Cancer Institute A national cancer institute
designated cancer center
Cancer Clinical Trials Office

Regulatory Resources

Safety Reporting and Deviations

Reporting Internal SAEs:
Reporting External SAEs:
Documenting and Reporting Protocol Deviations

Protocol Deviations comprise of any unapproved discrepancies from a protocol research plan or Good Clinical Practice Guidelines (GCP).

  1. Protocol Directors or their designee must document all protocol deviations in the participant’s study records in a narrative summary or on a case report form.
  2. Any deviation that affects the safety of participants, impacts study endpoints, or is IRB reportable must be documented in OnCore by the research staff.
  3. Clinical Research Staff must report applicable deviations to the IRB directly using eProtocol.  See Refer to IRB policy guidance  “Events and Information that Require Prompt Reporting to the IRB” for further information.

Failure to properly document deviations may result in DSMC and IRB corrective action such as a temporary hold on enrollment, or study closure.

Protocol Deviation Resources

Stanford Medicine Resources:

Footer Links: