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Monday, April 16, 2012

Site Startup Series

Welcome to The Lead CRA Blog Site Startup Series.  This course of blog posts is designed to step you through the various activities of launching a clinical trial site.

What are the regulatory requirements before recruitment can begin? What are typical sponsor requirements? How do clinical trial sites even get chosen? These topics and more, demystified in the series below:
  • What are the typical milestones of site startup?
  • Metrics, trackers, reports, and dashboards
  • What is feasibility? How do sponsors choose which clinical trial sites they work with?
  • What is an essential document package and a regulatory submission?
  • Informed Consent Form templates
  • Why do contracts take so long? How are they complicated?
  • Site Budgets
  • IRB submissions
  • Calculating Investigational Product needs
  • Providing study supplies and source documents
  • Ensuring sites are adequately trained and prepared to participate
  • Developing Investigative Site Patient Recruitment Plans
  • What correspondence goes in the Trial Master File?
  • Gating tasks...bottlenecks
  • Lessons learned, where did the process breakdown?
  • How to speed up site startup?
Are there other questions or topics that you would like me to cover related to site startup? Please leave me a comment or drop me an email at


LJN said...

Thanks Nadia...excellent topic!

LJN said...

Thanks Nadia! Great topic!

Anonymous said...

What do one do before and during siv including documents you should collect for tmf/tracking.

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