Barnett International and CHI's Inaugural Clinical Trial Oversight Summit June 4-7, 2012 Omni Parker House Boston, MA

Size: px
Start display at page:

Download "Barnett International and CHI's Inaugural Clinical Trial Oversight Summit June 4-7, 2012 Omni Parker House Boston, MA"

Transcription

1 Barnett International and CHI's Inaugural Clinical Trial Oversight Summit June 4-7, 2012 Omni Parker House Boston, MA This presentation is the property of DynPort Vaccine Company LLC, a CSC company, and may not be reproduced in any form without express written consent. 1

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

3 Introduction Looking Ahead to the Future How can we partner with FDA in: Establishing the next Gold Standard for monitoring clinical trials Aligning industry practices with FDA Compliance Programs Identifying key components for a robust risk-based monitoring plan incorporating Quality Assurance (QA) aspects 3

4 Scope Our focus will be on establishing the infrastructure for a Quality Auditing Program tailored around QA/Quality Control (QC) measures to mitigate risk to the successful conduct of a clinical trial We will not discuss the following QA processes and associated documents: Quality manual Quality plans Routine audit standard operating procedures (SOPs) QA templates (e.g., audit reports) 4

5 Goals Understand Good Clinical Practice (GCP) and auditing standards Define a Quality Auditing Program around high-risk activities such as: Study planning and start-up (i.e., key decision-making activities) Data collection, review and management Monitoring Auditing Identify risks inherent in data collection and management Discuss current FDA guidance on risk-based monitoring Establish strategies for the development of quality tools such as monitoring and auditing checklists 5

6 GCP Considerations ICH GCP 2.10 All clinical trial information should be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification. ICH GCP The sponsor is responsible and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s). ICH GCP Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly. 6

7 Auditing Standards Statement of Work (SOW) Lessons learned program Regulatory standards (GCP) Project-related Protocols Clinical Operations and Data Management SOPs Plans (i.e., clinical monitoring, data management, statistical analysis, deviation management, auditing, etc.) Guidelines (i.e., case report form [CRF] completion, edit checks, etc.) 7

8 Discussion Points Establish a quality infrastructure (i.e., qualify Contract Research Organizations [CROs], sites and systems, etc.) as a baseline prior to clinical trial execution Accept continuous monitoring and auditing concepts Deploy non-traditional monitoring and auditing roles Build in risk mitigation strategy across Bioresearch Monitoring Program (BIMO) activities Tailor monitoring and auditing around risk-based decisions More monitoring and auditing strategies and tools 8

9 Establish a Quality Infrastructure to Base Your Risk-Based Monitoring and Auditing Quality of reported data is dependent on adequate resources, processes and systems Robust systems (e.g., Clinical Data Management System [CDMS] versus electronic data capture [EDC]) should produce better quality data through automation Cross-functional components (e.g., Data Management [DM], Clinical Operations, Biostats, Quality Assurance [QA]) need to be in place for planning and continuous monitoring of a clinical trial Risk-based monitoring and auditing tools are therefore designed to: 1. Verify the quality of the critical data 2. Assess the system that produces that data 3. Develop action plans to mitigate risk to poor quality data 9

10 Key Decision-Making Activities Activity Responsible QA Check CRO Selection SOW Contractual Requirements Sponsor Project Team Sponsor PM and CRO PM Capabilities, procedures and compliance assessment Prior lessons learned reflective in SOW TORO Sponsor PM and CRO PM 21 CFR EDC Build and Validation Adequacy Project-Related Plans and Guidelines (i.e., Clinical Monitoring, DM, Deviation Management, CRF Completion and Edit Checks) Final DB Deliverable Acceptance Sponsor PM, QA and CRO DM Sponsor PM and QA Sponsor PM and QA Design specifications and validation results Plans and guidelines are developed reflective of acceptable FDA guidance's and Industry practices Compliant with HL SOP and acceptable DB audit CRF = case report form; CRO = Contract Research Organization; DB = Database; DM = Data Management; HL = Hard Lock; PM = Project Manager; QA = Quality Assurance; SOP = standard operating procedure; SOW = Statement of Work; TORO = Transfer of Regulatory Obligations 10

11 Definition: Data Quality Accuracy Data in database (DB) equal to source documents (e.g., > 95% confidence interval [CI]) Timeliness Data provided for decision-making activities Relevance Data useful for decision-making activities Completeness Data in DB 100% accounted for in source Understood Data generated supported by sound procedures and methods Trusted Confidence in programming efforts and data in DB 11

12 Identify Risks to Quality Data Audit Trail compromised Poor planning (i.e., monitoring, data management, etc.) Data validation (i.e., QA/QC) process inadequate Data quality issues (i.e., listing reviews, audits) Sponsor and Clinical Investigator oversight issues (i.e., medical monitor eligibility assessment, Principal Investigator [PI] adverse event [AE] assessment) Poor monitoring 12

13 Data Collection Data used to make decisions in clinical trials must be accurate. Decisions about dosages, risk of adverse event and risk-benefit profiles of the treatment are made using these data Study objectives Primary and secondary efficacy endpoint Primary and secondary safety endpoint Critical data are defined during the protocol development phase by the statistician, clinical science, and reviewed and agreed by the study team 13

14 Data Monitoring More than on-site visits conducted by Clinical Research Associates (CRAs) (i.e., monitors) Any action taken by the sponsor throughout the conduct of the clinical trial to ensure regulatory compliance and program performance QC activity Ongoing process 14

