From the Editors 1check out the facility to see if there was any fine-tuning required. I am pleased...

DATA BASICSDATA BASICSS C D MS C D MS C D MS C D M

Volume 8Number 1Spring 2002

PromotingClinical DataManagementExcellence

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

questions. The proceedings will be summarizedin the next issue of Data Basics.

Welcome to the start of a new publishing year.This issue contains the results of the JanuaryBoard of Trustees strategy meeting, an articlediscussing the benefits of tracking CRF printorder processing electronically, a poem to thewonders of a data management trainingprogram, a discussion of the role of the board oftrustees, an update on CDISC, an article fromthe Certification Committee, and a call for inputto a new Data Basics feature “Comments fromthe Membership”.

Regards,Tam & Cathie

1Letter From the Editors

Call for Letters to the Editor

2Comments from the Membership

3Notes from the Chair

of the Society For ClinicalData Management

5Objectives for the 2002

Society For Clinical Data ManagementCalendar of SCDM Events

7The Clinical Data Management

Certificate Program: A Student’s Viewpoint

8Keeping Sight of the Goal:

Professional Recognition for CDMs

11News from CDISC

15Society For Clinical Data Management

Code of EthicsIntroducing Your SCDM Officers

and Committee Chairs

16Using the Internet for Tracking

Order Processing and Shipment of Paper Case Report Forms in the Global Pharmaceutical

Trial Arena

18Has Your E-Mail Changed?Call for Papers and Session Chairs: 2000 Fall Conference

Got A Website?

19Call for Articles and Advertising

Having just returned from the rescheduled 2001 Fall

Conference held in Seattle, we’d like

to take a moment toextend a very sincere “Thank you” to all thepresenters, session chairs, vendors, organizers, andattendees who helped make it a success. Theefforts of all demonstrated the amazing flexibilityand ability to take initiative in the midst ofdifficult situations characterized by the professionalswho comprise the field of data management.The rescheduled conference presented manylogistical and personal challenges for everyoneinvolved. The turnout was fantastic andattendees asked insightful and stimulating

From the Editors

TOCall for Letters the EditorsDo you have an opinion or concern about some activity of one

of SCDM’s various committees? Do you have a question you feel needs more discussion or a more in-depth answer?

Have you been wishing for a way to express yourself to both the society membership and those serving on a specific committee?

Well the wait is OVER! Your opportunity to express yourself is here.

Data Basics has created the “Comments from the Membership” column in order to give you that opportunity.We want to hear from you, the membership, on any data management or society related topic that interests you.

All letters should be submitted for publication to Data Basics co-editors Tam Blackstone([email protected]) or Cherie Stabell ([email protected]). Materials are requested to besubmitted in electronic form (MS Word) but may be submitted via e-mail, fax, or by mail.Acceptance for publication will be at the sole discretion of the Editorial Board. Thedecision to publish will be based primarily upon professional merit and suitability(i.e., topic, scope, and perceived interest to SCDM membership). Materialsaccepted for publication may be edited at the discretion of the Editorial Board(principally for formatting and grammar/spelling).

2 NEWSLETTER OF THE SCDM Promoting Clinical Data Management Excellence SPRING 2002

Dear Editors,

With regard to the certification program, itseemed to me that those people in ‘niche’ DMpositions should have the opportunity to becertified in the niches for which they haveexpertise. A certain amount of general DMknowledge would be required, and then theycould take specialized tests to certify them inthose ‘niche’ areas.

“It would be more work to devise such tests, ofcourse. But would be more useful for theindustry and for the individuals. The fullcertification, would of course, be most desirable,but one could take tests in additional areas ashis/her knowledge base grows.

Just a thought.

Michelle AltonDirector, Data ManagementBio-Technology General Corp.

Dear Editors,

It has come to my attention that some people are confused about the SCDM CertificationProgram. I understand that SCDM’sCertification will be given as a result of testing,but I have heard several people ask if that is thesame as the Certification being granted aftercompleting a specific training course beingoffered by several universities. I understand thatthese are two different things, but using samename for both is clearly confusing.

How about using two different names for thesetwo different things? Colleges and universitiesconsistently offer ‘Certification Programs’ in avariety of fields, where upon after completing thecourse a Certificate is given to the participant.This part is at least consistent with what is donein other fields. However there are a number ofnames used to describe what is earned bycompeting a professional examination in anygiven field. Accreditation is one that is often usedand might better suit our needs in the field ofClinical Data Management. Perhaps theCertification Committee could research this a bitand get some feed back from the rest of themembership?

Sincerely,

Cherie StabellGenentech, Inc.

