Site visits need to be disciplined and organized with the organization taking place before the monitor leaves his or her office. This includes reviewing all previously submitted forms to see if they have been completed unambiguously. (See also under the heading "quality control" in the next chapter.) Too frequent use of "other and unspecified" categories should be a red flag. The frequencies of adverse events, missing forms, and patient withdrawal should be compared with those at other study sites.
I recommend each visit include a sit down meeting with the investigator and/or the site coordinator whether or not there are problems. The purpose of such a meeting is primarily motivational, to share with the investigator information concerning the overall status of the project. Of ongoing concern is the priority the investigator is giving to your clinical trial—it cannot be allowed to drop off his or her viewing screen. Additional compensation should be provided (tickets to movies or sports events, or a restaurant gift coupon) on an ongoing basis to the individual(s) responsible for data entry at each site.
Visits should rarely be made on a fixed frequency to a given location. A site should be visited more frequently and the stay be of longer duration if the site is new to the study or has a prior history of problems.
At least one visit should be made simply to ensure that
• Assignment to treatment is adhered to—in inadequately monitored single-blind studies, physicians have been known to ignore the treatment assignment from day 1.
• Treatment procedures are adhered to.
• Data recording methods are adhered to.
• Informed consent forms are administered correctly.
• Samples and specimens requiring off-site review are dispatched promptly.
Sites with novice investigators, lagging enrollment, delays in submission of informed consent and other forms, and or exceptional frequencies of adverse events should be visited more frequently.
The project manager needs to oversee the monitors' schedules; personality conflicts are not unknown and there is a natural reluctance on anyone's part to return to an area where a hostile reception is anticipated.
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