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May 17, 2012
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DVD Good Clinical Practice: Practical Application and Implementation
April 26, 2012
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DVD CRC Role/Responsibilities Training
April 24, 2012
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DVD Adverse Event Monitoring for CRAs
April 13, 2012
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DVD Adverse Events for Medical Devices
April 9, 2012
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DVD Quality Risk Management in Clinical Trials and Pharmacovigilance
April 3, 2012
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DVD Preparing Clinical Research Sites for FDA Inspections
April 2, 2012
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DVD Strategies for Protocol Operationalization and Adherence
March 29, 2012
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DVD Implementation of Procedural Documents
March 16, 2012
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DVD Tools for Trainers: Clinical Research Job-Aids and Checklists
March 13, 2012
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DVD Preparing for SOP Inspection: An Auditor's Perspective
March 9, 2012
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DVD Worldwide Orphan Drug Designation Applications and Requirements
March 6, 2012
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DVD Five Key Strategic Steps for Developing Global SOPs
March 1, 2012
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DVD New FDA Guideline to Informed Consent
February 28, 2012
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DVD SOP on SOPs and Procedural Document Templates
February 20, 2012
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DVD Procedural Document System: Organized Development
February 1, 2012
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DVD Investigator Selection Criteria & Strategies
January 31, 2012
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DVD Adequate Sponsor Monitoring Systems
January 13, 2012
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DVD Corrective Action Plans
December 14, 2011
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DVD FDA's Bioresearch Monitoring (BIMO) Program: New Guidance
December 7, 2011
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DVD Investigator Initiated Trials: Roles and Responsibilities
November 29, 2011
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DVD Trial Master File (TMF) for Sponsors: Set-Up and Maintenance
November 28, 2011
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DVD Strategies for Managing Difficult Clinical Research Sites
November 18, 2011
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DVD Principal Investigator Training: Roles and Responsibilities
November 17, 2011
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DVD Final FDA Guidance: How to Complete the FDA Form 1572
November 16, 2011
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DVD Monitoring Plan Development
November 15, 2011
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DVD Informed Consent Content & Process Requirements
November 1, 2011
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DVD Electronic Source Documentation
October 28, 2011
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DVD Implications of New FDA Guideline Risk-Based
October 18, 2011
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DVD Monitoring Reports: 10 Rules of Effective Report Writing
October 17, 2011
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DVD Use of Notes to File in CT Documentation
October 17, 2011
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DVD Principal Investigator Oversight
September 27, 2011
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DVD Risk-Based Site Monitoring
September 27, 2011
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DVD Writing and Updating the Investigator's Brochure
September 26, 2011
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DVD Drug Safety and Pharmacovigilance
September 8, 2011
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DVD RECIST 1.0 and 1.1
June 14, 2011
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DVD Preparing for a Safety Inspection
May 24, 2011
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DVD Informed Consent Form Review and Compliance: Onsite Strategies
May 12, 2011
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DVD Writing Clinical Study Protocols
May 4, 2011
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DVD Changes and Challenges in Foreign Clinical Research
April 15, 2011
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DVD Quality Systems: A Controlled Approach to GCP Compliance
April 12, 2011
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DVD Monitoring Oncology Clinical Trials
April 4, 2011
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DVD Key Components of a Successful Study Site Start-up
March 30, 2011
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DVD Site Management and the Art of Assertiveness
March 24, 2011
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DVD GCP Training for Investigators
March 21, 2011
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DVD HIPAA Team Training
March 18, 2011
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DVD Vendor Management for the Clinical Data Manager
March 11, 2011
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DVD Writing and Maintaining the EU CTA (Clinical Trial Authorization)
March 8, 2011
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DVD Writing and Maintaining the Canadian CTA
March 7, 2011
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DVD HIPAA//HITECH Requirement Changes and Enforcement
March 4, 2011
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DVD Clinical Research Site Quality Improvement Strategies
February 23, 2011
