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2013 CTN Web Seminar Series
GETTING MULTI-SITE TRIALS UP
AND RUNNING ON TIME
Presented by:
Colleen Allen, MPH
Eve Jelstrom, CRNA, MBA
Frankie Kropp, MS
November 20, 2013
Produced by: NIDA CTN CCC Training Office
"This training has been funded in whole or in part with Federal funds from the National Institute on Drug Abuse,
National Institutes of Health, Department of Health and Human Services, under Contract No.HHSN271201000024C."
Objectives
• Identify critical components of multi-site
trials for effective implementation.
• Explain preparation activities and
requirements from stakeholders for site
endorsement.
• Consider methods to overcome
challenges.
2
Resource Collaborators for Trial
Implementation
3
Resource Collaborators for Trial
Implementation (continued)
• Composition of the Lead Team
– CCTN
– Node/RRTC
– DSC
– CCC
• All in the CTN engage in research; this
presentation will focus on the efforts of the
Node/RRTC, the Clinical Coordinating
Center, and the Data & Statistics Center
4
CRITICAL COMPONENTS OF
MULTI-SITE TRIALS
5
Pre-Implementation Milestones
•
•
•
•
•
•
Development
Protocol Approval
Trial Development and Logistics
Data Management Meeting
National Training
Study Start
6
Timeline from Development to
Study Start
Protocol Reviews:
PRB, DSMB, Lead Node IRB
Approval
Site Selection
Other Regulatory Submission(s)
Revise eCRFs at DM meeting
Then, revise Ops Manual as
needed (recruitment materials, logs
et. al.)
Selected Sites Hiring Staff
Initiation Visits (Node
QA/CCC)
Site Endorsements
Start Enrollment
4 wks before
study start
Dev’t
Protocol
Approval
Trial Dev
& Logist.
DM
Meeting
Nat’l
Training
Study
Start
6-8 wks before
nat’l trng
CCTN Concept Approval
CTN Number assigned
Initial Budget/revise as needed
Timeline Development
Other Study Docs in Dev’t:
eCRFs, Ops Manual, QA Plan, SOPs
Training Dev & Planning
Meds, Labs, and Supplies Contracts
Sites to submit for IRB Approval
Training Doc Form
Delegation Log
Regulatory Training/Document
Collection
Supplies/Meds to sites
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PREPARATION ACTIVITIES
AND REQUIREMENTS
8
9
Development
Node/RRTC
• Protocol development
and improvement
• Budget development
• Protocol Concept
Submission
• Cost-benefit ratio for each
study procedure
• Expected rate of recruitment
for target N
• Number of sites required to
reach target N
• Impact of
inclusion/exclusion criteria
on recruitment
• Potential safety issues and
how they will be managed
10
Development (continued)
CCC
DSC
• Discuss division of
responsibilities
• Consult Lead Team to
clarify elements of the study
• Investigate study needs –
medication, packaging,
laboratory assessments or
other study needs –
important for budgeting and
cost allocation
• Collaborate on timeline
development
• Evaluate required
assessments and data
reporting and collection
• Tie assessments and data
collection to endpoints,
protocol adherence and
safety monitoring
• Define requirements and
specifications for CRFs
• Use standard forms to
streamline and expedite
database development
11
Protocol Approval
Node/RRTC
• Update study budget
throughout the approval
process
• Once approved, begin initial
work on the Ops Manual, the
Trial Performance Mgmt/QA
plan, Training Plan, Source
Doc development, etc.
• With CCC and NIDA identify
any additional regulatory
requirements that exist and
with CCC complete
submissions
• Determine # of staff hours for
each procedure
• Determine supplies and
training for personnel
• Determine costs for travel,
specialty training, etc.
