Selecting outstanding sites is the key in running a well-controlled clinical trial.  Failure to identify outstanding sites could result in added costs and could lead to delays in bringing much needed products to the bedside.  Investing upfront time in the selection process could yield a positive return.  Today’s clinical research landscape typically allows for minimal resources under tight timelines, requiring sponsors to quickly, yet effectively, decide which sites are the right fit for the job. Selecting sites is the responsibility of the sponsor as outlined in ICH-GCP 5.6.1, 21 CFR 812.43, 21 CFR 312.50, and ISO 14155:2011(E). There is not a great deal of detail in these regulations to provide further guidance to sponsors. It is truly the sponsor’s responsibility to take the time at the start of the study to carefully examine potential sites and ask important questions during the review process.