| {
|
| "status": "success",
|
| "message": "Risks generated successfully",
|
| "session_id": "foo6",
|
| "risk_count": {
|
| "total": 48,
|
| "potential": 10,
|
| "unsubstantiated": 5
|
| },
|
| "inserted_count": {
|
| "potential": 10,
|
| "unsubstantiated": 5
|
| },
|
| "updated_reason_for_review": 5,
|
| "potential": [
|
| {
|
| "risk_title": "Incomplete Data Due to High Participant Burden",
|
| "risk_description": "The protocol requires frequent eDiary completion (2x per week and immediately if symptoms occur) and multiple PRO assessments. This high burden on participants increases the risk of incomplete or inaccurate data, potentially affecting the study's primary endpoints and overall data quality. During ARI episodes, participants are required to complete PRO assessments preferably in the evenings and at the same time each day, which may lead to inconsistent or missing data for key symptom and quality of life measures.",
|
| "risk_category": "Data Quality",
|
| "severity": 3,
|
| "protocol_relevance": "Protocol CD388.SQ.3.06, Page 15, Table 2: 'eDiary longitudinal surveillance for occurrence of ARI' and 'PRO Assessments' sections. Page 19, Table 3: PRO Assessments section detailing frequency of ISSQ, EQ-5D-5L, and WPAI-GH completion. | Protocol CD388.SQ.3.06, Page 50, Section 8.3.3: 'During an ARI Episode, PRO assessments should be completed, preferably in the evenings and at the same time each day.' This includes multiple questionnaires (Influenza Symptom Self-Assessment, WPAI-GH, EQ-5D-5L) to be completed via eDiary.",
|
| "risk_keywords": [
|
| "eDiary",
|
| "PRO",
|
| "participant burden",
|
| "data quality",
|
| "compliance",
|
| "ARI Episode",
|
| "patient adherence"
|
| ],
|
| "lab_manual_section_utilized": "not_applicable",
|
| "lab_manual_section_evidence": "",
|
| "likelihood_level": 3,
|
| "historical_evidence": "Protocol deviation logs show a high frequency of participant non-compliance and incomplete procedures, directly aligning with the risk of incomplete data due to high participant burden. Across multiple studies, there were 48 instances of participants not complying with diary entries and 129 cases of incomplete or missed procedures. Specifically, subjects often failed to complete hypoglycemic diary entries as required, missed scheduled assessments, and were inconsistent in completing protocol-mandated documentation despite staff re-education efforts.",
|
| "confidence_score": 95,
|
| "mitigation_title": "Comprehensive Participant Engagement and Data Capture Strategy",
|
| "mitigation_plan": "Implement a multi-faceted approach to enhance participant compliance and data quality: 1) Deploy a user-friendly mobile app with customizable push notifications for eDiary and PRO completions. 2) Conduct mandatory pre-study participant training with competency verification on eDiary and PRO completion. 3) Establish a 24-hour post-visit compliance check by CRC, with immediate follow-up for any missing data. 4) Implement weekly site team reviews of participant compliance metrics, with PI-led action plans for non-compliant participants. 5) Create a participant toolkit with daily schedule templates and symptom tracking aids for ARI episodes.",
|
| "risk_id_ui": "RISK-001"
|
| },
|
| {
|
| "risk_title": "Inconsistent ARI Surveillance Reporting and Complex Visit Schedule Impacting Study Integrity",
|
| "risk_description": "Participants may fail to consistently complete the twice-weekly ARI surveillance screening question over the extended 197-day study duration, potentially missing early signs of influenza and compromising the study's primary efficacy endpoint. Additionally, the complex schedule of activities with multiple visits, phone calls, and assessments over the 197-day period increases the likelihood of missed visits, out-of-window assessments, or incomplete data collection, further compromising study integrity and data quality.",
|
| "risk_category": "Protocol Compliance",
|
| "severity": 3,
|
| "protocol_relevance": "Protocol CD388.SQ.3.06, Page 29: 'Participants will be asked to complete an ARI surveillance screening question approximately twice per week.' and 'The total planned duration of study participation for each participant will be 197 (± 7) days (approximately 29 weeks not including up to 21 days of screening).' | Protocol CD388.SQ.3.06, Pages 14-17, Table 2: Schedule of Activities: All Participants. The table shows a complex visit schedule with multiple timepoints and assessments.",