• Additional documents may
include OHRP – Prisoner
Certification or IND
(Investigational New Drug)
application or exemption
12
13
Protocol Approval (continued)
Node/RRTC
• Determine and document
site selection process
• Present selected sites for
Executive
Committee/NIDA
approval
• Inform sites once
approved
• Site criteria should be
clearly established. Decide
targeted sites vs. open call
• Develop site survey
documents and track results
• Determine and present
budget parameters, and
once informed, finalize sitespecific study budgets
14
Protocol Approval (continued)
CCC
• Processes
– identifying, recruiting,
consenting, screening
participants
– assessments, and medication
management and tracking
• Develop more detailed timeline
and chart responsibilities
• Discuss and help develop
plans for site needs and
resource management
• Discuss management plans for
particular study
– training, risk, monitoring
• Confirm study specific
regulatory requirements
DSC
• Begin development and
programming of CRFs
• Share drafts of CRFs with
the team for review and
input
• Consider planned study
workflow:
– How performance of
required assessments and
data collection/reporting
will work into study
operations
15
16
Break for Questions
Alternatively, questions can be directed to the presenter by sending an email to
[email protected]
17
TRIAL DEVELOPMENT AND
LOGISTICS
18
Trial Development and Logistics
Node/RRTC
• Coordinate with CCC and
DSC to complete
– Final drafts of study
documents and
management tools
– Final training plan and
documentation
– Approval of submitted
regulatory materials
– Pre-initiation checklist and
teleconferences
• Study documents
including the Ops Manual
and TPM/QA plans
• Tools including Study logs
and checklists, Progress
notes
• Provides approved
submission materials to
sites and posts on
LiveLink
19
Trial Development and Logistics
(continued)
CCC
DSC
• Collaborate to finalize study
medication, documents, and
management tools
• Finalize laboratory, consultant,
and vendor contracts
• Finalize Delegation of Authority
and Staff Signature Log
• On calls review Pre-Initiation
checklists addressing Lead
Node, CCC and DSC key
items
• Collect protocol wide
Regulatory Documents
• Complete and review drafts
of all CRFs prior to data
management meeting
• Plan for data management
meeting to be held 6-8
weeks prior to National
Training Meeting
• Develop AdvantageEDC
User’s Guide and CRF
Manual, GlobalTrace User’s
Guide and AdvantageEDC
Practicum
20
Data Management Meeting
Node/RRTC
• Lead Node works with CCC and DSC to
finalize eCRFs and database
• Finalize study guidance documents and tools
• Training plan and documentation form to
sites
• Lead Node monitors site progress towards
initiation weekly
21
Data Management Meeting
(continued)
CCC
DSC
• Integrate Ops Manual with
Protocol with CRFs
• Identify source documents
• Finalize all study guidance
docs and management tools
• Finalize training plans and
Investigator Meeting agenda
• 2 day meeting held 6-8 weeks
prior to National Training
Meeting
• Critically review CRFs
• Identify all changes to CRFs;
required to meet timeline for
database completion prior to
protocol training
• Trial progress and data status
reports planning – LN should
provide specifications for
reports to the DSC by the time
of the National Training
22
National Training
NODE/RRTC
• Lead Node coordinates with CCC and DSC to
complete all training events
• Lead Node tracks completion of training requirements
for all site and node personnel
• Lead Node continues monitoring site progress
towards initiation weekly
23
National Training (continued)
CCC
DSC
• Plan for Training 3-4 months
prior to training.
• Finalize Training
Documentation Form for use
by sites and approval by Lead
Node.
• Decide if Training to occur in
person or remotely in
consultation with CCTN.
• Develop agenda and timing for
on-site and webinar training
sessions.
•
•
•
•
•
•
Final study database to be available at
the time of the National Training
Meeting
Plan to provide training on
AdvantageEDC, GlobalTrace , and
Good Data Management Practices
Complete development of the
AdvantageEDC User’s Guide and CRF
Manual, GlobalTrace User’s Guide,
and Practicum
Issue and grade AdvantageEDC
practicum shortly after the training
Begin to develop Integrity queries
Begin to develop trial progress/data
status reports
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STUDY START-UP
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Study Start-up
NODE/RRTC
• Lead Node coordinates with CCC to monitor
results of site initiation visits and resolution of
outstanding items
• Lead Node transitions pre-initiation
teleconferences to study management
teleconferences
26
Study-Start Up (continued)
CCC
DSC
• Initiation visits by
QA/Node staff and CCC
• Initiation reports issued
• Action Items resolved
• Endorsement of each site
• Screening and
recruitment begins
• Begin to monitor data
quality as soon as first
participant is
enrolled/randomized
– Missing forms
– Missing values
– Integrity queries
• Begin to generate trial
progress and data status
report as soon as first
participant is
enrolled/randomized
27
Study Startup…
…success achieved when
all sites are enrolling.
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OVERCOME CHALLENGES
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Challenges
•
•
•
•
•
Unforeseen regulatory compliance issues
Keeping up with the timetable
Lack of effective communication
Sites and staff new to CTN research trials
Site may need to drop out of the study
after site selection
30
Tools
• Use the tools available
– Timeline Template
– Study Budget
– Pre-Implementation Calculator
31
Recap / Highlights
• Begin conversations about details early
• Consider the costs
• Determine what type of Lead Node you
want to be
• Communicate, communicate,
communicate
• Don't reinvent the wheel
• Reach out to existing resources
32
Q&A – Questions / Comments
Alternatively, questions can be directed to the presenter by sending an email to
[email protected]
33
Survey Reminder
The NIDA CCC encourages all to complete the survey issued to participants
directly following this webinar session, as this is the primary collective tool
for rating your experience with this and other webinars, and for
communicating the interests and needs of CTN members and associates.
Upcoming Webinar
SECONDARY ANALYSES FOR CLINICAL
TRIALS IN DEVELOPMENT
***Note the Date Change***
Friday, December 6, 2013
12:00 pm to 1:30 pm ET
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A copy of this presentation will be available
electronically after this session.
http://ctndisseminationlibrary.org
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Thank you for participating.
NIDA CTN Web Seminar Series
36

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