Clinical Trial Project Management

1
Clinical TrialProject Management

• Society of Research Administrators
• Georgia-South Carolina Chapter
• March 3, 2006
• Rosemary Biscardi, MBA
• Palmetto Health Research Administration

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 Investigators 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