AQC Knowledge Center CatalogAdvance to Specific Categories: Communication Governance/Organization Construct Inspection Leadership Metrics/Analytics/Technology Oversight Capability Maturity Model Provider Qualification Process Oversight ProtocolQuality Patient Engagement Quality Agreement Quality Oversight Management Framework Risk Risk-Based QualityManagement Roles and Responsibilities Site Quality Technical Oversight Summary of Knowledge Center Documents New Documents in DevelopmentCommunication: To achieve leading practice quality oversight, an organization must proactively and clearly define requiredcommunications, the types of stakeholders who must be informed, the media, venues, or forums expected, and the style ofthese communications.Return to TopComm Tool 00Communication GuidelineComm Tool 01Communication Management PlanComm Tool 03Issue Escalation ProcessComm Tool 04Escalation PathwaysComm Tool 05Risk Issue Triggers RACI Matrix TemplateComm Tool 07Risk or Issue Communication TemplateComm Tool 11Meeting Minutes TemplateComm Tool 12Action Item TemplateComm Tool 13Meeting Agenda TemplateComm Tool 14Issue Log TemplateComm Tool 15Leading Practices for MeetingsComm Tool 16Email Leading PracticesComm Tool 17Governance Meeting Constructs and AgendaComm Tool 20Setting Expectations WorksheetComm Tool 22Active Lessons Learned Process and Database ConstructComm Tool 24Active Lessons Learned Capture TemplateComm Tool 25Active Lessons Learned Project Review Meeting TemplateComm Tool 26Active Lessons Learned Review Meeting Facilitator GuideCommunication Resources18Governance/Organizational Construct: Governance leading practice concepts should apply throughout an organization.The leading practices and tools that are provided as part of this guideline should be tailored and fit-for-purpose for aspecific organization based on the sourcing models that are deployed, the maturity of the Sponsor/Provider relationship,services outsourced and other considerations.Return to TopGov Tool 00Governance and Organizational Construct GuidelineGov Tool 01Governance Structure and ObjectivesGov Tool 02Governance ChartersGov Tool 02aTemplate for a Governance CharterGov Tool 02bSample Executive Committee CharterGov Tool 02cSample Operations Mgmt Comm CharterGov Tool 02dSample Business Mgmt Comm CharterGov Tool 03Decision Making ModelsGov Tool 08Decision ScorecardAQC Knowledge Center Catalog 08July2021Page 1 of 17 2021 The Avoca Group
AQC Knowledge Center CatalogGov Tool 11Centers of ExcellenceGov Tool 12Quality UnitsGov Tool 13Template for Business Objectives and NeedsGov Tool 14Preparing a Governance PlanGov Tool 15Partnership Governance Plan TemplateGov Tool 17Risk and Issue TriggersGov Tool 23Cost Benefit AnalysisGov Tool 24Metrics Analytics OptimizationGov Tool 25System Scorecard TemplateGov Tool 26Multi-Project TrackerGovernance/Organizational Construct Resources19Inspection: As a leading practice for Inspection Readiness, the Sponsor, CRO and Clinical Sites should proactively preparefor inspections from all Health Authorities responsible for countries where Sponsors are seeking market authorizationapproval. Inspection Readiness is vital to ensure efficient review by Health Authorities of the clinical trial program.Return to TopINSP 00Inspection Readiness OverviewINSPA 00IR Agency Resource and Member ExperienceINSPA 00aAcronyms Inspection Readiness Agency Resource DocumentsINSPA 01Member Experience OverviewINSPA 01aRemote Inspection Focus Group - Feb 2021INSP 02Sponsor and CRO Inspection Readiness DashboardINSPA 02USA FDA Inspection Readiness Agency ResourceINSP 02aSponsor and CRO Functional Inspection Preparation ChecklistINSP 03Inspection Preparation Kickoff Meeting Presentation TemplateINSPA 03UK MHRA Inspection Readiness ResourceINSP 03aInspection Preparation Kickoff Email TemplateINSP 03bInspection Preparation Timeline TemplateINSP 04Inspection Preparation Storyboard TemplateINSPA 04EU EMA Inspection Readiness ResourceINSP 04aInspection Preparation Most Challenging QuestionsINSP 05Sponsor and CRO Inspection Logistics and Coordination ToolINSPA 05China NMPA Inspection Readiness ResourceINSP 05aDos and Do Nots During Inspection InterviewsINSP 06Inspection Preparation Logistics Presentation TemplateINSPA 06Japan PMDA Inspection Readiness Agency ResourceINSP 07ICH E6 (R2) OverviewINSPA 07Health Canada Inspection Readiness ResourceINSP 07aICH E6 R2 Mapping to a Quality Management SystemINSP 07bBackground and ResourcesINSP 07cAssessment of Resources and Process OperationsAQC Knowledge Center Catalog 08July2021Page 2 of 17 2021 The Avoca Group
