AQC Knowledge Center Catalog
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Avoca Quality Consortium
Knowledge Center Catalog
Advance to Specific Categories: Communication | Governance/Organization Construct |
Inspection | Issue Management | Leadership | Medical Device | Metrics/Analytics/Technology |
Oversight Capability Maturity Model| Pharmacovigilance | Provider Qualification | Process
Oversight | Protocol Quality | Patient Engagement | Quality Agreement | Quality Oversight
Management Framework | Risk | Risk-Based Quality Management| Roles and Responsibilities |
Site Quality | Technical Oversight | Summary of Knowledge Center Documents | New
Documents in Development
Communication: To achieve leading practice quality oversight, an organization must
proactively and clearly define required communications, the types of stakeholders who must
be informed, the media, venues, or forums expected, and the style of these communications.
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Comm Tool 00
Communication Guideline
Comm Tool 01
Communication Management Plan
Comm Tool 03
Issue Escalation Process
Comm Tool 04
Escalation Pathways
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
Comm Tool 13
Meeting Agenda Template
Comm Tool 14
Issue Log Template
Comm Tool 15
Leading Practices for Meetings
Comm Tool 16
Email Leading Practices
Comm Tool 17
Governance Meeting Constructs and Agenda
Comm Tool 20
Setting Expectations Worksheet
Comm Tool 22
Active Lessons Learned Process and Database Construct
Comm Tool 24
Active Lessons Learned Capture Template
Comm Tool 25
Active Lessons Learned Project Review Meeting Template
Comm Tool 26
Active Lessons Learned Review Meeting Facilitator Guide
Communication Resources
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Governance/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 a specific organization based on
the sourcing models that are deployed, the maturity of the Sponsor/Provider relationship,
services outsourced and other considerations.
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Gov Tool 00
Governance and Organizational Construct Guideline
Gov Tool 01
Governance Structure and Objectives
Gov Tool 02
Governance Charters
Gov Tool 02a
Template for a Governance Charter
Gov Tool 02b
Sample Executive Committee Charter
Gov Tool 02c
Sample Operations Mgmt Comm Charter
Gov Tool 02d
Sample Business Mgmt Comm Charter
Gov Tool 03
Decision Making Models
Gov Tool 08
Decision Scorecard
Gov Tool 11
Centers of Excellence
Gov Tool 12
Quality Units
Gov Tool 13
Template for Business Objectives and Needs
Gov Tool 14
Preparing a Governance Plan
Gov Tool 15
Partnership Governance Plan Template
Gov Tool 17
Risk and Issue Triggers
Gov Tool 23
Cost Benefit Analysis
Gov Tool 24
Metrics Analytics Optimization
Gov Tool 25
System Scorecard Template
Gov Tool 26
Multi-Project Tracker
Governance/Organizational Construct Resources
19
Inspection: As a leading practice for Inspection Readiness, the Sponsor, CRO and Clinical
Sites should proactively prepare for inspections from all Health Authorities responsible for
countries where Sponsors are seeking market authorization approval. Inspection Readiness is
vital to ensure efficient review by Health Authorities of the clinical trial program.
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INSP 00
Inspection Readiness Overview
INSP 02
Sponsor and CRO Inspection Readiness Dashboard
INSP 02a
Sponsor and CRO Functional Inspection Preparation Checklist
INSP 03
Inspection Preparation Kickoff Meeting Presentation Template
INSP 03a
Inspection Preparation Kickoff Email Template
INSP 03b
Inspection Preparation Timeline Template
INSP 04
Inspection Preparation Storyboard Template
INSP 04a
Inspection Preparation Most Challenging Questions
INSP 05
Sponsor and CRO Inspection Logistics and Coordination Tool
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INSP 05a
Dos and Do Nots During Inspection Interviews
INSP 06
Inspection Preparation Logistics Presentation Template
INSP 07
ICH E6 (R2) Overview
INSP 07a
ICH E6 R2 Mapping to a Quality Management System
INSP 07b
Background and Resources
INSP 07c
Assessment of Resources and Process Operations
INSP 07d
External Service Provider Oversight
INSP 07e
Risk Evaluation
INSP 07f
Risk Control
INSP 07g
Risk Review
INSP 07h
Risk Communication
INSP 07i
Process Improvement
INSP 07j
Risk Reporting
INSP 07k
Documentation
INSP 08
Sponsor and CRO Inspection Preparation Tool
INSP 09
QMS Annual Compliance Assessment Plan Process
INSP 09a
QMS Compliance Assessment Plan Schedule Template
INSP 09b
QMS Assessment Findings and Resolutions Template
INSP 11
Investigator Site Inspection Preparation Tool
INSP 12
Investigator Site Functional Inspection Preparation Checklist
INSP 13
Investigator Site Inspection Preparation Interview Question
Template
INSP 14
Investigator Site Inspection Logistics and Coordination Tool
INSP 15
Clinical Site Inspection Follow up
INSP 16
Investigator Site Inspection Preparation Most Challenging Questions
INSP 17
PMDA Required Foreign Investigative Site Inspection Documents
Tool
INSP 18
Pharmacovigilance Areas of Focus
INSP 19
Inspection Response Guide
INSP 20
Inspection Response Checklist
INSP 21
Inspection Response Tool
INSP 22
MHRA Blog Sponsor Oversight
INSP 23
AQC Quality Management System
INSP 24
Remote Inspection Tips for Logistics and Interviews
INSP 25
Clinical Data Flow Tool
INSPA 00
IR Agency Resource and Member Experience
INSPA 00a
Acronyms Inspection Readiness Agency Resource Documents
INSPA 01
Member Experience Overview
INSPA 01a
Remote Inspection Focus Group - Feb 2021
INSPA 01b
eTMF Inspection Focus Group Executive Summary
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INSPA 01c
FDA Inspection Focus Group - October 2021
INSPA 01d
MHRA Inspection Focus Group - November 2021
INSPA 01e
Health Canada Inspection Focus Group - March 2022
INSPA 01f
Swissmedic Inspection Focus Group – April 2022
INSPA 01g
EMA Inspection Focus Group – September 2022
INSPA 01h
PMDA Inspection Focus Group - 2023
INSPA 02
USA FDA Inspection Readiness Agency Resource
INSPA 03
UK MHRA Inspection Readiness Resource
INSPA 04
EU EMA Inspection Readiness Resource
INSPA 05
China NMPA Inspection Readiness Resource
INSPA 06
Japan PMDA Inspection Readiness Agency Resource
INSPA 07
Health Canada Inspection Readiness Resource
Inspection Resources
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Issue Management: A robust issue management process is critical to detect, document,
report, and address non-compliance and prevent recurrence.
