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Six Startup Questions to Discuss with Planned Sites Before Activation  

Site startup for a clinical trial will always be a challenge. Why? While driving the study forward and gathering cross-functional expertise to operationalize a successful study, site startup is comprised of many unexpected hurdles that may get in the way of meeting clinical development milestones. 

Site activation is not an easy or rapid process. Based on a recent experience where the site was held at a well-known institution, it can take approximately nine months to activate even at such an institution using local Institutional Review Boards (IRB). In this example, the institution required multiple committees to review and grant approval to activate the site. Alternatively, even sites willing to use a central IRB with less committee-required approvals can take an ample amount of time. 

When navigating site activation, the following questions will help you manage approvals and contracts, stay on top of the activation process, and maintain development timelines, all while staying ahead of those common hurdles. 

  1. What approvals will need to be in place for your institution to activate your site
  1. What are the meeting dates for each committee?  
  1. What documentation is required for submission to each of these committees and what is the due date based on each meeting
  1. Can submissions occur in parallel with contract and budget negotiations? 
  1. What other site-specific formalities may be needed to activate? 
  1. Once Site Initiation Visit (SIV) occurs, will the site be able to begin screening or are there any other internal activities that must occur before the site is deemed active?  

The important lesson for site startup is remembering every institution is different, and this understanding requires proper planning. Asking critical questions and providing clear communication with the site from the onset is key to planning and meeting deliverables and helping to enable clinical research success. 

Questions about your site activation? Or curious about how to establish a great site relationship from the beginning? Contact Halloran to discuss your challenges and opportunities. We’re here to support you.