Protocol
Deviation Reporting
Protocol
deviations occurring during study conduct can represent a change
in study design and therefore must be promptly reported to Goodwyn
IRB. When a significant deviation occurs, complete the deviation
report and forward it with any associated documentation to Goodwyn
IRB.
Please
note the following definitions:
Protocol
Deviation: Any change in the conduct of a research
study not recorded in an approved protocol or amendment.
Significant
Protocol Deviation: Any change in the conduct
of a research study that significantly affects the safety of the
subjects or the scientific quality of the study. For instance:
- Enrollment
of patients that do not meet the eligibility criteria for the
trial
-
Study procedures - in particular procedures in place to
monitor safety - are not performed or significantly delayed.
- Failure
to obtain informed consent prior to conducting any study procedure.
- Failure
to administer and/or account for study drug as described in
the protocol.
Deviation
Report Form
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