The first meeting generally takes place in an in-person format prior to study initiation and will last approximately 4 hours. Attendees include the PII, the study statistician, the DSMB/OSMB members, the NIAMS officials and the Executive Secretary. Any additional study staff must be approved by the NIAMS officials. The Executive Secretary will gather calendars, facilitate the meeting and distribute study materials that are prepared by the study personnel to the DSMB/OSMB members and NIAMS officials. Travel arrangements for the study staff attendees will be the responsibility of the study staff, per the [grant/contract].
- The DSMB/OSMB members vote to approve the Chairperson appointed by the NIAMS – The Chairperson is responsible for overseeing and leading the DSMB/OSMB meetings. In addition, the Chairperson works with the NIAMS and/or the Executive Secretary to prepare the agenda and summarize the meeting. The Chairperson is the primary contact person for the DSMB/OSMB.
- The DSMB/OSMB members vote to approve the designated Safety Officer (SO) appointed by the NIAMS – Serious Adverse Events (SAEs) should be sent to the designated DSMB/OSMB SO, the NIAMS officials and the Executive Secretary within 48 hours of the event. The Executive Secretary will follow up with the SO, if needed, and inform the PI, NIAMS and the DSMB/OSMB Chair what action, if any, has been recommended. Please note: Adverse Events will be reported to the DSMB/OSMB in aggregate summaries and listings.
- The PI gives a presentation about the study protocol – The purpose of this presentation is to provide the DSMB/OSMB members with background about the study and explain the basics of the study protocol. Please limit this presentation to 45 minutes to 1 hour.
- DSMB/OSMB members decide on the content of DSMB/OSMB reports – The DSMB/OSMB reviews the reports proposed by the study statistician and PI and provides instructions on what information they would like the study coordinating center/statistical office or statistician to include in future reports. Requirements for an interim analysis, if applicable, will also be determined by the DSMB/OSMB at this meeting. Reporting requirements may be augmented as the study progresses.