Web Seminar Recordings on Key Clinical Research Topics
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Archive: Investigational Product Accountability Best Practices
Archive: Investigational Product Accountability Best Practices
$735.00Archive: Investigational Product Accountability Best Practices
January 8, 2026
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Archive: Source Documentation: What is Adequate and Accurate?
Archive: Source Documentation: What is Adequate and Accurate?
$835.00Archive: Source Documentation: What is Adequate and Accurate?
December 22, 2025
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Archive: Establishing Quality Tolerance Limits: ICH E6 (R3)
Archive: Establishing Quality Tolerance Limits: ICH E6 (R3)
$735.00Archive: Establishing Quality Tolerance Limits: ICH E6 (R3)
December 10, 2025
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Archive: Preparation, Management, and Response to Inspections and Audits
Archive: Preparation, Management, and Response to Inspections and Audits
$1,045.00Archive: Preparation, Management, and Response to Inspections and Audits
December 10, 2025
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Archive: Approaches to Address Challenges in Vendor Management
Archive: Approaches to Address Challenges in Vendor Management
$835.00Archive: Approaches to Address Challenges in Vendor Management
December 2, 2025
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Archive: A Systematic Approach to Study Start-Up: Improving Site Activation
Archive: A Systematic Approach to Study Start-Up: Improving Site Activation
$735.00Archive: A Systematic Approach to Study Start-Up: Improving Site Activation
November 18, 2025
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Archive: Subject Recruitment: Proactive Project Plans and Issues Management
Archive: Subject Recruitment: Proactive Project Plans and Issues Management
$835.00Archive: Subject Recruitment: Proactive Project Plans and Issues Management
May 22, 2025
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Archive: ICH E6(R3) and ICH E8(R1) Updates: Impact on Sponsors
Archive: ICH E6(R3) and ICH E8(R1) Updates: Impact on Sponsors
$735.00Archive: ICH E6(R3) and ICH E8(R1) Updates: Impact on Sponsors
May 7, 2025
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Archive: RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials
Archive: RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials
$735.00Archive: RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials
May 1, 2025
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Archive: ICH GCP E6(R3) Updates: Sponsor Quality Management - Risk-Based/Risk Management Requirements and Approaches for Compliance
Archive: ICH GCP E6(R3) Updates: Sponsor Quality Management - Risk-Based/Risk Management Requirements and Approaches for Compliance
$835.00Archive: ICH GCP E6(R3) Updates: Sponsor Quality Management - Risk-Based/Risk Management Requirements and Approaches for Compliance
April 24, 2025
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Archive: ICH GCP E6(R3) Updates: Impact on Clinical Data Management
Archive: ICH GCP E6(R3) Updates: Impact on Clinical Data Management
$735.00Archive: ICH GCP E6(R3) Updates: Impact on Clinical Data Management
April 22, 2025
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Archive: ICH GCP E6(R3) Updates: Overview of Changes Impacting Sponsors, CROs, and Clinical Investigators/Sites
Archive: ICH GCP E6(R3) Updates: Overview of Changes Impacting Sponsors, CROs, and Clinical Investigators/Sites
$835.00Archive: ICH GCP E6(R3) Updates: Overview of Changes Impacting Sponsors, CROs, and Clinical Investigators/Sites
April 21, 2025
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Archive: FDA Drug Approval Process
Archive: FDA Drug Approval Process
$735.00Archive: FDA Drug Approval Process
April 18, 2025
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Archive: Inspection Readiness: Understanding BIMO Inspection Requirements for Sponsors, CROs, Monitors and Investigators
Archive: Inspection Readiness: Understanding BIMO Inspection Requirements for Sponsors, CROs, Monitors and Investigators
$735.00Archive: Inspection Readiness: Understanding BIMO Inspection Requirements for Sponsors, CROs, Monitors and Investigators
April 17, 2025
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Archive: Monitoring Oncology Clinical Trials
Archive: Monitoring Oncology Clinical Trials
$735.00Archive: Monitoring Oncology Clinical Trials
April 10, 2025
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Archive: Understanding ICH E6(R3) (GCP) Updates: Key Changes from R2
Archive: Understanding ICH E6(R3) (GCP) Updates: Key Changes from R2
$835.00Archive: Understanding ICH E6(R3) (GCP) Updates: Key Changes from R2
April 10, 2025
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Archive: ICH GCP E6(R3) Updates: Key Changes Impacting Sponsors and CROs
Archive: ICH GCP E6(R3) Updates: Key Changes Impacting Sponsors and CROs
$835.00Archive: ICH GCP E6(R3) Updates: Key Changes Impacting Sponsors and CROs
April 8, 2025
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Archive: FDA Requirements for Electronic Source Data in Clinical Investigations
Archive: FDA Requirements for Electronic Source Data in Clinical Investigations
$735.00Archive: FDA Requirements for Electronic Source Data in Clinical Investigations
February 26, 2025
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Archive: FDA's Updated Informed Consent Guidance: What's New?
