This presentation is part 3 in a 3 part series of presentations on optimizing the clinical start up activities.

1. Optimizing Start-up Activities to Decrease
Your Study Timeline
Part 3: Prequalification

2. Areas of Focus
• Part 3 - Prequalification

3. Decision-making process
• Consider these personal examples:
– Have you ever hired based on a CV and phone
interview?
– Have you bought a car without taking it for a test
drive?
– Have you bought a house from the information on
www.realtor.com without an inspection?
• Why select sites without a test drive?

4. Prequalification Agenda
• Meet the Enrollment Drivers
• Tour the Facilities
• Consider the “Not So Hidden” Agenda
• Trip Report

5. Meet with the Enrollment Drivers
• What should you expect?
– Typically 1 FTE = 4.3 studies1
– Study Coordinators report that one to six studies
is manageable
• Over 50% of the respondents were working on 7 or
more studies2
– How long have they been at the site?
• Staff turnover = lower patient adherence3
• If you can’t identify the Enrollment Driver, you may have identified a
potential problem.
1- Neuer A. 2002. The rising tide of CRC workload and turnover. The CenterWatch Monthly; 9(8):1-5.
2 - Duane, C. 2007. Study Coordinators’ Perceptions of their work experiences. Monitor: 39-42.
3 – Harris Interactive. 2004. “Most Physicians Do Not Participate in Clinical Trials Because of Lack of Opportunity, Time, Personnel Support
and Resources. Health Care News 4(9):1-8.

6. Meet with the Enrollment Drivers
• The Study Coordinator
and Appointment
Scheduler
– What is their time
allocation to research?
– 87% of sites surveyed
were devoting 50% or
less to research. 4
• What are their other
commitments (research
and clinical)?
4 – Graziosi A. 2010. Investigator Site Survey, Applied Clinical Trials
Research Utilization
5-25%
67%
26-50%
20% 51-75%
8%
>75%
5%

7. Tour the Facilities
• Confirm the expected
– Device Storage, study binders, sample freezers,
technology, etc.
• Check for the unexpected
– Take the “Patient Tour”
• Ask to experience the patient visits per the protocol
• Are they located close to support services (imaging, labs, etc.)
This provides a patient-centric perspective and
useful data on the site and your protocol

8. The “Not So Hidden” Agenda
• Get there early
– How does the site welcome you?
– How are patients treated?
• Are they given attention? Viewed as a burden?
– How does scheduling/follow-up occur?
• Assess the intangibles of the facilities
– Are the research coordinators at the facility?
• How are potential patients identified?
• How are they approached about the study?
• How accessible is the Investigator for Coordinator or Monitor
questions?
– Is there designated monitoring space?
– How will the source documents be provided for monitoring?
• Confirm the data
– Enrollment rate / Query rate for the indication

9. Trip Report
• Ensure congruency between the study requirements and the
prequalification visit outcomes
• Discuss any red flags identified and their potential impact
• Add sites with longer lead times or short-term resource
constraints to the “contingency pool”

10. Prequalification Costs
• Direct costs
• Staff*= $960
• Travel**= $1500
• Total= $2460/visit
• * - Staff costs assumes a CRA II ($60/hr salary and benefits) utilized for a one day visit and one day for administrative preparation
(agenda / document preparation) and trip report completion.
• **- Travel includes a 1 day visit with an overnight accommodation, meals, rental car, mileage and airport parking
• Site Initiation costs= $30,0005
• By reducing the number of non-performing sites by 5%:
5- Li, G. 2010. Planning the Right Number of Investigative Sites for a Clinical Trial. Monitor: 54-58.

11. Optimizing Start-up Activities to Decrease
Your Study Timeline
For more information or to schedule a
discussion, contact us at:
info@emergentclinical.com