AQC Knowledge Center CatalogINSP 07dINSP07eINSP07fINSP 07gINSP 07hINSP 07iINSP 07jINSP 07kINSP 08INSP 09INSP 09aINSP 09bINSP 11INSP 12INSP 13INSP 14INSP 15INSP 16INSP 17INSP 18INSP 19INSP 20INSP 21INSP 22INSP 23Inspection ResourcesExternal Service Provider OversightRisk EvaluationRisk ControlRisk ReviewRisk CommunicationProcess ImprovementRisk ReportingDocumentationSponsor and CRO Inspection Preparation ToolQMS Annual Compliance Assessment Plan ProcessQMS Compliance Assessment Plan Schedule TemplateQMS Assessment Findings and Resolutions TemplateInvestigator Site Inspection Preparation ToolInvestigator Site Functional Inspection Preparation ChecklistInvestigator Site Inspection Preparation Interview Question TemplateInvestigator Site Inspection Logistics and Coordination ToolClinical Site Inspection Follow upInvestigator Site Inspection Preparation Most Challenging QuestionsPMDA Required Foreign Investigative Site Inspection Documents ToolPharmacovigilance Areas of FocusInspection Response GuideInspection Response ChecklistInspection Response ToolMHRA Blog Sponsor OversightAQC Quality Management System50Oversight Leadership Requirements: Leadership is essential to any group or organization. What a leader does is usuallydifficult to describe and is often situational. Leading practice for individuals in leadership roles that provide oversight ofoutsourced projects is the ability to accomplish tasks through others by providing clear direction, vision, and motivation.Return to TopLead Tool 00Oversight Leadership GuidelineLead Tool 03Balanced vs MicromanagementLead Tool 04Leadership StylesLead Tool 05The Six Leadership Styles at a GlanceLead Tool 06Leadership Characteristics of Vendor Oversight TeamLead Tool 07AAAA FrameworkLead Tool 10Vendor Oversight Interviewing TemplateLead Tool 14Culture of QualityOversight Leadership Requirement Resources8AQC Knowledge Center Catalog 08July2021Page 3 of 17 2021 The Avoca Group
AQC Knowledge Center CatalogMetrics/Analytics/Technology: Metrics and their supporting analytics seek to improve operations through oversight andmanagement of factors that impact outcomes. Good utilization of metrics, analytics, and associated decision processes candrive efficiency, support accountability, create consistency, enhance quality, and promote an outcomes-focused culture andeffective risk management.Return to TopMet Tool 00Metrics/Analytics/Technology GuidelineMet Tool 01Quality and Oversight Metric TaxonomyMet Tool 06Strategy MapsMet Tool 11Development Worksheet for Special Metric Short ListsMet Tool 18Metrics Plan Thought MapMet Tool 20Metric Dashboard Example: Balanced ScorecardMet Tool 21AQC Catalog of Quality and Oversight MetricsMet Tool 22Organizational Metrics CurriculumMetrics/Analytics/Technology Resources8Oversight Capability Maturity Model: Sponsor oversight capability, as it relates to Provider oversight, forbiopharmaceutical R&D is important for the industry to drive greater efficiency and quality and reduced cycle time and risk.Advanced capability by Sponsors can offer benefits in fewer findings during audits and regulatory inspections. Sponsorcapabilities also impact CROs by enabling better more effective partnerships.Return to TopOCMM 00aOversight StrategyOCMM 00bGovernance/Organization ConstructOCMM 00cOversight LeadershipOCMM 00dProcess OversightOCMM 00eMetrics/Analytics/TechnologyOCMM 00fProactive Risk and Opportunity ManagementOCMM 00gBudget, Sourcing, Contractual, Financial OversightOCMM 00hCommunication Associated with External Party OversightOCMM 00iRoles and Responsibilities within Oversight LandscapeOCMM 00jTechnical OversightOCMM 02Oversight Capability Maturity Model WorksheetOCMM 03Oversight Capability Maturity Model InstructionsOCMM 04Conceptual FoundationOCMM 05Oversight Capability Maturity Model ImageOCMM 06Virtual and Lean Models for OversightOversight Capability Maturity Model Resources15Provider Qualification: A compilation of industry standards and tools for qualification of Clinical Service Providers. Thestandards are either specifically defined by health authority regulations or guidance documents, have been extrapolatedAQC Knowledge Center Catalog 08July2021Page 4 of 17 2021 The Avoca Group
