Web Seminar Recordings on Key Clinical Research Topics
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Archive: Investigator Initiated Trials: Roles and Responsibilities 
Archive: Investigator Initiated Trials: Roles and Responsibilities
$735.00Archive: Investigator Initiated Trials: Roles and Responsibilities
July 16, 2021
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Archive: State Laws Governing Clinical Trial Regulatory Compliance 
Archive: State Laws Governing Clinical Trial Regulatory Compliance
$735.00Archive: State Laws Governing Clinical Trial Regulatory Compliance
April 12, 2021
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Archive: Strategies for Remote Auditing of Investigative Sites 
Archive: Strategies for Remote Auditing of Investigative Sites
$1,195.00Archive: Strategies for Remote Auditing of Investigative Sites
March 12 - 19, 2021
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Archive: Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets 
Archive: Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets
$735.00Archive: Minimizing Risk in Negotiating Clinical Trial Contracts and Budgets
March 10, 2021
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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: Writing Clinical Study Protocols 
Archive: Writing Clinical Study Protocols
$835.00Archive: Writing Clinical Study Protocols
November 16, 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: 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: Protocol Deviations: Documenting, Managing, and Reporting 
Archive: Protocol Deviations: Documenting, Managing, and Reporting
$735.00Archive: Protocol Deviations: Documenting, Managing, and Reporting
November 10, 2020
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Archive: Risk-Based Site Monitoring 
Archive: Risk-Based Site Monitoring
$735.00Archive: Risk-Based Site Monitoring
October 27, 2020
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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: 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: 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: 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: Good Clinical Practice: Practical Application and Implementation 
Archive: Good Clinical Practice: Practical Application and Implementation
$835.00Archive: Good Clinical Practice: Practical Application and Implementation
September 24, 2020
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Archive: Monitoring Reports: 10 Rules of Effective Report Writing 
Archive: Monitoring Reports: 10 Rules of Effective Report Writing
$835.00Archive: Monitoring Reports: 10 Rules of Effective Report Writing
September 23, 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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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: eTMF Quality Oversight: A Risk-Based Approach 
Archive: eTMF Quality Oversight: A Risk-Based Approach
$835.00Archive: eTMF Quality Oversight: A Risk-Based Approach
September 11, 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: 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: 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: 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: 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: 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: Introduction to Medicare Coverage Analysis: Impact on Site Revenue Cycles 
Archive: Introduction to Medicare Coverage Analysis: Impact on Site Revenue Cycles
$735.00Archive: Introduction to Medicare Coverage Analysis: Impact on Site Revenue Cycles
May 7, 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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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: Writing the Clinical Study Report 
Archive: Writing the Clinical Study Report
$735.00Archive: Writing the Clinical Study Report
January 15, 2020
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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: The IND in a CTD/eCTD Format 
Archive: The IND in a CTD/eCTD Format
$735.00Archive: The IND in a CTD/eCTD Format
December 18, 2019
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Archive: Sponsor Responsibilities for Global Drug Studies 
Archive: Sponsor Responsibilities for Global Drug Studies
$735.00Archive: Sponsor Responsibilities for Global Drug Studies
December 17, 2019
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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 16, 2019
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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
December 9, 2019
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Archive: Managing CRAs to Improve Performance and Study Outcomes 
Archive: Managing CRAs to Improve Performance and Study Outcomes
$625.00Archive: Managing CRAs to Improve Performance and Study Outcomes
December 3, 2019
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Archive: Auditing Sponsors and CROs: Deconstruction and Application of the FDA's Compliance Program Guidance Manual 
Archive: Auditing Sponsors and CROs: Deconstruction and Application of the FDA's Compliance Program Guidance Manual
$735.00Archive: Auditing Sponsors and CROs: Deconstruction and Application of the FDA's Compliance Program Guidance Manual
November 19, 2019
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Archive: Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance 
Archive: Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance
$835.00Archive: Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance
November 18, 2019
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Archive: Informed Consent Procedure: Lessons Learned from Inspection Findings 
Archive: Informed Consent Procedure: Lessons Learned from Inspection Findings
$735.00Archive: Informed Consent Procedure: Lessons Learned from Inspection Findings
November 4, 2019
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Archive: Use of Electronic Health Record Data in Clinical Investigations 
Archive: Use of Electronic Health Record Data in Clinical Investigations
$835.00Archive: Use of Electronic Health Record Data in Clinical Investigations
September 18, 2019
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Archive: Final ICH GCP E6 R2: Changes Impacting Clinical Investigators, Sites, and IND Holders (Sponsors-Investigators and Institutions) 
Archive: Final ICH GCP E6 R2: Changes Impacting Clinical Investigators, Sites, and IND Holders (Sponsors-Investigators and Institutions)
$835.00Archive: Final ICH GCP E6 R2: Changes Impacting Clinical Investigators, Sites, and IND Holders (Sponsors-Investigators and Institutions)
September 17, 2019
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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
September 3, 2019
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Archive: Working with Clinical Research Sites: Strategic Planning and Operations for Sponsors and CROs 
Archive: Working with Clinical Research Sites: Strategic Planning and Operations for Sponsors and CROs
$735.00Archive: Working with Clinical Research Sites: Strategic Planning and Operations for Sponsors and CROs
August 28, 2019
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Archive: Drug Development and FDA Regulations 
Archive: Drug Development and FDA Regulations
$735.00Archive: Drug Development and FDA Regulations
July 16, 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: Regulatory Intelligence 
Archive: Regulatory Intelligence
$735.00Archive: Regulatory Intelligence
May 22, 2019
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Archive: ABCs of GCP and the 13 Principles of ICH GCP E6 
Archive: ABCs of GCP and the 13 Principles of ICH GCP E6
$735.00Archive: ABCs of GCP and the 13 Principles of ICH GCP E6
May 10, 2019
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Archive: Root Cause Analysis: Applying the Concept for Better Study Compliance Management 
Archive: Root Cause Analysis: Applying the Concept for Better Study Compliance Management
$625.00Archive: Root Cause Analysis: Applying the Concept for Better Study Compliance Management
May 9, 2019
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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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