whileattending the 2004 SCDM fallconference in Toronto.

During the conference, Ioverheard some fellow attendeesdescribing a particular table atlunch where many of the peopleseated were all related. I wassurprised to learn that one of the members at the table was a formerwork colleague of mine. Dorothy Dorotheo-Africa and I haveworked together at two companies over the past few years. I discov-ered that Dorothy has several family members who all work in theindustry.

Currently, Dorothy is the Director of Data Management atIntermune, Inc. located in Brisbane, CA. Her sister, Emily-AnneSantos, is a consultant with BioPharm Systems located in SanMateo, CA. Another sister, Paulynn Dorotheo-Hein, is the AssociateDirector of Clinical Data Management at Clinimetrics, Inc. locatedin San Jose, CA. Dorothy’s sister-in-law, Melinda Dorotheo, is aManager of Clinical Data Management at Icon Clinical Researchlocated in Redwood City, CA. Jose Dorotheo, Dorothy’s brother, is aData Entry Specialist II, also at Icon. Dorothy’s niece and Melinda’sdaughter, Carla Dorotheo, is a Clinical Data Associate II at NovaceaInc. in South San Francisco, CA.

So what’s it like to have so many members of the family working inthe same industry? “The best part is that we can use each other asresources,” explains Dorothy. In fact, everyone agrees that the mostattractive aspect of pursuing a career in data management washaving other family members available as “sources of experience.”And the family members have a wealth of experience to share withone another. Three members of the Dorotheo clan, Dorothy, Emily-Anne and Melinda, began their Data Management careers at Syntex.Dorothy has over 23 years of experience in the industry and was thefirst family member to pursue data management as a career. Emilybegan working in the industry in 1989. Melinda started her career

in data management in 1990. Paulynn has 6 years and Carla has 5years of experience in the industry. And Jose just began working inthe industry in 2004.

Outside of work everyone is very close. The family members oftenparticipate in brainstorming sessions regarding data managementissues at family gatherings interspersed with party games andkaraoke marathons. Throughout all of their discussions, they are veryaware of the proprietary and confidential information that eachfamily member has from their respective companies. And I discov-ered that having “family” in the same industry can create efficiencieswhen attending conferences, where generally there are options formultiple family members to attend different track sessions. However,there are some disadvantages. “We would never want to be accusedof nepotism,” explains Emily. And no one has had a professionalreporting relationship with another family member. In fact,professional relationships can become quite complex. Emily’s formerboss is Paulynn’s current boss. “There is definitely constant pressureto live up to the family’s reputation,” admits Carla.

In an industry in which reputation is critical, the family membershave an extensive network of colleagues that they use to assesspotential candidates for industry job opportunities. If you believe inthe notion of “six degrees of separation,” there’s a very good chancethat you may have worked with one of the members of the Dorotheoclan. Or you may know someone who has. They’re a great exampleof why it is so important to establish and continually maintain highprofessional standards and relationships within the industry. Afterall, you never know when your paths may cross with “family.”

Seated from left to right: Jose Dorotheo, Emily-Anne Santos, Paulynn Dorotheo-Hein, Paul Wilds, Carla DorotheoStanding from left to right: Dorothy Dorotheo-Africa, Melinda Dorotheo


SCDM Membership Survey 2004By: SCDM Membership Committee

The SCDM Membership Committee issued a survey in the Springof 2004 to solicit member opinions regarding the need for andestablishment of local CDM groups. The results of the survey wereavailable at the SCDM Fall 2004 conference and are summarizedbelow.

Here are some overall numbers. The survey ran from April 5, 2004through May 3, 2004, for a total of 29 days. The survey was sent to1,484 contacts, with 308 contacts (21%) completing the survey. Ofthe responders, there were 302 SCDM members and 5 non-members. Responders classified themselves as data managers (35%),data associates/data coordinators (22%), and directors (20%). Themajority of the responders were employed by PharmaceuticalCompanies (37%), Contract Research Organizations (28%), andBiotech Companies (18%).

The major issue encountered in conducting the survey was thatsome company firewalls prevented members from receiving thesurvey. SCDM worked with individual companies to resolve theissue and for the next survey a “link” to the survey was provided inSCDM’s on-line newsletter, Data Connections.

So what were the results of the survey?· The responders felt that there should be local chapters (62%)

and an overwhelming majority felt that the local chaptersshould be affiliated with SCDM (92%).

· 95% of the responders would attend local chapter meetings,84% would help recruit speakers, 76% would provide presenta-tions, 70% would pay dues to the local chapter, 64% are willingto help establish local chapters, and 59% are willing to helpsecure meeting locations.

· Most responders felt that the meetings needed to be heldquarterly and be within 1 hour driving time, and that themeetings should be 1-2 hours in duration.

Of the responders with direct reports:· 64% would support their staff attending local chapters.· 63% would support their staff being involved with local

chapters beyond just attending.

The responders felt that the top 3 areas for the local chapters to focuson are:· Idea sharing· Networking· Professional development/increased exposure

Clearly the results show that the SCDM membership feels there isneed for local chapters and that the local chapters should beaffiliated with SCDM. Which leads us to “what are the next steps?”The membership committee is working on developing the localchapter concept, including recommending local chapter structure,relationship to SCDM and implementation of local chapters. Lookfor more information later in 2005.

