Feasibility Assessment – CTIU

Prior to starting an industry-sponsored study, the investigator and/or their department should evaluate the study on the basis of the research interests of the individual investigator and the perceived availability of research participants. Another part of this evaluation should include the administrative feasibility of conducting each trial.

Below are just a few of the general questions investigators should be asking:

  • Am I adequately staffed to conduct all study activities?
  • Will extended staff hours or weekend hours be required?
  • Are there enough potential participants I can recruit to meet the sponsor’s expectations?
  • When is the sponsor expecting me to start the study and will I be prepared in time?
  • Who will be negotiating and approving the final budget?
  • Does the sponsor require specific training for the study?
  • Does the sponsor require equipment and site qualification, and if so, is it compatible with our current standards?
  • Who will ensure regulatory compliance on my behalf?

The Clinical Trials Innovation Unit (CTIU) strongly recommends using the Feasibility and Study Planning Guide to assess these questions and all other applicable sections for study feasibility.