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ISM 02
Issue Management Process Flow
ISM Tool 00
Issue Management Toolkit
ISM Tool 00a
Issue Management Process Metrics Toolkit Overview and
Implementation Guide
ISM Tool 00b
Issue Management Process Metrics Toolkit Overview Slides
ISM Tool 00c
Issue Management Process Map with Metrics
ISM Tool 01
Issue Management Process Metrics Workbook
ISM Tool A
Issue Management Process Key Performance Questions to Metrics
ISM Tool B
Issue Management Process Issues to Metrics
ISM Tool C
Issue Management Process Basic Advanced Metrics to Data
Elements
ISM Tool D
Issue Management Process Data Elements to Metrics
ISM Tool E
Issue Management Process Metrics Reporting Planning Worksheet
Process Tool 03h
Root Cause Analysis
Process Tool 03i
Root Cause Analysis Fishbone Diagram Template
Issue Management
Resources
11*
*
Total without duplicates sitting also in other sections
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Oversight Leadership Requirements: Leadership is essential to any group or organization.
What a leader does is usually difficult to describe and is often situational. Leading practice for
individuals in leadership roles that provide oversight of outsourced projects is the ability to
accomplish tasks through others by providing clear direction, vision, and motivation.
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Lead Tool 00
Oversight Leadership Guideline
Lead Tool 03
Balanced vs Micromanagement
Lead Tool 04
Leadership Styles
Lead Tool 05
The Six Leadership Styles at a Glance
Lead Tool 06
Leadership Characteristics of Vendor Oversight Team
Lead Tool 07
AAAA Framework
Lead Tool 10
Vendor Oversight Interviewing Template
Lead Tool 14
Culture of Quality
Oversight Leadership Requirement Resources
8
Medical Device: Leading practices for the design and development of Medical Devices or
Combination Products that have a device constituent.
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MedDev 01
Design Control Requirements
MedDev 01a
Design and Development Plan
MedDev 01aT
Design and Development Plan Template
MedDev 01b
User Needs
MedDev 01bT
User Needs Document Template
MedDev 01c
Design Input Requirements
MedDev 01cT
Traceability Matrix Template
MedDev 01d
Design Output Requirements
MedDev 01e
Design Verification
MedDev 01f
Design Validation
MedDev 01g
Design Transfer Requirements
MedDev 01gT
Design Transfer Template
MedDev 01h
Design Reviews
MedDev 01hT
Design Review Template
MedDev 01i
Design History File – Design and Development File
MedDev 01iT
Design History File – Design and Development File Template
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Metrics/Analytics/Technology: Metrics and their supporting analytics seek to improve
operations through oversight and management of factors that impact outcomes. Good
utilization of metrics, analytics, and associated decision processes can drive efficiency,
support accountability, create consistency, enhance quality, and promote an outcomes-
focused culture and effective risk management.
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Met Tool 00
Metrics/Analytics/Technology Guideline
Met Tool 01
Quality and Oversight Metric Taxonomy
Met Tool 06
Strategy Maps
Met Tool 11
Development Worksheet for Special Metric Short Lists
Met Tool 18
Metrics Plan Thought Map
Met Tool 20
Metric Dashboard Example: Balanced Scorecard
Met Tool 21
AQC Catalog of Quality and Oversight Metrics
Met Tool 22
Organizational Metrics Curriculum
Metrics/Analytics/Technology Resources
8
Oversight Capability Maturity Model: Sponsor oversight capability, as it relates to Provider
oversight, for biopharmaceutical 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. Sponsor capabilities also
impact CROs by enabling better more effective partnerships.
