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