15 Example: Data Review Plan Type of Data Purpose Process/Responsible Party Frequency Tools CRF and external data To check data are complete, logical and correct DM: Continuous review discrepancies generated by the validation specifications; monitoring the quality of discrepancy management Ongoing CRF, Study Reports Key data for efficacy data and signal detection Focused medical data review and signal detection Performs medical data review and detection of potential signals and risk management. Monthly, additional time point/ongoing CRF Review, Study Reports 15

16 Current FDA Guidance on Risk-Based Monitoring FDA monitoring regulations per 21 CR s (drugs) and s (devices) remain unchanged ICH E6 GCP Guideline remains unchanged however new DRAFT takes exception in that it now encourages centralized monitoring whereas it was previously recommended in exceptional circumstances only (E ) At minimum, some on-site monitoring is still recommended depending on risk-based assessment Monitoring Plans can be submitted to FDA for review and comment Guidance emphasizes using a combination of monitoring activities 16

17 Align Industry Practices with FDA Compliance Programs BIMO CP , Sponsor, CRO and Monitors Role of the FDA Field Investigator and BIMO Reviewer Verify the accuracy and reliability of clinical trial data submitted to FDA Assess adequacy of risk-based monitoring 17

18 Key Elements Risk-Based Monitoring Checklist Identify regulatory or global standards (i.e., Part 11 ICH GCP E6) Identify risks related to resources (i.e., key personnel backup) and systems (i.e., CDMS) Identify key processes and plans related to ensuring quality data is collected, reviewed and reported Identify QA/QC activities around key processes 18

19 GCP Critical Control Checklist Institutional Policies (i.e., CRA access to electronic medical records [EMR]) Inpatient versus Outpatient Setting (i.e., logistics) 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 19

20 GCP Monitoring Strategies Activity Pre-Qualification of Clinical Sites TMF Creation and Maintenance Clinical Supply Management Monitoring Data Listing CRF-SDV; Protocol Raw Data, Records and Specimens Verification GCP Compliance Description Identify disparate points of entry for source documentation/raw data, 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 (e.g., IVRS, EDC, etc). 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 transcribed on CRFs are consistent with source document by reviewing actual source data versus photocopies. Direct method of verifying results study data conformed to protocol requirements. Adopt an automated CTMS for easy visibility of operations for continuous monitoring and auditing; ease of metrics. CRF = case report form; CRO = Contract Research Organization; CTMS = clinical trial management system; EDC = Electronic Data Capture; GCP = Good Clinical Practice; IVRS = Interactive Voice Response System; SDV = Source Data Verification; SOP = standard operating procedure; TMF = Trial Master File 20

21 GCP Auditing Strategies Activity Audit Strategy Audit Plan Audit Technique Description Describes type of audits to be performed (e.g., system, site audit supplier) critical phase selection (i.e., pivotal Phase 3). Describes scope of a QA audit schedule, identifies audit team, outlines audit standards (e.g., FDA GCP/ICH, FDA GLP/ISO, protocol) FDA compliance programs (i.e., CP ), Story Approach interview links process with performance Performance Audits (a) Process (b) System (c) Pre-qualification (d) Data (a) (b) (c) (d) Ability of the process to achieve desired results (i.e., IP accountability) Ability to achieve organizational goals (i.e., monitoring, data management) Assures quality-compliant structure in place prior to work being performed Assure quality and integrity of data prior to FDA submission Requirements Setting Flow Chart Audit Report Deviation/CAPA Management Plan External (i.e., CFR, ISO, etc.), Internal (i.e., SOPs) Describe all collection points for source data/raw data Evaluate/categorize audit findings for metrics (trend analysis) Deviations are identified, evaluated and are tracked/prioritized for root cause analysis/corrective action CRF = case report form; GCP = Good Clinical Practice; GLP = Good Laboratory Practice; IP = Investigational Product; SOP = standard operating procedure 21

22 Putting it All Together Define the risks and develop the controls to assure quality data Establish the ultimate checklist for risk management, monitoring and data management 22

23 Final Deliverable Evidence of successfully captured and validated (QC/QA) clinical research data At study completion for a complete and accurate final database deliverable package 23

24 Summary Identifying GCP critical control points is the first step in effective monitoring and auditing Effective monitoring and auditing approach includes integration with risk management plan The checklist approach establishes minimum expected steps in a complex iterative research process Efficient and effective monitoring and auditing is key to assuring quality research Key Monitoring and Auditing Tools Monitoring and auditing SOPs and plans Automated tools (e.g., CTMS, IVRS) Comprehensive flowcharts and checklists covering respective BIMO activities Monitoring and auditing reports serves as metrics for evaluating performance Build in lessons learned from successes and failures back into the project development efforts 24

25 Thank You! Jan Holladay Pierre, MPH Quality Principal Leader DynPort Vaccine Company LLC, A CSC Company 25

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

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

More information

QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH

QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH Martin Valania, Executive Director, Corporate QA and Compliance Introduction Pharmaceutical companies recognize the benefits of carefully managing

More information

CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE]

CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE] CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE] CONTRACT RESEARCH ORGANIZATION SPONSOR [NAME] [ADDRESS] 1 TABLE OF CONTENTS 1. Purpose 3 2. References 3 3. Study Roles and Responsibilities

More information

Data Management Unit Research Institute for Health Sciences, Chiang Mai University

Data Management Unit Research Institute for Health Sciences, Chiang Mai University Data Management Unit Research Institute for Health Sciences, Chiang Mai University Clinical Data Management is the process of handling data from clinical trials. The inherent goal of any clinical data

More information

DHHS/NIH/OD/OIR/OHSRP 1/2/2015

DHHS/NIH/OD/OIR/OHSRP 1/2/2015 DHHS/NIH/OD/OIR/OHSRP 1/2/2015 The audience for this course is Principal Investigators (PIs), investigators and Research Coordinators (RCs) serving on the study team of human clinical studies and trials.