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DVD Regulatory Intelligence
February 17, 2011
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DVD The IND in a CTD/eCTD Format
February 17, 2011
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DVD FDA Meetings Drugs and Biologics
February 16, 2011
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DVD Final FDA Guidance for Supervisory Responsibilities
February 16, 2011
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DVD Regulatory 101 Navigating the Background, Laws & Regulations
February 15, 2011
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DVD Final AE Regulatory Guidance
February 2, 2011
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DVD FDA Drug Approval Process
February 1, 2011
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DVD FDA Guidance: IRB Continuing Review of Clinical Investigations
January 12, 2011
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DVD Subject Recruitment for Clinical Research Sites
December 15, 2010
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DVD How to Prepare and Submit a Bullet Proof 510(k) Submission
December 14, 2010
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DVD Introduction to Data Management
December 9, 2010
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DVD Pediatric Drug Development
December 6, 2010
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DVD FDA Proposed Rule 2010: Sponsor Requirements to Report Fraud
December 3, 2010
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DVD Risk-Based Decisions in Clinical Trial Site Management
December 3, 2010
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DVD Clinical Trials for Pharmaceuticals: Design and Development
November 29, 2010
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DVD Making Good Teams Better: Taking Your Cross-Functional Global Team
November 11, 2010
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DVD Presentation Skills Training for Clinical Research Professionals
November 9, 2010
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DVD CRA Site Performance Improvement Monitoring Model
October 29, 2010
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DVD Introduction to the FDA
October 25, 2010
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DVD Introduction to Combination Products
October 22, 2010
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DVD FDA's Human Subject Protection /Bioresearch Monitoring Initiative
September 30, 2010
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DVD Examining Revisions to the FDA/ORA Compliance Guidance Manual
September 29, 2010
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DVD ABC of Clinical Research for Clinical Administrative Support Staff
September 13, 2010
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DVD Root Cause Analysis
August 26, 2010
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DVD Auditing Clinical Research Studies
August 26, 2010
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DVD Good Clinical Practice: Practical Application and Implementation
August 24, 2010
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DVD Medical Device Tracking
August 18, 2010
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DVD Approaches to Address Challenges in Vendor Management
August 13, 2010
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DVD Medical Device Reporting
August 11, 2010
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DVD Adverse Event Monitoring for CRAs
August 6, 2010
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DVD Train-the-Trainer: Successful Web-Based Training Strategies
July 27, 2010
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DVD Source Documentation: What is Adequate & Accurate?
July 20, 2010
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DVD Meeting HIPAA & FDA Requirements for Case Histories
July 20, 2010
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DVD Introduction to Signal Detection and Data Mining
June 28, 2010
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DVD Critical Decision Points in Design & Conduct of Patient Registries
June 24, 2010
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DVD Study Feasibility: Eliminating Low and Late Enrollment
June 23, 2010
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DVD Monitoring Phase I Clinical Trials
June 3, 2010
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DVD Essential Documentation in Clinical Trials at Research Sites
June 1, 2010
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DVD GCP Training: Core Human Subject Protection Training
May 24, 2010
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DVD Fraud in Clinical Research: An Overview
May 12, 2010
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DVD Site Relationship Management
May 11, 2010
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DVD Clinical Trial Design for Medical Devices
May 5, 2010
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DVD Adverse Events for Medical Devices
May 4, 2010
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DVD Electronic Medical Records and Source Document Verification
April 19, 2010
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DVD Sponsor Management of Investigator Non-Compliance
April 15, 2010
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DVD Drug Development and FDA Regulations
April 6, 2010
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DVD Transitioning Pharma Professionals to Medical Device Professionals
April 5, 2010
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DVD Developing and Negotiating Research Site Clinical Study Budgets
March 29, 2010
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DVD Monitoring Informed Consent: The Process and Document
March 29, 2010
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DVD Managing CRAs to Improve Performance & Study Outcomes
March 26, 2010
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