Comments from the MembershipComments from the MembershipWelcome to a new section of Data Basics. This section will appear from time to time as comments areforwarded to Data Basics. A great deal of interest and discussion was generated by the session relating toDM Certification presented at the fall conference. The following items were sent to SCDM. “ThankYou” to the first two volunteers for this feature!

“Why Palms Springs?” I hear you say. Not only it is ita nice place to spend two days of intensivediscussions, it is also the location of the 2003 SpringForum. So one of the purposes of the meeting was tocheck out the facility to see if there was any fine-tuning required. I am pleased to report thateverything went very smoothly and I can thoroughlyrecommend attendance at the Spring Forum to beheld there. The content, as always, will be of a highstandard and the location will be excellent.

So what did we do at the ‘strategy meeting’? As usualthere were two main focuses, one looking at themission and long term vision of the society, the otherbeing the planning of the next year’s activities,consistent with the mission and vision.

We are a volunteer organization with limitedresources, therefore it is very important that we have avery clear mission and activities are consistent withthat mission. I am pleased to write that the BOT doesindeed have a very clear view of the role of the SCDM.It is best summed up in the words of one of the

trustees, Cherie Stabell, namely “PromotingClinical Data Management

Excellence”. This clearlydifferentiates us from

other organizationsin North America

with involvement in clinical data managementactivities. Also it succinctly summarizes the fivecomponents of our mission detailed in our by-laws.Other than give us a nice slogan that we can use onour slides and in promotional material how does ithelp? As we evaluate how we can best use our scarceresources, it enables us to focus on improving thestandards of data management and enablingindividuals to achieve excellence within their jobs.

Two prime examples are the Good Clinical DataManagement Practices (GCDMP) document and theCertification Program.

The GCDMP document is being recognized asdefining excellence in data management withacknowledgement from the FDA, the DIA and otherclinical data management organizations. As an exampleof how our new mission statement helps the BOT inits decision-making, a request came from the GCDMPcommittee to move the GCDMP document from theMembers Only section to the open area. If ourmission were to maximize membership or revenuethen we would have left the document where it was,restricting it to our members’ only section, requiringpeople to join the society to get the benefit. Howeveras our mission is to get the message of Clinical DataManagement excellence spread as broadly as possible,the decision is clear. The GCDMP document hasbeen moved to the public section of our web site so itwill be accessible for everyone. We have also made itavailable to the FDA and to other CDMorganizations to share with their membership.Preliminary discussions have also taken place with theDrug Information Association to see how they canhelp us get the message out to a wider audience.

Similarly, consistent with our mission, Clinical DataManagement Certification will be available to

Hugh Donovan – Aventis

from the Chair of the SocietyFor Clinical Data Management

3SPRING 2002 NEWSLETTER OF THE SCDM Promoting Clinical Data Management Excellence

At the time of writing I have just returned from the excellent 2001 ‘Fall’ Conference held in Seattle.While I was there several people asked me what does the Board of Trustees (BOT) do? I thought Iwould use the opportunity of my letter to the membership to let them and you know what it is we do,using the concrete example of our recent Board of Trustees two-day strategy meeting in Palm Springs.

Notes


Notes from the Chair continued from previous page

You will see greater detail from eachcommittee in this and future editions ofData Basics so I will not go into details here,but these discussions occupied a considerableamount of our time in Palm Springs.

We also discussed interactions with otherorganizations. Of particular note is theBOT’s decision to pursue formal interactionswith the FDA and the DIA. Although theorganizations are very different, the purposeof both of these initiatives are the same, thatis to promote CDM excellence by spreadingthe message of the GCDMP document andthe Certification Program to a much broaderaudience.

The cornerstones of our society remain thetwo (well usually two, 2002 being anexception) annual meetings, the SpringForum and the Fall Conference. The Boarddiscussed the 2002 Fall Conference in detail,approving the theme of ‘EDC: Making itReal’. The topic is a very important one forCDM and one that has major implicationsfor all CDM Professionals. It gives us theopportunity to take on more strategic roleswithin the organization, centered on theintegration of data and the provision ofinformation. I believe it is critical that oursociety tackles this topic, in order to giveunbiased, non-partisan information on atopic that has, in the majority of cases, beenpresented with a particular viewpoint andcommercial objectives in mind. I thereforeencourage all CDM professionals to activelyparticipate in the meeting. Just to show youthat we are not just focused on the short-term, you may be surprised to learn that theBOT also discussed potential meeting venuesfor 2008 and 2009, as most of the popularvenues require at least five-year lead-times.