More information

Managing & Validating Research Data

Managing & Validating Research Data Research Management Standard Operating Procedure ISOP-H02 VERSION / REVISION: 2.0 EFFECTIVE DATE: 01 03 12 REVIEW DATE: 01 03 14 AUTHOR(S): CONTROLLER(S): APPROVED BY: Information Officer; NBT Clinical

More information

Electronic Medical Records and Source Data for Research: What s the Difference?

Electronic Medical Records and Source Data for Research: What s the Difference? Electronic Medical Records and Source Data for Research: What s the Difference? Tammy Anderson, CCRC, CCRA, CRCP Director, Clinical Trials Office Virginia Commonwealth University Research Coordinator 4

More information

Risk based monitoring using integrated clinical development platform

Risk based monitoring using integrated clinical development platform Risk based monitoring using integrated clinical development platform Authors Sita Rama Swamy Peddiboyina Dr. Shailesh Vijay Joshi 1 Abstract Post FDA s final guidance on Risk Based Monitoring, Industry

More information

What is necessary to provide good clinical data for a clinical trial?

What is necessary to provide good clinical data for a clinical trial? What is necessary to provide good clinical data for a clinical trial? Alain Barrois, Assistant Clinical Trials Operations Manager #EBMT2015 www.ebmt.org Is this a (typical) clinical trial? 2 Agenda Introduction

More information

ROLE OF THE RESEARCH COORDINATOR

ROLE OF THE RESEARCH COORDINATOR Clinical and Translational Science Institute / CTSI at the University of California, San Francisco Welcome to Online Training for Clinical Research Coordinators ROLE OF THE RESEARCH COORDINATOR Data Collection

More information

CNE Disclosures. To change this title, go to Notes Master

CNE Disclosures. To change this title, go to Notes Master CNE Disclosures Successful Completion: Participants must complete an evaluation form to receive a certificate of completion Contact Hours: 1 contact hour is available to those who meet the successful completion

More information

No. 706. Page 1 of 5. Issue Date 4/21/2014

No. 706. Page 1 of 5. Issue Date 4/21/2014 Subject: ROUTINE MONITORING VISITS Standard Operating Procedure Prepared By: Beaumont Research Coordinating Center, Research Institute PURPOSE Prior Issue Date 8/15/2011 No. 706 Issue Date 4/21/2014 Page

More information

BUILDING QUALITY INTO CLINICAL TRIALS AN FDA PERSPECTIVE

BUILDING QUALITY INTO CLINICAL TRIALS AN FDA PERSPECTIVE BUILDING QUALITY INTO CLINICAL TRIALS AN FDA PERSPECTIVE Jean Toth-Allen, Ph.D. Biophysicist Office of Good Clinical Practice Office of the Commissioner May 14, 2012 1 Overview I. Background why we are

More information

Innovative Solutions Designed to Improve Operational Capacity, Efficiency and Effectiveness in Clinical Monitoring

Innovative Solutions Designed to Improve Operational Capacity, Efficiency and Effectiveness in Clinical Monitoring Innovative Solutions Designed to Improve Operational Capacity, Efficiency and Effectiveness in Clinical Monitoring Brett Barber, Sr. Director, Strategic Resourcing Nicole Baker, Sr. Director, Strategic

More information

Section 1 Project Management, Project Communication/Process Design, Mgmt, Documentation, Definition & Scope /CRO-Sponsor Partnership

Section 1 Project Management, Project Communication/Process Design, Mgmt, Documentation, Definition & Scope /CRO-Sponsor Partnership Section 1 Project Management, Project Communication/Process Design, Mgmt, Documentation, Definition & Scope /CRO-Sponsor Partnership PROJECT MANAGEMENT - SCOPE DEFINITION AND MANAGEMENT Understands the

More information

New Investigator Collaborations and Interactions: Regulatory

New Investigator Collaborations and Interactions: Regulatory Your Health and Safety... Our priority Votre santé et votre Securité notre priorité New Investigator Collaborations and Interactions: Regulatory NCIC Clinical Trials Group New Investigator Clinical Trials

More information

The Monitoring Visit. Denise Owensby, CCRP Sr. Clinical Research Coordinator Clinical & Translational Science Center University of California, Davis

The Monitoring Visit. Denise Owensby, CCRP Sr. Clinical Research Coordinator Clinical & Translational Science Center University of California, Davis The Monitoring Visit Denise Owensby, CCRP Sr. Clinical Research Coordinator Clinical & Translational Science Center University of California, Davis Disclosure The information herein is not intended to

More information

Clinical Data Management is involved in all aspects of processing the clinical data, working with a range of computer applications / database systems

Clinical Data Management is involved in all aspects of processing the clinical data, working with a range of computer applications / database systems Clinical Data Management is involved in all aspects of processing the clinical data, working with a range of computer applications / database systems to support collection, cleaning and management of subject