Thanks to all of you who responded to this survey. Your opinionsand ideas are very valuable and absolutely necessary in planning forSCDM’s future!

Please Note: SCDM does not sell its

membership list and does not condone

the use of the on-line membership

database for electronic broadcast

marketing activities.


2005 SCDM Annual Fall Conference

DATES TO REMEMBERJune 2005 Preliminary Program to be Mailed

August 5, 2005 Early Bird Conference Registration Deadline

September 8, 2005 Sheraton San Diego Hotel & Marina Cut-Off

September 23, 2005 Conference Registration Deadline(Late fees apply after this date)

September 30, 2005 (Register on-site after this date)

October 9-12, 2005 2005 SCDM Annual Fall Conference


Special Addition: Sneak Peek Preview Summary of the 2005Spring Forum from Atlanta GA

The SCDM 2005 Spring Forum was held inAtlanta Georgia, at the Hyatt, Buckhead. Ifthe conference had been held in the eigh-teen-hundreds, we’d of called it Irbyvilleinstead. The 803 acre area now calledBuckhead earned it’s name from a taverndecorated with the same. The previouslocation of the tavern, Irby’s Tavern, is nowadorned with a bronze Frank Fleming statue,“The Story Teller”.

True to SCDM tradition, the Spring Forumwas a small group of industry leaders,convened for two days of small discussiongroups of current interest. However, thisyear’s Spring Forum was all about the future.In fact, the forum was designed to start theprocess of creating a collective vision for theprofession. This year, the topics revolvedaround four areas in our industry wherethere are is a substantial amount of change.There was one discussion group per topic,standards & technology, the regulatory environment, Data Manage-ment as a business proposition including outsourcing & off-shoring,and Clinical Data Management as a profession including certifica-tion.

The Spring Forum Facilitators lead discussion topics on day one.Attendees, in small groups of 15, rotated through the four discussiontopics. In the wrap-up session, the attendees synthesized the resultsand trends from all of the day one discussion groups. They discussedwith other industry leaders, and analyzed the information in termsof what external influences and drivers leaders in theindustry were seeing, what changes making in theirown organizations, and what other things they wouldbe doing to address the industry changes.

We couldn’t have hand picked a better cross-section of organizations as a vantage point fromwhich to examine these issues. Pharmaceutical,biotech, and decive companies, both large andsmall were represented, as well as vendors, CROs,and AROs. Many of the organizations were atdifferent places with respect to standards andtechnology adoption, as well as utilizing differentresourcing models. Some leaders represented organiza-tions that had already adopted EDC, and were imple-menting CDISC SDTM, and pushing towards collectingeSource data directly from point-of-care medical devices.Others were just beginning EDC implementations, andhad not yet begun a CDISC implementation.

All of the information from the sessions, both the day one discussiontopics, and the day two collective visioning will be reported in thenext issue of Data Basics. Until then, watch for updates on theSCDM website! We’ll be posting written summaries of the sessionsalong with images of the flip-charts and other visual tools that wereused in the members area of the website.

The vision doesn’t stop here! Other ideas for broadening the inputand getting feedback on what we have so far, are a possible interac-tive session at the 2005 Fall Conference, articles in the next Data

Basics issue, and possibly a white or other paper.

2005 ConferencePlanning CommitteeCo-Chair: Judy Pyke, AssistantDirector, Clinical Data Management,

Kendle International, Inc.

Co-Chair: Meredith Nahm, Director,Clinical Data Integration Duke Clinical

Research Institute

Advisor: David Sabritt, President, Sabritt SolutionsLLC


Snapshots of the SCDM Spring Forum

(Above) Gregg Dearhammer fields questions from the participants.

(Above) Facilitators from left: Don Rosen, Principal, RosenConsulting, Gregg Dearhammer, Director, Biometrics, KendleInternational, Kit Howard, Principal, Kestrel Consultants, JonathanAndrus, Vice President, Quality Assurance, Phoenix Data Systems

(Left) “There’s a little time for fun between sessions!” Fromleft: SCDM Board Chair, Sharon Miller, Pilar Moore,Kyowa Pharmaceuticals, Meredith Nahm, Spring ForumCo-Chair, and Crystal Lewis, Kyowa Pharmaceuticals Inc.

(Above) “The spirit of the Spring Forum is small groupsof members sharing ideas.” Pictured from left: AngelLazarov, I3 Statprobe, Inc. and Allison Salke, Tombolo,Inc.

(Right) “Behind thescenes, the worknever stops!” Whileattendees are busy indiscussion groups,SCDM ExecutiveDirector KimBreitbach, SpringForum Co-ChairJudy Pyke, andFacilitator KitHoward areplanning the nextday’s details.


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Documents

Copy of spring05-nwsltr2 PUBLICATION OF THE SCDM Promoting Clinical Data Management Excellence SPRING 2005 DATA BASICSEditorial Policies EDITORIAL BOARD (also known as Publications