Канал: Kathy Barnett

Inspection Readiness: Understanding BIMO Inspection Req for Sponsors, CROs, Monitor, Investigators

Inspection Readiness: Understanding BIMO Inspection Req for Sponsors, CROs, Monitor, Investigators

ICH E8 (R1): Designing Quality into Clinical Studies

ICH E8 (R1): Designing Quality into Clinical Studies

Trial Master File (TMF) for Sponsors: Set Up and Maintenance

Trial Master File (TMF) for Sponsors: Set Up and Maintenance

Approaches to Address Challenges in Vendor Management

Approaches to Address Challenges in Vendor Management

Corrective Action Plans: Essential Documentation of a Site’s Response to GCP Deficiencies

Corrective Action Plans: Essential Documentation of a Site’s Response to GCP Deficiencies

Managing Phase I Clinical Trials

Managing Phase I Clinical Trials

CRO Partner Management

CRO Partner Management

Overseeing Teams and Projects

Overseeing Teams and Projects

Introduction to Statistics for Non-Statisticians

Introduction to Statistics for Non-Statisticians

ICH GCP E6 R2 and R3 Updates Implementing Risk Management Approaches for Compliance

ICH GCP E6 R2 and R3 Updates Implementing Risk Management Approaches for Compliance

Good Clinical Practice: A Question & Answer Reference Guide 2024/2025

Good Clinical Practice: A Question & Answer Reference Guide 2024/2025

Introduction to Statistics for Non Statisticians

Introduction to Statistics for Non Statisticians

ICH E6 (R3) and ICH E8 (R1)Updates: Impact on Sponsors

ICH E6 (R3) and ICH E8 (R1)Updates: Impact on Sponsors

FDA’s Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors

FDA’s Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors

ICH GCP E6 R2 and R3 Updates: Implementing Risk Management Approaches for Compliance

ICH GCP E6 R2 and R3 Updates: Implementing Risk Management Approaches for Compliance

ICH E6 (R3) and ICH E8 (R1) Updates: Impact on Sponsors

ICH E6 (R3) and ICH E8 (R1) Updates: Impact on Sponsors

Developing Clinical Study Budgets for Sponsors

Developing Clinical Study Budgets for Sponsors

Risk-Based Monitoring & Quality Mgmt of Clinical Trials: Recent Guidance Updates from FDA & EMA

Risk-Based Monitoring & Quality Mgmt of Clinical Trials: Recent Guidance Updates from FDA & EMA

ClinicalTrials.Gov Requirements

ClinicalTrials.Gov Requirements

Electronic Medical Records: Approaches for Ensuring Source Document & 21 CFR Part 11 Req. Components

Electronic Medical Records: Approaches for Ensuring Source Document & 21 CFR Part 11 Req. Components

Investigator Initiated Trials: Roles and Responsibilities

Investigator Initiated Trials: Roles and Responsibilities

Electronic Informed Consent Guidance: Regulatory Updates

Electronic Informed Consent Guidance: Regulatory Updates

Ensuring Success Through Smarter Site Selection and Study Feasibility

Ensuring Success Through Smarter Site Selection and Study Feasibility

Strategies for Managing Difficult Clinical Research Sites

Strategies for Managing Difficult Clinical Research Sites

TMF/eTMF Audit Strategies

TMF/eTMF Audit Strategies

Trial Master File (TMF) for Sponsors: Set Up and Maintenance

Trial Master File (TMF) for Sponsors: Set Up and Maintenance

ICH E8 (R1): Changes Impacting Sponsors/CROs

ICH E8 (R1): Changes Impacting Sponsors/CROs

TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings

TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings

State Laws Governing Clinical Trial Regulatory Compliance

State Laws Governing Clinical Trial Regulatory Compliance

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155

ICH E8 (R1): Changes Impacting Sponsors/CROs

ICH E8 (R1): Changes Impacting Sponsors/CROs

Strategies for Remote Auditing of Investigative Sites

Strategies for Remote Auditing of Investigative Sites

Inspection Readiness: Understanding BIMO Inspection Req. for Sponsors, CROs, Monitors, Investigators

Inspection Readiness: Understanding BIMO Inspection Req. for Sponsors, CROs, Monitors, Investigators

Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets

Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets

Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools

Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools

ICH E8 (R1): Designing Quality into Clinical Studies

ICH E8 (R1): Designing Quality into Clinical Studies

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance

Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning

Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning

Overseeing Teams and Projects

Overseeing Teams and Projects

Writing Clinical Study Protocols

Writing Clinical Study Protocols

Introduction to Clinical Research

Introduction to Clinical Research

The GCPs of Essential Documents

The GCPs of Essential Documents

Data Management Plan Creation: Content and Rationale

Data Management Plan Creation: Content and Rationale

Protocol Deviations: Documenting, Managing, and Reporting

Protocol Deviations: Documenting, Managing, and Reporting

FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors

FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors

Risk-Based Site Monitoring

Risk-Based Site Monitoring

Monitoring Medical Device Trials: An Introduction

Monitoring Medical Device Trials: An Introduction

Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective

Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective

TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings

TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings

Final ICH GCP E6 R2: Implementing Risk Management Approaches for Compliance

Final ICH GCP E6 R2: Implementing Risk Management Approaches for Compliance

The Revised HHS Common Rule: What You Need to Know Now

The Revised HHS Common Rule: What You Need to Know Now

Data Quality in Clinical Trials: Rationale and Impact

Data Quality in Clinical Trials: Rationale and Impact

Monitoring Reports: 10 Rules of Effective Report Writing

Monitoring Reports: 10 Rules of Effective Report Writing

Good Clinical Practice: Practical Application and Implementation

Good Clinical Practice: Practical Application and Implementation

Final ICH GCP E6 R2: Impact on Clinical Data Management

Final ICH GCP E6 R2: Impact on Clinical Data Management

Case Report Form Design, Strategy, and Standards

Case Report Form Design, Strategy, and Standards

Cases in Advanced GCP: A Problem-Solving Practicum

Cases in Advanced GCP: A Problem-Solving Practicum

Building Quality by Design and Risk-Based Quality Management (RBQM) Systems into Clinical Operations

Building Quality by Design and Risk-Based Quality Management (RBQM) Systems into Clinical Operations

Recent Trends in Noncompliance

Recent Trends in Noncompliance

ICH E8 (R1): Changes Impacting Sponsors/CROs

ICH E8 (R1): Changes Impacting Sponsors/CROs

eTMF Quality Oversight Trailer

eTMF Quality Oversight Trailer

Establishing Quality Tolerance Limits

Establishing Quality Tolerance Limits

Auditing Techniques: A Problem-Solving Practicum

Auditing Techniques: A Problem-Solving Practicum

Final ICH GCP E6 R2: Sponsor Quality Management - Risk-Based/Risk Management Requirements

Final ICH GCP E6 R2: Sponsor Quality Management - Risk-Based/Risk Management Requirements

Preparing Clinical Research Sites for FDA Inspections

Preparing Clinical Research Sites for FDA Inspections

Risk Based Site Monitoring Trailer

Risk Based Site Monitoring Trailer

Strategies for Managing Difficult Clinical Research Sites

Strategies for Managing Difficult Clinical Research Sites

Quality Systems: A Controlled Approach to GCP Compliance

Quality Systems: A Controlled Approach to GCP Compliance

Leading Teams in a Changing Clinical Research Environment

Leading Teams in a Changing Clinical Research Environment

Centralized TMF Management: The CRO Sponsor Partnership

Centralized TMF Management: The CRO Sponsor Partnership

Strategies for Effective Remote Monitoring

Strategies for Effective Remote Monitoring

The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring

The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring

CAP and CLIA Requirements for Clinical Research Laboratories

CAP and CLIA Requirements for Clinical Research Laboratories

Introduction to Medicare Coverage Analysis: Impact on Site Revenue Cycles

Introduction to Medicare Coverage Analysis: Impact on Site Revenue Cycles

Managing Clinical Trials During the COVID-19 Pandemic

Managing Clinical Trials During the COVID-19 Pandemic

Investigational Product Accountability Best Practices

Investigational Product Accountability Best Practices

Essential Documentation in Clinical Trials at Research Sites

Essential Documentation in Clinical Trials at Research Sites

Risk-Based Auditing: Effective Compliance Strategies

Risk-Based Auditing: Effective Compliance Strategies

Inspection Readiness: Understanding BIMO Inspection Requirements for Sponsor/CRO/Monitor/ Invest

Inspection Readiness: Understanding BIMO Inspection Requirements for Sponsor/CRO/Monitor/ Invest

Approaches to Address Challenges in Vendor Management

Approaches to Address Challenges in Vendor Management

COVID-19 Protocol Deviations: Documenting, Managing, and Reporting

COVID-19 Protocol Deviations: Documenting, Managing, and Reporting

Writing the Clinical Study Report

Writing the Clinical Study Report

Source Documentation: What is Adequate and Accurate?