|
| "risk_keywords": [
|
| "ARI surveillance",
|
| "participant fatigue",
|
| "compliance",
|
| "longitudinal",
|
| "efficacy endpoint",
|
| "visit schedule",
|
| "missed assessments",
|
| "protocol compliance",
|
| "data quality"
|
| ],
|
| "lab_manual_section_utilized": "not_applicable",
|
| "lab_manual_section_evidence": "",
|
| "likelihood_level": 3,
|
| "historical_evidence": "Historical PD data shows a high frequency of protocol compliance issues directly related to the risk. There were 129 instances of incomplete or missed procedures across 11 protocols, with patterns including Required assessment or procedure not completed due to technical issues and Hypoglycemic diary not completed or inconsistently filled by subject. Additionally, 63 occurrences of visit schedule deviations across 14 protocols indicate persistent challenges with complex visit schedules, including Study visit conducted outside of protocol-defined window and Visit missed or skipped.",
|
| "confidence_score": 95,
|
| "mitigation_title": "Integrated ARI Surveillance and Visit Compliance System",
|
| "mitigation_plan": "Implement a multi-faceted approach to ensure consistent ARI surveillance reporting and visit adherence: 1) Deploy an automated twice-weekly reminder system for ARI screening, with escalation to site staff after two consecutive missed reports. 2) Develop a participant-specific visit schedule tool, incorporating all study activities and assessments, to be reviewed and confirmed by participants at each visit. 3) Establish a weekly site review process to identify upcoming visits, potential conflicts, and historical compliance, triggering proactive outreach for at-risk participants. 4) Implement a buddy system pairing participants with a designated site contact for personalized support throughout the 197-day study duration.",
|
| "risk_id_ui": "RISK-002"
|
| },
|
| {
|
| "risk_title": "Inadequate informed consent process leading to participant rights violations",
|
| "risk_description": "Failure to properly obtain, document, or update informed consent, especially for minors or in cases of rescreening, may result in ethical violations and compromised participant rights and well-being.",
|
| "risk_category": "Regulatory & Ethics",
|
| "severity": 3,
|
| "protocol_relevance": "Protocol CD388.SQ.3.06, Page 66-67, Section 11.3: 'An ICF meeting the requirements of 21 Code of Federal Regulations §50, local regulations, ICH guidelines, and HIPAA requirements (where applicable), must be reviewed and approved by the Sponsor and the IRB/IEC before use, and be available for inspection.' and 'Participants must be re-consented to the most current version of the ICF during their participation in the study.'",
|
| "risk_keywords": [
|
| "informed consent",
|
| "ICF",
|
| "minors",
|
| "assent",
|
| "rescreening",
|
| "re-consent"
|
| ],
|
| "lab_manual_section_utilized": "not_applicable",
|
| "lab_manual_section_evidence": "",
|
| "likelihood_level": 3,
|
| "historical_evidence": "Historical PD logs show a high frequency of informed consent deviations across multiple protocols. Common patterns include using incorrect versions of consent forms, failing to reconsent participants within required timeframes, and missing or incomplete consent documentation. These deviations directly align with the risk of inadequate informed consent processes, potentially compromising participant rights and ethical standards.",
|
| "confidence_score": 95,
|
| "mitigation_title": "Comprehensive Informed Consent Verification and Documentation System",
|
| "mitigation_plan": "Implement a multi-step informed consent verification process: 1) Pre-visit ICF version check by CRC 48 hours before each visit. 2) PI/SD to certify ICF review completion before participant signs. 3) CRC to use a mandatory ICF checklist during consent process, including special provisions for minors. 4) Weekly automated alerts for upcoming re-consent needs. 5) Post-visit quality check of ICF documentation within 24 hours. 6) Monthly PI review of consent metrics and deviations.",
|
| "risk_id_ui": "RISK-003"
|
| },
|
| {
|
| "risk_title": "Delayed or missed ARI episode identification due to participant non-compliance",
|
| "risk_description": "The protocol relies heavily on participant self-reporting and rapid action in case of ARI symptoms. Failure to promptly report symptoms, perform self-administered tests, or contact the study site could lead to missed or delayed identification of ARI episodes, compromising a key study objective.",