AQC Knowledge Center Catalogbased on regulations and guidance, or have become expected requirements based on leading practices, as defined by anadvisory board of biopharmaceutical and Contract Research Organizations through the Avoca Quality Consortium.Return to TopPQUAL 01Core StandardsPQUAL 01aCore RFI TemplatePQUAL 01bCore Scorecard TemplatePQUAL 01cCore Visit Checklist TemplatePQUAL 02Central Labs StandardsPQUAL 02aCentral Labs RFI TemplatePQUAL 02bCentral Labs Scorecard TemplatePQUAL 02cCentral Labs Visit Checklist TemplatePQUAL 03Bioanalytical Lab StandardsPQUAL 03aBioanalytical Lab RFI TemplatePQUAL 03bBioanalytical Lab Scorecard TemplatePQUAL 03cBioanalytical Lab Visit Checklist TemplatePQUAL 04Biomarker Lab StandardsPQUAL 04aBiomarker Lab RFI TemplatePQUAL 04bBiomarker Lab Scorecard TemplatePQUAL 04cBiomarker Lab Visit Checklist TemplatePQUAL 05IxRS Provider StandardsPQUAL 05aIxRS RFI TemplatePQUAL 05bIxRS Scorecard TemplatePQUAL 05cIxRS Visit Checklist TemplatePQUAL 06ECG Provider StandardsPQUAL 06aECG RFI TemplatePQUAL 06bECG Scorecard TemplatePQUAL 06cECG Visit Checklist TemplatePQUAL 07Medical Imaging Provider StandardsPQUAL 07aMedical Imaging RFI TemplatePQUAL 07bMedical Imaging Scorecard TemplatePQUAL 07cMedical Imaging Visit Checklist TemplatePQUAL 08COA and eCOA Provider StandardsPQUAL 08aCOA and eCOA RFI TemplatePQUAL 08bCOA and eCOA Scorecard TemplatePQUAL 08cCOA and eCOA Visit Checklist TemplatePQUAL 09CRO Monitoring StandardsPQUAL 09aCRO Monitoring RFI TemplatePQUAL 09bCRO Monitoring Scorecard TemplatePQUAL 09cCRO Monitoring Visit Checklist TemplatePQUAL 10CRO Data Management StandardsAQC Knowledge Center Catalog 08July2021Page 5 of 17 2021 The Avoca Group
AQC Knowledge Center CatalogPQUAL 10aPQUAL 10bPQUAL 10cPQUAL 11PQUAL 11aPQUAL 11bPQUAL 11cPQUAL 12PQUAL 12aPQUAL 12bPQUAL 12cPQUAL 13PQUAL 13aPQUAL 13bPQUAL 13cPQUAL 14PQUAL 14aPQUAL 14bPQUAL 14cPQUAL 15PQUAL 15aPQUAL 15bPQUAL 15cPQUAL 16PQUAL 16aPQUAL 16bPQUAL 16cPQUAL 17PQUAL 17aPQUAL 17bPQUAL 17cPQUAL 18PQUAL 18aPQUAL 18bPQUAL 18cPQUAL 19PQUAL 19aPQUAL 19bPQUAL 19cPQUAL 20CRO Data Management RFI TemplateCRO Data Management Scorecard TemplateCRO Data Management Visit Checklist TemplateCRO Biostatistics StandardsCRO Biostatistics RFI TemplateCRO Biostatistics Scorecard TemplateCRO Biostatistics Visit Checklist TemplateCRO Medical Writing StandardsCRO Medical Writing RFI TemplateCRO Medical Writing Scorecard TemplateCRO Medical Writing Visit Checklist TemplatePhase I Unit StandardsPhase I Unit RFI TemplatePhase I Unit Scorecard TemplatePhase I Unit Visit Checklist TemplateElectronic Regulatory Binder-eISF StandardsElectronic Regulatory Binder-eISF RFI TemplateElectronic Regulatory Binder-eISF Scorecard TemplateElectronic Regulatory Binder-eISF Visit Checklist TemplateeConsent StandardseConsent RFI TemplateeConsent Scorecard TemplateeConsent Checklist TemplateMobile Health Care Provider Visits StandardsMobile Health Care Provider Visits RFI TemplateMobile Health Care Provider Visits Visit Scorecard TemplateMobile Health Care Provider Visits Visit Checklist TemplateeHealth Records for Patient Recruitment and Feasibility StandardseHealth Records for Patient Recruitment and Feasibility RFI TemplateeHealth Records for Patient Recruitment and Feasibility Scorecard TemplateeHealth Records Patient Recruitment and Feasibility Visit Checklist TemplateeTMF StandardseTMF RFI TemplateeTMF Scorecard TemplateeTMF Checklist TemplateTelemedicine Telehealth StandardsTelemedicine Telehealth RFI TemplateTelemedicine Telehealth Scorecard TemplateTelemedicine Telehealth Visit Checklist TemplateGeneral Wearable Sensor Device StandardsAQC Knowledge Center Catalog 08July2021Page 6 of 17 2021 The Avoca Group
