Tuesday, February 3, 2026
Introducing protocol deviation alert system
Introducing protocol deviation alert system
Sai Anurag Modalavalasa
Sai Anurag Modalavalasa
Protocol Adherence Challenges in Multi-Stage, Multi-Arm Clinical Trials
In a clinical trial, patients are enrolled into specific study arms, each with a predefined treatment plan that varies by study arm and study day. At every visit, clinicians quickly understand the patient’s trial context and determine the intervention based on the protocol . In high-volume clinical settings, especially when protocols are complex and patients are at different stages of the trial, this process becomes cognitively demanding. As protocol complexity and operational load increase, the likelihood of unintentional protocol deviations also increases, which can affect patient safety, data integrity, and trial outcomes.
Our protocol deviation alert system: Design and Capabilities
Configurable Deviation Alert Specification
Our protocol deviation alert system enables trial teams to explicitly define what constitutes a protocol deviation during trial setup. The system provides a configuration interface that allows trial investigators to define specifications to identify deviations in natural language, scoped to trial-day–specific case record form (CRF) templates. The attributes supported by the system include:
Context dependent rules: Deviation definitions can depend on patient-specific and trial-specific context, such as enrolled study arm, trial day, or historical clinical data. For example, investigators may specify that for patients enrolled in Arm A, the administered Bortezomib dose must not exceed dosage_factor × body surface area (BSA), where BSA is derived from previously recorded height and weight. The system automatically retrieves the relevant context and evaluates the rule accordingly.
Conditional and nested rules: Specifications can include conditional logic to reflect real-world protocol complexity. For instance:
If a patient is enrolled in Arm A and has no recorded adverse events, a standard dosing schedule applies.
If the same patient has experienced Grade 2 or higher peripheral neuropathy, a reduced dose or treatment hold is required.
The system determines which condition applies for a given patient and trial day, then evaluates the appropriate rule
No imposed limits on number of rules: There is no limit to the number of deviation specifications that can be configured per form, allowing comprehensive coverage of all protocol adherence checks.
By defining deviation rules once during setup, the system enables principal investigators to establish a single source of truth for protocol adherence, ensuring consistent interpretation of the protocol across all patients, trial stages, and study arms.
Automated real-time deviation alerts during trial
On a trial day, clinicians may capture source documentation using ambient clinical conversations or uploaded files. Our application automatically generates the trial-day case record form using automated form-filling capabilities. As the CRF is populated, the system:
Identifies all deviation rules applicable to the patient’s study arm, trial day, and clinical history
Extracts relevant information from source files and the CRF, applies the conditional logic and rules, and determines whether any protocol deviations are present
When a deviation is identified, the system surfaces an automated alert that highlights the violated rule, the supporting clinical context, and the expected protocol-compliant action. This enables clinicians to quickly assess the situation, correct errors when appropriate, or document justified exceptions, thereby reducing the incidence of unintentional deviations that could affect patient safety, data integrity, or trial outcomes.
To try this feature, log in to your account and follow the links below:
If you have any questions, you may contact us at anurag@fosterhealth.ai
Protocol Adherence Challenges in Multi-Stage, Multi-Arm Clinical Trials
In a clinical trial, patients are enrolled into specific study arms, each with a predefined treatment plan that varies by study arm and study day. At every visit, clinicians quickly understand the patient’s trial context and determine the intervention based on the protocol . In high-volume clinical settings, especially when protocols are complex and patients are at different stages of the trial, this process becomes cognitively demanding. As protocol complexity and operational load increase, the likelihood of unintentional protocol deviations also increases, which can affect patient safety, data integrity, and trial outcomes.
Our protocol deviation alert system: Design and Capabilities
Configurable Deviation Alert Specification
Our protocol deviation alert system enables trial teams to explicitly define what constitutes a protocol deviation during trial setup. The system provides a configuration interface that allows trial investigators to define specifications to identify deviations in natural language, scoped to trial-day–specific case record form (CRF) templates. The attributes supported by the system include:
Context dependent rules: Deviation definitions can depend on patient-specific and trial-specific context, such as enrolled study arm, trial day, or historical clinical data. For example, investigators may specify that for patients enrolled in Arm A, the administered Bortezomib dose must not exceed dosage_factor × body surface area (BSA), where BSA is derived from previously recorded height and weight. The system automatically retrieves the relevant context and evaluates the rule accordingly.
Conditional and nested rules: Specifications can include conditional logic to reflect real-world protocol complexity. For instance:
If a patient is enrolled in Arm A and has no recorded adverse events, a standard dosing schedule applies.
If the same patient has experienced Grade 2 or higher peripheral neuropathy, a reduced dose or treatment hold is required.
The system determines which condition applies for a given patient and trial day, then evaluates the appropriate rule
No imposed limits on number of rules: There is no limit to the number of deviation specifications that can be configured per form, allowing comprehensive coverage of all protocol adherence checks.
By defining deviation rules once during setup, the system enables principal investigators to establish a single source of truth for protocol adherence, ensuring consistent interpretation of the protocol across all patients, trial stages, and study arms.
Automated real-time deviation alerts during trial
On a trial day, clinicians may capture source documentation using ambient clinical conversations or uploaded files. Our application automatically generates the trial-day case record form using automated form-filling capabilities. As the CRF is populated, the system:
Identifies all deviation rules applicable to the patient’s study arm, trial day, and clinical history
Extracts relevant information from source files and the CRF, applies the conditional logic and rules, and determines whether any protocol deviations are present
When a deviation is identified, the system surfaces an automated alert that highlights the violated rule, the supporting clinical context, and the expected protocol-compliant action. This enables clinicians to quickly assess the situation, correct errors when appropriate, or document justified exceptions, thereby reducing the incidence of unintentional deviations that could affect patient safety, data integrity, or trial outcomes.
To try this feature, log in to your account and follow the links below:
If you have any questions, you may contact us at anurag@fosterhealth.ai