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OCMM 00a
Oversight Strategy
OCMM 00b
Governance/Organization Construct
OCMM 00c
Oversight Leadership
OCMM 00d
Process Oversight
OCMM 00e
Metrics/Analytics/Technology
OCMM 00f
Proactive Risk and Opportunity Management
OCMM 00g
Budget, Sourcing, Contractual, Financial Oversight
OCMM 00h
Communication Associated with External Party Oversight
OCMM 00i
Roles and Responsibilities within Oversight Landscape
OCMM 00j
Technical Oversight
OCMM 02
Oversight Capability Maturity Model Worksheet
OCMM 03
Oversight Capability Maturity Model Instructions
OCMM 04
Conceptual Foundation
OCMM 05
Oversight Capability Maturity Model Image
OCMM 06
Virtual and Lean Models for Oversight
Oversight Capability Maturity Model Resources
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Pharmacovigilance: A compilation of Pharmacovigilance related tools to assist in qualifying
PV providers, establishing a working agreement, and ensuring appropriate safety reporting.
These materials have been developed based on regulations and guidance or have become
leading practices based on contributions and advisement from the Avoca Quality Consortium
contributing members and WCG Avoca Subject Matter Experts.
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PVSF 01
Pharmacovigilance Agreement Template
PQUAL 23
CRO Pharmacovigilance Standards
PQUAL 23a
CRO Pharmacovigilance RFI Template
PQUAL 23b
CRO Pharmacovigilance Scorecard Template
PQUAL 23c
CRO Pharmacovigilance Visit Checklist Template
Pharmacovigilance Resources
1*
*
Total without duplicates sitting also in other sections
Provider Qualification: A compilation of industry standards and tools for qualification of
Clinical Service Providers. The standards are either specifically defined by health authority
regulations or guidance documents, have been extrapolated based on regulations and
guidance, or have become expected requirements based on leading practices, as defined by
an advisory board of biopharmaceutical and Contract Research Organizations through the
Avoca Quality Consortium.
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PQUAL 01
Core Standards
PQUAL 01a
Core RFI Template
PQUAL 01b
Core Scorecard Template
PQUAL 01c
Core Visit Checklist Template
PQUAL 02
Central Labs Standards
PQUAL 02a
Central Labs RFI Template
PQUAL 02b
Central Labs Scorecard Template
PQUAL 02c
Central Labs Visit Checklist Template
PQUAL 03
Bioanalytical Lab Standards
PQUAL 03a
Bioanalytical Lab RFI Template
PQUAL 03b
Bioanalytical Lab Scorecard Template
PQUAL 03c
Bioanalytical Lab Visit Checklist Template
PQUAL 04
Biomarker Lab Standards
PQUAL 04a
Biomarker Lab RFI Template
PQUAL 04b
Biomarker Lab Scorecard Template
PQUAL 04c
Biomarker Lab Visit Checklist Template
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PQUAL 05
IxRS Provider Standards
PQUAL 05a
IxRS RFI Template
PQUAL 05b
IxRS Scorecard Template
PQUAL 05c
IxRS Visit Checklist Template
PQUAL 06
ECG Provider Standards
PQUAL 06a
ECG RFI Template
PQUAL 06b
ECG Scorecard Template
PQUAL 06c
ECG Visit Checklist Template
PQUAL 07
Medical Imaging Provider Standards
PQUAL 07a
Medical Imaging RFI Template
PQUAL 07b
Medical Imaging Scorecard Template
PQUAL 07c
Medical Imaging Visit Checklist Template
PQUAL 08
COA and eCOA Provider Standards
PQUAL 08a
COA and eCOA RFI Template
PQUAL 08b
COA and eCOA Scorecard Template
PQUAL 08c
COA and eCOA Visit Checklist Template
PQUAL 09
CRO Monitoring Standards
PQUAL 09a
CRO Monitoring RFI Template
PQUAL 09b
CRO Monitoring Scorecard Template
PQUAL 09c
CRO Monitoring Visit Checklist Template
PQUAL 10
CRO Data Management Standards
PQUAL 10a
CRO Data Management RFI Template
PQUAL 10b
CRO Data Management Scorecard Template
PQUAL 10c
CRO Data Management Visit Checklist Template
PQUAL 11
CRO Biostatistics Standards
PQUAL 11a
CRO Biostatistics RFI Template
PQUAL 11b
CRO Biostatistics Scorecard Template
PQUAL 11c
CRO Biostatistics Visit Checklist Template
PQUAL 12
CRO Medical Writing Standards
PQUAL 12a
CRO Medical Writing RFI Template
PQUAL 12b
CRO Medical Writing Scorecard Template
PQUAL 12c
CRO Medical Writing Visit Checklist Template
PQUAL 13
Phase I Unit Standards
PQUAL 13a
Phase I Unit RFI Template
PQUAL 13b
Phase I Unit Scorecard Template
PQUAL 13c
Phase I Unit Visit Checklist Template
PQUAL 14
Electronic Regulatory Binder-eISF Standards
PQUAL 14a
Electronic Regulatory Binder-eISF RFI Template
PQUAL 14b
Electronic Regulatory Binder-eISF Scorecard Template
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PQUAL 14c
Electronic Regulatory Binder-eISF Visit Checklist Template
PQUAL 15
eConsent Standards
PQUAL 15a
eConsent RFI Template
PQUAL 15b