AQC Knowledge Center CatalogPQUAL 20aPQUAL 20bPQUAL 20cPQUAL 21PQUAL 21aPQUAL 21bPQUAL 21cPQUAL 22PQUAL 22aPQUAL 22bPQUAL 22cPQUAL 25PQUAL 25aPQUAL 25bPQUAL 25cPQUAL 26PQUAL 27PQUAL 28PQUAL 29PQUAL 30PQUAL 31PQUAL 32PQUAL 32aPQUAL 32bPQUAL 32cGeneral Wearable Sensor Device RFI TemplateGeneral Wearable Sensor Device Scorecard TemplateGeneral Wearable Sensor Device Visit Checklist TemplateeHealth Record to EDC Connector Apps StandardseHealth Record to EDC Connector Apps RFI TemplateeHealth Record to EDC Connector Apps Scorecard TemplateeHealth Record to EDC Connector Apps Checklist TemplateActigraphy Motion Sensors StandardsActigraphy Motion Sensors RFI TemplateActigraphy Motion Sensors Scorecard TemplateActigraphy Motion Sensors Visit Checklist TemplateMobile Cardiac Monitoring StandardsMobile Cardiac Monitoring RFI TemplateMobile Cardiac Monitoring Scorecard TemplateMobile Cardiac Monitoring Checklist TemplateProvider Selection Rationale TemplateHigh Level CRO Qualification ScorecardProvider Assessment Report TemplateCentral Provider Assessments Tracking TableApproved Provider List TableCRO Qualification and SelectionPatient Feasibility Recruitment Retention StandardsPatient Feasibility Recruitment Retention RFI TemplatePatient Feasibility Recruitment Retention Scorecard TemplatePatient Feasibility Recruitment Retention Checklist TemplateProvider Qualification Resources102Process Oversight: Process oversight includes the activities and behaviors necessary to manage and improve operations byoverseeing process control and by surveillance of how activities are performed. Process oversight is a vital part of and is akey leading practice for Quality Oversight. Good process oversight drives quality not only in the context of operational risk,but also compliance risk.Return to TopProcess Tool 00Process Oversight GuidelineProcess Tool 01Elements of Process OversightProcess Tool 03Process Document ControlProcess Tool 03bJoint Process DevelopmentProcess Tool 03eProcess Development DocumentProcess Tool 03fProcess ImprovementProcess Tool 03gLean and Kaizen EventsProcess Tool 03hRoot Cause AnalysisProcess Tool 03iRoot Cause Analysis Fishbone Diagram TemplateAQC Knowledge Center Catalog 08July2021Page 7 of 17 2021 The Avoca Group
AQC Knowledge Center CatalogProcess Tool 03jProcess Tool 04Process Tool 04bProcess Tool 04cProcess Tool 04gProcess Tool 04hProcess Tool 04kProcess Tool 05eProcess Tool 06Process Tool 06aProcess Tool 06bProcess Tool 07Process Tool 07aProcess Tool 07bProcess Tool 07cProcess Tool 07dProcess Tool 07eProcess Tool 08Process Tool 09Process Tool 10Process Tool 11Process Oversight ResourcesStatistical Process ControlQuality by Design PrinciplesQbD for Pharma GCP ActivitiesOperationalizing QbD for Clinical TrialsQbD Template FMEAQbD Leading Practices when OutsourcingQbD Risk Assessment and PrioritizationJoint Quality Management PlanChange Management Leading PracticesChange Management Plan TemplateOrganizational Change Management Presentation Template for a New QMSQuality Audit ProcessQuality Audit Plan TemplateQuality Audit Agenda and ChecklistQuality Audit Schedule TemplateSite Quality Audit Report TemplateProvider Quality Audit Report TemplateFunctional Service Provider Quality Oversight PlanKick Off Meeting AgendaStudy Closeout Study Level ChecklistStudy Closeout Investigator Site Checklist30Protocol Quality: A high-quality protocol is critical not only to the full appraisal of a study’s scientific objectives, but also toits proper, timely, and cost-effective implementation.Return to TopPROQ 01Protocol Quality Review ChecklistPROQ 02Leading Practices in Quality Protocol DevelopmentPROQ 02aDefining Meaningful Scientific QuestionsPROQ 02bDeveloping Rigorous Feasible Attractive Study DesignsPROQ 02cProtocol Authoring with Functional InputPROQ 02dProtocol Review QC and ApprovalPROQ 02eAssess Implementation Experience and Measure PerformanceProtocol Quality Resources7Patient Engagement: The use of patient input during trial design and execution can enhance the quality and efficiency ofclinical development activities and results, as well as serving the patient need to be appreciated as a research partner. Thefollowing tools help support operationalizing such initiatives.Return to TopPTEN 00Patient Engagement PlaybookPTEN 00bPatient Engagement Reading ListPTEN 00cDefinitions and Considerations for Patient Engagement StrategyAQC Knowledge Center Catalog 08July2021Page 8 of 17 2021 The Avoca Group
