b. After appropriate medical intervention has been instituted, the Principal Investigator or his/her designee will be notified within 24 hours. c. File appropriate reports immediately by phone/fax with appropriate agencies, as described above. d. Notify the patient’s primary physician or referring physician within a medically appropriate timeframe, depending on the classification of the adverse event. e. Submit written reports to appropriate agencies. f. Document the adverse event in the patient’s chart, using a progress note to describe the event and treatment, if appropriate. g. File copies of all forms/correspondence relating to the adverse event in the patient’s chart. D. Clinical Trials Monitoring Operational Procedures (Table 3) 1. Clinical Data Documentation a. Monthly monitoring: All patients actively enrolled in the study are seen monthly. Clinical labs are evaluated each month for the devel opment of toxicity (adverse events) related to the vaccine for up to 30 days following the last vaccine. Results are recorded on a clinical lab flow sheet that shows lab values over the course of the study. This document becomes part of the patient chart at the end of the study. Any abnormal lab values are faxed to the patient’s physician and followed with a letter. The Research M.D.