Archive: FDA's Updated Informed Consent Guidance: What's New?
$835.00Archive: FDA's Updated Informed Consent Guidance: What's New?
February 24, 2025
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Archive: Introduction to Clinical Research
Archive: Introduction to Clinical Research
$735.00Archive: Introduction to Clinical Research
February 20, 2025
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Archive: Strategies for Having Difficult Conversations
Archive: Strategies for Having Difficult Conversations
$735.00Archive: Strategies for Having Difficult Conversations
February 10, 2025
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Archive: Introduction to Data Management
Archive: Introduction to Data Management
$735.00Archive: Introduction to Data Management
January 27, 2025
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Archive: Strategies for Managing Difficult Clinical Research Sites
Archive: Strategies for Managing Difficult Clinical Research Sites
$835.00Archive: Strategies for Managing Difficult Clinical Research Sites
January 27, 2025
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Archive: Essential Documentation in Clinical Trials at Research Sites
Archive: Essential Documentation in Clinical Trials at Research Sites
$735.00Archive: Essential Documentation in Clinical Trials at Research Sites
January 7, 2025
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Archive: Implementing Quality Agreements
Archive: Implementing Quality Agreements
$735.00Archive: Implementing Quality Agreements
December 16, 2024
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Archive: EU Clinical Trial Regulation (EU-CTR) Requirements
Archive: EU Clinical Trial Regulation (EU-CTR) Requirements
$735.00Archive: EU Clinical Trial Regulation (EU-CTR) Requirements
December 10, 2024
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Archive: ICH E6 (R3) Draft: A Discussion
Archive: ICH E6 (R3) Draft: A Discussion
$835.00Archive: ICH E6 (R3) Draft: A Discussion
December 9, 2024
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Archive: Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155
Archive: Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155
$735.00Archive: Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155
November 18, 2024
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Archive: GCP Renovation (ICH E8 R1 and ICH E6 R3)
Archive: GCP Renovation (ICH E8 R1 and ICH E6 R3)
$835.00Archive: GCP Renovation (ICH E8 R1 and ICH E6 R3)
November 13, 2024
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Archive: Developing and Negotiating Research Site Clinical Study Budgets and Contracts
Archive: Developing and Negotiating Research Site Clinical Study Budgets and Contracts
$835.00Archive: Developing and Negotiating Research Site Clinical Study Budgets and Contracts
November 5, 2024
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Archive: Medical Writing Fundamentals: How to Write Regulatory Documents
Archive: Medical Writing Fundamentals: How to Write Regulatory Documents
$735.00Archive: Medical Writing Fundamentals: How to Write Regulatory Documents
October 15, 2024
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Archive: Overseeing Teams and Projects
Archive: Overseeing Teams and Projects
$835.00Archive: Overseeing Teams and Projects
May 13, 2024
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Archive: ICH E8 (R1): Designing Quality into Clinical Studies
Archive: ICH E8 (R1): Designing Quality into Clinical Studies
$735.00Archive: ICH E8 (R1): Designing Quality into Clinical Studies
May 7, 2024
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Archive: Managing Phase I Clinical Trials
Archive: Managing Phase I Clinical Trials
$735.00Archive: Managing Phase I Clinical Trials
April 4, 2024
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Archive: Building Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Systems into Clinical Operations
Archive: Building Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Systems into Clinical Operations
$735.00Archive: Building Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Systems into Clinical Operations
March 19, 2024
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Archive: ICH GCP E6 R2 and R3 Updates: Implementing Risk Management Approaches for Compliance