AQC Knowledge Center CatalogPTEN 00dBusiness Objectives for Patient EngagementPTEN 00gTimepoints of Entry for Patient EngagementPTEN 00hPatient Engagement from Patient PerspectivePTEN 01Trial Participant Survey GuidancePTEN 01aTrial Participant Survey at EnrollmentPTEN 01bTrial Participant Survey at Mid-StudyPTEN 01cTrial Participant Survey at End of StudyPTEN 01dMock Survey Enrollment Report for PatientsPTEN 01eMock Survey Enrollment Report for Sites Sponsor CROPTEN 01fMock Survey End of Study Report for PatientsPTEN 01gMock Survey End of Study Report for Sites Sponsor CROPTEN 01hStudy Participant LetterPTEN 02Online Patient Communities What Why When HowPTEN 02aPatient Insights and BenefitsPTEN 02bOnline Community Moderation PrimerPTEN 02cOnline Community Set Up ChecklistPTEN 02dOnline Focus Groups and SurveysPTEN 02eVirtual Patient Advisory BoardsPTEN 02fPrivate Clinical Trial CommunitiesPTEN 02gTrial Alumni Communities and Long Term RelationshipsPTEN 03Use of Disease Information and Clinical Trial Participation Opinion SurveysPTEN 03aSample Disease Information SurveyPTEN 03bSample Clinical Trial Participation Opinion SurveyPTEN 04Sample Patient Survey Objectives and Information for IRB SubmissionPTEN 05Evaluation Tool for Patient Centricity at SitesPTEN 06Evaluation Tool for Patient Centricity at Sponsor or CROPTEN 07Patient Engagement Program Key Success FactorsPTEN 09Innovative Approaches to Patient-Centric Protocol DesignPatient Engagement Resources31Quality Agreement: The Clinical Quality Agreement has been developed for use by The Avoca Group Quality Consortium.Clinical Quality Agreements may be composed for use at the project level, the program level, or the relationship level.Return to TopQAGR 01AQC Quality Agreement TemplateQAGR 02Table of Contents and AcronymsQAGR 03ScopeQAGR 04StandardsQAGR 04aStandard ProcessesQAGR 04bStandards Review and OversightQAGR 05GovernanceQAGR 05aGovernance BenefitsAQC Knowledge Center Catalog 08July2021Page 9 of 17 2021 The Avoca Group
AQC Knowledge Center CatalogQAGR 06CommunicationQAGR 07Risk ManagementQAGR 08Protocol and Process DeviationQAGR 09Quality MetricsQAGR 10Selection and Training of PersonnelQAGR 11Third Party Vendors and SuppliersQAGR 12Audits and Issue ResolutionQAGR 12aLead AuditorQAGR 12bSOPs and Findings DefinitionsQAGR 12cGeneral Audit StrategyQAGR 12dAudits Initiated by CROQAGR 12eAudits by Sponsor of CROQAGR 12fAudit Follow UpQAGR 12gAudit of Sites by SponsorQAGR 13InspectionsQAGR 13aInspection Readiness PlanQAGR 13bUnannounced InspectionsQAGR 13cQA Support of InspectionsQAGR 13dInspection Follow UpQAGR 14Performance ControlQAGR 15Biostatistics and ProgrammingQAGR 16Data ManagementQAGR 17Investigator Selection and TrainingQAGR 18Investigator Site Watch and Deviation ManagementQAGR 19Medical Writing of Trial DocumentsQAGR 20MonitoringQAGR 21PharmacovigilanceQuality Agreement Resources35Quality Oversight Management Framework: The Quality Oversight Management Framework (QOMF) offers a high-levelview of the AQC library of leading practices for effective Quality Oversight. This QOMF framework shares the eight elementsthat drive effective oversight and shows how they fit together. This framework is supported by the eight “AQC swim lane”view. The QOMF framework also includes a glossary that supports the entire AQC library, across the eight swim lanes andacross the other AQC workstreams supported by the library.Return to TopQOMF 01Proactive Quality Oversight ManagementQOMF 02Avoca Quality Consortium GlossaryQuality Oversight Management Framework Resources2AQC Knowledge Center Catalog 08July2021Page 10 of 17 2021 The Avoca Group
