The IRB/IEC will be kept informed by the Investigator, Sponsor’s monitoring CRO or the Sponsor, as required by national regulations, as to the progress of the study as well as to any serious and unexpected adverse events. 11.3 Patient Privacy In order to maintain patient confidentiality, all case report forms, study reports and communications relating to the study will identify patients by initials and assigned patient numbers; patients should not be identified by name. In accordance with local, national or federal regulations, the Investigator will allow the Sponsor or designee personnel access to all pertinent medical records in order to verify the data gathered on the case report forms and to audit the data collection process. Regulatory agencies such as the US Food and Drug Administration (FDA) may also request access to all study records, i ncluding source documentation for inspection. Clinical information will not be released without the written permission of the patient as outlined in the patient consent form. 12.0 DATA HANDLING AND RECORD KEEPING 12.1 Data to be Entered Directly in the Case Report Form The CRF will be the source record. 12.2 Recording of Data Data collected during the study will be entered in the patient’s Case Report Form (CRF) by the investigational site staff. The staff will keep records of the patient’s visit in the files considere d as source documents for the site, e.g., hospital chart, research chart. The Investigator will be responsible for the recording of all data on the CRF and for submitting the data to the Sponsor or their designee in a timely manner . Should any value be significantly different from normal, the Investigator will comment in the appropriate sections provided in the CRF. The Investigator will provide access to his/her original records to permit a representative from the Sponsor to verify the proper transcripti on of data. To facilitate photocopying, entries must be recorded legibly in black ink only. Erroneous entries will be crossed out with a single line, so as to remain legible. The correct value will be entered above the error and then initialed and dated by the person authorized to make the correction.