Archive: ICH GCP E6 R2 and R3 Updates: Implementing Risk Management Approaches for Compliance
$835.00Archive: ICH GCP E6 R2 and R3 Updates: Implementing Risk Management Approaches for Compliance
March 15, 2024
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Archive: Corrective Action Plans: Essential Documentation of a Site's Response
Archive: Corrective Action Plans: Essential Documentation of a Site's Response
$835.00Archive: Corrective Action Plans: Essential Documentation of a Site's Response
February 21, 2024
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Archive: CRO Partnership Management
Archive: CRO Partnership Management
$735.00Archive: CRO Partnership Management
February 15, 2024
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Archive: Introduction to Statistics for Non-Statisticians
Archive: Introduction to Statistics for Non-Statisticians
$835.00Archive: Introduction to Statistics for Non-Statisticians
September 19, 2023
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Archive: Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning
Archive: Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning
$835.00Archive: Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning
April 20, 2023
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Archive: FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors
Archive: FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors
$735.00Archive: FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors
November 9, 2022
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Archive: ClinicalTrials.Gov Requirements: Clinical Trial Registration and Trial Results Reporting, Expanded Registry and Results Data Bank
Archive: ClinicalTrials.Gov Requirements: Clinical Trial Registration and Trial Results Reporting, Expanded Registry and Results Data Bank
$835.00Archive: ClinicalTrials.Gov Requirements: Clinical Trial Registration and Trial Results Reporting, Expanded Registry and Results Data Bank
February 24, 2022
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Archive: Risk-Based Monitoring and Quality Management of Clinical Trials: Recent Guidance Updates from the FDA and EMA
Archive: Risk-Based Monitoring and Quality Management of Clinical Trials: Recent Guidance Updates from the FDA and EMA
$735.00Archive: Risk-Based Monitoring and Quality Management of Clinical Trials: Recent Guidance Updates from the FDA and EMA
February 16, 2022
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Archive: Developing Clinical Study Budgets for Sponsors
Archive: Developing Clinical Study Budgets for Sponsors
$735.00Archive: Developing Clinical Study Budgets for Sponsors
February 7, 2022
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Archive: Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components
Archive: Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components
$835.00Archive: Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components
January 27, 2022
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Archive: Ensuring Success Through Smarter Site Selection and Study Feasibility
Archive: Ensuring Success Through Smarter Site Selection and Study Feasibility
$735.00Archive: Ensuring Success Through Smarter Site Selection and Study Feasibility
December 16, 2021
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Archive: Electronic Informed Consent Guidance: Regulatory Updates
Archive: Electronic Informed Consent Guidance: Regulatory Updates
$735.00Archive: Electronic Informed Consent Guidance: Regulatory Updates
December 15, 2021
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Archive: TMF/eTMF Audit Strategies
Archive: TMF/eTMF Audit Strategies
$735.00Archive: TMF/eTMF Audit Strategies
October 15, 2021
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Archive: TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings
Archive: TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings
$835.00Archive: TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings
September 10, 2021
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Archive: ICH E8 (R1): Changes Impacting Sponsors/CROs
Archive: ICH E8 (R1): Changes Impacting Sponsors/CROs
$735.00Archive: ICH E8 (R1): Changes Impacting Sponsors/CROs
July 29, 2021
Please register using your academic affiliation. If academic affiliation is not provided, commercial rates will apply.