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GETTING MULTI-SITE TRIALS UP AND RUNNING ON TIME. Presented by: Colleen Allen, MPH Eve Jelstrom, CRNA, MBA Frankie Kropp , MS November 20, 2013. Objectives. Identify critical components of multi-site trials for effective implementation.

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Presentation Transcript
Getting multi site trials up and running on time


Presented by:

Colleen Allen, MPH

Eve Jelstrom, CRNA, MBA

Frankie Kropp, MS

November 20, 2013


  • 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.

Resource collaborators for trial implementation continued
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

Critical components of multi site trials


Protocol Approval

Trial Dev’t and Logistics

Data Management

National Training

Study Start

Critical components of multi-site trials

Pre implementation milestones
Pre-Implementation Milestones

  • Development

  • Protocol Approval

  • Trial Development and Logistics

  • Data Management Meeting

  • National Training

  • Study Start

Timeline from development to study start
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


Trial Dev & Logist.

DM Meeting

Nat’l Training

Study Start


6-8 wks before nat’ltrng

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



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

  • Protocol development and improvement

  • Budget development

  • Protocol Concept Submission

Development continued
Development (continued)



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

  • 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

Protocol approval
Protocol Approval


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

  • 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

Protocol approval continued
Protocol Approval (continued)


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

  • Determine and document site selection process

  • Present selected sites for Executive Committee/NIDA approval

  • Inform sites once approved

Protocol approval continued1
Protocol Approval (continued)



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

  • 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

Break for questions
Break for Questions

Alternatively, questions can be directed to the presenter by sending an email to [email protected]

Trial development and logistics1
Trial Development and Logistics


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

  • 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

Trial development and logistics continued
Trial Development and Logistics (continued)



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

  • 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

Data management meeting
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

Data management meeting continued
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

National training
National Training


  • 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

National training continued
National Training (continued)



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

  • 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.

Study start up1
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

Study start up continued
Study-Start Up (continued)

  • DSC

  • CCC

  • 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

Study startup
Study Startup…

…success achieved when

all sites are enrolling.


  • 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


  • Use the tools available

    • Timeline Template

    • Study Budget

    • Pre-Implementation Calculator

templateS available on the

CTN Investigator toolbox


Recap highlights
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

Q a questions comments
Q&A – Questions / Comments

Alternatively, questions can be directed to the presenter by sending an email to [email protected]

Survey reminder
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.

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A copy of this presentation will be available electronically after this session.

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