AQC Knowledge Center CatalogProactive Risk/Opportunity Management: Proactive Risk and Opportunity Management includes the coordinated activitiesand behaviors necessary to direct and control an organization regarding risk and opportunities. Effective proactivemanagement of risk drives quality on many fronts, including business, operational, patient-facing, and compliance risk.Return to TopRisk Tool 00Proactive Risk and Opportunity Management GuidelineRisk Tool 01Elements of Risk ManagementRisk Tool 02Elements of Opportunity ManagementRisk Tool 03Risk Management ToolsRisk Tool 03aRisk Matrix with InstructionsRisk Tool 03bFMECA ToolRisk Tool 03dRisk Ranking and FilteringRisk Tool 03eSample Risk MatrixRisk Tool 03fRisk Ranking TemplateRisk Tool 03gRisk Matrix TemplateRisk Tool 04Opportunity Management Plan, Matrix and Tracking TemplateRisk Tool 06aRisk Prevention and Detection ControlsRisk Tool 06bRisk Plan with Bubble PlotRisk Tool 07Risk Management Plan TemplateRisk Tool 07bKey Risk Indicators and Central Statistical MonitoringRisk Tool 09Project Warning Signs and RecoveryRisk Tool 09aProject Transition PracticesRisk Tool 09bProject Transition Plan TemplateRisk Tool 09cProject Recovery Plan TemplateRisk Tool 10Measures of Risk and Opportunity Mgmt SuccessRisk Tool 12Risk Evaluation of Wearable DevicesRisk Tool 13Value Risk Framing Analysis and AggregationRisk Tool 14Risk Metric FrameworkRisk Tool 14aIdentification and Review of Risk Drivers and Risk MetricsProactive Risk/Opportunity Management Resources24Risk-Based Quality Management: Regulatory authorities encourage the use of risk-based approaches in the developmentof clinical study design and execution in order to support Quality Management. These leading practices assist users inapplying these approaches to support their compliance with regulatory authority expectations.RBQM 01RBQM 01aRBQM 01bRBQM 02RBQM 03RBQM 04Return to TopDevelopment of a Risk-Based Monitoring PlanRisk-Based Monitoring Plan TemplateRisk-Based Monitoring FrameworkCentralized Monitoring Procedural StandardsSubject Data Sampling Methods for Risk Based Source Data MonitoringProcess for Establishing Critical to Quality (CTQ) Factors and Quality Tolerance Limits(QTLs)AQC Knowledge Center Catalog 08July2021Page 11 of 17 2021 The Avoca Group
AQC Knowledge Center CatalogRBQM 04aRBQM 05RBQM 05aRBQM 06RBQM 07Critical to Quality (CTQ) Factors TemplateProcess for De-Risking ProtocolsProtocol De-Risking ChecklistIntegrated Quality Risk Management Plan (IQRMP)Provider Risk Rating and Comparison WorkbookRisk-Based Quality Management Resources11Roles/Responsibilities: Roles and Responsibilities should be understood throughout an organization and its partners todrive oversight and efficient clinical operations. Roles and Responsibilities should be proactively defined before projectwork begins and refined and enhanced on a periodic basis.Return to TopRnR Tool 00Roles and Responsibilities GuidelineRnR Tool 01Sourcing Models and OversightRnR Tool 02Core CompetencyRnR Tool 04RACI Analysis and TemplateRnR Tool 05Performance Management Initiatives for Outsourcing OversightRnR Tool 07Leading Practices in Performance MeasurementRnR Tool 08SMART GoalsRnR Tool 09Provider Onboarding TemplateRnR Tool 10Core Competency Decision ToolRnR Tool 11Task Ownership MatrixRnR Tool 12Transfer of ObligationsRnR Tool 13Role-Based Transition Plan TemplateRnR Tool 14Provider Oversight Plan TemplateRoles/Responsibilities Resources13Site Quality: The Avoca Quality Consortium (AQC) recognizes that the biopharmaceutical industry cannot elevate quality tothe highest levels without involving sites as a critical component of the holistic clinical trial quality value system. As a result,the AQC has brought investigative site needs into the mix with Sponsors and Providers via the Site Quality Center andleading practices associated with the 12-component AQC Investigator Site Quality Management System construct. (See alsoInvestigator Site Inspection Readiness leading practices (INSP 11-17)).Return to TopSQMS 01Proactive Quality Framework for Sites - Quality Culture and PracticesSQMS 02Introduction to Quality Management Systems for the Clinical Trial SiteSQMS 03Proactive Quality Framework for Sites - Investigator ResponsibilitiesSQMS 04Investigator Site Personnel Onboarding Training and Selection to a Trial Study TeamSQMS 05aClinical Site Investigator Master Delegation and Training MatrixSQMS 05bSite Staff Qualifications Assessment, Onboarding, Training Plans and DocumentationSQMS 05cSite Staff Orientation Agenda and ScheduleSQMS 06Site and Team Management Tool: RACI ModelSQMS 06aSample Clinical Site RACI ChartAQC Knowledge Center Catalog 08July2021Page 12 of 17 2021 The Avoca Group
