CLINICAL TRIAL PROJECT MANAGEMENT

1. Clinical Trial
Project
Management

2. Standardization
• Saves time and money
• Use flowcharts, check sheets, and
templates
• Key in reducing project risk

3. Flexibility
• Flexibility needed for differences in projects
• Situations will arise during projects

4. Marketing the Site for 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
• Notification of 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 Receiving Full 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
• After receiving full protocol
• Include all affected parties
• Use draft budget and meeting agenda as
discussion tools

10. Study Budget
• Internal budget 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
• Part of 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
• Draft contract 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
• Use local 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
• PI presents 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
• FDA Form 1572
• Protocol signature page, financial
disclosures of investigators
• IRB member roster and OHRP assurance
• IRB and RPB approval letters

21. Clinical Setup
• Good Clinical Practice Guidelines
• Standard Operating Procedures
• Recruitment plan for study
• Site Initiation

22. Site Initiation
• Government mandate to study sponsor
• On-site initiation or Investigator’s Meeting
• CRFs and study procedures discussed in
detail

23. On-Going Study Coordinator Duties
• Subject screening, enrollment, scheduling,
and CRF completion
• Monitor visits
• IRB and AE submissions
• Regular meetings with PI

24. Study Close-out
• Close-out visit 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