Clinical Trial Project Management

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