|
| "risk_category": "Efficacy & Endpoint Integrity",
|
| "severity": 3,
|
| "protocol_relevance": "Protocol CD388.SQ.3.06, Page 18, Table 3: 'As soon as an ARI Alert occurs, the participant must immediately complete the following:' section detailing required participant actions.",
|
| "risk_keywords": [
|
| "ARI episode",
|
| "self-reporting",
|
| "participant compliance",
|
| "endpoint integrity"
|
| ],
|
| "lab_manual_section_utilized": "not_applicable",
|
| "lab_manual_section_evidence": "",
|
| "likelihood_level": 3,
|
| "historical_evidence": "Historical PD data shows a strong pattern of participant non-compliance, particularly with self-reporting and completing required study tasks. There were 48 instances of participant non-compliance across 2 protocols, with specific issues such as failure to complete diary entries, missed visits, and non-adherence to protocol-specified procedures. This directly aligns with the risk of delayed or missed ARI episode identification due to participant non-compliance.",
|
| "confidence_score": 90,
|
| "mitigation_title": "Immediate ARI Symptom Reporting and Testing Compliance System",
|
| "mitigation_plan": "Implement a multi-faceted ARI compliance system: 1) Deploy daily automated symptom reminders via preferred participant contact method. 2) Establish mandatory weekly PI review of participant compliance data, with defined escalation thresholds. 3) Conduct bi-weekly CRC-led participant re-education sessions on ARI reporting importance and procedures. 4) Implement a 24/7 site hotline for immediate ARI reporting with structured triage protocol. Track metrics for 100% reminder delivery, <1-hour site response time, and zero missed ARI reports.",
|
| "risk_id_ui": "RISK-004"
|
| },
|
| {
|
| "risk_title": "Inconsistent execution of ARI visit workflow compromising data consistency",
|
| "risk_description": "The ARI visit workflow is complex, with multiple visits, assessments, and decision points based on test results and symptom resolution. Inconsistent execution of this workflow across sites and participants could lead to variability in data collection and compromise the integrity of ARI-related endpoints.",
|
| "risk_category": "Site Performance & Operations",
|
| "severity": 3,
|
| "protocol_relevance": "Protocol CD388.SQ.3.06, Pages 18-20, Table 3: Schedule of Activities: Participants with an Acute Respiratory Infection Alert. The table outlines a complex series of visits and assessments triggered by an ARI alert.",
|
| "risk_keywords": [
|
| "ARI workflow",
|
| "site performance",
|
| "data consistency",
|
| "operational complexity"
|
| ],
|
| "lab_manual_section_utilized": "not_applicable",
|
| "lab_manual_section_evidence": "",
|
| "likelihood_level": 3,
|
| "historical_evidence": "Historical PD patterns reveal frequent inconsistencies in executing complex study procedures, particularly in visit scheduling and completing required assessments. Multiple protocols show deviations in procedure timing, missed assessments, and out-of-window visits, directly aligning with the risk of inconsistent ARI visit workflow execution. These patterns suggest widespread challenges in maintaining procedural consistency across sites, potentially compromising data integrity for complex, multi-step processes like the ARI workflow.",
|
| "confidence_score": 90,
|
| "mitigation_title": "Standardized ARI Workflow Execution and Monitoring System",
|
| "mitigation_plan": "Implement a comprehensive ARI Workflow Execution System: 1) Deploy an ARI Visit Checklist and Decision Tree for site staff, detailing each step, assessment, and decision point. 2) Establish a mandatory pre-visit planning process 48 hours before each ARI-related visit. 3) Conduct weekly site team huddles to review upcoming ARI visits and recent executions. 4) Implement a post-visit verification process within 24 hours to confirm adherence to the ARI workflow. 5) Institute PI oversight with a weekly review of all ARI-related visits and deviations.",
|
| "risk_id_ui": "RISK-005"
|
| },
|
| {
|
| "risk_title": "Inconsistent Safety Monitoring and Reporting Due to Unclear Assessment Timing",
|