eConsent Scorecard Template
PQUAL 15c
eConsent Checklist Template
PQUAL 16
Mobile Health Care Provider Visits Standards
PQUAL 16a
Mobile Health Care Provider Visits RFI Template
PQUAL 16b
Mobile Health Care Provider Visits Visit Scorecard Template
PQUAL 16c
Mobile Health Care Provider Visits Visit Checklist Template
PQUAL 17
eHealth Records for Patient Recruitment and Feasibility Standards
PQUAL 17a
eHealth Records for Patient Recruitment and Feasibility RFI Template
PQUAL 17b
eHealth Records for Patient Recruitment and Feasibility Scorecard
Template
PQUAL 17c
eHealth Records Patient Recruitment and Feasibility Visit Checklist
Template
PQUAL 18
eTMF Standards
PQUAL 18a
eTMF RFI Template
PQUAL 18b
eTMF Scorecard Template
PQUAL 18c
eTMF Checklist Template
PQUAL 19
Telemedicine Telehealth Standards
PQUAL 19a
Telemedicine Telehealth RFI Template
PQUAL 19b
Telemedicine Telehealth Scorecard Template
PQUAL 19c
Telemedicine Telehealth Visit Checklist Template
PQUAL 20
General Wearable Sensor Device Standards
PQUAL 20a
General Wearable Sensor Device RFI Template
PQUAL 20b
General Wearable Sensor Device Scorecard Template
PQUAL 20c
General Wearable Sensor Device Visit Checklist Template
PQUAL 21
eHealth Record to EDC Connector Apps Standards
PQUAL 21a
eHealth Record to EDC Connector Apps RFI Template
PQUAL 21b
eHealth Record to EDC Connector Apps Scorecard Template
PQUAL 21c
eHealth Record to EDC Connector Apps Checklist Template
PQUAL 22
Actigraphy Motion Sensors Standards
PQUAL 22a
Actigraphy Motion Sensors RFI Template
PQUAL 22b
Actigraphy Motion Sensors Scorecard Template
PQUAL 22c
Actigraphy Motion Sensors Visit Checklist Template
PQUAL 23
CRO Pharmacovigilance Standards
PQUAL 23a
CRO Pharmacovigilance RFI Template
PQUAL 23b
CRO Pharmacovigilance Scorecard Template
PQUAL 23c
CRO Pharmacovigilance Visit Checklist Template
PQUAL 24
CRO Investigator Site Budget Contract Payment Standards
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PQUAL 24a
CRO Investigator Site Budget Contract Payment RFI Template
PQUAL 24b
CRO Investigator Site Budget Contract Payment Scorecard Template
PQUAL 24c
CRO Investigator Site Budget Contract Payment Checklist Template
PQUAL 25
Mobile Cardiac Monitoring Standards
PQUAL 25a
Mobile Cardiac Monitoring RFI Template
PQUAL 25b
Mobile Cardiac Monitoring Scorecard Template
PQUAL 25c
Mobile Cardiac Monitoring Checklist Template
PQUAL 26
Provider Selection Rationale Template
PQUAL 27
High Level CRO Qualification Scorecard
PQUAL 28
Provider Assessment Report Template
PQUAL 29
Central Provider Assessments Tracking Table
PQUAL 30
Approved Provider List Table
PQUAL 31
Provider Qualification and Selection
PQUAL 32
Patient Feasibility Recruitment Retention Standards
PQUAL 32a
Patient Feasibility Recruitment Retention RFI Template
PQUAL 32b
Patient Feasibility Recruitment Retention Scorecard Template
PQUAL 32c
Patient Feasibility Recruitment Retention Checklist Template
PQUAL 33
Investigational and Medicinal Product Management Standards
PQUAL 33a
Investigational and Medicinal Product Management RFI Template
PQUAL 33b
Investigational and Medicinal Product Management
Scorecard Template
PQUAL 33c
Investigational and Medicinal Product Management Visit
Checklist Template
PQUAL 34
Mobile Biomarker Sensors Standards
PQUAL 34a
Mobile Biomarker Sensors RFI Template
PQUAL 34b
Mobile Biomarker Sensors Scorecard Template
PQUAL 34c
Mobile Biomarker Sensors Visit Checklist Template
PQUAL 35
Mobile Respiratory Sensors Standards
PQUAL 35a
Mobile Respiration Sensors RFI Template
PQUAL 35b
Mobile Respiratory Sensors Scorecard Template
PQUAL 35b
Mobile Respiratory Sensors Visit Checklist Template
PQUAL 36
CRO Project Management Standards
PQUAL 36a
CRO Project Management RFI Template
PQUAL 36b
CRO Project Management Scorecard
PQUAL 36c
CRO Project Management Visit Checklist
PQUAL 37
DCT Management Standards
PQUAL 37a
DCT Management RFI Template
PQUAL 37b
DCT Management Scorecard
PQUAL 37c
DCT Management Visit Checklist
PQUAL 38
Risk-Based Provider Qualification and Oversight
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PQUAL 39
EDC Standards
PQUAL 39a
EDC RFI Template
PQUAL 39b
EDC Scorecard Template
PQUAL 39c
EDC Visit Checklist
Provider Qualification Resources
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Process Oversight: Process oversight includes the activities and behaviors necessary to
manage and improve operations by overseeing process control and by surveillance of how
activities are performed. Process oversight is a vital part of and is a key leading practice for
Quality Oversight. Good process oversight drives quality not only in the context of
operational risk, but also compliance risk.
