Data and Safety Monitoring Services
A Division of Western Institutional Review Board
3525 Seventh Avenue, SW · Olympia, WA 98502-5010
(360) 252-2443 · Fax (360) 252-2490
WIRB provides data and safety monitoring services.
These services vary depending on the scope of individual needs. This may include the establishment of data and/or safety monitoring committees; Data Monitoring Committee (DMC), Data and Safety Monitoring Board (DSMB), or Safety Monitoring Committee (SMC). The services offered include charter development based on the FDA Draft Guidance for Clinical Trial Data Monitoring Committees and applicable NIH Policy for Data and Safety Monitoring, committee member selection and training, and administrative support (including meeting scheduling, scribing of minutes and record retention).
The membership includes individuals who collectively have the relevant expertise and knowledge of clinical trial design, conduct, and interpretation of data. Data and Safety Monitoring is established upon request for a single protocol or a group of protocols for the same product and indication, and serves as an independent advisor to the sponsor. The Committee will operate for the life of the research to provide a confidential and unbiased review of study progress and safety data.
A sample request for Data and Safety Monitoring Services may include the following elements:
Planning Meeting
A planning meeting and/or teleconference to be held between the Sponsor representatives and the Committee is strongly recommended in order to define operations, relations and responsibilities.
Development of the Charter
Data and Safety Monitoring Committees are required to operate according to a charter, which is developed based on the relevant guidelines, the protocol, and the Sponsor's requirements.
Initial Review Meeting
Committee meetings may include open and closed sessions. The sponsor representatives may participate in the open session; the closed session is restricted to Committee members and Data and Safety Monitoring Services staff and may include the review of unblinded data. The format of the sessions is predefined in the charter. Open and closed sets of minutes are recorded. The sponsor receives a copy of the minutes and a committee report after each meeting.
The FDA recommends that initial meetings be held in person, but it is not required. Initial meetings by video or teleconference can be arranged. The initial meeting consists of an organizational session in which members discuss the operation of the Committee and training materials, and review the protocol.
Data Review Meetings
The Committee meets periodically according to a predefined schedule to review study progress and predetermined data. The Committee has the ability to convene quickly in the event of unexpected events.
The Committee makes recommendations regarding the safety profile of the research, study progress and quality of data.
Data and Safety Monitoring Services provides administrative support for the meetings to include:
- Timely scheduling of the meetings (open and closed sessions)
- Obtaining confidentiality agreements, conflict of interest statements, Committee members Curriculum vitae and other relevant member documents
- Preparation of the agenda
- Preparation and distribution of meeting packets including review documents and training materials (Charter, guidelines, SOPs)
- Preparation of open and closed meeting minutes
- Preparation and distribution of reports on Committee recommendations
- Retention of records until study termination (study charter, amendments, study protocol and monitoring plan, study data and safety summaries, minutes of each meeting, Committee reports and recommendations)
For additional information, contact details are listed below.
Assistant Vice President, New Business Development
Phone: (360) 252-2443
Fax: (360) 252-2490
E-mail: lmorrison@wirb.com
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