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Training
for Clinical Trial Data Managers
A Cooperative Group Perspective
Beverly
Koski
NCIC
Clinical Trials Group
Society
For Clinical Trials 2007May22
Outline
Characteristics
of the NCIC CTG
Challenges
for training
How training
is organized
Thoughts
for future plans
Acknowledgements
Tracey
Messerschmidt
Amy Doherty
NCIC CTG
Study Coordinators and Research Associates
The
NCIC CTG
A cooperative
group funded by the National Cancer Institute of Canada (NCIC)
At Queen00 University in Kingston
Ontario Canada since 1980
80 Canadian
member institutions
Approximately
150 coordinating centre staff
Trial
Team Composition
Physician
Coordinators
Study Coordinators (30)
Research
Associates (14)
Clinical
Trials Assistants (19)
Challenges
Accrual by Disease Site
Challenges
Accrual by Trial Type
Challenges
Expectations
Regulatory
Guidelines (e.g. GCP)
Industry
Challenges
Breadth of Role
Role:
Protocol/CRF
development
Central
and Local Activation
Randomization
Process
Serious
Adverse Event Report
Review
and querying of CRFs and supporting documentation
Monitoring
safety and protocol compliance
Interactions
Disease
Site and Trial committees, industry, other cooperative groups, site
and coordinating centre staff
Challenges
Flow of Data
Central
review of paper CRFs and supporting documentation
ORACLE
database
SAS database
Challenges
Time for Training
Defining
training needs and content
Length
of training period
Training
time competes with other tasks
Challenges
Other Considerations
Extended
leaves (e.g. maternity leave)
Coverage
for statutory holidays (e.g. Christmas break)
Modes
of training
WEB-Based
NIH
ethics requirements
GCP (NCIC
CTG slides)
Compulsory
training sessions
Trial
specific training
Notification
of changes
Independent
learning
Training
Requirements Documented on Approved SOPs and Work Instructions
1
C = Compulsory,
R = Read Only
-
Data Entry Clerk
-
Data Reviewer
-
Clinical Trials Assistant
C
Research Associate
C
Study Coordinator
R
Physician Coordinator
-
Oracle Programmer
-
Biostatistician
-
Senior Biostatistician
Trial teams1
Content
Basic
curriculum :
Introductory
information
(e.g. introduction to the NCIC CTG, eligibility, medical review, data
queries, adverse event reporting)
Core curriculum
scheduled based on :
Stage
of trial
Activities
specific to a trial
Time of
year
(e.g. CRF development, central radiotherapy review, preparing tables
for the Group Participant00
meeting)
Organization
Coordinated
by Quality Assurance Office
New staff
have the opportunity to attend one of two sessions scheduled
Staff
can attend as many times as they like
Participants
register on-line
All planned
sessions are posted on the coordinating centre intranet site
Those
required to attend are sent an E-mail notification
Registered
participants receive an E-mail reminder the day before
Individual
Session
Topic
: Data queries
Trainer
: Content expert
Duration
: Approximately one hour
Training
material :
Slides
and handouts
Training
Records
Sign
in sheet for trainer and participants
Training
log : Excel spreadsheet
Topic
Date of
session
Participants
Date of
slides used for the session
Trial
team reviewers signature log in trial records
Resources
Available
Intranet
site
Further Challenges
Clinical
data management for an individual trial requires :
Understanding
how the data fields relate to the trial objectives
Judgment
about how to handle specific situations for individual trials/cases
and when to ask questions
Understanding
the requirements of other trial partners (e.g. industry)
Trial
Specific Training
Trainer
: Physician Coordinator, content expert, peer
Methods
:
Task
is explained, completed and checked until it can be done independently
Regular
meetings with the Physician Coordinator
Records
Protocol
Data Management
Guidebook
CRF Review
Plan
Query
Repository
Interpretation
Log
Paper
trail in patient Chart
Notice
of Changes
Notice
of Implementation
Implementation
date
Relevant
types of trials
Relevant
document
Brief
description of change
Training
Compulsory
Optional
Study
Coordinator Meeting
E-mail
notification
Independent Learning
Mentors
Open question
sessions
Meetings
Peers
Trial
partners
Group
Participants00
Meeting
Educational
Evaluation
of Training
00/b>Training Session Evaluation Form00
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
Plans
Continue
to develop the training curriculum including practice situations and
exercises
Develop
Basic
certification for specific tasks
A training
log for the trial specific training
A more
systematic way of incorporating ongoing trial specific issues into the
training content
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