Source Documentation: What is Adequate and Accurate?

EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques

EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques

Final ICH GCP E6 R2 Addendum: Overview of Changes Impacting Sponsors/CROs/Clinical Investigator/Site

Final ICH GCP E6 R2 Addendum: Overview of Changes Impacting Sponsors/CROs/Clinical Investigator/Site

The IND in a CTD/eCTD Format

The IND in a CTD/eCTD Format

Sponsor Responsibilities for Global Drug Studies

Sponsor Responsibilities for Global Drug Studies

Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets

Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets

Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools

Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools

Managing CRAs to Improve Performance and Study Outcomes

Managing CRAs to Improve Performance and Study Outcomes

Key Considerations in Medical Writing

Key Considerations in Medical Writing

Investigator Initiated Trials: Roles and Responsibilities

Investigator Initiated Trials: Roles and Responsibilities

HIPAA Team Training: Fundamental Training Specifically for Clinical Research Setting

HIPAA Team Training: Fundamental Training Specifically for Clinical Research Setting

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155

CRO Partnership Management

CRO Partnership Management

Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance

Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance

Introduction to Statistics for Non-Statisticians

Introduction to Statistics for Non-Statisticians

Auditing Sponsors and CROs: Deconstruction and Application of the FDA's CPGM

Auditing Sponsors and CROs: Deconstruction and Application of the FDA's CPGM

FDAs BIMO Program: Inspection of Sponsors, CROs, and Monitors

FDAs BIMO Program: Inspection of Sponsors, CROs, and Monitors

Ensuring Success Through Smarter Site Selection

Ensuring Success Through Smarter Site Selection

Implementing Quality Agreements

Implementing Quality Agreements

The GCPs of Essential Documents Trailer

The GCPs of Essential Documents Trailer

Informed Consent Procedure Trailer

Informed Consent Procedure Trailer

Introduction to Clinical Research Trailer

Introduction to Clinical Research Trailer

Electronic Source Data in CI Trailer

Electronic Source Data in CI Trailer

Risk Based Thinking Monitors Trailer

Risk Based Thinking Monitors Trailer

Protocol Deviations Trailer

Protocol Deviations Trailer

Systematic Approach to Clinical Study Startup Trailer

Systematic Approach to Clinical Study Startup Trailer

Intro to Data Management Trailer

Intro to Data Management Trailer

State Laws Governing Clinical Trial Regulatory Compliance Trailer

State Laws Governing Clinical Trial Regulatory Compliance Trailer

RECIST 1.0 and 1.1 Trailer

RECIST 1.0 and 1.1 Trailer

TMF/eTMF Audit Strategies Trailer

TMF/eTMF Audit Strategies Trailer

Use of Electronic Health Record Data in Clinical Investigations Trailer

Use of Electronic Health Record Data in Clinical Investigations Trailer

Developing Clinical Study Budgets for Sponsors Trailer

Developing Clinical Study Budgets for Sponsors Trailer

Final ICH GCP E6 R2: Changes Impacting Clinical Investigators Trailer

Final ICH GCP E6 R2: Changes Impacting Clinical Investigators Trailer

Monitoring Oncology Clinical Trials Trailer

Monitoring Oncology Clinical Trials Trailer

Working with Clinical Research Sites Trailer

Working with Clinical Research Sites Trailer

Building Quality by Design Trailer

Building Quality by Design Trailer

Managing Phase I Clinical Trials Trailer

Managing Phase I Clinical Trials Trailer

ABCs of Clinical Research for Clinical Admin Staff Trailer

ABCs of Clinical Research for Clinical Admin Staff Trailer

Drug Development and FDA Regulations Trailer

Drug Development and FDA Regulations Trailer

TMF eTMF Regulatory Agency Expectations Trailer

TMF eTMF Regulatory Agency Expectations Trailer

Recent Trends in Noncompliance Trailer

Recent Trends in Noncompliance Trailer

