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Archive: ICH E6 (R3) and ICH E8 (R1) Updates: Impact on Sponsors
December 4, 2023
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Archive: Introduction to Statistics for Non-Statisticians
September 19, 2023
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Archive: FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors
November 9, 2022
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Archive: ICH GCP E6 R2 and R3 Updates: Implementing Risk Management Approaches for Compliance
July 8, 2022
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Archive: 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
February 16, 2022
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Archive: 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
January 27, 2022
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Archive: Ensuring Success Through Smarter Site Selection and Study Feasibility
December 16, 2021
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Archive: Electronic Informed Consent Guidance: Regulatory Updates
December 15, 2021
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Archive: Strategies for Managing Difficult Clinical Research Sites
October 25, 2021
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Archive: Trial Master File (TMF) for Sponsors: Set-Up and Maintenance
October 15, 2021
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Archive: TMF/eTMF Audit Strategies
October 15, 2021
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Archive: TMF/eTMF Regulatory Agency Expectations, Inspections, and Findings
September 10, 2021
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Archive: ICH E8 (R1): Changes Impacting Sponsors/CROs
July 29, 2021
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Archive: Investigator Initiated Trials: Roles and Responsibilities
July 16, 2021
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Archive: Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155
May 14, 2021
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Archive: State Laws Governing Clinical Trial Regulatory Compliance
April 12, 2021
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Archive: Inspection Readiness: Understanding BIMO Inspection Requirements for Sponsors, CROs, Monitors and Investigators
March 30, 2021
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Archive: Strategies for Remote Auditing of Investigative Sites
March 12, 2021
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Archive: 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
February 17, 2021
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Archive: ICH E8 (R1): Designing Quality into Clinical Studies
January 14, 2021
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Archive: Overseeing Teams and Projects
November 25, 2020
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Archive: Introduction to Clinical Research
November 17, 2020
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Archive: Writing Clinical Study Protocols
November 16, 2020
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Archive: The GCPs of Essential Documents
November 11, 2020
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Archive: Data Management Plan Creation: Content and Rationale
November 11, 2020
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Archive: Protocol Deviations: Documenting, Managing, and Reporting
November 10, 2020
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Archive: Risk-Based Site Monitoring
October 27, 2020
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Archive: Monitoring Medical Device Trials: An Introduction
October 22, 2020
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Archive: Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective
October 22, 2020
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Archive: Data Quality in Clinical Trials: Rationale and Impact
October 14, 2020
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Archive: Case Report Form Design, Strategy, and Standards
September 30, 2020
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Archive: Good Clinical Practice: Practical Application and Implementation
September 24, 2020
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Archive: Final ICH GCP E6 R2: Impact on Clinical Data Management
September 23, 2020
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Archive: 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
September 21, 2020
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Archived: The Revised HHS Common Rule: What You Need to Know Now
September 18, 2020
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Archive: Cases in Advanced GCP: A Problem-Solving Practicum
September 16, 2020
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Archive: Building Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Systems into Clinical Operations
September 14, 2020
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Archive: eTMF Quality Oversight: A Risk-Based Approach
September 11, 2020
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Archive: Establishing Quality Tolerance Limits
August 13, 2020
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Archive: Final ICH GCP E6 R2: Sponsor Quality Management - Risk-Based/Risk Management Requirements and Approaches for Compliance
July 21, 2020
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Archive: Preparing Clinical Research Sites for FDA Inspections
July 15, 2020
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Archive: Auditing Techniques: A Problem-Solving Practicum
July 9, 2020
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Archive: Strategies for Effective Remote Monitoring
June 1, 2020
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Archive: Leading Teams in a Changing Clinical Research Environment
May 27, 2020
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Archive: 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
May 13, 2020
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Archive: 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
May 7, 2020
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Archive: Managing Clinical Trials During the COVID-19 Pandemic
April 27, 2020
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Archive: Centralized TMF Management: The CRO Sponsor Partnership
April 24, 2020
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Archive: Investigational Product Accountability Best Practices
April 23, 2020
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Archive: Essential Documentation in Clinical Trials at Research Sites
April 14, 2020
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Archive: Risk-Based Auditing: Effective Compliance Strategies
March 18, 2020
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Archive: Approaches to Address Challenges in Vendor Management
March 3, 2020
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Archive: Source Documentation: What is Adequate and Accurate?
