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Objectives and Obligations
In the process of developing, conducting, and analyzing its studies, the
Clinical Trials Group assumes the following responsibilities to participating
investigators across the country:
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to subject proposals for new studies to a fair and expeditious review with
respect to their scientific merit and feasibility;
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to provide methodologic and technical assistance in the development of
study protocols and in the assessment of feasibility;
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to ensure that all information in its possession relevant to carrying out
a treatment protocol or to obtaining informed consent is made available
to investigators;
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to obtain approval of all its protocols by the appropriate Ethics Committee
(Institutional Review Board) at Queen's
University;
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to maintain accurate and timely data files on all patients entered on studies;
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to monitor protocol compliance and treatment toxicity and to report to
participating investigators any unexpected or unexpectedly severe adverse
effects of protocol therapy;
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to preserve the confidentiality of all patient data in the manner specified
in individual protocols and in consent forms;
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to carry out timely and statistically correct data analyses at the frequency
specified in study protocols.
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