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Role of the Chairs
Each committee chair is provided with an information and policy package
which explains in detail the responsibilities of the position. The following
is a summary of that document.
1.5.4.1 - Disease Site Committee Chair
The Disease Site Chair is appointed by the Director in consultation with
the Clinical Trials Committee and the Site Committee. The appointment is
for a three-year term, renewable to six years; in rare cases, a third renewal
to a total of nine years will be granted.
The Disease Site Chair has a variety of duties, all related to an overall
responsibility to seek to develop an excellent programme of studies within
his/ her site, subject to the constraint that all initiatives must be evaluated
and approved at the Group level by the Clinical Trials Committee and the
Director. Some of these are:
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to evaluate new proposals and to decide, in consultation with the central
office and others as needed, which should be brought to the site committee
for comments on feasibility and scientific merit;
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to generate new ideas, to keep track of developments within the site, and
to recognize and stimulate new study proposals;
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to review selection of site committee composition, and make recommendations
as necessary;
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to appoint, in consultation with the central office and others as appropriate,
study chairs;
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to assess the need for and suggest site committee meetings in addition
to the annual meeting;
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to chair site committee meetings, i.e. to develop agendas, prepare appropriate
background material, chair sessions, and compose minutes for circulation;
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to represent the Group to external agencies as appropriate, by attending
meetings of other cooperative groups, meetings with industry, and so on;
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to resolve problems within the site committee and ensure the success of
the programme within the site;
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to ensure that the site committee sets clear priorities;
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to prepare an annual report describing the progress and future plans of
the site committee;
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to present the activities of the site committee and defend its track record
before the Site Review Team when the review of the Group and its clinical
trials programme is evaluated.
1.5.4.2 - Trial Committee Chair
The appointment of study chairs is the joint responsibility of the Director
of the Group or the Director of the IND Program and the appropriate site
chair. Generally, the individual most responsible for the genesis of the
trial is offered the position of study chair, but as well considerations
such as track record and qualifications are taken into account.
Duties of the Study Chair are as follows:
prior to trial:
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to write trial protocol with the assistance of central office staff and
trial committee;
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to appoint members of the writing and trial committee;
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to review and approve trial data collection forms;
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to identify essential data for the computerized database;
during trial:
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to adjudicate cases of eligibility, evaluability, response, and outcome
in consultation with central office staff;
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to review the data collection forms of trial patients, at a minimum all
the problem cases identified by central office staff;
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to participate in the formulation of and approve all protocol amendments;
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to assess and resolve problems, as required;
on trial closure:
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to advise the involved senior biostatistician on information needed in
the final analysis;
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to prepare abstracts and manuscripts reporting the overall study results;
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to participate in the selection of co-authors of papers and abstracts,
ensure that the selection process follows Group policies, and adjudicate
differences of opinion with regard to the decisions made.
1.5.4.3 - Other Committee Chairs
The duties of chairs of other committees vary with the objectives of the
committees. Many are similar to those of disease site committees.
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