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. Author manuscript; available in PMC: 2021 Jul 13.
Published in final edited form as: Contemp Clin Trials. 2019 Dec 24;89:105918. doi: 10.1016/j.cct.2019.105918
Recommendation Investigators / Delegates Sponsors CROs
At the beginning of the site selection process, provide the draft or completed protocol to potential site teams so that investigators can assess their ability to conduct the protocol and identify any learning requirements. This transparency is crucial to establishing a collaborative approach to identifying qualified investigators and their delegates.
Before the start of the trial, allow site teams to review the protocol and provide feedback on potential feasibility issues or concerns, so that problems can be addressed prior to initiation. In addition, site teams who have previously reviewed a protocol will better understand the protocol requirements once the study begins. This exchange of information is a critical part of the learning necessary for each new protocol and engages the site team in a way that didactic instruction does not.
Complete thorough pre-study visits. To support the recommendations, CTTI has developed a framework of characteristics to help guide the assessment and selection of sites [15].
To prepare for a specific trial, request the protocol—even if only in draft—as soon as a sponsor or CRO contacts the site for possible selection, and assess whether the site and its delegates are adequately qualified and prepared to conduct the trial.
Discuss the assessment findings openly with the sponsor to close any gaps in preparedness. Such transparency and collaboration can help to ensure that the educational resources provided by the sponsor are customized to support the site team’s efforts to meet the specific needs of a protocol and conduct a quality trial.