Writing Clinical Study Protocols Trailer

Writing Clinical Study Protocols Trailer

TMF for Research Sites BI 11387

TMF for Research Sites BI 11387

Investigator Selection BI 10761

Investigator Selection BI 10761

RECIST 1.0 and 1.1 Trailer

RECIST 1.0 and 1.1 Trailer

Risk Based Site Monitoring Trailer

Risk Based Site Monitoring Trailer

Revised HHS Common Rule Trailer

Revised HHS Common Rule Trailer

Preparing Clinical Research Sites for FDA Inspection Trailer

Preparing Clinical Research Sites for FDA Inspection Trailer

FDA Drug Approval Process Trailer

FDA Drug Approval Process Trailer

Establishing Quality Tolerance Limits Trailer

Establishing Quality Tolerance Limits Trailer

Final ICH GCP E6 R2 Addendum Trailer

Final ICH GCP E6 R2 Addendum Trailer

Risk Based Monitoring: The Data Management Connection Trailer

Risk Based Monitoring: The Data Management Connection Trailer

Regulatory Intelligence Trailer

Regulatory Intelligence Trailer

FDAs BIMO Program Trailer

FDAs BIMO Program Trailer

Monitoring Visit Reports for Med Dev Studies Trailer

Monitoring Visit Reports for Med Dev Studies Trailer

Monitoring Medical Device Trials Trailer

Monitoring Medical Device Trials Trailer

Leading Teams in a Changing Clinical Research Environment Trailer

Leading Teams in a Changing Clinical Research Environment Trailer

Dev and Neg Research Site Budgets and Contracts Trailer

Dev and Neg Research Site Budgets and Contracts Trailer

Case Report Form Design Strat and Stand Trailer

Case Report Form Design Strat and Stand Trailer

Protocol Deviations Doc Mnging and Reporting Trailer

Protocol Deviations Doc Mnging and Reporting Trailer

Final ICH GCP Impement Risk Mgmt Trailer

Final ICH GCP Impement Risk Mgmt Trailer

Risk Based Thinking Trailer

Risk Based Thinking Trailer

Data Quality in Clinical Trials Trailer

Data Quality in Clinical Trials Trailer

Investigator Initiated Trials Roles and Responsibilities Trailer

Investigator Initiated Trials Roles and Responsibilities Trailer

Medical Writing Fundamentals Trailer

Medical Writing Fundamentals Trailer

GCP Practical App and Implementation Trailer

GCP Practical App and Implementation Trailer

ClinicalTrialsGov Requirements Trailer

ClinicalTrialsGov Requirements Trailer

Ensuring Success Site Selection Trailer

Ensuring Success Site Selection Trailer

Strategies for Having Difficult Conversations Trailer

Strategies for Having Difficult Conversations Trailer

Principal Investigator Oversight Trailer

Principal Investigator Oversight Trailer

Monitoring Reports 10 Rules Trailer

Monitoring Reports 10 Rules Trailer

Monitoring Plan Development Trailer

Monitoring Plan Development Trailer

Final ICH GCP E6 R2: Sponsor Quality Management RBM Trailer

Final ICH GCP E6 R2: Sponsor Quality Management RBM Trailer

ClinicalTrials.Gov Requirements Trailer

ClinicalTrials.Gov Requirements Trailer

Building Relationships with Clinical Research Sites Trailer

Building Relationships with Clinical Research Sites Trailer

Auditing Clinical Research Studies: An Overview Assessing GCP Compliance Trailer

Auditing Clinical Research Studies: An Overview Assessing GCP Compliance Trailer

Final ICH GCP E6 R2 Addendum Overview of Changes Trailer

Final ICH GCP E6 R2 Addendum Overview of Changes Trailer

Implementing Quality Agreements Trailer

Implementing Quality Agreements Trailer

Cases in Advanced GCP Practicum Trailer

Cases in Advanced GCP Practicum Trailer

Coaching Skills for Leaders Trailer

Coaching Skills for Leaders Trailer

The GCPs of Essential Documents Trailer

The GCPs of Essential Documents Trailer

Introduction to Data Management Trailer Final

Introduction to Data Management Trailer Final

Writing the Clinical Study Report Trailer

Writing the Clinical Study Report Trailer

Adverse Event Monitoring for CRAs Trailer

Adverse Event Monitoring for CRAs Trailer

CRA Role in Risk-Based Monitoring Strat Trailer

CRA Role in Risk-Based Monitoring Strat Trailer