| "risk_description": "The protocol lacks specific timing for safety assessments beyond the initial 30-minute observation period. This ambiguity may result in inconsistent monitoring practices across sites, potentially missing important safety signals or delayed reporting of adverse events. The laboratory manual provides a structured schedule for safety-related assessments, including biochemistry and hematology tests, which can support consistent safety monitoring practices. Additionally, failure of investigators to provide timely and accurate safety reports to the IRB/IEC may result in delayed identification of safety issues and inadequate protection of study participants.",
|
| "risk_category": "Safety Reporting",
|
| "severity": 3,
|
| "protocol_relevance": "Protocol CD388.SQ.3.06, Page 23, Section 2.2.3: 'Safety will be closely monitored by the Investigator throughout the study. Safety and tolerability assessments (including vital signs, physical examinations, and clinical laboratory tests) will be performed at scheduled visits and assessment of adverse events [AEs]/serious adverse events [SAEs]) will be conducted throughout the study.' | Protocol CD388.SQ.3.06, Page 65, Section 11.2.1: 'The Investigator will provide written summaries of the status of the study and any other significant safety findings to the IRB/IEC annually or more frequently in accordance with its requirements, policies, and procedures.'",
|
| "risk_keywords": [
|
| "safety monitoring",
|
| "assessment timing",
|
| "adverse events",
|
| "reporting delays",
|
| "IRB",
|
| "IEC",
|
| "timely reporting",
|
| "participant safety"
|
| ],
|
| "lab_manual_section_utilized": "laboratory_visit_schedule_and_assessments",
|
| "lab_manual_section_evidence": "Biochemistry and hematology tests are scheduled at specific visits with defined windows (e.g., Day 8 ±3, Day 29 ±3) as shown in Figure 33 (Page 35).",
|
| "likelihood_level": 3,
|
| "historical_evidence": "Historical PD patterns show frequent issues with safety monitoring and reporting. Deviations indicate missed or delayed assessments, inconsistent completion of safety documentation, and failure to follow protocol-specified procedures. These align directly with the risk of inconsistent safety monitoring due to unclear assessment timing. Multiple protocols were affected, suggesting a systemic issue in safety monitoring practices across studies.",
|
| "confidence_score": 90,
|
| "mitigation_title": "Structured Safety Monitoring and Reporting System Implementation",
|
| "mitigation_plan": "Implement a comprehensive safety monitoring and reporting system with clear timelines and responsibilities. Establish a standardized safety assessment schedule, integrating protocol requirements and laboratory manual timings. Deploy a Safety Monitoring Checklist for each visit, ensuring consistent completion of all required assessments. Initiate a weekly PI-led safety review to promptly identify and escalate potential safety signals. Implement an automated alert system to flag overdue safety assessments or reports, triggering immediate follow-up actions.",
|
| "risk_id_ui": "RISK-006"
|
| },
|
| {
|
| "risk_title": "Complex Inclusion/Exclusion Criteria Leading to Enrollment Errors",
|
| "risk_description": "The protocol has extensive and complex inclusion/exclusion criteria across two primary strata, increasing the likelihood of site staff misinterpreting or overlooking key eligibility requirements, potentially leading to incorrect participant enrollment.",
|
| "risk_category": "Protocol Compliance",
|
| "severity": 3,
|
| "protocol_relevance": "Protocol CD388.SQ.3.06, Pages 31-36, Sections 5.2 and 5.3. The inclusion and exclusion criteria span multiple pages with numerous sub-criteria and notes, creating a high cognitive load for site staff during eligibility assessment.",
|
| "risk_keywords": [
|
| "eligibility",
|
| "inclusion criteria",
|
| "exclusion criteria",
|
| "enrollment errors",
|
| "protocol compliance"
|
| ],
|
| "lab_manual_section_utilized": "not_applicable",
|
| "lab_manual_section_evidence": "",
|
| "likelihood_level": 3,
|
| "historical_evidence": "Historical PD data strongly supports this risk. Multiple protocols show a recurrent pattern of subjects being randomized despite not meeting inclusion/exclusion criteria. Specific examples include enrolling subjects with out-of-range BMI, incomplete eligibility lab results, and failure to meet cognitive test criteria. These deviations directly reflect site staff's difficulty in accurately applying complex eligibility requirements, aligning closely with the described risk mechanism.",
|
| "confidence_score": 90,
|
| "mitigation_title": "Structured Eligibility Verification and Pre-Enrollment Review Process",