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Process Tool 00
Process Oversight Guideline
Process Tool 01
Elements of Process Oversight
Process Tool 03
Process Document Control
Process Tool 03b
Joint Process Development
Process Tool 03e
Process Development Document
Process Tool 03f
Process Improvement
Process Tool 03g
Lean and Kaizen Events
Process Tool 03h
Root Cause Analysis
Process Tool 03i
Root Cause Analysis Fishbone Diagram Template
Process Tool 03j
Statistical Process Control
Process Tool 04b
Industry Resources for Applying QbD in Clinical Trials
Process Tool 04c
Operationalizing QbD for Clinical Trials
Process Tool 04g
QbD Template FMEA
Process Tool 04h
QbD Leading Practices when Outsourcing
Process Tool 04k
QbD Risk Assessment and Prioritization
Process Tool 05e
Joint Quality Management Plan
Process Tool 06
Change Management Leading Practices
Process Tool 06a
Change Management Plan Template
Process Tool 06b
Organizational Change Management Presentation Template for a
New QMS
Process Tool 07
Quality Audit Process
Process Tool 07a
Quality Audit Plan Template
Process Tool 07b
Quality Audit Agenda and Checklist
Process Tool 07c
Quality Audit Schedule Template
Process Tool 07d
Site Quality Audit Report Template
Process Tool 07e
Provider Quality Audit Report Template
Process Tool 08
Functional Service Provider Quality Oversight Plan
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Process Tool 09
Kick Off Meeting Agenda
Process Tool 10
Study Closeout Study Level Checklist
Process Tool 11
Study Closeout Investigator Site Checklist
Process Oversight Resources
29
Protocol Quality: A high-quality protocol is critical not only to the full appraisal of a study’s
scientific objectives, but also to its proper, timely, and cost-effective implementation.
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PROQ 01
Protocol Quality Review Checklist
PROQ 02
Leading Practices in Quality Protocol Development
PROQ 02a
Defining Meaningful Scientific Questions
PROQ 02b
Developing Rigorous Feasible Attractive Study Designs
PROQ 02c
Protocol Authoring with Functional Input
PROQ 02d
Protocol Review QC and Approval
PROQ 02e
Assess Implementation Experience and Measure Performance
Protocol Quality Resources
7
Patient Engagement: The use of patient input during trial design and execution can
enhance the quality and efficiency of clinical development activities and results, as well as
serving the patient need to be appreciated as a research partner. The following tools help
support operationalizing such initiatives.
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PTEN 00
Patient Engagement Playbook
PTEN 00b
Patient Engagement Reading List
PTEN 00c
Definitions and Considerations for Patient Engagement Strategy
PTEN 00d
Business Objectives for Patient Engagement
PTEN 00g
Timepoints of Entry for Patient Engagement
PTEN 00h
Patient Engagement from Patient Perspective
PTEN 01
Trial Participant Survey Guidance
PTEN 01a
Trial Participant Survey at Enrollment
PTEN 01b
Trial Participant Survey at Mid-Study
PTEN 01c
Trial Participant Survey at End of Study
PTEN 01d
Mock Survey Enrollment Report for Patients
PTEN 01e
Mock Survey Enrollment Report for Sites Sponsor CRO
PTEN 01f
Mock Survey End of Study Report for Patients
PTEN 01g
Mock Survey End of Study Report for Sites Sponsor CRO
PTEN 01h
Study Participant Letter
PTEN 02
Online Patient Communities What Why When How
PTEN 02a
Patient Insights and Benefits
PTEN 02b
Online Community Moderation Primer
PTEN 02c
Online Community Set Up Checklist
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PTEN 02d
Online Focus Groups and Surveys
PTEN 02e
Virtual Patient Advisory Boards
PTEN 02f
Private Clinical Trial Communities
PTEN 02g
Trial Alumni Communities and Long Term Relationships
PTEN 03
Use of Disease Information and Clinical Trial Participation Opinion
Surveys
PTEN 03a
Sample Disease Information Survey
PTEN 03b
Sample Clinical Trial Participation Opinion Survey
PTEN 04
Sample Patient Survey Objectives and Information for IRB
Submission
PTEN 05
Evaluation Tool for Patient Centricity at Sites
PTEN 06
Evaluation Tool for Patient Centricity at Sponsor or CRO
PTEN 07
Patient Engagement Program Key Success Factors
PTEN 09
Innovative Approaches to Patient-Centric Protocol Design
Patient Engagement Resources
31
Quality 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.