Developing and Negotiating Research S Budg and Contracts Trailer

Developing and Negotiating Research S Budg and Contracts Trailer

Introduction to Statistics for Non Statisticians Trailer

Introduction to Statistics for Non Statisticians Trailer

Implications of FDA Guidance for a RB Approach to Monitoring Trailer

Implications of FDA Guidance for a RB Approach to Monitoring Trailer

Investigator Initiated Trials: Roles and Responsibilities Trailer

Investigator Initiated Trials: Roles and Responsibilities Trailer

Use of Notes to File in Clinical Trial Essential Documentation Trailer

Use of Notes to File in Clinical Trial Essential Documentation Trailer

Auditing Sponsors and CROs Trailer

Auditing Sponsors and CROs Trailer

Final ICH GCP E6 R2: Changes Impacting Clinical Investigators, Sites, and IND Holders Trailer

Final ICH GCP E6 R2: Changes Impacting Clinical Investigators, Sites, and IND Holders Trailer

Monitoring Reports: 10 Rules of Effective Report Writing Trailer

Monitoring Reports: 10 Rules of Effective Report Writing Trailer

Introduction to Clinical Research Trailer

Introduction to Clinical Research Trailer

Introduction to Statistics for Non-Statisticians Trailer

Introduction to Statistics for Non-Statisticians Trailer

TMF eTMF Audit Strategies Trailer

TMF eTMF Audit Strategies Trailer

Strategies for Managing Difficult Clinical Research Sites Trailer

Strategies for Managing Difficult Clinical Research Sites Trailer

Good Clinical Practice: Practical Applications & Implementation Trailer

Good Clinical Practice: Practical Applications & Implementation Trailer

Writing the Clinical Study Report Trailer

Writing the Clinical Study Report Trailer

Subject Recruitment: Proactive Project Plans and Issues Management Trailer

Subject Recruitment: Proactive Project Plans and Issues Management Trailer

The Revised HHS Common Rule: What You Need to Know Now Trailer

The Revised HHS Common Rule: What You Need to Know Now Trailer

Source Documentation What is Adequate and Accurate Trailer

Source Documentation What is Adequate and Accurate Trailer

Use of Electronic Health Records Data in Clin Invest Trailer

Use of Electronic Health Records Data in Clin Invest Trailer

Managing CRAs to Improve Study Outcomes Trailer

Managing CRAs to Improve Study Outcomes Trailer

GCP for Medical Devices ICH ISO Trailer

GCP for Medical Devices ICH ISO Trailer

Final ICH GCP E6 R2 Addendum Changes Impacting Spon CRO CI Sites Trailer

Final ICH GCP E6 R2 Addendum Changes Impacting Spon CRO CI Sites Trailer

Preparation, Management, and Response to Inspections and Audits Trailer

Preparation, Management, and Response to Inspections and Audits Trailer

EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques Trailer

EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques Trailer

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance Trailer

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance Trailer

Electronic Medical Records: Approaches for Ensuring Source Document Components Trailer

Electronic Medical Records: Approaches for Ensuring Source Document Components Trailer

Monitoring Oncology Clinical Trials Trailer

Monitoring Oncology Clinical Trials Trailer

Final ICH GCP E6 R2: Implementing Risk Management Approaches for Compliance Trailer

Final ICH GCP E6 R2: Implementing Risk Management Approaches for Compliance Trailer

TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings Trailer

TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings Trailer

Final ICH GCP E6 R2: Sponsor Quality Management Trailer

Final ICH GCP E6 R2: Sponsor Quality Management Trailer

Informed Consent Procedure: Lessons Learned from Inspection Findings Trailer

Informed Consent Procedure: Lessons Learned from Inspection Findings Trailer

ABCs of Clinical Research for Clinical Administrative Support Staff Trailer

ABCs of Clinical Research for Clinical Administrative Support Staff Trailer

Writing and Updating Investigator Brochure Trailer

Writing and Updating Investigator Brochure Trailer