2013 CTN Web Seminar Series Produced by: NIDA CTN CCC Training Office "This training has been funded...
If you can't read please download the document
2013 CTN Web Seminar Series Produced by: NIDA CTN CCC Training Office "This training has been funded in whole or in part with Federal funds from the National
2013 CTN Web Seminar Series 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." GETTING MULTI-SITE TRIALS UP
AND RUNNING ON TIME Presented by: Colleen Allen, MPH Eve Jelstrom,
CRNA, MBA Frankie Kropp, MS November 20, 2013
Slide 2
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
Slide 3
Resource Collaborators for Trial Implementation 3
Slide 4
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
Slide 5
CRITICAL COMPONENTS OF MULTI-SITE TRIALS 5
Slide 6
Pre-Implementation Milestones Development Protocol Approval
Trial Development and Logistics Data Management Meeting National
Training Study Start 6
Slide 7
7 Timeline from Development to Study Start Devt Protocol
Approval Natl Training DM Meeting Study Start Trial Dev &
Logist. 6-8 wks before natl trng 4 wks before study start CCTN
Concept Approval CTN Number assigned Initial Budget/revise as
needed Timeline Development 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 Training
Doc Form Delegation Log Regulatory Training/Document Collection
Supplies/Meds to sites Other Study Docs in Devt: eCRFs, Ops Manual,
QA Plan, SOPs Training Dev & Planning Meds, Labs, and Supplies
Contracts Sites to submit for IRB Approval
Slide 8
PREPARATION ACTIVITIES AND REQUIREMENTS 8
Slide 9
9
Slide 10
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
Slide 11
Development (continued) CCC 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 DSC 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
Slide 12
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
Slide 13
13
Slide 14
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 site-
specific study budgets 14
Slide 15
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
Slide 16
16
Slide 17
Break for Questions 17 Alternatively, questions can be directed
to the presenter by sending an email to [email protected].
Slide 18
TRIAL DEVELOPMENT AND LOGISTICS 18
Slide 19
Trial Development and Logistics 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
Node/RRTC
Slide 20
Trial Development and Logistics (continued) CCC 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 DSC 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 Users Guide and CRF Manual,
GlobalTrace Users Guide and AdvantageEDC Practicum 20
Slide 21
Data Management Meeting 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 Node/RRTC
Slide 22
Data Management Meeting (continued) 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 CCCDSC
Slide 23
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
Slide 24
National Training (continued) CCC 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. DSC 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 Users Guide and CRF Manual, GlobalTrace Users 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 24
Slide 25
STUDY START-UP 25
Slide 26
Study Start-up 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 NODE/RRTC
Slide 27
Study-Start Up (continued) 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 CCC DSC
Slide 28
Study Startup 28
Slide 29
OVERCOME CHALLENGES 29
Slide 30
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
Slide 31
Tools 31 Use the tools available Timeline Template Study Budget
Pre-Implementation Calculator
Slide 32
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
Slide 33
Q&A Questions / Comments 33 Alternatively, questions can be
directed to the presenter by sending an email to
[email protected].
Slide 34
Survey Reminder Upcoming Webinar 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. 34 SECONDARY
ANALYSES FOR CLINICAL TRIALS IN DEVELOPMENT ***Note the Date
Change*** Friday, December 6, 2013 12:00 pm to 1:30 pm ET SECONDARY
ANALYSES FOR CLINICAL TRIALS IN DEVELOPMENT ***Note the Date
Change*** Friday, December 6, 2013 12:00 pm to 1:30 pm ET
Slide 35
A copy of this presentation will be available electronically
after this session. http://ctndisseminationlibrary.org 35
Slide 36
Thank you for participating. NIDA CTN Web Seminar Series
36