More information

Data Manager s Role in Data Quality

Data Manager s Role in Data Quality Data Manager s Role in Data Quality and KPI for Data Management Process May 17 th, 2011 Beijing, China Joyce Lai MSD (Shanghai) Pharmaceutical Consultancy Co, Ltd. Agenda Why is the Data Manager So Important

More information

U.S. Food and Drug Administration

U.S. Food and Drug Administration U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA s website for reference purposes only. It was current when produced, but is no longer maintained

More information

Objectives. Monitoring & Auditing of Clinical Trials. Overview. Pre-study Qualification Visit. Industry-sponsored Trials

Objectives. Monitoring & Auditing of Clinical Trials. Overview. Pre-study Qualification Visit. Industry-sponsored Trials Objectives Monitoring & Auditing of Clinical Trials Sponsored by Center for Cancer Research National Cancer Institute Guidelines suggest that following the good clinical research practice of monitoring/auditing

More information

What is Clinical Data Management

What is Clinical Data Management What is Clinical Data Management Clinical Data Management is involved in all aspects of processing the clinical data, working with a range of computer applications, database systems to support collection,

More information

Monitoring & Auditing of Clinical Trials. Sponsored by Center for Cancer Research National Cancer Institute

Monitoring & Auditing of Clinical Trials. Sponsored by Center for Cancer Research National Cancer Institute Monitoring & Auditing of Clinical Trials Sponsored by Center for Cancer Research National Cancer Institute Objectives Guidelines suggest that following the good clinical research practice of monitoring/auditing

More information

Data Management and Good Clinical Practice Patrick Murphy, Research Informatics, Family Health International

Data Management and Good Clinical Practice Patrick Murphy, Research Informatics, Family Health International Data Management and Good Clinical Practice Patrick Murphy,, Family Health International 1 What is GCP? Good Clinical Practice is an international ethical and scientific quality standard for designing,

More information

Clinical Data Management (Process and practical guide) Nguyen Thi My Huong, MD. PhD WHO/RHR/SIS

Clinical Data Management (Process and practical guide) Nguyen Thi My Huong, MD. PhD WHO/RHR/SIS Clinical Data Management (Process and practical guide) Nguyen Thi My Huong, MD. PhD WHO/RHR/SIS Training Course in Sexual and Reproductive Health Research Geneva 2013 OUTLINE Overview of Clinical Data

More information

The role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations

The role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations The role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations Maria Luisa Paoloni OPBG Clinical & Research Services Monitoring and Responsible of monitoring:

More information

through advances in risk-based

through advances in risk-based Insight brief Quintiles is a market leader with >100 risk-based monitoring studies Quintiles developed solutions that bring as much as 25% cost reduction over traditional trial execution approaches Transform

More information

Clinical Data Management. Sponsored by Center for Cancer Research National Cancer Institute

Clinical Data Management. Sponsored by Center for Cancer Research National Cancer Institute Clinical Data Management Sponsored by Center for Cancer Research National Cancer Institute Introduction Clinical data management (CDM) consists of various activities involving the handling of data or information

More information

An information platform that delivers clinical studies better, faster, safer and more cost effectively

An information platform that delivers clinical studies better, faster, safer and more cost effectively An information platform that delivers clinical studies better, faster, safer and more cost effectively Powering Process & Performance Proactively manage study start-up and execution Risk profile new sites

More information

1 The Clinical Research Coordinator (CRC)... 1

1 The Clinical Research Coordinator (CRC)... 1 TABLE OF CONTENTS Acknowledgments... xi Introduction... xiii 1 The Clinical Research Coordinator (CRC)... 1 Background and Training of the CRC...1 Personality and Skills... 2 Where Do CRCs Work?... 2 CRC

More information

Managing Data in Clinical Research. Developed by Center for Cancer Research, National Cancer Institute, NIH Endorsed by the CTN SIG Leadership Group

Managing Data in Clinical Research. Developed by Center for Cancer Research, National Cancer Institute, NIH Endorsed by the CTN SIG Leadership Group Managing Data in Clinical Research Developed by Center for Cancer Research, National Cancer Institute, NIH Endorsed by the CTN SIG Leadership Group Objectives Clinical data management (CDM) is a multidisciplinary

More information

Good Documentation Practices

Good Documentation Practices Good Documentation Practices Clinical Research Operations & Regulatory Support Ann Glasse, RN, BSN, MBA Director, Regulatory Support Author: Johanna Stamates, RN, MA, CCRC, CHRC Objectives Recognize the

More information

The use of computer systems

The use of computer systems Technology Update Computer Systems Validation, Part 1 Software Purchase and GCP Compliance Teri Stokes Teri Stokes, PhD, is senior consultant and director of GXP International, 131 Sudbury Road, Concord,

More information

Signature Requirements for the etmf

Signature Requirements for the etmf Wingspan Technology Signature Requirements for the etmf A Regulatory and Technological Assessment Kathie Clark Director, Product Management Wingspan Technology 1 November 2012 Signature Requirements for

More information

ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS

ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS STANDARD OPERATING PROCEDURE NO SOP 09 DATE RATIFIED 4/7/13 NEXT REVIEW DATE 4/7/14 POLICY STATEMENT/KEY OBJECTIVES:

