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Risk Based Monitoring in Clinical Trials - Impact on Sites

This Risk Based Monitoring - Impact on Sites overview presentation, on targeted topics, was delivered to the ACRP Raleigh - Durham Chapter's Annual Conference in 2013.

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Risk Based Monitoring in Clinical Trials - Impact on Sites

  1. 1. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Hidden Risks with Risk Based Monitoring- Site Perspective Liz Wool, RN, BSN, CCRA, CMT President and CEO QD-Quality and Training Solutions, Inc. www.qd-qts.com lizwool@qd-qts.com Franklin, TN Member, Standards Committee, Society of Clinical Research Sites Member Board of Trustees Association of Clinical Research Professionals (ACRP) ACRP Raleigh-Durham Chapter Annual Conference 2013
  2. 2. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Learning Objectives • Identify two (2) areas for site’s to assess regarding the impact of Risk - Based Monitoring to site practices in clinical trials. • Describe two (2) questions to ask the Sponsor/CRO for a Risk-Based Monitoring model in order to assist in determining the resourcing plan and trial budget.
  3. 3. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved
  4. 4. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Quality Quality is characterized by the ability to : 1. Effectively and efficiently answer the intended questions about the benefits and risks of a medical product (therapeutic or diagnostic) or procedure, while, 2. Ensuring protection of human subjects Clinical Trials Transformation Initiative FDA- CTTI
  5. 5. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved GCP Quality Management System “Building Quality Into the Clinical Program” GCP Process Performance –Systems, Processes, Documentation to “Quality Standards” Quality-Performance Monitoring System (QC/QA) Corrective & Preventive Action (CAPA) System Change Management System, CQI, Document Control Management Review: On-Going Acceptability of the QMS Management Responsibilities Quality Culture, Policy , Objectives Resources Quality Commitment: All Staff Knowledge Management Risk Management Study Start Up Data Analysis, CSR Study Conduct Study Close-Out Protocol Design & Operational Design Study Planning Marketing Application Enabler Investigational Product-Device Enabler QMS Elements
  6. 6. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Let’s Normalize the Terminology
  7. 7. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Centralized RBM TargetedRBM Adaptive RBM
  8. 8. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved The THREE PILLARS OF RBM™ Centralized (Statistical) Monitoring Remote Site Management On-Site Site Management www. Wordpress.com 8
  9. 9. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Focuses on “Performance Monitoring of the Trial” 9 Reliance on electronica data sources Examples include...
  10. 10. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved E-Data Sources EDC EPRO CTMS EHR - EMR IWRS 10
  11. 11. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved E-Data Sources
  12. 12. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Centralized Monitoring Plan Data Analytics (performance reporting through various edata sources) Metrics and Tolerance Limits for ‘error rate’ Adhere to Monitoring Plan requirements Determine outlier ranges for analysis and further investigation *Review EDC and query rates, various reports/metrics on an ongoing basis per e-data sources for trial* Documentation *refer to FDA Guidance Remote Site Management Plan Site Relationship: Webex video /webcam– not just email, personal touch still needed! Early communication, evaluation and re-training for performance issues/gaps; tracking regulatory requirements and site adherence to GCP/HSP/EDC/protocol requirements Adhere to Monitoring Plan requirements * Site Specific Plan: customization for site performance issues Documentation *refer to FDA Guidance On-Site - Site Management Plan Site Management: HSP, GCP Performance gaps and issues Adhere to Monitoring Plan requirements Site Specific Monitoring Plan: customization for site performance issues Documentation *refer to FDA Guidance 12
  13. 13. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Centralized Monitoring Plan Data Analytics (performance reporting through various edata sources) Metrics and Tolerance Limits for ‘error rate’ Adhere to Monitoring Plan requirements Determine outlier ranges for analysis and further investigation *Review EDC and query rates, various reports/metrics on an ongoing basis per e-data sources for trial* Documentation *refer to FDA Guidance Remote Site Management Plan Site Relationship: Webex video /webcam– not just email, personal touch still needed! Early communication, evaluation and re- training for performance issues/gaps; tracking regulatory requirements and site adherence to GCP/HSP/EDC/protocol requirements Adhere to Monitoring Plan requirements * Site Specific Plan: customization for site performance issues Documentation *refer to FDA Guidance On-Site - Site Management Plan Site Management: HSP, GCP Performance gaps and issues Adhere to Monitoring Plan requirements Site Specific Monitoring Plan: customization for site performance issues Documentation *refer to FDA Guidance 13
