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Compliance In Focus
Posted by Ashton Steinhagen on Thu, Jul 9, 2015

Site Selection - What to Look For?

Site SelectionSelecting clinical sites for research purposes may be a difficult and seemingly overwhelming task  for a Site_Selectionsponsor.  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?
Given the list above, the sponsor may want to contract out these tasks with companies who focus on clinical research site selection.  Often an undervalued task, site selection can play an immense role in the success of a research study.

What do you think is most important for the sponsor to consider in regards to site selection?

2014 Top FDA Warning Letter Findings | IMARC Research

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Topics: Sponsors, Site Selection, FDA

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