Clinical Trial

Project
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