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CLINICAL TRIAL PROJECT MANAGEMENT
This document outlines the standard procedures for clinical trial project management, including standardizing processes, maintaining flexibility, marketing to sponsors, setting up feasibility assessments, developing budgets and contracts, working with regulatory bodies for approval, conducting site initiations, ongoing study coordination, and closing out projects. Key aspects are using templates and checklists, determining feasibility at multiple stages, negotiating budgets, navigating regulatory requirements, and coordinating clinical setup and study conduct. The goal is to save time and reduce risks through standardized yet adaptable processes.
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CLINICAL TRIAL PROJECT MANAGEMENT
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- 2. Standardization • Saves timeand money • Use flowcharts, check sheets, and templates • Key in reducing project risk
- 3. Flexibility • Flexibility neededfor differences in projects • Situations will arise during projects
- 4. Marketing the Sitefor Trial Opportunities • CenterWatch www.centerwatch.com • Clinical Investigators Directory online www.clinicalinvestigators.com • Pharma company websites • Networking, word of mouth, previous experience
- 5. Study/Investigator Match • Notificationof study opportunity by sponsor • Database of potential Investigators to match with opportunities • Physician or staff contact with research office, protocol in hand
- 6. Project Setup Procedure •Can be standardized for most projects • Early feasibility determinations made • Assures minimum time and effort spent on an infeasible project
- 7. Feasibility after ReceivingFull Protocol • First team feasibility assessment • Can more accurately determine potential subject population • Pharmacy issues • Logistical issues of facilities, manpower
- 8. Site Evaluation Visit •Receive letter from CRA outlining requirements • Schedule time with all affected study site personnel • Host the visit by accompanying the CRA
- 9. Team Meeting • Afterreceiving full protocol • Include all affected parties • Use draft budget and meeting agenda as discussion tools
- 10. Study Budget • Internalbudget of actual costs and indirect costs • Tool for project management • Justification to sponsor of requested amounts during negotiation • Use for planning and fund allocation throughout project
- 11. Budget Development and Negotiation •Standard startup costs and hourly rates for Study Coordinator time • Draft budget modified per type of protocol, discussions • Use budget for negotiation with sponsor
- 12. Payment Schedule • Partof Clinical Trial Agreement • Startup payments, non-refundable • Pro-rated payments during project correspond to effort • Have good cash flow during project
- 13. Feasibility after Budget Negotiations •Is negotiated amount sufficient • May be a deal breaker • Site may decide to take on project anyway
- 14. Project Implementation Phase •Feasibility has been determined • Continue with contract review, IRB and regulatory submissions, and clinical setup simultaneously
- 15. Contract Review • Draftcontract provided by sponsor • Budget is part of contract • Use templates for standard language
- 16. Standard Contract Language •Publication Restrictions, Intellectual Property • Indemnification • Confidential information and HIPAA
- 17. IRB/Regulatory Submissions • Uselocal IRB • Research Privacy Board • Regulatory documents submitted to Sponsor/CRO • Copies of submissions kept in study files
- 18. Informed Consent Document •21 CFR 50 and 45 CFR 46 • Use lay language and appropriate reading comprehension level • Template usually provided by sponsor
- 19. IRB Review • PIpresents protocol to local IRB • IRB issues a modification request letter • Consent Form modifications are first approved by the Sponsor • IRB approval letter is issued
- 20. Regulatory Submissions • FDAForm 1572 • Protocol signature page, financial disclosures of investigators • IRB member roster and OHRP assurance • IRB and RPB approval letters
- 21. Clinical Setup • GoodClinical Practice Guidelines • Standard Operating Procedures • Recruitment plan for study • Site Initiation
- 22. Site Initiation • Governmentmandate to study sponsor • On-site initiation or Investigator’s Meeting • CRFs and study procedures discussed in detail
- 23. On-Going Study CoordinatorDuties • Subject screening, enrollment, scheduling, and CRF completion • Monitor visits • IRB and AE submissions • Regular meetings with PI
- 24. Study Close-out • Close-outvisit by monitor • Return of supplies and study drug • Inform the IRB of closure • Final data completion and query resolution
- 25. Study Project Payments •Startup fees upon contract execution • Per-subject, per-visit payments at intervals during project • Some payments must be invoiced separately • Final payment upon query resolution of all data