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.

Site Start-up

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 leadcra@clinopstoolkit.com.
Thinking About Site Startup
Happy Thanksgiving
About The Author

The Lead CRA

Nadia started The Lead CRA blog in 2007. She is now lead author for ClinOps Toolkit. Nadia is currently working as a Clinical Program Manager at a small specialty pharmaceutical company in the San Francisco Bay Area. You can reach Nadia via email at leadcra@clinopstoolkit.com anytime.

5 Comments

  • Anonymous

    October 11, 2013

    I would like a tracker to document CRA activities. Could anyone send me a template, please? I want to document CRA weekly site contacts and communications. Thanks

  • Anonymous

    January 4, 2013

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

    • Alyn

      August 15, 2014

      It’s great to find an expert who can explain things so well

  • LJN

    May 8, 2012

    Thanks Nadia! Great topic!

  • LJN

    May 8, 2012

    Thanks Nadia…excellent topic!

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