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GETTING MULTI-SITE TRIALS UP AND RUNNING ON TIME

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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GETTING MULTI-SITE TRIALS UP AND RUNNING ON TIME

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  1. GETTING MULTI-SITE TRIALS UP AND RUNNING ON TIME Presented by: Colleen Allen, MPH Eve Jelstrom, CRNA, MBA Frankie Kropp, MS November 20, 2013

  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.

  3. Resource Collaborators for Trial Implementation

  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

  5. Development Protocol Approval Trial Dev’t and Logistics Data Management National Training Study Start Critical components of multi-site trials

  6. Pre-Implementation Milestones • Development • Protocol Approval • Trial Development and Logistics • Data Management Meeting • National Training • Study Start

  7. 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 ProtocolApproval Trial Dev & Logist. DM Meeting Nat’l Training Study Start Dev’t 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

  8. preparation activities and requirements

  9. template available on the CTN Investigator toolbox At www.ctndsc2.com/

  10. Development Node/RRTC 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

  11. Development (continued) CCC 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 • 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

  12. Protocol Approval Node/RRTC 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

  13. template available on the CTN Investigator toolbox At www.ctndsc2.com/

  14. Protocol Approval (continued) Node/RRTC 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

  15. Protocol Approval (continued) CCC 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 • 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

  16. template available on the CTN Investigator toolbox At www.ctndsc2.com/

  17. Break for Questions Alternatively, questions can be directed to the presenter by sending an email to CTNtraining@emmes.com.

  18. Trial Development and Logistics

  19. Trial Development and Logistics Node/RRTC 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

  20. Trial Development and Logistics (continued) CCC 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 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

  21. 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

  22. 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

  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

  24. National Training (continued) CCC 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 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.

  25. Study start-up

  26. 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

  27. 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

  28. Study Startup… …success achieved when all sites are enrolling.

  29. Overcome challenges

  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

  31. Tools • Use the tools available • Timeline Template • Study Budget • Pre-Implementation Calculator templateS available on the CTN Investigator toolbox At www.ctndsc2.com/

  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

  33. Q&A – Questions / Comments Alternatively, questions can be directed to the presenter by sending an email to CTNtraining@emmes.com.

  34. 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

  35. A copy of this presentation will be available electronically after this session. http://ctndisseminationlibrary.org

  36. Thank you for participating. NIDA CTN Web Seminar Series

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