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| § |
Amendments
should be filed when changes
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or
additions are necessary between the
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required annual renewals
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| § |
Amendments
frequently take the form of a
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one-page
letter submitted on line through
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RASCAL
with the revised item: protocol,
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consent
form, questionnaire, new study
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staff
names attached
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| § |
Amendments
that do not change the risk
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status
of the protocol may qualify for
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expedited
review
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