|
| "mitigation_plan": "Implement a mandatory three-tier eligibility verification process: (1) Site CRC completes a detailed eligibility checklist for each criterion 48 hours before scheduled enrollment visit. (2) Study Coordinator conducts an independent review within 24 hours, flagging discrepancies. (3) PI performs final verification during pre-enrollment visit, documenting each criterion electronically. Institute weekly eligibility audits by the core team, reviewing 100% of enrolled participants for the first month, then 25% thereafter. Establish an escalation protocol for any identified discrepancies, requiring immediate PI notification and corrective action plan within 48 hours.",
|
| "risk_id_ui": "RISK-007"
|
| },
|
| {
|
| "risk_title": "Data Integrity Issues Due to Delayed or Incomplete Source Data Verification",
|
| "risk_description": "Site staff may fail to consistently or promptly enter source data into the eCRF, leading to discrepancies between source documents and eCRF data. This can result in data integrity issues, delayed identification of errors, and increased burden during monitoring visits.",
|
| "risk_category": "Data Quality",
|
| "severity": 2,
|
| "protocol_relevance": "Protocol CD388.SQ.3.06, Page 68, Section 11.9: 'Data entered in the eCRF that are transcribed from source documents must be consistent with the source documents or the discrepancies must be explained.' and 'Study monitors will perform ongoing SDV to confirm that data entered into the eCRF by authorized site personnel are accurate, complete, and verifiable from source documents'",
|
| "risk_keywords": [
|
| "source data verification",
|
| "eCRF",
|
| "data integrity",
|
| "monitoring"
|
| ],
|
| "lab_manual_section_utilized": "not_applicable",
|
| "lab_manual_section_evidence": "",
|
| "likelihood_level": 3,
|
| "historical_evidence": "Historical PD logs show frequent data integrity issues related to delayed or incomplete source data entry. Multiple protocols reported inconsistent or delayed data entry in source documents, with one category specifically noting Inconsistent or delayed data entry in source documents as a common pattern. This directly aligns with the risk of site staff failing to consistently or promptly enter source data into the eCRF.",
|
| "confidence_score": 90,
|
| "mitigation_title": "Real-Time Source Data Verification System with Escalation Workflow",
|
| "mitigation_plan": "Implement a daily Source Data Verification (SDV) process using a structured checklist. CRCs must complete SDV within 24 hours of each participant visit, cross-referencing source documents against eCRF entries. Establish an automated alert system to flag discrepancies, triggering immediate CRC review. Institute a weekly PI oversight review of SDV completion rates and unresolved discrepancies. If SDV completion falls below 95% or discrepancies remain unresolved for >48 hours, escalate to the PI for immediate intervention.",
|
| "risk_id_ui": "RISK-008"
|
| },
|
| {
|
| "risk_title": "Missed or Delayed PK and Immunogenicity Samples Due to Complex Sampling Schedule",
|
| "risk_description": "Site staff may fail to collect pharmacokinetic (PK) and anti-drug antibody (ADA) samples at the specified timepoints for the subset of participants, potentially compromising the integrity of these key secondary endpoints. The complex sampling schedule, which includes specific collection windows for PK and ADA samples across multiple visits, increases the risk of missed or delayed samples.",
|
| "risk_category": "Protocol Compliance",
|
| "severity": 2,
|
| "protocol_relevance": "Protocol CD388.SQ.3.06, Page 53, Sections 8.5 and 8.7: 'The plasma and calculated PK parameters of CD388 will be assessed from a sub-sample of participants based on blood (plasma) samples collected from all participants in both Primary Stratum A and B as outlined in the SoA (Section 1.3).' 'Anti-drug antibodies (ADAs) to CD388 will be evaluated in a sub-sample of participants using serum samples collected from all participants in both Primary Stratum A and B as outlined in the SoA (Section 1.3).'",
|
| "risk_keywords": [
|
| "pharmacokinetics",
|
| "immunogenicity",
|
| "sampling",
|
| "protocol compliance"
|
| ],
|
| "lab_manual_section_utilized": "laboratory_visit_schedule_and_assessments",
|
| "lab_manual_section_evidence": "Blood Sparse PK and ADA samples are collected at specific visits with defined windows (e.g., Day 8 ±3, Day 29 ±3) for a subset of participants (Page 35, Figure 33).",
