Site Interest Letters & Questionnaires
When study sponsors are recruiting sites to participate in their research studies, they will often send out interest letters and/or questionnaires to potential sites. The sites that they approach are often sites that the sponsor or coordinating center has worked with before or through other recommendations.
When a site interest letter or questionnaire is received, it is usually accompanied by a brief protocol synopsis. In other cases, it could be sent with a Confidentiality Disclosure Agreement (CDA) and full protocol.
Site questionnaires are to be completed by sites in a relatively short amount of time and are meant to provide basic information to the study sponsor in order for them to perform a cursory evaluation of the potential site. Often the questionnaires request basic demographics such as investigator, sub-investigator, study coordinator, and pharmacy information, as well as details of the institution’s IRB. Questions specific to the therapeutic area being studied and expected enrollment numbers may often be requested, too.
When data elements are requested, such as expected enrollment numbers, it is preferred that true numbers obtained via the Information Warehouse (IW) should be used rather than making an educated guess. The IW can provide preparatory to research data through their Honest Broker Protocol that will allow the researcher to complete the questionnaire and also assess feasibility of the study at the site.