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QAGR 01
AQC Quality Agreement Template
QAGR 02
Table of Contents and Acronyms
QAGR 03
Scope
QAGR 04
Standards
QAGR 04a
Standard Processes
QAGR 04b
Standards Review and Oversight
QAGR 05
Governance
QAGR 05a
Governance Benefits
QAGR 06
Communication
QAGR 07
Risk Management
QAGR 08
Protocol and Process Deviation
QAGR 09
Quality Metrics
QAGR 10
Selection and Training of Personnel
QAGR 11
Third Party Vendors and Suppliers
QAGR 12
Audits and Issue Resolution
QAGR 12a
Lead Auditor
QAGR 12b
SOPs and Findings Definitions
QAGR 12c
General Audit Strategy
QAGR 12d
Audits Initiated by CRO
QAGR 12e
Audits by Sponsor of CRO
QAGR 12f
Audit Follow Up
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QAGR 12g
Audit of Sites by Sponsor
QAGR 13
Inspections
QAGR 13a
Inspection Readiness Plan
QAGR 13b
Unannounced Inspections
QAGR 13c
QA Support of Inspections
QAGR 13d
Inspection Follow Up
QAGR 14
Performance Control
QAGR 15
Biostatistics and Programming
QAGR 16
Data Management
QAGR 17
Investigator Selection and Training
QAGR 18
Investigator Site Watch and Deviation Management
QAGR 19
Medical Writing of Trial Documents
QAGR 20
Monitoring
QAGR 21
Pharmacovigilance
QAGR 22
Essential Documents/Trial Master File (TMF)
Quality Agreement Resources
36
Quality Oversight Management Framework: The Quality Oversight Management
Framework (QOMF) offers a high-level view of the AQC library of leading practices for
effective Quality Oversight. This QOMF framework shares the eight elements that 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 and across the other AQC workstreams
supported by the library.
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QOMF 01
Proactive Quality Oversight Management
QOMF 02
Avoca Quality Consortium Glossary
Quality Oversight Management Framework Resources
2
Proactive Risk/Opportunity Management: Proactive Risk and Opportunity Management
includes the coordinated activities and behaviors necessary to direct and control an
organization regarding risk and opportunities. Effective proactive management of risk drives
quality on many fronts, including business, operational, patient-facing, and compliance risk.
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INNO 01
DCT Risk Evaluation
Risk Tool 00
Proactive Risk and Opportunity Management Guideline
Risk Tool 02
Elements of Opportunity Management
Risk Tool 03b
FMECA Tool
Risk Tool 03g
Risk Matrix Template
Risk Tool 04
Opportunity Management Plan, Matrix and Tracking Template
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Risk Tool 07
Risk Management Plan Template
Risk Tool 07b
Key Risk Indicators and Central Statistical Monitoring
Risk Tool 09
Project Warning Signs and Recovery
Risk Tool 09a
Project Transition Practices
Risk Tool 09b
Project Transition Plan Template
Risk Tool 09c
Project Recovery Plan Template
Risk Tool 10
Measures of Risk and Opportunity Mgmt Success
Risk Tool 13
Value Risk Framing Analysis and Aggregation
Risk Tool 14
Risk Metric Framework
Risk Tool 14a
Identification and Review of Risk Drivers and Risk Metrics
Proactive Risk/Opportunity Management Resources
16
Risk-Based Quality Management: Regulatory authorities encourage the use of risk-based
approaches in the development of clinical study design and execution in order to support
Quality Management. These leading practices assist users in applying these approaches to
support their compliance with regulatory authority expectations.
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RBQM 01
Development of a Risk-Based Monitoring Plan
RBQM 01a
Risk-Based Monitoring Plan Template
RBQM 01b
Risk-Based Monitoring Framework
RBQM 02
Centralized Monitoring Procedural Standards
RBQM 03
Subject Data Sampling Methods for Risk Based Source Data
Monitoring
RBQM 04
Process for Establishing Critical to Quality (CTQ) Factors and Quality
Tolerance Limits (QTLs)
RBQM 04a
Critical to Quality (CTQ) Factors Template
RBQM 05
Process for De-Risking Protocols
RBQM 05a
Protocol De-Risking Checklist
RBQM 06
Integrated Quality Risk Management Plan (IQRMP)
RBQM 07
Provider Risk Rating and Comparison Workbook
RBQM 08
Integrated Risk Tool
RBQM 09
Specifications for Risk-based Systems for Digital Oversight of Risk
RBQM 10
Guidance for Risk-Based Trial Master File (TMF) Review
RBQM 12
Risk-based Centralized Monitoring Guidance
RBQM 11
Site Diversity Recruitment and Comparison Workbook
RBQM 13
ICH E8 R1 RBQM Change Toolkit
RBQM 14
RBQM in Data Management SOPs and Data Management Plan
Risk-Based Quality Management Resources
18
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Roles/Responsibilities: Roles and Responsibilities should be understood throughout an
organization and its partners to drive oversight and efficient clinical operations. Roles and
Responsibilities should be proactively defined before project work begins and refined and
enhanced on a periodic basis.
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RnR Tool 00
Roles and Responsibilities Guideline
RnR Tool 01
Sourcing Models and Oversight
RnR Tool 02
Core Competency
RnR Tool 04
RACI Analysis and Template
RnR Tool 05
Performance Management Initiatives for Outsourcing Oversight
RnR Tool 07
Leading Practices in Performance Measurement
RnR Tool 08
SMART Goals
RnR Tool 09
Provider Onboarding Template
RnR Tool 10
Core Competency Decision Tool
RnR Tool 11
Task Ownership Matrix
RnR Tool 12
Transfer of Obligations
RnR Tool 13
Role-Based Transition Plan Template
RnR Tool 14
Provider Oversight Plan Template
Roles/Responsibilities Resources
13
Site Quality: The Avoca Quality Consortium (AQC) recognizes that the biopharmaceutical
industry cannot elevate quality to the 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
and leading practices associated with the 12-component AQC Investigator Site Quality
Management System construct. (See also Investigator Site Inspection Readiness leading
practices (INSP 11-17)).
