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Training for Clinical Trial Data Training for Clinical Trial Data ManagersManagers
A Cooperative Group PerspectiveA Cooperative Group Perspective
Beverly KoskiBeverly Koski
NCIC Clinical Trials GroupNCIC Clinical Trials Group
Society For Clinical Trials 2007May22Society For Clinical Trials 2007May22
OutlineOutline
Characteristics of the NCIC CTG
Challenges for training
How training is organized
Thoughts for future plans
AcknowledgementsAcknowledgements
Tracey MesserschmidtTracey Messerschmidt
Amy DohertyAmy Doherty
NCIC CTG Study Coordinators and NCIC CTG Study Coordinators and Research AssociatesResearch Associates
The NCIC CTGThe NCIC CTG
A cooperative group funded by the A cooperative group funded by the National Cancer Institute of Canada National Cancer Institute of Canada (NCIC)(NCIC)
At Queen’s University in Kingston At Queen’s University in Kingston Ontario Canada since 1980Ontario Canada since 1980
80 Canadian member institutions80 Canadian member institutions
Approximately 150 coordinating centre Approximately 150 coordinating centre staffstaff
Trial Team CompositionTrial Team Composition
Physician CoordinatorsPhysician Coordinators Study Coordinators (30)Study Coordinators (30) Research Associates (14)Research Associates (14) Clinical Trials Assistants (19)Clinical Trials Assistants (19)
ChallengesChallengesAccrual by Disease SiteAccrual by Disease Site
0
1000
2000
3000
4000
5000
6000
7000
2000 2001 2002 2003 2004 2005 2006
SYMPTOM CONTROL
SARCOMA
MELANOMA
LUNG
IND
HEMATOLOGIC
HEAD AND NECK
GYNECOLOGIC
GENITO-URINARY
GASTRO-INTESTINAL
BREAST
BRAIN
ChallengesChallengesAccrual by Trial TypeAccrual by Trial Type
0
1000
2000
3000
4000
5000
6000
7000
2000 2001 2002 2003 2004 2005 2006
NCIC - International
NCIC - Intergroup
NCIC
Intergroup - Other
IND
ChallengesChallengesExpectationsExpectations
Regulatory Guidelines (e.g. GCP)Regulatory Guidelines (e.g. GCP)
IndustryIndustry
ChallengesChallenges Breadth of Role Breadth of Role
Role:Role:
Protocol/CRF developmentProtocol/CRF development
Central and Local ActivationCentral and Local Activation
Randomization ProcessRandomization Process
Serious Adverse Event ReportSerious Adverse Event Report
Review and querying of CRFs and supporting Review and querying of CRFs and supporting documentationdocumentation
Monitoring safety and protocol complianceMonitoring safety and protocol compliance
InteractionsInteractions
Disease Site and Trial committees, industry, Disease Site and Trial committees, industry, other cooperative groups, site and coordinating other cooperative groups, site and coordinating centre staffcentre staff
ChallengesChallengesFlow of DataFlow of Data
Central review of paper CRFs and Central review of paper CRFs and supporting documentationsupporting documentation
ORACLE databaseORACLE database
SAS databaseSAS database
ChallengesChallenges Time for Training Time for Training
Defining training needs and contentDefining training needs and content Length of training periodLength of training period Training time competes with other Training time competes with other
taskstasks
ChallengesChallengesOther ConsiderationsOther Considerations
Extended leaves (e.g. maternity leave)Extended leaves (e.g. maternity leave)
Coverage for statutory holidays (e.g. Coverage for statutory holidays (e.g. Christmas break)Christmas break)
Modes of trainingModes of training
WEB-BasedWEB-Based NIH ethics requirementsNIH ethics requirements GCP (NCIC CTG slides)GCP (NCIC CTG slides)
Compulsory training sessionsCompulsory training sessions Trial specific trainingTrial specific training Notification of changesNotification of changes Independent learningIndependent learning
Training Requirements Documented on Training Requirements Documented on Approved SOPs and Work InstructionsApproved SOPs and Work Instructions
Trial teams1
Senior Biostatistician --
Biostatistician --
Oracle Programmer --
Physician Coordinator RR
Study Coordinator CC
Research Associate CC
Clinical Trials Assistant --
Data Reviewer --
Data Entry Clerk --
1 C = Compulsory, R = Read Only
ContentContent
Basic curriculum :Basic curriculum : Introductory information Introductory information
(e.g. introduction to the NCIC CTG, eligibility, (e.g. introduction to the NCIC CTG, eligibility, medical review, data queries, adverse event medical review, data queries, adverse event reporting)reporting)
Core curriculum scheduled based on :Core curriculum scheduled based on : Stage of trial Stage of trial Activities specific to a trialActivities specific to a trial Time of year Time of year