January 15, 2020
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Archive: Writing the Clinical Study Report
January 15, 2020
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Archive: Final ICH GCP E6 R2 Addendum: Overview of Changes Impacting Sponsors, CROs, Clinical Investigators/Sites
December 19, 2019
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Archive: 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
December 18, 2019
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Archive: 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
December 16, 2019
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Archive: HIPAA Team Training: Fundamental Training Specifically for Clinical Research Settings
December 9, 2019
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Archive: CRO Partnership Management
December 6, 2019
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Archive: Managing CRAs to Improve Performance and Study Outcomes
December 3, 2019
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Archive: Implementing Quality Agreements
November 22, 2019
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Archive: 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
November 18, 2019
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Archive: Informed Consent Procedure: Lessons Learned from Inspection Findings
November 4, 2019
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Archive: Electronic Source Data in Clinical Investigations: Navigating the Final FDA Guidance
October 21, 2019
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Archive: A Systematic Approach to Study Start-Up: Improving Site Activation
October 18, 2019
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Archive: Introduction to Data Management
October 16, 2019
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Archive: RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials
September 24, 2019
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Archive: 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)
September 17, 2019
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Archive: 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
August 28, 2019
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Archive: Managing Phase I Clinical Trials
August 12, 2019
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Archive: Monitoring Oncology Clinical Trials
August 1, 2019
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Archive: Drug Development and FDA Regulations
July 16, 2019
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Archive: FDA Drug Approval Process
June 3, 2019
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Archive: Developing and Negotiating Research Site Clinical Study Budgets and Contracts
May 30, 2019
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Archive: Risk-Based Monitoring: The Data Management Connection
May 29, 2019
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Archive: Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning
May 23, 2019
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Archive: Regulatory Intelligence
May 22, 2019
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Archive: 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
May 9, 2019
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Archive: Corrective Action Plans: Essential Documentation of a Site's Response to GCP Deficiencies
May 2, 2019
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Archive: Current FDA and EMA Inspection Findings: Lessons Learned
May 2, 2019
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Archive: Monitoring Visit Reports for Medical Device Studies
April 30, 2019
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Archive: Medical Writing Fundamentals: How to Write Regulatory Documents
April 10, 2019
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Archive: Strategies for Having Difficult Conversations
March 26, 2019
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Archive: Building Relationships with Clinical Research Sites
March 20, 2019
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Archive: Principal Investigator Oversight and the Appropriate Delegation of Tasks
March 19, 2019
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Archive: Monitoring Plan Development
February 21, 2019
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Archive: Coaching Skills for Leaders
February 7, 2019
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Archive: Adverse Event Monitoring for CRAs
January 16, 2019
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Archive: Use of Notes to File in Clinical Trial Essential Documentation
November 13, 2018
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Archive: Subject Recruitment: Proactive Project Plans and Issues Management
July 20, 2018
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Archive: Preparation, Management, and Response to Inspections and Audits
June 5, 2018
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Archive: Writing and Updating the Investigator's Brochure
May 9, 2018
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Archive: Final ICH GCP E6 R2: Changes Impacting Sponsors/CROs
May 8, 2018
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Archive: FDA Medical Device Approval Process
May 7, 2018
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Archive: Tools for Trainers: Clinical Research Job-Aids and Checklists
May 2, 2018
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Archive: Adequate Sponsor Monitoring Systems In Anticipation of FDA Sponsor GCP Inspections
January 30, 2018
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Archive: Writing and Maintaining the EU Clinical Trial Authorization
November 8, 2017
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Archive: eTMF Implementation Strategies
June 2, 2017
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Archive: Data Management in the Electronic Data Capture Arena
April 11, 2017
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Archive: Case Narrative Writing for Reporting Adverse Events
March 23, 2017
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Archive: Final AE Regulatory Guidance
March 13, 2017
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Archive: Quality by Design in Clinical Research: Is This Only for the Protocol?