Promoting Clinical Data ManagementExcellence requires resources, both human andfinancial. We have been very fortunate with theextent of volunteering for committees but wecan always do with more assistance; pleasevisit our website and volunteer for whateveryou are interested. As for financial resources,the BOT spent considerable time at ourstrategy meeting finalizing the 2002 budget.This year is particularly challenging for two

reasons. First, the postponement of the 2001Fall Conference has presented accountingchallenges (for example our 2001 pre-paidFall Conference registrations are shown asliabilities in the balance sheet and have notbeen considered revenue in 2001, leading toan apparent loss on the year even though wehave received the payments up front). Thepostponement also presents a moresignificant challenge and that is the potentialfunding issue due to running two “Fall”Conferences in one year and the need toattract two full contingents of attendees andexhibitors. I am confident that the theme forAtlanta will enable us to meet the challengebut your help is needed to make it a success.The second financial challenge, made all themore difficult because of the uncertaintyaround revenue generation, is the majorinvestment required to make the CertificationProgram a reality. I am pleased to report that,consistent with our mission, the BOT hadthe courage to commit the necessary fundingfor the development of the program. Pleasesupport this crucial initiative in whatever wayyou can.

I have tried to capture the highlights of ourdiscussion (the complete list of 2002objectives as agreed upon at the strategymeeting is shown in the accompanying tablefor those who would like to see more details).Hopefully you will now better understandwhat the role of your elected board is, andwill recognize the individual effort andcontribution required from each trustee.

Finally I hope that 2002 has got off to agood start for you; it certainly has for theSCDM, with our great ‘Fall’ Conference,thanks in large part to the organizers, JeanMazalewski and Karen Klingler, and theirteams of session chairs and speakers.

Please remember that the SCDM is yoursociety and I ask you all to contribute toPromoting Clinical Data ManagementExcellence. As always, if you have anyquestions or comments, please contact me at [email protected].

members and non-members alike. At itsstrategy meeting, the BOT approved thebudget for the development of the certificationprogram, a major investment in the promotionclinical data management excellence.

Also at the strategy meeting, the BOTapproved a new vision statement: “To be theOrganization of Choice for the ClinicalData Management Professional”. We believethat CDM professionals will recognize thevalue of the two activities highlighted above.However we recognize that other, moreshort-term, ongoing benefits are also neededin addition to these long-term, relativelyfixed, deliverables. Therefore we have askedthe Website Committee to develop discussionforums to enable members to share and learn.Also we have approved the MembershipCommittee’s request to survey the membersagain to determine what will be required tomake us the organization of choice for datamanagement professionals.

A recent addition to our variouscommunication vehicles has been the e-newsletter, introduced on a trial basis in2001. At our strategy meeting we approvedits continuation as a vehicle to provideregular informational updates out to ourmembers. The BOT reiterated its support forData Basics, which has a different focus fromthe e-newsletter, with its emphasis on longerarticles on all aspects of CDM, from processesand technologies to human-interest stories. I encourage all members of considercontributing to Data Basics. Please sendcontributions to Tam Blackstone([email protected]).

So how do these clear mission and visionstatements translate into activities for 2002?Each committee, through its BOT Liaison,presented its 2002 objectives and budget.


Building on the GCDMP document

Globalization of the document

Additional Chapters

Incorporating FDA Input

Implementing the beta-test of Certification program

Defining and implementing a regulatory interaction strategy, to discuss issues relatedto CDM with focus on ICH-GCP, 21CRF11 and electronic submission.

Defining and implementing interaction strategies with other associations that have afocus on CDM activities (e.g., DIA, ACRP in North America, ACDM in UK)

Increasing communication

Continuing to grow Data Basics

Increasing the use of the Internet (Discussion forums, balloting, questionnaires)

Increasing the content of e-newsletter

Extending Advertising

Membership survey to determine value of current offerings and future needs

Reviewing Long-term strategy

Identifying new initiatives based on membership desires and long-term strategywhere necessary.

Achieving full attendance at Spring Forum

Holding 2 “Fall” Conferences with over 400 attendees ateach & exhibition space full.

Objectives for the 2002 Society For Clinical Data Management Calendar of

SCDM EventsCalendar of

SCDM EventsMarch 10-12, 2002

Successful Data ManagementImplementations and How You Get There

Spring ForumRadisson Bahia Mar

Beach ResortFort Lauderdale, FL

October 6-9, 2002EDC: Is it the Real Thing?

Fall ConferenceGrand Hyatt BuckheadAtlanta, GA

March 16-18, 2003Spring ForumPalm Springs Marquis

Conference ResortPalm Springs, CA

September 21-24, 2003Fall ConferenceCheyenne Mountain

Conference ResortColorado Springs, CO

March 21-23, 2004SCDM Spring ForumLa Mansion del Rio HotelSan Antonio, TX

October 10-13, 2004SCDM Fall ConferenceRoyal York HotelToronto, Canada

The Clinical Data Management Certificate Program: A Student’s ViewpointDoris Kennedy


While one day reading the newspaperAn article I did findAbout a Clinical Data Management ProgramThe very first of its kind.