More information

DAIDS Bethesda, MD USA. POLICY Requirements for Clinical Quality Management Plans

DAIDS Bethesda, MD USA. POLICY Requirements for Clinical Quality Management Plans CHANGE SUMMARY: This policy and associated appendices have been reviewed for accuracy and updated to meet 508 compliance guidelines. Key changes to the policy require all sites to submit a bi-annual Clinical

More information

Risk Based Approach to on site monitoring Do we need to check everything? Roger Newbery, VP Clinical Management EMEA, PPD

Risk Based Approach to on site monitoring Do we need to check everything? Roger Newbery, VP Clinical Management EMEA, PPD Risk Based Approach to on site monitoring Do we need to check everything? Roger Newbery, VP Clinical Management EMEA, PPD Highlights of FDA Guidance on Risk Based Trials 4 to 8 week monitoring visit intervals

More information

EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART

EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART Framework Labs generate data that are used to make decisions on the safety and efficacy of medicinal products; consequently,

More information

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure 703 1 of 11 POLICY The Beaumont Research Coordinating Center (BRCC) will provide advice to clinical trial investigators on protocol development, content and format. Upon request, the BRCC will review a

More information

Clinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity

Clinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity Clinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity Michelle Quaye Regulatory Manager, Advanced Therapy Trials University College London Overview The Principles of Good

More information

Marie-Claire Rickard, GCP & Governance Manager Rachel Fay, GCP & Governance Manager Elizabeth Clough, R&D Operations Manager

Marie-Claire Rickard, GCP & Governance Manager Rachel Fay, GCP & Governance Manager Elizabeth Clough, R&D Operations Manager Standard Operating Procedures (SOP) for: Monitoring SOP 28 Version 7.0 Number: Number: Effective Date: 29 th November 2015 Review Date: 6 th January 2017 Author: Reviewer: Reviewer: Authorisation: Name

More information

Synergizing global best practices in the CRO industry

Synergizing global best practices in the CRO industry Synergizing global best practices in the CRO industry KREARA - India Established on April 24 th 2004 Contract Research Services to Pharmaceutical companies Clinical Data management and Biometrics Interactive

More information

DAIDS Bethesda, MD USA POLICY. Requirements for Clinical Quality Management Plans

DAIDS Bethesda, MD USA POLICY. Requirements for Clinical Quality Management Plans NOTE: This policy and associated appendices have been reviewed for accuracy and updated to meet 508 compliance guidelines. DAIDS has clearly stated the minimum requirements for the CQMP and provided examples

More information

Position Paper: Risk-Based Monitoring Methodology

Position Paper: Risk-Based Monitoring Methodology Position Paper: Risk-Based Monitoring Methodology 1. Abstract Current On-site Monitoring practices are frequency-based, conform to a prescribed monitoring visit schedule, and provide generalized quality

More information

Introduction. The Evolution of the Data Management Role: The Clinical Data Liaison

Introduction. The Evolution of the Data Management Role: The Clinical Data Liaison Introduction The CDL is a new role that will become a standard in the industry for companies that want to make more efficient use of limited resources: time and money. A CDL is key in that he or she conducts

More information

IMP management at site. Dmitry Semenyuta

IMP management at site. Dmitry Semenyuta IMP management at site Dmitry Semenyuta TOP 5 FDA inspections finding 1999-2009 Center of Drug Evaluation and Research (CDER) Failure to follow the protocol Failure to keep adequate and accurate records

More information

Data Management DM STANDARD OPERATING PROCEDURE FOR Data Management

Data Management DM STANDARD OPERATING PROCEDURE FOR Data Management Data Management DM 401.00 STANDARD OPERATING PROCEDURE FOR Data Management Approval: Nancy Paris, MS, FACHE President and CEO 08 March 2012 (Signature and Date) Approval: Frederick M. Schnell, MD, FACP

More information

This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled.

This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document

More information

Data Management: Good Team Work is de sleutel tot succes!

Data Management: Good Team Work is de sleutel tot succes! Data Management: Good Team Work is de sleutel tot succes! Gerald Ruiter Senior Data Manager Topics Introduction Data Management Activities People Process Technology Clinical Data Management: introduction

More information

US EPA REGION III QUALITY MANAGEMENT PLAN REVIEW CHECKLIST

US EPA REGION III QUALITY MANAGEMENT PLAN REVIEW CHECKLIST US EPA REGION III Organization: EPA Organization: EPA Program: Contact: EPA Contact: EPA Contract/Grant/IAG Number: Phone Number: Phone Number: Reviewer: Date Reviewed: Reviewer Organization: Check New

More information

The Concept of Quality in Clinical Research. Dorota Śwituła Senior Clinical Quality Assurance Advisor

The Concept of Quality in Clinical Research. Dorota Śwituła Senior Clinical Quality Assurance Advisor The Concept of Quality in Clinical Research Dorota Śwituła Senior Clinical Quality Assurance Advisor 1 Agenda What is quality? How we define quality in clinical research? The standard components of a Quality

More information

Needs, Providing Solutions

Needs, Providing Solutions Identifying Needs, Providing Solutions 1 I n d u s t r y The growth of medical research and the countless innovations coming from the pharmaceutical, biotechnology and medical device industry, has improved

More information

Remote Monitoring of Clinical Trials and EMRs

Remote Monitoring of Clinical Trials and EMRs Remote Monitoring of Clinical Trials and EMRs Sandra SAM Sather, MS, BSN, CCRA, CCRC Vice-President Clinical Pathways LLC samsather@clinicalpathwaysresearch.com Lindsey Spangler, J.D. Associate Director,

