C. Study team (PI, Co -PIs, co investigators, study coordinator) will adhere to the following requirements and responsibilities issued by the USAMRMC ORP HRPO: 1) The protocol will be conducted in accordance with the protocol submitted and approved by the USAMRMC ORP HRPO and will not be initiated until written notification of approval of the research project is issued by the USAMRMC ORP HRPO. 2) Accurate and complete study records will be maintained and made available to representatives of the US Army Medical Research and Material Command as part of their responsibility to protect human subjects in research. Research reco rds will be stored in a confidential manner so as to protect the confidentiality of subject information. 3) The knowledge of any pending compliance inspection/visit by the FDA, PHRP, or other government agency concerning clinical investigation research, the i ssuance of Inspection Reports, FDA From 483, warning letters, or actions taken by any Regulatory Agencies, including legal or medical actions, and any instances of serious or continuing noncompliance with the regulations or requirements will be reported immediately to USAMRMC ORP HRPO. 29.