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IQUAL 01
Investigator Site Qualification Standards
SDEI 01
Clinical Research Site Diversity, Equity, and Inclusion Standards
SFS 01
Clinical Research Site Feasibility and Selection Solution Overview
SFS 01a
Clinical Research Site Profile Content Standard
SFS 01b
Site Diversity Profile Form
SFS 01c
Trial Specific Interest and Feasibility Form
SFS 01d
Use of Virtual Site Tours and Video Conferencing – Telephone
Capabilities to Qualify Research
SFS 01e
Virtual Site Tour Content Checklist
SQMS 02
Introduction to Quality Management Systems for the Clinical Trial
Site
SQMS 03
Proactive Quality Framework for Sites - Investigator Responsibilities
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SQMS 04
Investigator Site Personnel Onboarding Training and Selection to a
Trial Study Team
SQMS 05a
Clinical Site Investigator Master Delegation and Training Matrix
SQMS 05b
Site Staff Qualifications Assessment, Onboarding, Training Plans and
Documentation
SQMS 05c
Site Staff Orientation Agenda and Schedule
SQMS 06
Site and Team Management Tool: RACI Model
SQMS 06a
Sample Clinical Site RACI Chart
SQMS 07
Clinical Site Standard Operating Procedures Overview and
Management Standards for SOP Development
SQMS 07a
Clinical Site SOP Management Log
SQMS 08
Clinical Site Investigator Trial Oversight-Supervision Procedural
Document Standards
SQMS 08a
Clinical Site Investigator Trial Oversight Supervision Template
SQMS 10
Clinical Site Source Document Management Procedural Standards
for SOP and Policy Development
SQMS 10a
Clinical Site Source Document Location Log
SQMS 11
Clinical Site IP Mgmt Accountability Procedural Doc Standards for
SOP and Policy Development
SQMS 11a
Clinical Site Investigational Product Temperature Log
SQMS 12
Clinical Site Handling of Protocol Amendments New Study
Information Procedural Standards for SOP and Policy Development
SQMS 12a
Clinical Site Protocol Amendment Tracking Log and New Study
Information Tracking Log
SQMS 13
Clinical Site Protocol Deviation Management Procedural Document
Standards for SOP and Policy Development
SQMS 13a
Clinical Site Protocol Deviation Tracking Log
SQMS 14
Clinical Site Users of Electronic Systems Log Template
SQMS 15
Clinical Site Risk-based Quality Management of Informed Consent
Process
SQMS 15a
Basic Clinical Site Informed Consent Process Illustration Tool
SQMS 16
Clinical Site Risk-based Quality Management of IRB and EC
Responsibilities
SQMS 16a
Clinical Site IRB and EC Interaction Compliance Priorities
Identification Tool
SQMS 17
Role of Audits and Inspections in Clinical Site Risk-based Quality
Management
SQMS 17a
Clinical Site Guidelines for Internal Audits
SQMS 17b
Outline for Clinical Site Yearly Audit Plan
SQMS 18
Clinical Site Risk-based Quality Management of the Safety and
Adverse Event Reporting Process
SQMS 18a
Clinical Site Adverse Event Definitions, Recording, and Reporting
Requirements Tool
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SQMS 18b
Clinical Site Adverse Event Log Template
SQMS 19
Clinical Site Risk-based Quality Management of Root Cause Analysis
SQMS 20
Business Impact Analysis Template
SQMS 21
Business Continuity Plan Template
SQMS 23
Clinical Research Site General Role Ladder, Profile, and Training
Resource
SQMS 24
Clinical Site Risk Assessment Tools
SQMS 25
Clinical Site Risk Prevention and Detection Controls
SQMS 26
Clinical Site Risk Management Plan Template
SQMS 27
Site Quality Agreement Template
SQMS 28
Clinical Site Risk and Issues Triggers
SQMS 29
Site Communication Plan Template
SQMS 30
Site FAQ Reference Document
SQMS 32
Site Study Team Meetings Agenda and Minutes Template
SQMS 33
Site Protocol Transition Form for Change in Research Coordinator
SQMS 34
Site SOP Abbreviations and Glossary
SQMS 35
General Administration SOP - Site GA-100
SQMS 36
Regulatory Affairs SOP - Site RA-200
SQMS 37
Project Management SOP - Site PM-300
SQMS 38
Trial Participant Management SOP - Site TPM-400
SQMS 39
Data Management SOP - Site DM-500
SQMS 40
Quality Assurance SOP - Site QA-600
SQMS 41
Site SOP Related Resources
SQMS 42
Evaluating Computerized Systems and Electronic Tools
Site Quality Resources
61
Technical Oversight: Technical oversight includes the activities and behaviors necessary to
manage and improve operations by overseeing the engagement and management of third
parties (CROs and other third parties) that are conducting technical activities in support of
clinical programs including the services that support the technologies.