(e.g. CRF development, central radiotherapy (e.g. CRF development, central radiotherapy review, preparing tables for the Group review, preparing tables for the Group Participant’s meeting)Participant’s meeting)
Organization Organization
Coordinated by Quality Assurance OfficeCoordinated by Quality Assurance Office New staff have the opportunity to New staff have the opportunity to
attend one of two sessions scheduledattend one of two sessions scheduled Staff can attend as many times as they Staff can attend as many times as they
likelike Participants register on-lineParticipants register on-line All planned sessions are posted on the All planned sessions are posted on the
coordinating centre intranet sitecoordinating centre intranet site Those required to attend are sent an E-Those required to attend are sent an E-
mail notificationmail notification Registered participants receive an E-mail Registered participants receive an E-mail
reminder the day beforereminder the day before
Individual SessionIndividual Session
Topic : Data queriesTopic : Data queries Trainer : Content expertTrainer : Content expert Duration : Approximately one hourDuration : Approximately one hour Training material :Training material :
Slides and handoutsSlides and handouts
Training RecordsTraining Records
Sign in sheet for trainer and Sign in sheet for trainer and participantsparticipants
Training log : Excel spreadsheet Training log : Excel spreadsheet TopicTopic Date of sessionDate of session ParticipantsParticipants Date of slides used for the sessionDate of slides used for the session
Trial team reviewers signature log in Trial team reviewers signature log in trial recordstrial records
Resources AvailableResources Available
Intranet siteIntranet site
Further ChallengesFurther Challenges
Clinical data management for an Clinical data management for an
individual trial requires :individual trial requires :
Understanding how the data fields Understanding how the data fields
relate to the trial objectivesrelate to the trial objectives
Judgment about how to handle Judgment about how to handle
specific situations for individual specific situations for individual
trials/cases and when to ask questionstrials/cases and when to ask questions
Understanding the requirements of Understanding the requirements of
other trial partners (e.g. industry)other trial partners (e.g. industry)
Trial Specific Training Trial Specific Training
Trainer : Physician Coordinator, Trainer : Physician Coordinator, content expert, peercontent expert, peer
Methods :Methods :
Task is explained, completed and Task is explained, completed and checked until it can be done checked until it can be done independentlyindependently
Regular meetings with the Physician Regular meetings with the Physician CoordinatorCoordinator
RecordsRecords
ProtocolProtocol
Data Management GuidebookData Management Guidebook
CRF Review PlanCRF Review Plan
Query RepositoryQuery Repository
Interpretation Log Interpretation Log
Paper trail in patient ChartPaper trail in patient Chart
Notice of ChangesNotice of Changes
Notice of ImplementationNotice of Implementation Implementation dateImplementation date Relevant types of trialsRelevant types of trials Relevant documentRelevant document Brief description of changeBrief description of change TrainingTraining
CompulsoryCompulsory OptionalOptional Study Coordinator MeetingStudy Coordinator Meeting E-mail notification E-mail notification
Independent LearningIndependent Learning
MentorsMentors
Open question sessionsOpen question sessions
MeetingsMeetings PeersPeers Trial partnersTrial partners Group Participants’ MeetingGroup Participants’ Meeting EducationalEducational
Evaluation of TrainingEvaluation of Training
‘Training Session Evaluation Form’ Review of tasks completed SOPs and Work Instructions have a five
question self-test Summaries of the trial data Reviews of the coordinating centre
Future PlansFuture Plans
Continue to develop the training Continue to develop the training curriculum including practice situations curriculum including practice situations and exercisesand exercises
DevelopDevelop
Basic certification for specific tasksBasic certification for specific tasks
A training log for the trial specific A training log for the trial specific trainingtraining
A more systematic way of A more systematic way of incorporating ongoing trial specific incorporating ongoing trial specific issues into the training contentissues into the training content
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