What is a protocol violation in clinical trials?

Protocol violation. A divergence from the protocol that materially (a) reduces the quality or completeness of the data, (b) makes the Informed Consent Form inaccurate, or (c) impacts a subject’s safety, rights, or welfare.

Are prospective protocol deviations allowed?

FDA drug regulations do not explicitly address protocol deviations. A protocol deviation could be a limited prospective exception to the protocol (e.g. agreement between sponsor and investigator to enroll a single subject who does not meet all inclusion/exclusion criteria).

Are protocol deviations bad?

It is important to monitor protocol deviations Deviations of this kind typically include a more serious breach such as falsifying records or data, failing to obtain informed consent prior to any study procedures, and working under an expired professional license/certification.

Are protocol deviations reported to the IRB?

The ISU IRB recognizes that deviations from the approved protocol may occur during the course of a research study. All such deviations must be promptly reported to the IRB. This policy outlines the responsibilities for reporting deviations and the process by which these deviations will be reviewed.

What is the definition of a protocol violation?

Protocol violations are changes in the conduct of a IRB-approved research protocol that are under the investigator’s control and made without prior IRB approval. Incidents are any problematic or unanticipated events that are not protocol violations and that may adversely impact on the study participants or the conduct of the study.

Where do you report a research protocol violation?

All protocol violations should be reported to the research sponsor or funding agency in a timely fashion and according to that company’s or agency’s policy. All protocol violations should be documented in the investigator’s research study files.

When is a clinical trial deviation from the protocol?

Protocol Deviations. Clinical trials should be conducted in accordance with the approved protocol unless an Urgent Safety Measure must be taken. Unintended (non-serious) departures from the approved protocol would be considered ‘protocol deviations’; they are usually identified retrospectively through monitoring and data validation of CRFs.

What is a minor protocol violation or non-compliance?

Minor Protocol Violations / Non-Compliance. A protocol violation or non-compliance is any deviation from the protocol, study or sponsor procedures that is not approved by the sponsor/REC/MHRA prior to its implementation.