CLINICAL TRIAL PROJECT MANAGEMENT
-
Upload
rohit-patel -
Category
Health & Medicine
-
view
825 -
download
27
Transcript of CLINICAL TRIAL PROJECT MANAGEMENT
Clinical TrialProject
Management
Standardization
• Saves time and money
• Use flowcharts, check sheets, and templates
• Key in reducing project risk
Flexibility
• Flexibility needed for differences in projects
• Situations will arise during projects
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
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
Project Setup Procedure
• Can be standardized for most projects
• Early feasibility determinations made
• Assures minimum time and effort spent on an infeasible project
Feasibility after Receiving Full Protocol
• First team feasibility assessment
• Can more accurately determine potential subject population
• Pharmacy issues
• Logistical issues of facilities, manpower
Site Evaluation Visit
• Receive letter from CRA outlining requirements
• Schedule time with all affected study site personnel
• Host the visit by accompanying the CRA
Team Meeting
• After receiving full protocol
• Include all affected parties
• Use draft budget and meeting agenda as discussion tools
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
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
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
Feasibility after Budget Negotiations
• Is negotiated amount sufficient
• May be a deal breaker
• Site may decide to take on project anyway
Project Implementation Phase
• Feasibility has been determined
• Continue with contract review, IRB and regulatory submissions, and clinical setup simultaneously
Contract Review
• Draft contract provided by sponsor
• Budget is part of contract
• Use templates for standard language
Standard Contract Language
• Publication Restrictions, Intellectual Property
• Indemnification
• Confidential information and HIPAA
IRB/Regulatory Submissions
• Use local IRB
• Research Privacy Board
• Regulatory documents submitted to Sponsor/CRO
• Copies of submissions kept in study files
Informed Consent Document
• 21 CFR 50 and 45 CFR 46
• Use lay language and appropriate reading comprehension level
• Template usually provided by sponsor
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
Regulatory Submissions
• FDA Form 1572
• Protocol signature page, financial disclosures of investigators
• IRB member roster and OHRP assurance
• IRB and RPB approval letters
Clinical Setup
• Good Clinical Practice Guidelines
• Standard Operating Procedures
• Recruitment plan for study
• Site Initiation
Site Initiation
• Government mandate to study sponsor
• On-site initiation or Investigator’s Meeting
• CRFs and study procedures discussed in detail
On-Going Study Coordinator Duties
• Subject screening, enrollment, scheduling, and CRF completion
• Monitor visits
• IRB and AE submissions
• Regular meetings with PI
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
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