Study ConductGlossary Term
ICH E6(R3) Section 4.5
Any change, divergence, or departure from the study design or procedures defined in the protocol that is not implemented through a formal protocol amendment.
A protocol deviation represents any instance where trial conduct does not conform to the approved protocol requirements. These departures from the protocol may range from minor administrative variations, such as a visit occurring slightly outside the specified window, to significant violations that may compromise participant safety or data integrity. Understanding and properly managing protocol deviations is essential for maintaining the scientific and ethical integrity of clinical trials.
Protocol deviations may result from various causes, including site error, participant non-compliance, system failures, or circumstances beyond anyone's control. Some deviations occur proactively to protect participant safety when following the protocol would pose unacceptable risk; the protocol itself typically authorizes such departures without requiring prior approval when immediate action is necessary. Other deviations represent failures to follow required procedures and may indicate inadequate training, insufficient resources, or protocol requirements that are impractical to implement.
The management of protocol deviations involves detection, documentation, assessment, reporting, and corrective action. Sites must have systems in place to identify deviations promptly and document them completely. Each deviation must be assessed to determine its impact on participant safety, data integrity, and overall trial validity. Significant deviations require reporting to the sponsor, IRB/IEC, and potentially regulatory authorities. Perhaps most importantly, the root causes of deviations must be analyzed and addressed through corrective and preventive actions to reduce the likelihood of recurrence.
Timing deviation
"The Week 8 visit was conducted on Day 60, outside the protocol-specified window of Day 52-58, due to the participant's unavoidable travel commitment. The deviation was documented and reported to the sponsor."
Safety-driven deviation
"When a participant developed severe symptoms, the investigator deviated from the protocol by providing rescue medication before the protocol-specified waiting period, documenting this as a deviation required to protect the participant's welfare."
A procedure in which one or more parties involved in the trial are kept unaware of the treatment assignment to reduce bias in the assessment of outcomes.
A professional employed by the sponsor or contract research organization who monitors clinical trials at investigational sites to ensure protocol compliance, data quality, and participant safety.
A specialized research professional who works at the investigational site under the supervision of the investigator to coordinate and manage the day-to-day operational aspects of clinical trials.
The act of overseeing the progress of a clinical trial and ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
The process of assigning trial subjects to treatment or control groups using an element of chance to reduce bias in allocating interventions.
ICH E6(R3) Section 4.5
Any change, divergence, or departure from the study design or procedures defined in the protocol that is not implemented through a formal protocol amendment.
A protocol deviation represents any instance where trial conduct does not conform to the approved protocol requirements. These departures from the protocol may range from minor administrative variations, such as a visit occurring slightly outside the specified window, to significant violations that may compromise participant safety or data integrity. Understanding and properly managing protocol deviations is essential for maintaining the scientific and ethical integrity of clinical trials.
Protocol deviations may result from various causes, including site error, participant non-compliance, system failures, or circumstances beyond anyone's control. Some deviations occur proactively to protect participant safety when following the protocol would pose unacceptable risk; the protocol itself typically authorizes such departures without requiring prior approval when immediate action is necessary. Other deviations represent failures to follow required procedures and may indicate inadequate training, insufficient resources, or protocol requirements that are impractical to implement.
The management of protocol deviations involves detection, documentation, assessment, reporting, and corrective action. Sites must have systems in place to identify deviations promptly and document them completely. Each deviation must be assessed to determine its impact on participant safety, data integrity, and overall trial validity. Significant deviations require reporting to the sponsor, IRB/IEC, and potentially regulatory authorities. Perhaps most importantly, the root causes of deviations must be analyzed and addressed through corrective and preventive actions to reduce the likelihood of recurrence.
Timing deviation
"The Week 8 visit was conducted on Day 60, outside the protocol-specified window of Day 52-58, due to the participant's unavoidable travel commitment. The deviation was documented and reported to the sponsor."
Safety-driven deviation
"When a participant developed severe symptoms, the investigator deviated from the protocol by providing rescue medication before the protocol-specified waiting period, documenting this as a deviation required to protect the participant's welfare."
A procedure in which one or more parties involved in the trial are kept unaware of the treatment assignment to reduce bias in the assessment of outcomes.
A professional employed by the sponsor or contract research organization who monitors clinical trials at investigational sites to ensure protocol compliance, data quality, and participant safety.
A specialized research professional who works at the investigational site under the supervision of the investigator to coordinate and manage the day-to-day operational aspects of clinical trials.
The act of overseeing the progress of a clinical trial and ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and applicable regulatory requirements.
The process of assigning trial subjects to treatment or control groups using an element of chance to reduce bias in allocating interventions.