|
| "likelihood_level": 3,
|
| "historical_evidence": "Historical PD logs show a strong pattern of missed or delayed sample collections, particularly for complex schedules. There were frequent deviations related to laboratory assessments, including PK samples not collected at scheduled visits and endpoint assessment samples missing. The data indicates persistent challenges with adhering to protocol-specified sampling schedules across multiple studies.",
|
| "confidence_score": 90,
|
| "mitigation_title": "Implement PK/ADA Sampling Precision Protocol",
|
| "mitigation_plan": "Deploy a multi-tiered PK/ADA Sampling Precision Protocol to ensure accurate collection of pharmacokinetic and anti-drug antibody samples. Establish a dedicated PK/ADA Sampling Coordinator role at each site, responsible for implementing a visit-specific PK/ADA checklist, conducting pre-visit readiness reviews, and overseeing real-time sample collection tracking. Institute mandatory weekly PI oversight reviews of PK/ADA compliance metrics, with predefined escalation thresholds for missed or delayed samples.",
|
| "risk_id_ui": "RISK-009"
|
| },
|
| {
|
| "risk_title": "Inadequate risk-based quality management leading to undetected data integrity issues",
|
| "risk_description": "Failure to effectively implement risk-based quality management processes, including QTLs and centralized monitoring, may result in undetected data integrity issues or protocol deviations. This risk extends to laboratory processes, where critical result ranges and clinical significance of lab values require careful monitoring.",
|
| "risk_category": "Quality & Compliance",
|
| "severity": 2,
|
| "protocol_relevance": "Protocol CD388.SQ.3.06, Page 67, Section 11.6: 'Beginning at the onset of study design and protocol development and continuing for the duration of the study, the Sponsor will conduct a periodic risk assessment to proactively identify critical data points and study conduct processes with potential risks that could impact the study results and the participants' safety, rights, and well-being.'",
|
| "risk_keywords": [
|
| "risk-based quality management",
|
| "QTLs",
|
| "centralized monitoring",
|
| "data integrity",
|
| "protocol deviations"
|
| ],
|
| "lab_manual_section_utilized": "quality_control_and_compliance_requirements",
|
| "lab_manual_section_evidence": "Critical result ranges for hematology and chemistry tests are specified in Table 6.2 (Page 58).",
|
| "likelihood_level": 3,
|
| "historical_evidence": "Historical PD logs show a high frequency of deviations related to risk-based quality management processes. Across multiple protocols, there were numerous instances of missed or incomplete assessments, protocol-specified procedures not followed, and data integrity issues. Specifically, there were 129 occurrences of incomplete or missed procedures, 175 study procedure deviations, and 47 laboratory assessment deviations. These patterns directly align with the risk of inadequate risk-based quality management leading to undetected data integrity issues and protocol deviations.",
|
| "confidence_score": 90,
|
| "mitigation_title": "Implement Comprehensive Risk-Based Quality Management System",
|
| "mitigation_plan": "Establish a rigorous risk-based quality management system with immediate effect. Deploy a centralized monitoring dashboard to track critical data points and study conduct processes. Implement weekly site-level QTL (Quality Tolerance Limit) reviews by CRCs, with mandatory PI sign-off. Conduct bi-weekly cross-functional data review meetings to assess emerging trends. Institute a lab value alert system for results outside critical ranges, requiring same-day PI review and documented action plan. Implement a deviation prevention checklist for all participant visits, to be completed by site staff pre- and post-visit, with 100% compliance monitored daily by the study coordinator.",
|
| "risk_id_ui": "RISK-010"
|
| }
|
| ],
|
| "unsubstantiated": [
|
| {
|
| "risk_title": "Failure to identify and report product complaints due to confusion with adverse events",
|
| "risk_description": "Site staff may struggle to distinguish between product complaints and adverse events, potentially leading to underreporting of important product quality issues. This could result in missed opportunities to identify and address product defects or malfunctions. Laboratory staff should be aware that certain critical lab values may indicate clinically significant abnormalities requiring active management, which could be related to product quality issues.",