AQC Knowledge Center CatalogSQMS 07SQMS 07aSQMS 08SQMS 08aSQMS 09SQMS 10SQMS 10aSQMS 11SQMS 11aSQMS 12SQMS 12aSQMS 13SQMS 13aSQMS 14SQMS 15SQMS 15aSQMS 16SQMS 16aSQMS 17SQMS 17aSQMS 17bSQMS 18SQMS 18aSQMS 18bSQMS 19SQMS 20SQMS 21SQMS 24SQMS 25SQMS 26SQMS 27SQMS 28SQMS 29Clinical Site Standard Operating Procedures Overview and Management Standards for SOPDevelopmentClinical Site SOP Management LogClinical Site Investigator Trial Oversight-Supervision Procedural Document StandardsClinical Site Investigator Trial Oversight Supervision TemplateClinical Site Investigator Delegation of Duties and Tasks Procedural Document Standardsfor SOP and Policy DevelopmentClinical Site Source Document Management Procedural Standards for SOP and PolicyDevelopmentClinical Site Source Document Location LogClinical Site IP Mgmt Accountability Procedural Doc Standards for SOP and PolicyDevelopmentClinical Site Investigational Product Temperature LogClinical Site Handling of Protocol Amendments New Study Information ProceduralStandards for SOP and Policy DevelopmentClinical Site Protocol Amendment Tracking Log and New Study Information Tracking LogClinical Site Protocol Deviation Management Procedural Document Standards for SOP andPolicy DevelopmentClinical Site Protocol Deviation Tracking LogClinical Site Users of Electronic Systems Log TemplateClinical Site Risk-based Quality Management of Informed Consent ProcessBasic Clinical Site Informed Consent Process Illustration ToolClinical Site Risk-based Quality Management of IRB and EC ResponsibilitiesClinical Site IRB and EC Interaction Compliance Priorities Identification ToolRole of Audits and Inspections in Clinical Site Risk-based Quality ManagementClinical Site Guidelines for Internal AuditsOutline for Clinical Site Yearly Audit PlanClinical Site Risk-based Quality Management of the Safety and Adverse Event ReportingProcessClinical Site Adverse Event Definitions, Recording, and Reporting Requirements ToolClinical Site Adverse Event Log TemplateClinical Site Risk-based Quality Management of Root Cause AnalysisBusiness Impact Analysis TemplateBusiness Continuity Plan TemplateClinical Site Risk Assessment ToolsClinical Site Risk Prevention and Detection ControlsClinical Site Risk Management Plan TemplateSite Quality Agreement TemplateClinical Site Risk and Issues TriggersSite Communication Plan TemplateSite Centricity Resources42AQC Knowledge Center Catalog 08July2021Page 13 of 17 2021 The Avoca Group
AQC Knowledge Center CatalogTechnical Oversight: Technical oversight includes the activities and behaviors necessary to manage and improve operationsby overseeing the engagement and management of third parties (CROs and other third parties) that are conductingtechnical activities in support of clinical programs including the services that support the technologies.Return to TopTech Tool 00Technical Oversight GuidelineTech Tool 01Core Oversight PracticesTech Tool 02Project Management OversightTech Tool 03Study Start Up OversightTech Tool 03aStudy Start Up ExperienceTech Tool 03bStudy Start Up FeedbackTech Tool 04Monitoring OversightTech Tool 04aMonitoring ExperienceTech Tool 04bMonitoring FeedbackTech Tool 05Enrollment OversightTech Tool 05aEnrollment ExperienceTech Tool 05bEnrollment FeedbackTech Tool 06Data Management OversightTech Tool 06aData Management ExperienceTech Tool 06bData Management FeedbackTech Tool 07Biostatistics OversightTech Tool 07aBiostatistics ExperienceTech Tool 07bBiostatistics FeedbackTech Tool 08Medical Writing OversightTech Tool 08aMedical Writing ExperienceTech Tool 08bMedical Writing FeedbackTech Tool 09Regulatory OversightTech Tool 09aRegulatory ExperienceTech Tool 10CTMS OversightTech Tool 11Third Party Organization Start Up and OversightTech Tool 12Central Lab OversightTech Tool 12aCentral Lab ExperienceTech Tool 12bCentral Lab FeedbackTech Tool 13IxRS and IRT Provider OversightTech Tool 13aIxRS and IRT ExperienceTech Tool 13bIxRS and IRT FeedbackTech Tool 14ECG Provider and Reader OversightTech Tool 14aECG Provider and Reader ExperienceTech Tool 14bECG Provider and Reader FeedbackTech Tool 15Imaging Provider and Reader OversightTech Tool 15aImaging Provider and Reader ExperienceAQC Knowledge Center Catalog 08July2021Page 14 of 17 2021 The Avoca Group
