The investigator is expected to maintain all documentation required by the sponsor of the study including case report forms and all other clinical site documentation.

The investigator is expected to maintain all correspondence from the MHIRB and copies of all correspondence sent to the MHIRB. The investigator is responsible for ensuring that all correspondence has the accurate study number, title and information. The documentation between investigator and MHIRB includes, but is not limited to:

• The PI's submittal of the protocol and informed consent form to the MHIRB
• The MHIRB's notification to the PI of approval of the protocol and informed consent
• The PI's notification to the IRB of amendments and revisions to the protocol, and, where appropriate, of changes to the informed consent resulting from these amendments and revisions
• Proposed subject recruitment advertisements sent to the IRB by the PI
• The PI's notifications to the MHIRB of any serious adverse events that occurred while subjects were on study at that site
• The PI's notifications to the MHIRB of announcements by the sponsor that address adverse events at other investigative sites
• Annual reports and any other reports of study progress sent to the MHIRB by the PI
• The PI's notifications to the MHIRB of study close-out and final report
• Copies of the PI's promptly submitted written responses to any MHIRB requests for changes to an informed consent, more information about an adverse event, the investigator brochure, or other data
• A list, obtained by the PI, of MHIRB members and their affiliations, which has been checked to establish that the MHIRB is properly composed
• The investigator is expected to forward copies of any regulatory violations correspondence from the sponsor, monitor or associated agencies to the MHIRB in a timely manner. Regulatory violations are those variances from the protocol that increase the risk to the research subject and/or cause or lead to harm to the research subject.