|
| "risk_category": "Quality & Compliance",
|
| "severity": 2,
|
| "protocol_relevance": "Protocol CD388.SQ.3.06, Page 56, Section 9.1.3 Definition of Product Complaints. The protocol emphasizes the importance of distinguishing product complaints from AEs and provides examples specific to the single-dose, SQ injected, prefilled syringe.",
|
| "risk_keywords": [
|
| "product complaints",
|
| "adverse events",
|
| "product quality",
|
| "reporting"
|
| ],
|
| "lab_manual_section_utilized": "quality_control_and_compliance_requirements",
|
| "lab_manual_section_evidence": "Clinically significant lab abnormalities suggesting disease or organ toxicity require active management, including dose changes or drug discontinuation (Section 6.3).",
|
| "likelihood_level": 1,
|
| "historical_evidence": "No historical pattern found in the PD logs",
|
| "confidence_score": 95,
|
| "risk_id_ui": "RISK-011",
|
| "reason_for_review": "Risk lacks historical evidence in PD logs, requiring manual validation of potential underreporting concerns."
|
| },
|
| {
|
| "risk_title": "Failure to identify and report product complaints due to confusion with adverse events",
|
| "risk_description": "Site staff may struggle to distinguish between product complaints and adverse events, potentially leading to underreporting of important product quality issues. This could result in missed opportunities to identify and address product defects or malfunctions. Laboratory staff should be aware that certain critical lab values may indicate clinically significant abnormalities requiring active management, which could be related to product quality issues.",
|
| "risk_category": "Quality & Compliance",
|
| "severity": 2,
|
| "protocol_relevance": "Protocol CD388.SQ.3.06, Page 56, Section 9.1.3 Definition of Product Complaints. The protocol emphasizes the importance of distinguishing product complaints from AEs and provides examples specific to the single-dose, SQ injected, prefilled syringe.",
|
| "risk_keywords": [
|
| "product complaints",
|
| "adverse events",
|
| "product quality",
|
| "reporting"
|
| ],
|
| "lab_manual_section_utilized": "quality_control_and_compliance_requirements",
|
| "lab_manual_section_evidence": "Clinically significant lab abnormalities suggesting disease or organ toxicity require active management, including dose changes or drug discontinuation (Section 6.3).",
|
| "likelihood_level": 1,
|
| "historical_evidence": "No historical pattern found in the PD logs",
|
| "confidence_score": 95,
|
| "risk_id_ui": "RISK-012",
|
| "reason_for_review": "Risk lacks historical evidence in PD logs, requiring manual validation of potential underreporting concerns."
|
| },
|
| {
|
| "risk_title": "Failure to identify and report product complaints due to confusion with adverse events",
|
| "risk_description": "Site staff may struggle to distinguish between product complaints and adverse events, potentially leading to underreporting of important product quality issues. This could result in missed opportunities to identify and address product defects or malfunctions. Laboratory staff should be aware that certain critical lab values may indicate clinically significant abnormalities requiring active management, which could be related to product quality issues.",
|
| "risk_category": "Quality & Compliance",
|
| "severity": 2,
|
| "protocol_relevance": "Protocol CD388.SQ.3.06, Page 56, Section 9.1.3 Definition of Product Complaints. The protocol emphasizes the importance of distinguishing product complaints from AEs and provides examples specific to the single-dose, SQ injected, prefilled syringe.",
|
| "risk_keywords": [
|
| "product complaints",
|
| "adverse events",
|
| "product quality",
|
| "reporting"
|
| ],
|
| "lab_manual_section_utilized": "quality_control_and_compliance_requirements",
|
| "lab_manual_section_evidence": "Clinically significant lab abnormalities suggesting disease or organ toxicity require active management, including dose changes or drug discontinuation (Section 6.3).",
|
| "likelihood_level": 1,
|
| "historical_evidence": "No historical pattern found in the PD logs",
|
| "confidence_score": 95,
|
| "risk_id_ui": "RISK-013",
|
| "reason_for_review": "Risk lacks historical evidence in PD logs, requiring manual validation of potential underreporting concerns."