I think I’ll applyWhat have I got to lose?And if I am luckyI’ll be one that they choose.

So I went through the processI gave it a shotAnd as luck would have itI was given a spot.

Clinical Data ManagementWhat is that about?Little did I know I was about to find out!

So I and 14 othersBegan on a trackTo become CDM’sThere was no turning back

We were ready for the challengesThat we would have to faceLike learning each Module’s lessonsIn a very short time space!

We began with StatisticsAnd SQL and SASAnd Microsoft AccessOnly 3 weeks did pass!

We were set up in teams There was not much dissentionA few disagreements But too few to mention.

The pressures were manyThe stress undeniableThe Data Management Plan aloneSeemed so undefineable.

We learned not only the lessonsBut a new language tooOur vocabulary of acronymsJust grew and grew!!

There were CRFs, DCRs, Validations, SAEs, Queries and tables,NDAs, GCPs.

RDE, Audit trails,Guidelines and lab ranges,ICH, FDA,And those document changes.

SOPs, CROs,Clinical Trials, statisticians,Edits and Protocols,CRAs and clinicians.

We were taught, “It’s the Process!”We got lots of exposureFrom database entry To database closure.

We all worked quite hardWe would groan and lamentAbout how many times That we had to present.

continued on page 13


The Certification Committee formed in late 1999 andspent a bit of time trying to get their arms aroundwhat is a very large task – developing a professionallyrecognized certification for clinical data managers,and building a support and maintenance organizationfor it.

The Certification Committee consists of a solid coreof diverse Clinical Data Managers (CDMs) who havecommitted their time and energy to creating a way of professionally recognizing CDMs. Althoughcommittee members have seen many personal andprofessional changes over the last 2 years, one thingremains consistent; they are all focused and committedto the goal of creating a professional certification forclinical data managers.

Led by Armelde Pitre, the committee defined theircharter, developed a 5 year plan and was sanctionedby the SCDM Board of Trustees to proceed with theplan in 2000.

Today, after more than 2 years of research and work,the committee has a great deal to show for its efforts.With the current deliverables and the plans for thisyear, it is a very achievable goal to deliver a beta test ofthe certification at the 2002 Fall Conference in Atlanta.

There are several major activities under way in thecommittee. Colleen Cox and I have been working onthe code of ethics – both writing the code itself andcreating a set of rules around its application. Gatheringinput from SCDM Spring Forum 2001 attendees,Colleen drafted a fine code of ethics that exemplifiesthe CDM professional. It has been honed throughreviews in the committee, by the Board of Trusteesand by our legal colleagues, and it is now ready forthe wider membership audience. The committee willwork this year to define guidelines and an oversightbody to act on complaints of misconduct. The Boardof Trustees will serve as the ethics oversight board aswe gain experience in this area.

Karen Fitzpatrick and Leigh Renee Smith head up theefforts to create a reference library of source materials,

and publicly available training and educationalopportunities that will assist the applicants inrounding out their knowledge prior to sitting for thecertification exam. SCDM current policy and activitiesare not focused on developing and delivering training,but rather toward assisting members to find some ofthe many fine CDM training programs readilyavailable in the marketplace. Stay tuned – thisreference library will be available on the publicportion of the SCDM web page.

Keeping Sight of the Goal: Professional Recognition for CDMsBy Karen Klingler – Wyeth-Ayerst

WHO CAN APPLY TO

TAKE THE CERTIFIED CDM TEST?

Balance of related work experience and educational background

Experience qualifications

—2 years fulltime CDM work experiencePLUS a BA (or higher)

—3 years of fulltime CDM workexperience PLUS an associates degree

—4 years of fulltime CDM workexperience (no educational requirement)

No distinction made regarding therelevance of the educational studies

—“Relevant” degrees are difficult tocatalog

Agreement on life sciences, computersciences and stats/math, but not otherdegrees

No college degrees for CDM currently exist

Questionable value of effort to “validate” a catalog of relevant degrees to CDMperformance


effort are Louise Deeming and Julie Grassellwho are doing research specifically on howindustry contributions for the Sr. CDMprofessional will be evaluated.

Marissa Volpe, Pat Teden and Julie Grassellwill also collaborate on a communicationplan and set of communications deliverablesto assure that there is a broad advertisementto CDM professionals about the professionalCertification and the process for achieving it.

