Regulatory Resources
Safety Reporting and Deviations
Reporting Internal SAEs:
- Report all SAEs CTCAE grade 3 and above to CCTO-Safety@stanford.edu using secure email for institute tracking and record keeping. The subject line should indicate the study OnCore or eProtocol number.
- Attach the study specific CRF and send any subsequent amendments or follow up reports as they occur. The DSMC is the monitoring entity for Stanford sponsored trials, and may request additional information and modification to safety reports.
Reporting External SAEs:
- In addition to sending IND Safety Reports to the Stanford investigator, Sponsors should also send a copy of all reports to CCTO-Safety@stanford.edu for administrative tracking in OnCore. The study coordinator must send reports, if not sent by the Sponsor.
Documenting and Reporting Protocol Deviations
Protocol Deviations comprise of any unapproved discrepancies from a protocol research plan or Good Clinical Practice Guidelines (GCP).
- 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.
- Any deviation that affects the safety of participants, impacts study endpoints, or is IRB reportable must be documented in OnCore by the research staff.
- 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
- Documenting and Reporting Protocol Deviations SOP
Oct 16, 2012
Trial Administration