  14. 14. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Centralized Monitoring Plan Data Analytics (performance reporting through various edata sources) Metrics and Tolerance Limits for ‘error rate’ Adhere to Monitoring Plan requirements Determine outlier ranges for analysis and further investigation *Review EDC and query rates, various reports/metrics on an ongoing basis per e-data sources for trial* Documentation *refer to FDA Guidance Remote Site Management Plan Site Relationship: Webex video /webcam– not just email, personal touch still needed! Early communication, evaluation and re-training for performance issues/gaps; tracking regulatory requirements and site adherence to GCP/HSP/EDC/protocol requirements Adhere to Monitoring Plan requirements * Site Specific Plan: customization for site performance issues Documentation*refer to FDA Guidance On-Site - Site Management Plan Site Management: HSP, GCP Performance gaps and issues Adhere to Monitoring Plan requirements Site Specific Monitoring Plan: customization for site performance issues Documentation *refer to FDA Guidance IMPLEMENTED DIFFERENTLY IN ORGANIZATIONS NEED TO KNOW HOW AN ORGANIZATION IS EXECUTING *All of these areas per job title? *One area per job title? *Other? *Example: CRA reviews e-TMF/EDC site information 14
  15. 15. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved A Risk Based Approach can only occur if there is a solid foundation Cynthia Kleppinger, MD Senior Medical Officer FDA, Office of Scientific Investigations, CDER DIA Annual Meeting 2012 15
  16. 16. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved IT’S ABOUT RISK MANAGEMENT! 16 Combination of the probability of occurrence of harm and the severity of that harm. And, detectability ...
  17. 17. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved How does RBM Impact Sites?
  18. 18. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Where to start?
  19. 19. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Site Impact Trial Execution Resourcing Financial Working With Sponsor and CRO Quality Program
  20. 20. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Areas to Assess • How does the organization define RBM ? • What is their model? – Some are saying ‘RBM’ – in reality it is reduced SDV only – Monitoring Plan for your site and other sites • When and how is the site informed and trained? Feasibility Questionnaire? Qualification Assessment? Investigator Meeting? Site Initiation? • What does the Monitoring Plan entail? What is the plan for communicating site performance to you via centralized statistical monitoring and data analytics review? Remote site management communications?
  21. 21. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Areas to Assess – Monitoring Plan for your site and other sites • Type and frequency of ‘on site’ visits –Static plan for ‘all sites’ –Variable approach and plan for site monitoring based on risk variables (history with your site, therapeutic area, phase of trial, IP requirements etc) »Do they perform ‘risk scoring of sites’ and take this into account for the Monitoring Plan? * This is not an all inclusive list of questions to ask*
  22. 22. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Areas to Assess • Resources and execution of the RBM – Who is your ‘one point of contact’ • What is their title? • What is their role and responsibilities? – Who will your site be engaging with – multiple communication modalities – for the study? • Job title • Role • Responsibility • Internal communications Will one person be calling your site? Or Multiple people be calling your site? * This is not an all inclusive list of questions to ask*
  23. 23. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Usage of and frequency of site surveys 'how are we as the Sponsor/CRO doing? 'areas for improvement?'
  24. 24. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Allows for understanding of the model for sites to: • Develop study budget and contract terms • Resource Allocations – Personnel attributes – Resource modeling – Scheduling personnel for the study • Quality Management Plan for the Trial • Identify potential risks in trial execution • Determine communication plans
  25. 25. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved What about your Site Practices?
  26. 26. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Ask questions for each ‘monitoring model’ • Historically – what has been performed during a site visit? • What will or will not be done at a site visit? • What elements of GCP or the protocol/investigational plan can ONLY be verified by visiting the site? • ‘’5” Risk Assessment Questions • AND MORE!
  27. 27. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved People & Site Resources Operations, Standards, Processes Technology
  28. 28. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Risk Assessment 1. What might go wrong? 2. What needs to go right? 3. What is the likelihood (probability) it will go wrong? 4. What are the consequences – impact (severity)? 5. How will these be detected?
  29. 29. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Site Practices Business Impact Cost modeling for RBM – ‘all the work’ previously performed with ‘site visits’ Resource Models Personnel Assignments Team meetings Meetings with PI Quality Management System *Protocol Quality Plan* * This is not an all inclusive list *
  30. 30. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Site Practices Business Impact Good Documentation Practices (phone contacts, retain emails, responses to requests etc *CRITICAL*) Monitoring ‘trial performance’ Sponsors/CRO adherence to their monitoring plan On –site visits – costing this out as well Monitoring site staff performance and adherence to study and monitoring plan commitments (e.g., respond to calls, queries) Access EDC reports of your site performance * This is not an all inclusive list *