More information

Clinical database/ecrf validation: effective processes and procedures

Clinical database/ecrf validation: effective processes and procedures TITOLO SLIDE Testo Slide Testo Slide Testo Slide Clinical database/ecrf validation: effective processes and procedures IV BIAS ANNUAL CONGRESS Padova September, 26 th 2012 PQE WORKSHOP: What's new in Computerized

More information

Nova Southeastern University Standard Operating Procedure for GCP. Title: Electronic Source Documents for Clinical Research Study Version # 1

Nova Southeastern University Standard Operating Procedure for GCP. Title: Electronic Source Documents for Clinical Research Study Version # 1 Nova Southeastern University Standard Operating Procedure for GCP Title: Electronic Source Documents for Clinical Research Study Version # 1 SOP Number: OCR-RDM-006 Effective Date: August 2013 Page 1 of

More information

Job Profile Clinical Research Associate I/II (CRA)

Job Profile Clinical Research Associate I/II (CRA) PART 1 - PROFILE You are an experienced CRA with a strong background in Clinical Research who is passionate about drug development and are seeking a challenging and rewarding career in a quality focussed

More information

Quality Monitoring Checklist

Quality Monitoring Checklist Quality Monitoring Checklist Instructions: For each task below, the Quality Monitor indicates in the appropriate column if the Monitor accomplished the task by using the following codes Yes No N/A = Monitor

More information

Welcome to the training on the TransCelerate approach to Risk-Based Monitoring. This course will take you through five modules of information to

Welcome to the training on the TransCelerate approach to Risk-Based Monitoring. This course will take you through five modules of information to Welcome to the training on the TransCelerate approach to Risk-Based Monitoring. This course will take you through five modules of information to introduce you to the concepts behind risk-based monitoring,

More information

Clinical Data Management (Process and practical guide) Dr Nguyen Thi My Huong WHO/RHR/RCP/SIS

Clinical Data Management (Process and practical guide) Dr Nguyen Thi My Huong WHO/RHR/RCP/SIS Clinical Data Management (Process and practical guide) Dr Nguyen Thi My Huong WHO/RHR/RCP/SIS Training Course in Sexual and Reproductive Health Research Geneva 2012 OUTLINE Clinical Data Management CDM

More information

Job Profile Clinical Research Associate III (CRA)

Job Profile Clinical Research Associate III (CRA) PART 1 - PROFILE You are an experienced CRA with a strong background in Clinical Research who is passionate about drug development and are seeking a challenging and rewarding career in a quality focussed

More information

ICH CRA Certification Guide March 2009

ICH CRA Certification Guide March 2009 ICH CRA Certification Guide March 2009 ICH CRA CERTIFICATION GUIDE... 1 GENERAL INFORMATION... 2 BENEFITS OF CERTIFICATION... 2 INDUSTRY RECOGNITION... 2 ABOUT THE EXAM... 2 CRA DEFINITION... 2 REQUIREMENTS

More information

Clinical Training Management

Clinical Training Management Clinical Training Management Learning and Compliance for Clinical Research Helping to Fuel the Growth of CROs and Service Providers According to clinical researcher CenterWatch, the FDA and global regulatory

More information

Metrics 101. Produced by the TMF Reference Model Metrics and Reporting Sub-team. 1 August 2014

Metrics 101. Produced by the TMF Reference Model Metrics and Reporting Sub-team. 1 August 2014 Metrics 101 Produced by the TMF Reference Model Metrics and Reporting Sub-team 1 August 2014 Agenda Why a metrics program? Goals of a metrics program Types of metrics Further analytics on metrics Metrics

More information

The Importance of Good Clinical Data Management and Statistical Programming Practices to Reproducible Research

The Importance of Good Clinical Data Management and Statistical Programming Practices to Reproducible Research The Importance of Good Clinical Data Management and Statistical Programming Practices to Reproducible Research Eileen C King, PhD Research Associate Professor, Biostatistics Acting Director, Data Management

More information

GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com

GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com Common Misconception Good Laboratory Practices 1) A quality system concerned with the organizational process

More information

INSERT COMPANY LOGO HERE BEST PRACTICES RESEARCH

INSERT COMPANY LOGO HERE BEST PRACTICES RESEARCH INSERT COMPANY LOGO HERE BEST PRACTICES RESEARCH Background and Company Performance Industry Challenges esource: Electronic Clinical Trial Solution Clinical trial sponsors and clinical research organizations

More information

LIBRARY GUIDE: Clinical Medical Device

LIBRARY GUIDE: Clinical Medical Device LIBRARY GUIDE: Clinical Medical Device Table of Contents Overview... 3 Clinical Curriculum Core Program Course Descriptions: A Tour of Health Canada (PHDV89)...5 A Tour of Health Europe (PHDV90)...5 A

More information

1 www.imarcresearch.com

1 www.imarcresearch.com Risk Management in Clinical Research: PROCESS DEVELOPMENT & APPLICATION Introduction Recently, two key pieces of guidance were released from Food and Drug Administration (FDA) and European Medicines Agency

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Oversight of Clinical Investigations A Risk-Based Approach to Monitoring U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research

