Adverse drug experience events submitted from the sponsor NEED NOT be reported to the Committee on Use of Human Subjects if they fall into the following classification:

1. Adverse experience reports that are definitely not related to participation in the study.
2. Adverse experience reports that are probably not related and have no impact on the local study site.
3. Adverse experience reports that are already disclosed in the consent form. The severity and frequency of the specific event must be consistent with the description in the consent form.

Adverse drug experience events that MUST BE reported to the Committee on Use of Human Subjects that fall into the following classification:

1. All adverse experience events that occurred with subjects enrolled at local study sites.
2. All adverse experience events that are possibly or probably or related, unexpected and not disclosed in the consent form.
3. Adverse experience events whose occurrence is more severe or frequent than described in the consent form.
4. All annual summary reports from the sponsor, e.g. Investigator's Brochures.

This policy is designed to ease the burden of reporting adverse experience events. The Committee on Use of Human Subjects will conduct periodic in-house site reviews of research files in the investigator's office to ensure that these guidelines are correctly interpreted. Such reviews will receive a two (2) weeks notice and apply to all correspondence of research files. Improper or incorrect reporting will receive official documentation and notification of violations of these guidelines.

Questions regarding these guidelines can be directed to the Office of the Committee on Use of Human Subjects at 988-2665.