|
| },
|
| {
|
| "risk_title": "Failure to identify and report product complaints due to confusion with adverse events",
|
| "risk_description": "Site staff may struggle to distinguish between product complaints and adverse events, potentially leading to underreporting of important product quality issues. This could result in missed opportunities to identify and address product defects or malfunctions. Laboratory staff should be aware that certain critical lab values may indicate clinically significant abnormalities requiring active management, which could be related to product quality issues.",
|
| "risk_category": "Quality & Compliance",
|
| "severity": 2,
|
| "protocol_relevance": "Protocol CD388.SQ.3.06, Page 56, Section 9.1.3 Definition of Product Complaints. The protocol emphasizes the importance of distinguishing product complaints from AEs and provides examples specific to the single-dose, SQ injected, prefilled syringe.",
|
| "risk_keywords": [
|
| "product complaints",
|
| "adverse events",
|
| "product quality",
|
| "reporting"
|
| ],
|
| "lab_manual_section_utilized": "quality_control_and_compliance_requirements",
|
| "lab_manual_section_evidence": "Clinically significant lab abnormalities suggesting disease or organ toxicity require active management, including dose changes or drug discontinuation (Section 6.3).",
|
| "likelihood_level": 1,
|
| "historical_evidence": "No historical pattern found in the PD logs",
|
| "confidence_score": 95,
|
| "risk_id_ui": "RISK-014",
|
| "reason_for_review": "Risk lacks historical evidence in PD logs, requiring manual validation of potential underreporting concerns."
|
| },
|
| {
|
| "risk_title": "Failure to identify and report product complaints due to confusion with adverse events",
|
| "risk_description": "Site staff may struggle to distinguish between product complaints and adverse events, potentially leading to underreporting of important product quality issues. This could result in missed opportunities to identify and address product defects or malfunctions. Laboratory staff should be aware that certain critical lab values may indicate clinically significant abnormalities requiring active management, which could be related to product quality issues.",
|
| "risk_category": "Quality & Compliance",
|
| "severity": 2,
|
| "protocol_relevance": "Protocol CD388.SQ.3.06, Page 56, Section 9.1.3 Definition of Product Complaints. The protocol emphasizes the importance of distinguishing product complaints from AEs and provides examples specific to the single-dose, SQ injected, prefilled syringe.",
|
| "risk_keywords": [
|
| "product complaints",
|
| "adverse events",
|
| "product quality",
|
| "reporting"
|
| ],
|
| "lab_manual_section_utilized": "quality_control_and_compliance_requirements",
|
| "lab_manual_section_evidence": "Clinically significant lab abnormalities suggesting disease or organ toxicity require active management, including dose changes or drug discontinuation (Section 6.3).",
|
| "likelihood_level": 1,
|
| "historical_evidence": "No historical pattern found in the PD logs",
|
| "confidence_score": 95,
|
| "risk_id_ui": "RISK-015",
|
| "reason_for_review": "Risk lacks historical evidence in PD logs, requiring manual validation of potential underreporting concerns."
|
| }
|
| ],
|
| "performance": {
|
| "request_count": 178,
|
| "error_count": 0,
|
| "retry_count": 0,
|
| "requests_per_minute": 24.267657544022516,
|
| "rate_limiter": {
|
| "current_rpm": 60,
|
| "total_429s": 0,
|
| "recent_error_rate": 0
|
| },
|
| "total_input_tokens": 577284,
|
| "total_output_tokens": 51866
|
| }
|
| }
|