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