As you can see, there is a great deal moreeffort around developing a professionalcertification than just developing the test. Yetthe test is what most of us think of first andget anxious over taking. The test is also thekey to making this certification worthy ofCDM professionals.

Armelde Pitre has worked tirelessly to identifyand gather responses from vendors to ourRequest For Proposals for the testdevelopment and delivery. One vendor,Galton, with a great deal of experience incertification testing, is currently under aletter of intent with SCDM. We expectcontracts to be signed very soon.

Test development has already begun. Manyon the Certification Committee arevolunteering to act as subject matter experts(SME) for writing test questions. The

committee is gathering names of other SMEvolunteers to write test questions for variousparts of the test. These SMEs will undergo atwo day training workshop by Galton, tolearn to write test questions properly. Theywill then be charged with writing up to 20test questions in their area of expertise. Thequestions will undergo rigorous review byGalton, the Certification committee andother SMEs in order to assure the rigor,quality and content of the questions. Thiseffort will take place over 2002 with the goalof being able to offer a beta certification examat the Fall Conference in Atlanta.

The Committee has a list of SME volunteersand may need more in specific task areas —please watch the e-newsletter for any calls formore volunteers. For those SCDM membersplanning to come to the Fall Conference inAtlanta, you might want to think aboutbeing a beta test participant. Join about 100of your professional colleagues in being thefirst to potentially become certified CDMprofessionals. This test will be offered at areduced rate, but once the scoring and scorecuts are defined, those who passed will beofficially certified. More information on thiswill come via the e-Newsletter and memberemails. The Certification Committee hopesto see you in Atlanta!

More challenging and controversial, activitiesto define prerequisites for taking the CDMcertification test and the requirements for theSenior CDM, have required extensiveSCDM membership input. Sue Croft, LouiseDeeming, Julie Grassell, Judy Pyke, and PatTeden led the committee through efforts togather and analyze this information. Surveysat the SCDM Spring Forum 2000, FallConference 2000, and discussion sessions at theSpring Forum 2001 were aimed at teasing outthe membership ideas on the CDMprofessional capabilities list and the pre-requisites for sitting for the certification exam.

Comparative research with other professionalcertifications and communications with theACDM on their certification activitiesrounded out the information. While it isdifficult to satisfy all members, the team andthe BOT feel they have set the pre-requisiteguidelines appropriately —with respect tothe ultimate goal: a professional level ofrecognition for the Clinical Data Managerconsistent with other industry certifications.This includes a very exclusive Senior ClinicalData Manager level of recognition based onlifetime achievement and contribution to the profession.

Judy Pyke and Kathy Shields are working onthe application process for the certificationexam. They have designed a framework forthis, working with information from otherprofessional groups and with the proposedvendor for our test creation and delivery.This year they will create the formalapplication, document the process forapplying, create an application review board,and publish the information for CDMCertification applicants and SCDMmembership.

One of the more challenging parts of thecertification program is to create the SeniorCDM professional certification. This ismeant to demonstrate lifetime industrycontributions to the profession. Evaluatingthis level is considered not conducive to a testmethodology. Pat Teden and Nanette Petkoare going to develop a portfolio reviewprocess and content of contributions forthese applicants. Also contributing to this

Among the improvements in ODM Version 1.1 are: increased support for incremental data transferssupport for multiple studies reusable metadata, more complete archiving of clinicaltrialsincreased compatibility with the CDISC clinicallaboratory data standards (LAB) and submission datastandard (SDS) modelsvendor extensibility. ODM version 1.1 being was releasedwith an extensive documentation set and a set of tools toencourage early adoption by the industry.

In July, in conjunction with the DIA annual meeting, a proofof concept “ConnectAThon” was held. During theConnectAThon, more than 20 companies demonstrated theability their products to work with the CDISC Version 1.0Operational Data Model. The event, which drew a crowdestimated at nearly 1,000, was “… the highlight of theconference” according to Meredith Nahm, a SCDM Boardof Trustees member, who currently serves as Director,Clinical Data Integration at Duke Clinical Research Institute.

Not to be outdone by the ODM team, the Submissions DataStandards team announced the publication of Version 2.0 ofthe CDISC Submission Standard Domain Models. TheSubmissions Data Standards team includes more than 20active members from major pharmaceutical companies andcontract research organizations.

Among the many improvements in the SDS Version 2.0domains are revisions to the core and non-core variablecontents, definitions and names, the addition of standardformats and decodes [including support for the LogicalObservation Identifier Names and Codes (LOINC) databasemaintained by the Regenstrief Institute], compatibility withthe ICH E2B standard for adverse event reporting, animproved presentation format, and expanded documentation.Version 2.0 also includes two new alternative verticalrepresentations of Vital Signs and ECG data, in addition to the horizontal representations originally prepared for theVersion 1.0 models.

