How Industry Can Partner with FDA in Defining a Risk- Based Monitoring Program

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1 How Industry Can Partner with FDA in Defining a Risk- Based Monitoring Program Presenter: Jan Holladay Pierre, MPH Quality Principal Leader DynPort Vaccine Company LLC, A CSC Company This presentation is the property of DynPort Vaccine Company LLC, A CSC Company, and may not be reproduced without express written consent.

2 Defining a Risk-Based Monitoring Program Presenter: Jan Holladay Pierre, MPH Quality Principal Leader DynPort Vaccine Company LLC, A CSC Company

3 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, Drug Information Association Inc., DIA and DIA logo are registered trademarks. All other trademarks are the property of their respective owners. 10

4 Summing it Up Prior Presentations Described key aspects of the new guidance document on risk-based monitoring Identified the importance of risk-based monitoring from a regulatory perspective Discussed the practicalities of developing and executing a Risk-Based Monitoring Plan

5 Objectives Understand Monitoring Strategies Discuss a Site-Specific QC Checklist Describe Elements of a Risk-Based Monitoring Checklist 12

6 Monitoring Strategies Activity Pre-qualification of clinical sites Trial Master File (TMF) creation and maintenance Clinical supply management Monitoring Data listing review; CRF- SDV; source back to protocol requirements GCP compliance Description Identify disparate points of entry for source document verification (SDV) verify adequately experienced staff to include ancillary roles and assure workload is appropriate (i.e., request active protocols). TMF assists sponsor in maintaining required essential documents. Electronic TMF allows sponsor-cro visibility. Develop procedures for receipt and distribution clinical supply, and test and control articles; develop automated tool for demand/supply forecasting/tracking/reconciliation (i.e., interactive voice response system [IVRS]). Non-traditional monitoring resources; SOP and or monitoring plan describing traditional and non-traditional monitoring, precise instructions on how the monitor should undertake SDV. Direct method of verifying data in line listing corresponds to data in EDC; verify data identified in CRFs are consistent with source document by reviewing actual source data versus photocopies. Direct method of verifying critical source against protocol requirements. Adopt an automated CTMS for easy visibility of operations for continuous monitoring and auditing; ease of metrics.

7 Site Specific QC- Checklist Institutional Policies (i.e., CRA access to electronic medical records [EMR]) Qualifications and Training (i.e., ancillary) Source Documentation Collection Points Delegation of Authority/Responsibilities Adverse Events/Serious Adverse Events Con Meds History and Physicals Screening/Enrollment/Protocol Deviation Logs Laboratory Data Standard or Protocol Investigational Product (IP) Accountability

8 Elements Risk-Based Monitoring Checklist Identify regulatory or global standards Identify risks related to resources (i.e., key personnel back-up) and systems (i.e., clinical data management system) Identify key processes and plans related to ensuring quality data is collected, reviewed and reported Identify QA/QC activities around key processes

9 Regulatory and Global Standards 21 CFR Part & CFR Part 11 ICH GCP E FDA Draft Guidance on Risk-Based Monitoring ALCOA and Good Documentation Practices 16

10 Risks Related to Resources Back-up for key personnel (i.e., data manager, monitors etc.) Back-up for Site personnel (i.e., study coordinator, sub-investigators) Vendor (i.e., labs) support and oversight Electronic systems capabilities 17

11 Key Processes Protocol design and development Maintaining the audit trail Plans (i.e., monitoring, data management ) Data validation (i.e., ongoing data review plans) Centralized and on-site monitoring activities 18

12 QA/QC Activities Prequalification Site and Vendor Audits System Validation (i.e., EDC, CDMS) Process Validation (i.e., manual edit checks, line listing generation) Periodic data review (i.e., EDC, trip reports, Site QC source documentation) 19

13 Putting it all Together Define the risks and develop the controls to assure quality data

14 Summary Redefine monitoring from a nontraditional perspective Identifying risks is the first step in monitoring The checklist approach establishes steps in a complex iterative research process Effective monitoring is key to assuring quality research 21

15 Thank You! Jan Holladay Pierre, MPH Quality Principal Leader DynPort Vaccine Company LLC, A CSC Company

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