  31. 31. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Site Practices Business Impact REVENUE: Charge for Time and Materials REVENUE: Unit Base Pricing REVENUE: Overhead Percentage FINANCIAL: Utilization FINANCIAL: Realization FINANCIAL: Variable Costs * This is not an all inclusive list *
  32. 32. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Internal Communication Plans Escalating Issues to Management Training and Re-training of Staff
  33. 33. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved What About HIPAA and Informed Consents?
  34. 34. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved If the CRA is visiting your site less frequently, what does your site need to ‘fill in’ or ‘do’....
  35. 35. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved GCP Quality Management System “Building Quality Into the Clinical Program” GCP Process Performance –Systems, Processes, Documentation to “Quality Standards” Quality-Performance Monitoring System (QC/QA) Corrective & Preventive Action (CAPA) System Change Management System, CQI, Document Control Management Review: On-Going Acceptability of the QMS Management Responsibilities Quality Culture, Policy , Objectives Resources Quality Commitment: All Staff Knowledge Management Risk Management Study Start Up Data Analysis, CSR Study Conduct Study Close-Out Protocol Design & Operational Design Study Planning Marketing Application Enabler Investigational Product-Device Enabler QMS Elements
  36. 36. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved • What is your current program? • Is your Quality Management Model defined with standards, methods and documentation for communicating to staff? • Resources to meet the needs for the size of your business/research enterprise? • Have you trained staff to the model? Their Roles? Their responsibilities for quality? • What are the required qualifications and training for staff with a ‘quality’ role? • How is this program deployed, managed and evaluation performed? (e.g., protocol, TA, staff, business enterprise etc.) • Continuous Quality Improvement during the trial? • QC for protocol, staff, programs • QA program: Internal Audits • HAVE YOU IDENTIFIED THE HIGH RISK AREAS: your business, and with each protocol?
  37. 37. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Goal is: HSP Data Quality Data Integrity DATA RELIABILITY
  38. 38. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved
  39. 39. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Protocol “Life – Cycle” Approach Site Contacted – Interest in Study Feasibility and Protocol Assessment Study Planning Study Initiation Study Conduct Study Close- Out Post – Study Activities Focus on Your Organization “How you do your business” Sub-processes for each ..map out.. “ safety risks, risk to clinical trial quality; risk to subjects; risk to data quality/integrity”
  40. 40. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved
  41. 41. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Site Impact Trial Execution Resourcing Financial Working With Sponsor and CRO Quality Program
  42. 42. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved “An investment in knowledge pays the best interest” Benjamin Franklin
  43. 43. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Learning Objectives • Identify two (2) areas for site’s to assess regarding the impact of Risk - Based Monitoring to site practices in clinical trials. • Describe two (2) questions to ask the Sponsor/CRO for a Risk-Based Monitoring model in order to assist in determining the resourcing plan and trial budget.
  44. 44. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved FARBMAES
  45. 45. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved References
  46. 46. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved References • Ball, L., Defining Quality in Clinical Trials: An FDA Perspective, DIA Annual Meeting, 2012 • Copeland, D., Is Your Site Ready for Risk – Based Monitoring, ACRP Global Conference, 2013 • CTTI: Developing Effective Quality Systems in Clinical Trials: An Enlightened Approach , Summary of an Expert Meeting held October 13–14, 2010 • Kleppinger, C., Ball., L., Building Quality in Clinical Trials with Use of a Quality Systems Approach, Clinical Infectious Diseases, 2010:51 (S1): S-111- S116
  47. 47. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved References • Sweeney, F., Defining Quality in Clinical Trials: EMA Perspective, DIA Annual Meeting, 2011 • Wool, L., Intertwining Quality Management Systems with Metrics to Improve Trial Quality, The Monitor, August, 2012 • Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making: Workshop Report,IOM 1999 at http://www.iom.edu/CMS/3740/5583.aspx
  48. 48. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved
  49. 49. ©Copyright QD-Quality and Training Solutions, Inc. All Rights Reserved Balancing Risk-Based Monitoring http://www.grc-lounge.com/en/ARIS-GRC/173329.html 49

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This Risk Based Monitoring - Impact on Sites overview presentation, on targeted topics, was delivered to the ACRP Raleigh - Durham Chapter's Annual Conference in 2013.

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