More information

Patient Centric Monitoring Methodology

Patient Centric Monitoring Methodology Patient Centric Monitoring Methodology The ICON approach to risk based monitoring in clinical trials An ICON White Paper Introduction The pharmaceutical and CRO industries are undergoing a radical shift

More information

Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com

Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com SAMPLE CRA CV Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com Education: Masters of Science, Healthcare Administration, Capital City University,

More information

From paper to electronic data

From paper to electronic data From paper to electronic data Bioindustrypark, October 10, 2013 Dr Alessandra Grande Ivrea GxP Test Facility QA Manager, Head Global BMT QA Research & Development Quality Assurance MerckSerono RBM Outline

More information

GCP INSPECTORS WORKING GROUP REFLECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DOCUMENTS USED IN CLINICAL TRIALS

GCP INSPECTORS WORKING GROUP <DRAFT> REFLECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DOCUMENTS USED IN CLINICAL TRIALS European Medicines Agency London, 17 October 2007 Doc. Ref. EMEA/505620/2007 GCP INSPECTORS WORKING GROUP REFLECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DOCUMENTS USED IN CLINICAL TRIALS

More information

Guidance for CTUs on Assessing the Suitability of Laboratories Processing Research Samples

Guidance for CTUs on Assessing the Suitability of Laboratories Processing Research Samples Guidance for CTUs on Assessing the Suitability of Laboratories Processing Research Samples UKCRC Registered CTUs Network Guidance for CTUs on Assessing the Suitability of Laboratories Processing Research

More information

Study Start-Up SS-204.01. STANDARD OPERATING PROCEDURE FOR Site Initiation Visit (SIV)

Study Start-Up SS-204.01. STANDARD OPERATING PROCEDURE FOR Site Initiation Visit (SIV) Study Start-Up SS-204.01 STANDARD OPERATING PROCEDURE FOR Site Initiation Visit (SIV) Approval: Nancy Paris, MS, FACHE President and CEO 08 March 2012 (Signature and Date) Approval: Frederick M. Schnell,

More information

Optimizing Quality Control / Quality Assurance Agents of a Global Sourcing / Procurement Strategy

Optimizing Quality Control / Quality Assurance Agents of a Global Sourcing / Procurement Strategy Optimizing Quality Control / Quality Assurance Agents of a Global Sourcing / Procurement Strategy Global Pharma Sourcing Conference December 6-7, 2011 Philadelphia, USA Nigel J. Smart, Ph.D. Smart Consulting

More information

Clinical Investigator Training Course

Clinical Investigator Training Course Clinical Investigator Training Course Investigator Responsibilities in Biomedical Research Covered by FDA Regulations Lisa Zimmerman Objectives Discuss Clinical Investigator Obligations according to FDA

More information

Clinical Site Monitoring

Clinical Site Monitoring Clinical Site Monitoring Walt Jones RN, MPH Nurse Consultant Clinical Monitoring Coordinator OCRA, DMID, NIAID November 1, 2007 Clinical Monitoring Contractor Contracted to PPD from Wilmington, North Carolina

More information

Investigator Responsibilities in Clinical Research: Insights and helpful hints for researchers

Investigator Responsibilities in Clinical Research: Insights and helpful hints for researchers Investigator Responsibilities in Clinical Research: Insights and helpful hints for researchers ITHS Clinical Research Education Series September 7, 2010 Objectives Understanding the requirements of DHHS

More information

Clinical Data Management Overview

Clinical Data Management Overview The 2 nd Clinical Data Management Training Clinical Data Management Overview Andrew Taylor ( 安 泰 乐 ), M.S. Head of Clinical Data Management August 30, 2010 Learning Objectives Overview of Process Related

More information

Good Clinical Practice 101: An Introduction

Good Clinical Practice 101: An Introduction Good Clinical Practice 101: An Introduction Presented by: Lester Jao Lacorte, MD Medical Officer Commissioner s Fellow Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological

More information

Guidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS

Guidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS Guidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS U.S. Department of Health and Human Services Food and Drug Administration Center for Biologic Evaluation and Research (CBER) Center for

More information

Speed to Market Abbott Nutrition Experience in Streamlining the Pediatric Clinical Research Process

Speed to Market Abbott Nutrition Experience in Streamlining the Pediatric Clinical Research Process Speed to Market Abbott Nutrition Experience in Streamlining the Pediatric Clinical Research Process Geraldine Baggs, Suzanne Monnin, Deborah Shye, Sue Zhang Abbott Nutrition Research & Development Abbott

More information

Clinical Investigator Inspections and FDA-483 Observations

Clinical Investigator Inspections and FDA-483 Observations Clinical Investigator Inspections and FDA-483 Observations Nancy A. Bellamy, Investigator Bioresearch Specialist/ BIMO Coordinator FDA Detroit District Office October 2, 2013 Objectives Background on FDA

More information

Infoset builds software and services to advantage business operations and improve patient s life

Infoset builds software and services to advantage business operations and improve patient s life Infoset builds software and services to advantage business operations and improve patient s life Clinical Data Management ecrf & EDC Patient Support Programs Medication Adherence Mobile e-health Big Data

More information

International GMP Requirements for Quality Control Laboratories and Recomendations for Implementation

International GMP Requirements for Quality Control Laboratories and Recomendations for Implementation International GMP Requirements for Quality Control Laboratories and Recomendations for Implementation Ludwig Huber, Ph.D. ludwig_huber@labcompliance.com Overview GMP requirements for Quality Control laboratories

