Selecting clinical sites for research purposes may be a difficult and seemingly overwhelming task for a sponsor. Familiarity with a site might help with selection, but multiple contributing factors can influence whether or not a site is ultimately chosen. Choosing the wrong sites could have a detrimental effect on the study including:
- Financial impact
- FDA audits with resulting in Form 483s or warning letters
- Incomplete and inaccurate data
- Noncompliances
- Subjects at greater risk for harm
Often, a sponsor can assess how well a site may conduct themselves during the study based on the site’s communication with the sponsor. Communication and the timeliness of responses can demonstrate the engagement and interest of a site. Other contributing factors to consider when selecting a site can include:
- Investigators and research coordinators:
- How experienced are they with this particular investigational product and therapeutic area?
- Do they have the time and resources to commit to the study?
- Proximity to sponsor – is the site easily accessible for sponsor and monitoring visits?
- Population – does the site have the appropriate patient population to potentially enroll?
- Previous experience with the site – if so, was this interaction positive or negative?
- Certifications – are they any necessary certificates that the site already maintains?
- Prior FDA audits and their outcomes
- IRB processes:
- Is the site using a central or local IRB?
- What is the typical turnaround time for full IRB approval?
- Facilities available – are these adequate?
- Number of other studies being conducted – are any of these competing?
What do you think is most important for the sponsor to consider in regards to site selection?
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