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A.3. Subcommittee Agendas: Committee meetings are most efficiently directed by specific topics of
discussion. Each topic is defined by specific action items (challenges or barriers) to implement the issue being
discussed. Each specific action item in turn should be assigned to one or more individuals for follow-up. All of
this activity should be documented using specific written formats. In this regard we have supplied the following
example agenda formats for each subcommittee that can be refined at their discretion (Appendix IV):
Executive Subcommittee – responsible for overall harmonization of all other subcommittee actions
• Informatics Subcommittee Meeting
• Biospecimen Subcommittee Meeting
• Operations Subcommittee Meeting
• Quality Control Subcommittee Meeting
• Regulatory Affairs Subcommittee Meeting
• Strategic Planning Subcommittee Meeting.
A.4. Coordination of Committee Meetings: The TRI Administrative Manager will be responsible for
coordination of all meetings. Responsibilities include:
1) Plan and conduct Committee Meetings – 1) Establish location for meeting, and make necessary
arrangements for conference facilities and accommodations for participants, and 2) Prepare draft agenda and
distribute for comment/additions.
2) Minutes - Prepare and distribute minutes, including a list of Action Items to be carried out.
A.4. Quality Assurance by On-Site Compliance Review: The PI of the TRI and other select TRI faculty and
staff will visit each Network Site 2 times per year. The initial one or two visits will be instructional and serve to
answer any questions about SOPs. As procedures become routine during the latter part of the first year these
visits will serve as an on-site compliance review. The PI will develop a checklist of compliance parameters and
the Network Site will receive a formal written report at the end of year 1, mid-year 2 and mid-year 3. This
process will function in a manner similar to the CAP Laboratory Accreditation Program whereby the Network
Site will have prior written documents describing a list of compliance items to be reviewed. Items on this list will
be graded from minor to major violations. An example of a major violation would be failure to procure the
minimum number of samples that pass quality control review. An example of a minor violation would be failure
to completely annotate specific data for a given sample. The Coordinating Committee will be responsible for
developing a series of strategic changes as a result of a maximum number of minor or major violations by any
Network Site.