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Prior
to the submission of a protocol to the IRB or the GAC, any of the
GCRC resources outlined earlier are available for consultation with
an investigator or staff.
Consider the following questions when developing your protocol:
-
Has the research team toured the GCRC and are they familiar with
the resources available?
-
Is the proposed protocol appropriate for the GCRC?
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Are GCRC billing procedures understood by the research team?
-
Is there a need to consult with the GCRC biostatistician on study
design or data analysis?
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Is there a need to consult with research bionutritionist?
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Are there patient care or clinical issues that should be discussed
with the nursing staff, (e.g. special needs of the patients to
be enrolled)?
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Do you have informed consent form?
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Do you have Patient Safety Monitoring Plan
plan in your protocol?
- Notice
of required education: As of October 1, 2000, all key
personnel involved in human research protocols must receive relevant
training. "Key personnel" in this context is defined
as those involved in the deign and/or conduct of the study. To
schedule for this training, please contact the IRB office.
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