More information

Model Approach for Risk-Based Monitoring

Model Approach for Risk-Based Monitoring Model Approach for Risk-Based Monitoring September 2013 Legal Disclaimer... 3 TransCelerate Risk-Based Monitoring Course... 5 Module 1 Introduction to Risk-Based Monitoring (RBM)... 7 Objective 1 Describe

More information

CLINICAL DATA MANAGEMENT

CLINICAL DATA MANAGEMENT J * Edition Practical Guide to CLINICAL DATA MANAGEMENT Susanne Prokscha (g) CRC Press Taylor Francis Croup London York CRC Press is an imprint of the Taylor Francis Croup, an buslness Preface Introduction

More information

KCR Data Management: Designed for Full Data Transparency

KCR Data Management: Designed for Full Data Transparency KCR Data Management: Designed for Full Data Transparency 6% Observational 4% Phase IV 2% Device 11% Phase I 28% Phase II 49% Phase III The quality of study data relies first and foremost on the quality

More information

PREP Course #27: Medical Device Clinical Trial Management

PREP Course #27: Medical Device Clinical Trial Management PREP Course #27: Medical Device Clinical Trial Management Presented by: Evelyn Huang Jeffrey Revello Office of Research Compliance North Shore-LIJ Health System CME Disclosure Statement The North Shore

More information

Role of eclinical Systems in FDA Regulated Studies. Jonathan S. Helfgott

Role of eclinical Systems in FDA Regulated Studies. Jonathan S. Helfgott Role of eclinical Systems in FDA Regulated Studies Presented by: Jonathan S. Helfgott Operations Research Analyst Office of Scientific Investigations Disclaimer The contents of this presentation are my

More information

STANDARD OPERATING PROCEDURES FOR GOOD CLINICAL PRACTICE

STANDARD OPERATING PROCEDURES FOR GOOD CLINICAL PRACTICE STANDARD OPERATING PROCEDURES FOR GOOD CLINICAL PRACTICE UNC OB/GYN (V.1) 9.1.2014 Page i TABLE OF CONTENTS INTRODUCTION. iii ABBREVIATIONS iv GLOSSARY v LISTING OF ATTACHMENTS.... xi I. 1.0 GENERAL ADMINISTRATION

More information

Statistical Operations: The Other Half of Good Statistical Practice

Statistical Operations: The Other Half of Good Statistical Practice Integrating science, technology and experienced implementation Statistical Operations: The Other Half of Good Statistical Practice Alan Hopkins, Ph.D. Theravance, Inc. Presented at FDA/Industry Statistics

More information

Version history Version number Version date Effective date 01 dd-mon-yyyy dd-mon-yyyy 02 dd-mon-yyyy dd-mon-yyyy 03 (current) dd-mon-yyyy dd-mon-yyyy

Version history Version number Version date Effective date 01 dd-mon-yyyy dd-mon-yyyy 02 dd-mon-yyyy dd-mon-yyyy 03 (current) dd-mon-yyyy dd-mon-yyyy Trial name: HOVON xxx yyy Sponsor: HOVON Version history Version number Version date Effective date 01 dd-mon-yyyy dd-mon-yyyy 02 dd-mon-yyyy dd-mon-yyyy 03 (current) dd-mon-yyyy dd-mon-yyyy QRMP authors

More information

Objectives. The Paper Tells the Story

Objectives. The Paper Tells the Story Notes to File: An Auditor s Perspective Lorrie D. Divers, CCRP, RQAP-GCP Executive Director, Global Quality Assurance & Compliance ACM Medical Laboratory / ACM Global Central Laboratory Clinical Translation

More information

Monitoring Clinical Trials with a SAS Risk-Based Approach

Monitoring Clinical Trials with a SAS Risk-Based Approach Paper DH05 Monitoring Clinical Trials with a SAS Risk-Based Approach Laurie Rose, SAS, Cary, NC USA ABSTRACT With global regulatory encouragement, the life sciences industry is gaining momentum to embrace

More information

Considerations When Validating Your Analyst Software Per GAMP 5

Considerations When Validating Your Analyst Software Per GAMP 5 WHITE PAPER Analyst Software Validation Service Considerations When Validating Your Analyst Software Per GAMP 5 Blair C. James, Stacy D. Nelson Introduction The purpose of this white paper is to assist

More information

Software Quality Subcontractor Survey Questionnaire INSTRUCTIONS FOR PURCHASE ORDER ATTACHMENT Q-201

Software Quality Subcontractor Survey Questionnaire INSTRUCTIONS FOR PURCHASE ORDER ATTACHMENT Q-201 PURCHASE ORDER ATTACHMENT Q-201A Software Quality Subcontractor Survey Questionnaire INSTRUCTIONS FOR PURCHASE ORDER ATTACHMENT Q-201 1. A qualified employee shall be selected by the Software Quality Manager

More information

The Global Guideline for GCP Audit

The Global Guideline for GCP Audit The Global Guideline for GCP Audit Author: JSQA: Hiroyasu Yamashita, e-mail: hiroyasu-yamashita@ds-pharma.co.jp Reviewed and Acknowledged by: BARQA: Patricia Fitzgerald, e-mail: Patricia.fitzgerald@adamas.co.uk

More information

Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL

Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL Page 1 of 10 Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL SOP ID Number: Effective Date:01/08/2012 Version Number & Date of Authorisation: V02,

More information