Significant news in support of the CDISC efforts was madein December when the FDA announced the CDER PatientProfile pilot project in the Federal Register on 5 December2001. This announcement acknowledges the planned use of

the CDISC Submissions Standard Domain Models for astandard representation of CRT data sets and metadata inconjunction with a pilot to test a new standard patient profileapplication.

The CDISC LAB team has worked to develop a contentmodel for lab data transfers. Specifically, they have definedcontent requirements consisting of a superset of data elements,including data type definitions, field length characteristicsand a logical structure for representing the data. Also, byteaming pairs of sponsors and central labs, the team alsotested the dataset to verify that requirements and definitionsare comprehensive and work for handling real data (both‘sends’ and ‘receives’). The LAB team is currently looking foropportunities for further standardization by use of standardizedcode lists. They are also considering multiple implementationoptions, including the CDISC ODM model and the HealthLevel 7 Reference information Model (HL7 RIM).

The CDISC Analysis Dataset Modeling team (ADaM) hasrecently published a draft set of guidelines for the submissionof analysis datasets. These include documentation and astrawman metadata model for percent change from baselinestatistical analysis. These documents are posted on theCDISC website and currently undergoing review and testingby FDA statisticians.

Information about the CDISC ODM and SDS models isavailable on the CDISC Web Site. Information about theFDA Patient Profile pilot program is available atwww.fda.gov/OHRMS/DOCKETS/98fr/12001a.htm.

CDISC is an open, non-profit organization committed to the development of worldwide industry standards to supportthe electronic acquisition, exchange, submission andarchiving of clinical trials data and metadata for medical and biopharmaceutical product development. The CDISCmission is to lead the development of standard, vendorneutral, platform independent data models to improve dataquality and accelerate product development in thebiopharmaceutical industry. It is a CDISC principle toensure that the data models support the scientific nature ofclinical research while improving process efficiency. For moreinformation visit the CDISC web site at www.cdisc.org orcontact Shirley Williams, Director of Operations, CDISC [email protected] or Rebecca Kush, Ph.D., President,[email protected].

News from CDISC


In November, CDISC announced the release of Version 1.1 of the CDISC Operational Data Model (ODM).This new version of the model, which was developed by a cross-functional team representing pharmaceuticaland biotechnology companies, technology providers, and contract research organizations, represents asubstantial improvement over Version 1.0.


At time I had doubtsIs this path right for me?But our instructors assured us“Just be patient and see”.I wasn’t so surePerhaps they were rightWhen this course has endedWould I see the light?We were assigned mentorsMine helped to show me the ropesWe talked of clinical trials andtribulations,And of dreams and of hopes.When I visited my mentor What a revelation I gotOnly half way through theprogramI had learned quite a lot!About CRFs, DCRs, Validations, SAEs, Queries and tables,NDAs, GCPs.RDE, Audit trails,Guidelines and lab ranges,ICH, FDA,And those document changes.SOPs, CROs,Clinical Trials, statisticians,Edits and Protocols,CRAs and clinicians.The program has endedThe first in the nationAnd we all were quite proudAt the first graduation.And we all have foundThat the lessons we learnedWere well worth the timeFor the rewards that we earned.I am now using my knowledgeIn a Data Management positionAnd thanks to the CDM program It’s been an easy transition.So if you are thinkingAbout this course to attendI can’t think of any opportunityI can more highly recommend.Sign up for this programJust give it a shot And if you are luckyYou’ll be given a spot.And before you know it In less than a yearThe CDM Program will lead youTo a rewarding career!

A Student’s Viewpointcontinued from page 7

13

Society of Clinical Data Management

Code of EthicsThe following Code of Ethics has been adopted by the board oftrustees and will be expected to be upheld by professionals who havebeen awarded the status of Certified Clinical Data Manager or of Certified Senior Clinical Data Manager.

Clinical Data Management is a key component of the developmentof new medications, medical procedures and devices. Clinical DataManagement professionals are:

COMMITTED to following the laws and guidelinesapplicable to clinical research (including the Declaration ofHelsinki), to participate in the protection of the safety,dignity and well being of patients and to maintain theconfidentiality of medical records.

COMMITTED to create, maintain and present qualityclinical data, thus supporting accurate and timely statisticalanalysis, and to adhere to applicable standards of quality andtruthfulness in scientific research.

COMMITTED to facilitate communication betweenclinical data management professionals and all other clinicalresearch professionals, to maintain competency in all areasof clinical data management, to keep current withtechnological advances, and to ensure the dissemination ofinformation to members of the clinical research team.