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Tech Tool 00
Technical Oversight Guideline
Tech Tool 01
Core Oversight Practices
Tech Tool 02
Project Management Oversight
Tech Tool 03
Study Start Up Oversight
Tech Tool 03a
Study Start Up Experience
Tech Tool 03b
Study Start Up Feedback
Tech Tool 04
Monitoring Oversight
Tech Tool 04a
Monitoring Experience
Tech Tool 04b
Monitoring Feedback
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Tech Tool 05
Enrollment Oversight
Tech Tool 05a
Enrollment Experience
Tech Tool 05b
Enrollment Feedback
Tech Tool 06
Data Management Oversight
Tech Tool 06a
Data Management Experience
Tech Tool 06b
Data Management Feedback
Tech Tool 07
Biostatistics Oversight
Tech Tool 07a
Biostatistics Experience
Tech Tool 07b
Biostatistics Feedback
Tech Tool 08
Medical Writing Oversight
Tech Tool 08a
Medical Writing Experience
Tech Tool 08b
Medical Writing Feedback
Tech Tool 09
Regulatory Oversight
Tech Tool 09a
Regulatory Experience
Tech Tool 10
CTMS Oversight
Tech Tool 11
Provider Start Up and Oversight
Tech Tool 12
Central Lab Oversight
Tech Tool 12a
Central Lab Experience
Tech Tool 12b
Central Lab Feedback
Tech Tool 13
IxRS and IRT Provider Oversight
Tech Tool 13a
IxRS and IRT Experience
Tech Tool 13b
IxRS and IRT Feedback
Tech Tool 14
ECG Provider and Reader Oversight
Tech Tool 14a
ECG Provider and Reader Experience
Tech Tool 14b
ECG Provider and Reader Feedback
Tech Tool 15
Imaging Provider and Reader Oversight
Tech Tool 15a
Imaging Provider and Reader Experience
Tech Tool 15b
Imaging Provider and Reader Feedback
Tech Tool 16
Biomarker Lab Oversight
Tech Tool 16a
Biomarker Lab Experience
Tech Tool 16b
Biomarker Lab Feedback
Tech Tool 17
Clinical Supply Management Provider Oversight
Tech Tool 17a
Clinical Supply Experience
Tech Tool 17b
Clinical Supply Feedback
Tech Tool 18
TMF eTMF Oversight
Tech Tool 18a
TMF eTMF Industry and Regulatory Landscape
Tech Tool 19
Bioanalytical Lab Oversight
Tech Tool 19a
Bioanalytical Lab Experience
Tech Tool 19b
Bioanalytical Lab Feedback
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Tech Tool 20
COA-eCOA and DHT Provider Oversight Provider Oversight
Tech Tool 20a
COA Experience
Tech Tool 20b
COA Feedback
Tech Tool 21
Pharmacovigilance Oversight
Tech Tool 21a
Pharmacovigilance Experience
Tech Tool 21b
Pharmacovigilance Feedback
Tech Tool 22
IDMC Oversight
Tech Tool 22a
IDMC Experience
Tech Tool 22b
IDMC Feedback
Tech Tool 23
Pt Recruitment Retention Oversight
Tech Tool 23a
Pt Recruit Retention Experience
Tech Tool 23b
Pt Recruit Retention Feedback
Tech Tool 24
Quality Assurance Audits Oversight
Tech Tool 24a
Quality Assurance Audit Experience
Tech Tool 24b
Quality Assurance Audit Feedback
Tech Tool 25
Clinical Trial Home Nursing Provider Oversight
Tech Tool 25a
Clinical Trial Home Nursing Provider Experience
Tech Tool 25b
Clinical Trial Home Nursing Provider Feedback
Tech Tool 26
Study Closeout Process Oversight
Technical Oversight Resources
67
Summary of Knowledge Center Resources
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Category of Leading Practices/Resources
Total Number
Communication
18
Governance/Organizational Construct
19
Inspection
59
Issue Management
11
Oversight Leadership
8
Medical Device
15
Metrics/Analytics/Technology
8
Oversight Capability Maturity Model
15
Pharmacovigilance
1
Provider Qualification
135
Process Oversight
29
Protocol Quality
7
Patient Engagement
31
Quality Agreement
36
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Quality Oversight Management Framework
2
Proactive Risk and Opportunity Management
16
Risk-Based Quality Management
18
Roles/Responsibilities
13
Site Quality
61
Technical Oversight
67
Total Available Knowledge Center Resources:
569
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New Documents in Development
ISM 03
Issue Management Effectiveness Checks
ISM 04
Issue Management Investigation and Root Cause Analysis
ISM 05
Issue Management Escalation Pathways
PQUAL 40
Medical Monitoring Standards
PQUAL 40a
Medical Monitoring RFI
PQUAL 40b
Medical Monitoring Scorecard
PQUAL 40c
Medical Monitoring Visit Checklist
PQUAL 41
Third Party Subcontracted Vendor Qualification and Oversight
RBQM 15
Risk-based Approaches to Audits
RBQM 15a
Risk-based Audit Selection Tool
RBQM 15b
Process Maturity Scorecard
RBQM 16
Standard list of defined KRIs with purpose and definition commonly used
for Centralized Monitoring
RBQM 17
Guidance on determining Critical to Quality Factors
SQMS 43
Guidance and Checklist for Site Qualification and Oversight of DCT Service
Providers
SQMS 44
Guidance and Checklist or Evaluating Protocols or Impact on Site
Operations
