Site selection for a clinical study is a very important task. The quality of selected sites will be reflected in the clinical data, quality, recruitment rate and compliance. Here is the step-by-step guide for an objective site selection based on data (not emotions).

1. SITE SELECTION METRICS
Kunal Sampat
Senior Manager, Clinical Affairs
Abbott Vascular
BEST PRACTICES FOR
SPONSORS AND CROS

2. SITE SELECTION
METRICS:
BEST PRACTICES
FOR SPONSORS
AND CROS
Determine key metrics
to make informed site
selection decisions
Gather, analyze and
present site selection
metrics to the cross-
functional teams
responsible for site
selection
Utilize feasibility
questionnaires to make
site selection decisions

3. THREE PRIMARY
GOALS FOR ANY
STUDY
1. Quick recruitment
2. High quality data
3. Regulatory compliance

4. WHAT TYPE OF SITES CRO/SPONSOR WANTS?
Start-up is quick Able to enroll qualified patients
Data quality meets or
exceeds our expectations
Grant amount represents fair
market value

5. WHAT METRICS SHOULD WE FOCUS ON THEN?
Research Coordinator Experience
Protocol Deviation Rate (Major)
Eligibility
Informed Consent
Late SAE reporting
Protocol Deviation Rate (Minor)
Follow-up compliance
Prior audit outcomes
Prior experience on other sponsor trials
Site responsiveness
Ability to speak English
Patient enrollment rate
Data entry compliance (% incomplete forms)
Master Service Agreement
Frequency of IRB/ Ethics Committee meeting
SITE PRINCIPAL INVESTIGATOR
Podium experience
Time to supervise the study
Geographical influence
STUDY-SPECIFIC
Ability to perform blinded visit
Ability to perform remote monitoring
Other

6. SITE SELECTION PROCESS
11. Create a spreadsheet with your site selection criteria as column headers
2. Email key stakeholders for site nominations - commercial, medical affairs,
3. clinical affairs, study PI and others
4. Populate the spreadsheet with site nominations
5. Input site metrics from 1-3 most recent or similar studies
6. Use EDC and CTMS as your source
7. Conduct site selection meeting to identify potential sites
8. Ask “selected” sites to complete feasibility questionnaire or call
9. Conduct sites for in-person or site assessment
10. Appoint study manager to review feasibility questionnaire and
assessment data
11. If no issues, “invite” site
12. Notify key stakeholders prior to or after site invitation

7. SITE SELECTION EFFICIENCY TIPS
Conduct site selection in phases (by country, region, 10-20
sites at once etc.)
Accept unlimited site nominations so everyone feels heard
Determine who is ultimately accountable for site selection
Ensure you have a system to follow-up with non-responsive
sites
Avoid multiple countries to avoid regulatory hurdles
Conduct country selection prior to site selection
Vet out every feasibility question, only ask what’s critical.
Don’t overwhelm sites
Set different weighting for each site selection criteria

8. WHY USE FEASIBILITY
QUESTIONNAIRES OR CALLS?
Weeds out unresponsive or uninterested sites
The act of completing a feasibility increases site commitment
Allows you to capture therapeutic data at the site level

9. THANK YOU
TEXT "CLINICAL" to "44222
clinicaltrialpodcast.com