COMMITTED to work as an integral member of a clinicalresearch team with honesty, integrity and respect. Strivingto make and communicate accountability for clinical datamanagement decisions and actions within the clinical trial process.

COMMITTED to maintain and respect proprietaryknowledge at all levels, to avoid the use of proprietaryknowledge for personal gain, and to disclose any conflict ofinterest. Committed to avoid any conduct or behavior thatis unlawful, unethical or that may otherwise reflectnegatively on the profession of clinical data management.

COMMITTED to advance the profession of clinical datamanagement through the development, distribution andimprovement of good clinical data management practices.Committed to aid the professional development andadvancement of colleagues within the clinical trial industry.

Introducing Your 2002 SCDM Officers and Committee Chairs

Chair of Hugh Donovanthe Society Aventis

([email protected]) / 908-231-3938

Vice-Chair of Sally Cassellsthe Society Lexington Clinical Data Systems


Treasurer of Judy Kasperczykthe Society TAP Pharmaceuticals


Secretary of Meridith Nahmthe Society Duke University


Effective Use Ken Carlsonof Technology Pfizer


GCDMP Armelde PitreDocument Pfizer


Membership Catherine CeligantGenetics Institute/Wyeth-Ayerst Research([email protected]) / 617-876-1170

CDM Armelde PitreCertification Pfizer


Worldwide Jeff SadikWebSite Immunex

([email protected]) / 206-587-0430 ex. 3736

Data Basics Tam BlackstoneAllos Therapeutics, Inc..([email protected]) / 720-540-5274

Cherie StabellGenentech, Inc.([email protected]) / 650-225-7672



The tracking of Case Report Forms (CRFs) is the subjectof this article. CRFs are one of the key documentationtools used during the clinical trial process. The purposeof this article is to describe an Internet based system thatenhances the order processing, shipment and tracking ofCase Reports Forms in the global arena

A successful Case Report Form (CRF) Production andQuality Assurance Program can be summarized into 10 key workflow steps. This article primarily addressesthe last step in the process. However, all 10 steps arepresented below for the reader’s general information.

1. Case Report Form vendor receives electronic filefrom client.

2. The vendor creates a Job Specification Sheet. This identifies all aspects of the job needed tocomplete the CRF, including a Job SpecificationSheet for each investigator site.

3. The file is then converted to processing format, andthe output of this file is proofed, using a plain papercopy.

4. A set-up page layout is created, and each page isreviewed for correctness in format and image quality.

5. After all images are set-up, a proof document isprocessed. If any adjustments need to be made, theyare corrected and resubmitted for an additional proof.

6. The production process, with ongoing proofing, isimplemented.

7. Binding and finishing of the printed materialsthen takes place.

8. The finished product is boxed forshipment.

9. A final quality check to assure thatpackaging and labeling are inaccordance with shippinginstructions is undertaken.

10. Shipment to each site, includingconfirmation of receipt, istracked.

While a pharmaceutical, biotechnology or other publicor private organization may be the sponsor of the clinicalstudy; the study itself typically takes place at multipleinvestigator sites. These sites can be widely dispersedgeographically, and can be domestic as well as international.

Given all of the above, it is important in today’s globalclinical trial arena to be able to easily coordinate andtrack the entire Case Report Form ordering andshipping process with an Internet based system. It can beextremely costly, for example, if a monitor visits a newsite and the Case Report Forms which were recentlyshipped cannot be located. In addition, being able toquickly identify when there is a delay in the process,such as a normally routine shipment being unexpectedlyheld up in customs is important. An Internet basedtracking system is a tool, which can help minimizesignificant study downtime.

An Internet based system offers the potential for e-mailalerts when designated milestones such as ordershipment and order receipt are completed. It also offersthe potential for the electronic archiving of CRF orderprocessing and shipping data on a dedicated web site.Being able to historically document the flow of thesematerials, from shipment through verification of receipt,is a valuable tool for all of the parties involved. Someexamples of why these features are important arepresented below.

Before the clinical study begins, it is important to beable to document that the investigator and sponsorhave received and reviewed the final CRF.

During the clinical study, it is important to be ableto document when amended versions of the CRFwere shipped, how many copies were shipped, and towhom they were shipped.

In same cases, it may also be important to documentthe number of CRFs shipped per investigator siterelative to the number of patients studied at that site.

