FAQ: Protocol Deviations

  1. When should a protocol deviation be reported to the IRB?

    Major protocol deviations should be reported promptly since the IRB considers these to be Unanticipated Problems. Minor protocol deviations should be summarized in narrative form and included as part of the study report at the time of continuing review.

  2. What should be included in the Protocol Deviation Report?

    The report should be made in eIRB in the Reportable Events workspace and should include summaries of what happened, an analysis of why it happened and of an action plan describing the steps that have been/will be taken to prevent a recurrence.

  3. Can an investigator ever deviate from the protocol-defined research plan?

    An investigator may deviate from the protocol whenever necessary to protect the subject's health, rights or welfare. For example, a study medication should be stopped if a subject develops an medically significant adverse reaction during administration. The physician should provide whatever medical treatment is needed necessary to the subject, without regard to whether the medications are permitted in the protocol. There is an obligation to deviate from the protocol in emergent or urgent situations.

  4. Can the investigator deviate from the protocol for non-emergent, non-urgent situations?

    In non-urgent/emergent situations, the investigator should obtained IRB-approval for the planned deviation. Approval from the study sponsor or medical monitor may also be necessary but by itself is not sufficient. The investigator should submit a request for a "planned deviation" which is really a request for a "single subject" or "one-time" protocol amendment. If the investigator anticipates that there will be future requests for the same deviation, then the protocol should be amended.

Top