AQC Knowledge Center CatalogTech Tool 15bImaging Provider and Reader FeedbackTech Tool 16Biomarker Lab OversightTech Tool 16aBiomarker Lab ExperienceTech Tool 16bBiomarker Lab FeedbackTech Tool 17Clin
Comm Tool 05 Risk Issue Triggers RACI Matrix Template Comm Tool 07 Risk or Issue Communication Template Comm Tool 11 Meeting Minutes Template Comm Tool 12 Action Item Template . General Wearable Sensor Device Scorecard Template . PQUAL 20c . General Wearable Sensor Device Visit Checklist Template
May 02, 2018 · D. Program Evaluation ͟The organization has provided a description of the framework for how each program will be evaluated. The framework should include all the elements below: ͟The evaluation methods are cost-effective for the organization ͟Quantitative and qualitative data is being collected (at Basics tier, data collection must have begun)
On an exceptional basis, Member States may request UNESCO to provide thé candidates with access to thé platform so they can complète thé form by themselves. Thèse requests must be addressed to esd rize unesco. or by 15 A ril 2021 UNESCO will provide thé nomineewith accessto thé platform via their émail address.
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Le genou de Lucy. Odile Jacob. 1999. Coppens Y. Pré-textes. L’homme préhistorique en morceaux. Eds Odile Jacob. 2011. Costentin J., Delaveau P. Café, thé, chocolat, les bons effets sur le cerveau et pour le corps. Editions Odile Jacob. 2010. 3 Crawford M., Marsh D. The driving force : food in human evolution and the future.
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Lời Nói Đầu K inh Bát-Nhã (Prajna) đƣợc lƣu hành rất sớm tại Ấn độ. Khoảng 700 năm sau khi Phật diệt độ (cuối thế kỷ II đầu thế kỷ III Tây lịch), lúc Bồ-tát Long Thọ
UNESCO in consultation with thé National Commission for UNESCO as well as b non- overnmental or anizations NGOs in officiai artnershi with UNESCO. Nominations must focus on a s ecific ESD ro'ect or ro ramme. Each Member State or NGO can make u to three nominations for an édition of thé Pri
1.2. Chương Trình 0% Lãi Suất Ưu Đãi Mua Sắm không áp dụng cho Chủ thẻ Tín Dụng Thương Mại. The Installment Plan With 0% Interest is not applicable for HSBC Business Credit Card. 1.3. Loại tiền tệ được sử dụng trong Chương Trình 0% L
For centuries, Baccarat has been privileged to create masterpieces for royal households throughout the world. Honoring that legacy we have imagined a tea service as it might have been enacted in palaces from St. Petersburg to Bangalore. Pairing our menus with world-renowned Mariage Frères teas to evoke distant lands we have
HƯỚNG DẪN LỰA CHỌN DÂY & CÁP HẠ THẾ DÂY & CÁP HẠ THẾ A/ LỰA CHỌN DÂY & CÁP : Khi chọn cáp, khách hàng cần xem xét những yếu tố sau: - Dòng điện định mức - Độ sụt áp - Dòng điện ngắn mạch - Cách lắp đặt - Nhiệt độ môi trường hoặc nhiệt độ đất
RACI Knowledge User Knowledge Author Knowledge Reviewer (Content SME) Knowledge Manager / Coordinator(s) Knowledge Mgt Process Owner 1.0 Identify Knowledge AR 2.0 Author / Update Knowledge AR R 3.0 Review and Update Knowledge C R AR 4.0 Publish Knowledge I I I
2020–2021 UMGC Catalog. and represents changes and additions made after original publication. Refer to the . 2020–2021 Catalog. for information on all other programs, services, and policies. 2020 2021 UMGC Catalog . 2020 2021 UMGC Catalog . 2020 2021 Catalog . 2020 2021 Catalog . ABO
Centre for Comparative and Clinical Anatomy, University of Bristol, Southwell Street, Bristol, BS2 8EJ. Receipt of these documents is a condition of our acceptance. If we do not receive these documents within 14 days of registration of the death we will be required to decline the bequest. At the time of donation the next of kin or executor will be asked to complete form ‘Instructions for the .