Clinical Research Site Information Sheets and Investigator Selection

Site Information Sheets: Site Study and PI SelectionAs a clinical research associate  or monitor, you may be called upon to help in the selection of suitable clinical study sites and principal investigators for your study. This is no easy task, but if you have a good head on your shoulders and know what to look for and where to look for it, you should have no problem getting this task accomplished. There are so many things that need to be considered to accomplish this task, and this article will give you some tips to get you on the right track.

 

How well do you know the clinical trial protocol?

The clinical trial protocol is the master document for the study. If you don't know the study's thereapeutic focus (cardiac? oncology? hypertension?, etc.), you'll have a hard time compiling information about your potential sites. Once you  have a solid understanding about the study at hand and its therapeutic focus, you are ready to start compiling information about your potential sites. Here is the crucial next steps.

Draft a Site Information Sheet for Each Potential Site

This part of your task serves the purpose of gathering information on each potiential site to see if the site would be a good match for the clinical study. A site selection information sheet document may contain the following:

1. General Site Information

  • Site name and address
  • Name of principal investigator (s) at the clinical site
  • Web address, telephone and fax numbers of the clinical trial site
  • Clinical coordinator (s) and other personnel at the clinical trial site
  • Type of IRB: local vs. central 

Next: Facilities, Equipment, Capabilities, and Therapeutic Areas of the Site

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