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The National Eye Institute (NEI) is establishing the following system for the appropriate monitoring and oversight of the conduct of observational studies supported by the cooperative agreement mechanism in order to ensure the safety of participants and the integrity of the data.
The NEI supports complex, large multi-centered and single-centered observational studies as cooperative agreements. When observational studies are conducted under a (U10) cooperative agreement, the NEI assumes a partner role in project activities by providing assistance, advice, and coordination of study activities without assuming the primary directorship of the study. This partnership between NEI and the study investigators is enhanced through the expert guidance provided by a Data Monitoring and Oversight Committee (DMOC), which is constituted to provide advice to both the NEI and study investigators. The overall role of DMOC is to assist the NEI and the study investigators in protecting the interests of study participants and in preserving the integrity and credibility of the study.
The specific role of the DMOC includes providing recommendations to the NEI Director or his designee and the study investigators regarding the following:
The NEI Director or his designee, in consultation with study investigators, is responsible for the establishment of the DMOC and appointment of its members. Study investigators will provide recommendations regarding potential members to the NEI Program Official, and will be consulted during the establishment process.
The aims of the study will dictate DMOC size and the types of expertise required of DMOC members. Membership will usually range from four-to-seven members. Expertise will be sought in the areas of epidemiology, survey methods, statistics, patient advocacy, and clinical expertise. The DMOC Chairperson will have experience in epidemiologic studies.
Any potential conflict of interest or the appearance of a conflict of interest must be documented prior to formal appointment of DMOC members and annually, thereafter. Potential conflicts may arise from interests in commercial products or services, which may be used in or could be affected by the study results. The appearance of conflict of interest may occur when DMOC members have affiliations with institutions that could benefit from the research, and this relationship can be seen as affecting objectivity in regard to study recommendations.
The non-voting members of the DMOC are the NEI Program Official, principal investigator, representatives of the statistical coordinating center; and, as appropriate, representatives of resource centers (i.e. the Photographic Reading Center) or those in a study leadership position. Additional investigators/consultants may be invited to the meetings as required.
The DMOC will meet on an annual basis though often the DMOC may require two meetings in the first year. Conference calls and interim meetings may be scheduled as needed.
The meeting will begin and end with a closed executive session attended by all voting members of the DMOC and the NEI Program Official. At the end of the closed executive session the DMOC Chairperson will verbally communicate the recommendations of the Committee to the study investigators. Adequate attendance, usually two-thirds of non-voting study members, is required.
Two-thirds of DMOC voting members constitute a quorum for voting recommendations. The DMOC should strive to achieve consensus in formulating specific study recommendations. Among those members present, a simple majority vote will define agreement for DMOC recommendations; dissenting and abstaining votes will be noted. DMOC recommendations regarding major protocol changes, regardless of whether these are initiated by DMOC or by the study investigators, will be sent simultaneously in a letter from the DMOC Chairperson to the NEI Director and the principal investigator.
The study investigators will prepare a draft agenda at least three weeks prior to the meeting. The draft agenda will be sent to the DMOC Chairperson and the NEI Program Official for review and comment. Meeting materials will be prepared and provided to the DMOC members at least one week prior to the meeting. Data submitted for review should be timely and of a high quality to allow the DMOC to adequately assess the integrity and progress in the study.
The study investigators will be responsible for preparing draft minutes from each meeting/conference call within 14 days. The minutes will be considered final only after review and approval by the DMOC Chairperson and the NEI Program Official.
This page was last modified in October 2004
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