The accuracy and organization of data collection for study patients is of utmost importance. Monitors should attempt to determine how a site manages data, and possibly provide input and recommendations to the site so that data collection will occur in a timely and organized fashion.

Medical Chart Set-up: It would be helpful for the monitor to know how a site operates and what to expect. Monitors may be able to help a site better organize their records system to adequately document the study conduct.

Filing Specifications: In order to effectively monitor a study, it is important to have a strong understanding of a site's handling of data. Determine whether there are specific filing specifications unique to the site that could cause problems with regard to data collection. For example, some sites may file an informed consent form in a patient's chart, and medical records may discard the consent because it does not have an authorized number.

"Study Only" Patients: Certain studies draw patients to a site who are not regular patients of the practicing physician. When that is the case, it is important ensure that these patients' medical history is accurate and complete. It may be a good idea to ask the investigator to request a letter from patients' primary physician stating what are their current medical conditions and medications.

CRF Completion: Monitors need to identify who at the site will be responsible for CRF completion and how often it will be done. It is important that site personnel complete CRFs as soon as possible following a patient visit. It may be helpful to determine whether site staff will have adequate time to complete CRFs within a reasonable period of time.