or the P.I. sees each study participant monthly and the following evaluations completed: toxicity evaluation, physical as sessment and adverse events summary (these evaluations are part of the source document that is filled out at each visit). Grade 1 and 2 non- serious and expected adverse events will be reviewed with the P.I. at a weekly clinical trials review meeting. All other adverse events will be reported to the Principal Investigator at the time they become known and reported on further as outlined above in Section C. Each patient chart is audited for completeness one month after enrollment. Each chart is again audi ted for completeness within one month of the final follow -up visit (30 days after the final vaccination). This audit will be conducted by the Research nurse every 3 months and the results will be presented to the Principal Investigator at weekly clinical meetings. The Research Nurse’s chart audit record form is located in the front of each patient chart. Charts are audited for completeness, legibility, and accuracy. All source documents must be filled out completely. The Research Nurse will review all charts for subject recruitment and retention, protocol adherence, follow -up, data quality, and participant risk versus benefit. Additionally, all correspondence with primary physicians and patients is maintained in the patient chart. Copies of email comm unications and telephone logs of verbal communications are maintained.