Trial board definition

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What Are the Limitations of a Trial Balance? Get Program Details. Once a study is implemented, the DSMB should convene as often as necessary, but at least once annually, to examine the accumulated safety and enrollment data, review study progress, and discuss other factors internal or external to the study that might impact continuation of the study as designed.

Meetings may be held by conference calls or videoconferences or as face-to-face meetings. Open Session : Issues relating to the general conduct and progress of the study are discussed including adverse events and toxicity issues, accrual, demographic characteristics of enrollees in aggregate, disease status of enrollees if relevant , comparability of groups with respect to baseline factors, protocol compliance, site performance, quality control, and timeliness and completeness of follow-up.

Any data provided must be presented without grouping by treatment assignment or otherwise by preserving the masking of all subjects. Outcome results are not generally discussed during this session.

The lead investigator and the study biostatistician should be in attendance in order to present results and respond to questions. This session is open to study investigators, coordinating center staff, representatives for industry collaborators, representatives from the Food and Drug Administration FDA , if applicable, and NIDCR program and regulatory staff. Closed Session : Grouped safety data and, if appropriate, efficacy data are reviewed with the study statistician s available for consultation at this session.

Grouped data should be presented by coded treatment arm. This session is normally attended only by voting members. This final session involves only DSMB voting members to ensure complete objectivity as they discuss outcome results, make decisions, and formulate recommendations regarding the study. A brief summary that describes the individual findings, overall safety assessment and DSMB recommendations will be the responsibility of the Chair and forwarded to NIDCR within one week of the meeting.

A quorum, as defined by the DSMB in the initial meeting, must be present either in person or by conference call. After a thorough discussion of DSMB members' opinions and rationale and an attempt to reach clarity regarding individual recommendations, the final recommendations of each DSMB member should be solicited during the Closed Session. A consensus opinion or recommendation among members is not required; each member may have individual opinions.

The final recommendations are recorded and either identified as majority or minority positions or are accompanied by actual vote tallies for each divergent recommendation, i. It is the responsibility of the PI to ensure that the DSMB is apprised of all new safety information relevant to the study product and the study. Summary safety and enrollment data should be forwarded periodically to the DSMB as described in the Charter. The DSMB should receive all protocol revisions and may receive other documents relating to the study.

Reports are prepared by the study statistician s. The study statistician should provide suggested formats or templates for data presentation for the initial meeting of the DSMB.