December 7, 2016
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Archive: Fraud in Clinical Research: An Overview
November 9, 2016
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Archive: EMA and FDA Inspections: Key Differences and Similarities
October 25, 2016
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Archive: Final FDA Guidance: How to Complete the Form FDA 1572
October 3, 2016
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Archive: CRO Selection Criteria, Eval, & Establishing the Relationship
September 16, 2016
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Archive: Establishing a Risk Management Framework for Clin Trial Conduct
August 24, 2016
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Archive: Detecting Risk Signals in Protocols, Data, and Monitoring
July 19, 2016
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Archive: Re-Engineering the RFP and Bid Defense Meeting
May 4, 2016
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Archive: Annual GCP Training Update: MHRA Inspection Findings for 2015
February 29, 2016
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Archive: Subject Enrollment: Creating Effective Enrollment Models
February 8, 2016
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Archive: Principal Investigator/Site GCP Compliance and Performance
February 3, 2016
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Archive: Data Management: Key Regulations Impacting the Role of the CDM
January 12, 2016
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Archive: SDTM and CDASH: What's the Connection?
January 12, 2016
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Archive: Quality Risk Management in Clinical Trials and Pharmacovigilance
December 10, 2015
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Archive: Study Feasibility: Eliminating Low and Late Enrollment
November 24, 2015
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Archive: Sponsor Management of Investigator Non-Compliance
November 20, 2015
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Archive: Establishing a Vendor Management Program
November 16, 2015
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Archive: Critical Decision Points in Design and Conduct of Patient Reg.
September 17, 2015
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Archive: Strategies for Developing Effective Training & Facilitation Skills
July 23, 2015
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Archive: Strategies for Ensuring Good Documentation Practices (GDP)
June 25, 2015
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Archive: Principal Investigator Training: Roles and Responsibilities
May 18, 2015
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Archive: Improving Readability of SOPs and Other Procedural Documents
May 5, 2015
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Archive: Writing Protocols for Diagnostic Studies
April 15, 2015
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Archive: Strategies for Conducting Vendor Audits
April 3, 2015
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Archive: Quality by Design: A Lean Six Sigma Approach to Risk-Based Mon.
March 24, 2015
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Archive: Study Initiation Strategies for Sponsors: Study and Site Start-Up
March 13, 2015
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Archive: Risk-Based Monitoring for Sites: Prepare Your Site for Success
December 1, 2014
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Archive: Using Data to Identify Risk Indicators in Risk-Based Monitoring
August 29, 2014
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Archive: Social Media in Clinical Research
August 22, 2014
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Archive: Auditor Emotional Intelligence
June 11, 2014
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Archive: Monitoring Phase I Clinical Trials
May 23, 2014
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Archive: Study Site Start-Up: Organization and Management Tips
May 6, 2014
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Archive: Phase I Study Management
April 11, 2014
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Archive: Writing Quality SOPs:Guidelines, Tools, Templates for SOP Creation
March 21, 2014
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Archive: Strategies for Protocol Operationalization and Adherence
March 17, 2014
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Archive: Real-World Monitoring: Tips for Success and Sanity
January 16, 2014
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Archive: Preparing for SOP Inspection: An Auditor's Perspective
December 5, 2013
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Archive: Trial Master File (TMF) for Research Sites: Set-Up and Maintenance
October 25, 2013
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Archive: Writing Clinical Study Reports for Diagnostic Studies
October 17, 2013
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Archive: GCP Training for Investigators
June 20, 2013
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Archive: Informed Consent Content & Process Requirements
June 10, 2013
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Archive: Managing Observational Studies
August 23, 2012
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Archive: Writing SOPs and Procedural Documents
August 22, 2012
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Archive: Design Considerations for GCP Training Programs
May 2, 2012
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Archive: CRC Role/Responsibilities Training
April 24, 2012
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Archive: Implementation of Procedural Documents
March 16, 2012
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Archive: Five Key Strategic Steps for Developing Global SOPs
March 1, 2012
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Archive: SOP on SOPs and Procedural Document Templates
February 20, 2012
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Archive: Procedural Document System: Organized Development
February 1, 2012
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Archive: Investigator Selection Criteria & Strategies
January 31, 2012
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Archive: Site Management and the Art of Assertiveness
March 24, 2011
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Archive: Making Good Teams Better: Taking Your Cross-Functional Global Team
November 11, 2010
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Archive: Presentation Skills Training for Clinical Research Professionals
November 9, 2010
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Archive: Introduction to the FDA
October 25, 2010
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Archive: Medical Device Tracking
August 18, 2010
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Archive: Transitioning Pharma Professionals to Medical Device Professionals
April 5, 2010
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