Web Seminar Recordings on Key Clinical Research Topics
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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: Implementing Quality Agreements
Archive: Implementing Quality Agreements
$735.00Archive: Implementing Quality Agreements
December 16, 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: 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: Managing Phase I Clinical Trials
Archive: Managing Phase I Clinical Trials
$735.00Archive: Managing Phase I Clinical Trials
July 15, 2024
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Archive: Monitoring Plan Development
Archive: Monitoring Plan Development
$735.00Archive: Monitoring Plan Development
August 29, 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: Overseeing Teams and Projects
Archive: Overseeing Teams and Projects
$835.00Archive: Overseeing Teams and Projects
May 13, 2024
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Archive: HIPAA Team Training: Fundamental Training Specifically for Clinical Research Settings
Archive: HIPAA Team Training: Fundamental Training Specifically for Clinical Research Settings
$625.00Archive: HIPAA Team Training: Fundamental Training Specifically for Clinical Research Settings
August 6, 2024
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Archive: Writing and Updating the Investigator's Brochure
Archive: Writing and Updating the Investigator's Brochure
$835.00Archive: Writing and Updating the Investigator's Brochure
September 26, 2024
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Archive: Key Considerations in Medical Writing: The Clinical Study Protocol, Investigator's Brochure, Informed Consent Form, and Adverse Events Narratives
Archive: Key Considerations in Medical Writing: The Clinical Study Protocol, Investigator's Brochure, Informed Consent Form, and Adverse Events Narratives
$735.00Archive: Key Considerations in Medical Writing: The Clinical Study Protocol, Investigator's Brochure, Informed Consent Form, and Adverse Events Narratives
December 3, 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: 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: 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: ABCs of Clinical Research for Clinical Administrative Support Staff
Archive: ABCs of Clinical Research for Clinical Administrative Support Staff
$835.00Archive: ABCs of Clinical Research for Clinical Administrative Support Staff
June 5, 2023
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Archive: eTMF Implementation Strategies
Archive: eTMF Implementation Strategies
$835.00Archive: eTMF Implementation Strategies
November 9, 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: 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: 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: 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: Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools
Archive: Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools
$735.00Archive: Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools
February 17, 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
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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: 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: 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: TMF/eTMF Audit Strategies
Archive: TMF/eTMF Audit Strategies
$735.00Archive: TMF/eTMF Audit Strategies
October 15, 2021
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Archive: Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective
Archive: Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective
$735.00Archive: Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective
October 22, 2020
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Archive: Preparing Clinical Research Sites for FDA Inspections
Archive: Preparing Clinical Research Sites for FDA Inspections
$625.00Archive: Preparing Clinical Research Sites for FDA Inspections
July 15, 2020
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Archive: Data Management Plan Creation: Content and Rationale
Archive: Data Management Plan Creation: Content and Rationale
$735.00Archive: Data Management Plan Creation: Content and Rationale
November 11, 2020
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Archive: Strategies for Effective Remote Monitoring
Archive: Strategies for Effective Remote Monitoring
$735.00Archive: Strategies for Effective Remote Monitoring
June 1, 2020
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Archive: Auditing Techniques: A Problem-Solving Practicum
Archive: Auditing Techniques: A Problem-Solving Practicum
$835.00Archive: Auditing Techniques: A Problem-Solving Practicum
July 9, 2020
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Archive: Case Report Form Design, Strategy, and Standards
Archive: Case Report Form Design, Strategy, and Standards
$735.00Archive: Case Report Form Design, Strategy, and Standards
September 30, 2020
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Archive: CAP and CLIA Requirements for Clinical Research Laboratories
Archive: CAP and CLIA Requirements for Clinical Research Laboratories
$835.00Archive: CAP and CLIA Requirements for Clinical Research Laboratories
May 12, 2020
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Archive: Monitoring Medical Device Trials: An Introduction
Archive: Monitoring Medical Device Trials: An Introduction
$735.00Archive: Monitoring Medical Device Trials: An Introduction
October 22, 2020
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Archive: Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters and Communications from the FDA, EMA, and Health Canada
Archive: Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters and Communications from the FDA, EMA, and Health Canada
$735.00Archive: Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters and Communications from the FDA, EMA, and Health Canada
September 21, 2020
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Archive: Data Quality in Clinical Trials: Rationale and Impact
Archive: Data Quality in Clinical Trials: Rationale and Impact
$735.00Archive: Data Quality in Clinical Trials: Rationale and Impact
October 14, 2020
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Archive: Leading Teams in a Changing Clinical Research Environment
Archive: Leading Teams in a Changing Clinical Research Environment
$735.00Archive: Leading Teams in a Changing Clinical Research Environment
May 27, 2020
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Archive: Quality Systems: A Controlled Approach to GCP Compliance
Archive: Quality Systems: A Controlled Approach to GCP Compliance
$735.00Archive: Quality Systems: A Controlled Approach to GCP Compliance
May 22, 2020
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Archive: Managing Clinical Trials During the COVID-19 Pandemic
Archive: Managing Clinical Trials During the COVID-19 Pandemic
$735.00Archive: Managing Clinical Trials During the COVID-19 Pandemic
April 27, 2020
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Archive: Centralized TMF Management: The CRO Sponsor Partnership
Archive: Centralized TMF Management: The CRO Sponsor Partnership
$735.00Archive: Centralized TMF Management: The CRO Sponsor Partnership
April 24, 2020
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Archived: The Revised HHS Common Rule: What You Need to Know Now
Archived: The Revised HHS Common Rule: What You Need to Know Now
$835.00Archived: The Revised HHS Common Rule: What You Need to Know Now
September 18, 2020
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Archive: Risk-Based Auditing: Effective Compliance Strategies
Archive: Risk-Based Auditing: Effective Compliance Strategies
$735.00Archive: Risk-Based Auditing: Effective Compliance Strategies
March 18, 2020
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Archive: The GCPs of Essential Documents
Archive: The GCPs of Essential Documents
$735.00Archive: The GCPs of Essential Documents
November 11, 2020
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Archive: The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring
Archive: The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring
$735.00Archive: The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring
May 13, 2020
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Archive: Current FDA and EMA Inspection Findings: Lessons Learned
Archive: Current FDA and EMA Inspection Findings: Lessons Learned
$735.00Archive: Current FDA and EMA Inspection Findings: Lessons Learned
May 2, 2019
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Archive: Risk-Based Monitoring: The Data Management Connection
Archive: Risk-Based Monitoring: The Data Management Connection
$735.00Archive: Risk-Based Monitoring: The Data Management Connection
May 29, 2019
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Archive: EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques
Archive: EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques
$945.00Archive: EMA and MHRA Inspections: Successful Planning and Execution Tips and Techniques
December 19, 2019
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Archive: Building Relationships with Clinical Research Sites
Archive: Building Relationships with Clinical Research Sites
$735.00Archive: Building Relationships with Clinical Research Sites
March 20, 2019
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Archive: Coaching Skills for Leaders
Archive: Coaching Skills for Leaders
$735.00Archive: Coaching Skills for Leaders
February 7, 2019
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