Using the Internet for Tracking Order Processing and Shipment of Paper Case Report Forms in the Global Pharmaceutical Clinical Trial Arena

Dave Mastro – Strata Companies


Providing automatic notification to thestudy coordinator, field management andothers regarding order receipts, shipmentreleases, and shipment arrivals

A permanent archival database

Flexibility to adapt the system for yourparticular needs

Some of the key benefits of this type of systeminclude:

Since each order can be tracked in real time,any shipment that is delayed or fails tomake its destination can be flagged at theearliest possible time, before it becomes amajor problem.

If a question arises from the field, the usercan easily locate accurate and up-to-dateon-line information instantly.

The archival database is a vital componentof this system, since it provides a permanentregister of all of the shipment informationcollected on every trial. Authorized personnelshould be able to review the completehistory of the study, or to limit the searchby site, investigator, time frame, etc.

In summary, the process described in thisarticle is intended to help make thecoordination of clinical trials smoother andeasier. First, the order can be placed via e-mailor on a dedicated web site. Once the order isplaced, a confirmation is sent to the originatorconfirming both the order and the scheduledrelease date of the shipment. Next, if a changeoccurs for any reason, a message reflecting thischange would be sent to the originator. Uponcompletion and release to the carrier of theshipment, an e-mail notification is sent. Finally,the system should also include an e-mailnotification confirming that the shipment hasarrived at its final destination, along with arecord of who signed for it. In addition, all ofthe above should be permanently archived in adedicated web site.

Examples of the type of data that could beincluded in this archival database are:

Protocol number

Site location

Investigator name

Content, number of boxes/CRFs

Carrier and shipment ID Number

Date shipped

Arrival date

Received by

A tracking system should include the followingfeatures:

Internet based with a dedicated web site

Tracking materials from shipment todelivery, with real-time e-mail alerts

Locating any delays in delivery

Providing fingertip access to theinformation about study materials andshipment details (both real time andhistorical data)

Allowing for secure, global access to thisinformation


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2002 Fall ConferenceEDC: Making it Real

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Contact Doug Schantz ([email protected]) if you need moreinformation.


EDITORIAL BOARD(also known as Newsletter Committee)

Tamela Blackstone, Co-editorAllos Therapeutics, Inc.Phone: 720-540-5274E-mail: [email protected]

Cherie Stabell, Co-editorGenentech, Inc.Phone: 650-225-7672E-mail: [email protected]

Cathie MuzaAverion, Inc.Phone: 508-416-2629E-mail: [email protected]

Kathy MeyerPfizerPhone: 743-622-7572E-mail: [email protected]

Felicia Ford-RiceAtheroGenics, Inc.Phone: 678-336-2713E-mail: [email protected]

Kit HowardPfizerPhone: 743-622-7848E-mail: [email protected]

Lynda HunterPRA InternationalPhone: 913-577-2972E-mail: [email protected]

Frannie RinkWyeth-Ayerst Research (retired)Phone: 616-341-5693E-mail: [email protected]

Saru SalviCoding PlusPhone: 760-966-6858E-mail: [email protected]

SUBMISSION DEADLINES(Articles and Advertising Art Work)Our quarterly publication schedule for the next 4 issues requires the following input deadlines:Volume 8, #2 (Summer) 26 April 2002Volume 8, #3 (Fall) 31 July 2002Volume 8, #4 (Winter) 25 October 2002Volume 9, #1 (Spring) 3 February 2003

PUBLICATION POLICYWe welcome submission of previously unpublished materials for publication in Data Basics. Materials shouldpreferably be submitted in electronic form (MS Word). Acceptance of materials for publication will be at thesole discretion of the Editorial Board. The decision will be based primarily upon professional merit andsuitability (i.e., topic, scope, and perceived interest to SCDM membership). Materials accepted for publicationmay be edited at the discretion of the Editorial Board.

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Ads not conforming to size and mechanical requirements will be returned.

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

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Please submit all forms, artwork, and payments to:

Society For Clinical Data Management, Inc. Phone: 908-359-0623c/o Professional Management Associates, LLC Fax: 908-359-7619203 Towne Centre Drive E-mail: [email protected], NJ 08844-4693

DATA BASICSDATA BASICS Call for Articles and AdvertisingThe content for Data Basics comes from you, our members. Without your articles,comments and thoughts, there is no Data Basics. We’ve had some very promising writersanswer the call! It’s your turn to share your experiences and thoughts with your peers. Please submit any articles, ideas, etc. for publication to the Editorial Board. Submit advertising as indicated in the Advertising policy section below.

Each issue is mailed to the membershipapproximately 6-7 weeks after the correspondingsubmission deadline and posted on the SCDMweb page (www.SCDM.org).

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Please contact SCDM @ PMA if you have questions about registration forupcoming meetings, advertising, renewal of membership, or if you need toprovide updated mailing/contact information.

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