These courses can be delivered on-site and as ‘modules’ via webinars. Please contact us for further information.

Foundational Courses

• Clinical Research Coordinator 101
• Clinical Research: An Overview
• Ethics and Conflict of Interest in Clinical Research
• FDA Final Guidance 2009: Investigator’s Supervisory Responsibilities
• Introduction to Drug Development
• Introduction to Medical Device Development
• Good Clinical Practices: Drugs & Biologics - Conducted under an IND
• Good Clinical Practices: Medical Devices - Conducted under an IDE
• ICH E-6 Good Clinical Practices: What every Site Needs to Know!
• Good Training Practices: Training Plans and On-the- Job Training
• Good Documentation Practices
• Investigator-Sponsored/Initiated Studies: Regulatory and Infrastructure Requirements for Human Subject Protection – SOPs and More!
• SOP Writing Workshop
• SOP Administration 101: Systems, Processes and Documentation

Intermediate Courses

• Case Histories, Source Documents and Source Data
• Communications with the IRB: Submissions, Approvals, Response to Questions
• FDA Final Guidance 2009: Investigator’s Supervisory Responsibilities – Implementation Strategies for Institutions and Investigators
• Genetic Research Consent Requirements
• Adverse Events: Identification, Documentation, Reporting and Managing the Subject’s Medical Care
• Identification and Reporting of Misconduct or Fraud
• Informed Consent: Process, Documentation and ‘Ongoing’ Consent
• Managing ‘Early Termination of a Study’ by the Sponsor
• Managing Non-Compliance and Inadequate Performance of Site Personnel
• Study Start-Up Management Topics
• Study Conduct Management Topics
• Test Article: Management, Accountability, Dispensation, Documentation, Control, Reconciliation and Destruction
• Subject Identification, Recruitment, Retention and Withdrawal
• Subject Privacy Topics

Advanced Courses

• Advanced Topics in Good Clinical Practices (contact us for our course listing)
• Electronic Medical Records: FDA Regulatory Requirements
• FDA Expectations for Clinical Site Quality Management System: Requirements, Design and Implementation!
• FDA Clinical Trial Registry Requirements: Requirements, Implementation and On-Going Management
• Monitoring Visits: Planning to Management of Activities
• Pediatric Clinical Research Requirements
• Project Management for the Study Coordinator and Site Manager
• Regulatory Agency Inspection Readiness
• Scanning Site Documents: What You Don’t Know Will Hurt You!
• Sponsor Audits: Expectations, Preparation, Conduct and Follow-Up