ABSTRACT
In addition to visits to the study site, the Monitor will keep informed about a site's progress concerning study activities with regular telephone contacts. The Monitor will document the content of these discussions for topics of substance. This includes, but is not limited to the following: l. Questions regarding eligibility (inclusion/exclusion criteria); 2. Significant problems, issues, or deviations from the protocol; 3. Resolution to any significant outstanding issue; 4. Any conversation pertaining to the site possibly or actually breaking the blind; 5. New information regarding changes in site personnel or facilities; 6. Discussions resulting in protocol-specific education, including process changes; 7. Any information regarding an Serious Adverse Experience (SAE); and 8. Specific requests for regulatory documents. The initial request for documents does
not have to be documented in a Telephone Contact Report; however, if multiple requests for the same document(s) are made, a Telephone Contact Report should be written to document the repeated attempts.
