What counts as a protocol violation?

A protocol violation is an accidental or unintentional change to the IRB-approved protocol procedures without prior sponsor and IRB approval. Violations, as opposed to simply deviations, generally affect the subject’s rights, safety, welfare, and/or the integrity of the resultant data. Examples of protocol violations include (not an exhaustive list): Informed consent obtained after the initiation [...]

What counts as a protocol deviation?

A protocol deviation is an incident involving noncompliance with the protocol, but one that typically does not have a significant effect on the subject’s rights, safety, welfare, and/or the integrity of the resultant data. Deviations may result from the action of the participant, investigator, or staff. Examples of protocol deviations include (not an exhaustive list): [...]

What should I do if I learn of an adverse event?

It is important that serious adverse events (SAEs), adverse events (AEs), or other unanticipated problems be reported immediately to both the Trial PI (Nitin Jain) & Trial Coordinator (Helen Koudelková). Information about Serious Adverse Events (SAEs) and Adverse Events (AEs) will be systematically collected via patient questionnaires. However, should study personnel become aware of such [...]

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