AQC Knowledge Center Catalog - 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