Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations

Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations is organized by Online Compliance Panel and would be held on Jun 15, 2017.

This training includes FDA's current recommendations on the use of Electronic Health Records (EHR) in clinical investigations and a refresher on key requirements for Computer Systems used in Clinical Investigations. Check out the key learning objectives and specific areas covered in this context. If you are a sponsor of a clinical trial involving a drug, biologic, medical device or combination product, a clinical investigator, a Contract Research Organization (CRO) or an Institutional Review Board (IRB), you stand to benefit from this training.

Conference Objectives are :
• Whether and how to use EHRs as a source of data in clinical investigations
• Using EHRs that are interoperable with electronic systems supporting clinical investigations
• Ensuring the quality and integrity of EHR data that are collected and used as electronic source data in clinical investigations
• Ensuring that the use of EHR data collected and used as electronic source data in clinical investigations meets FDA's inspection, record keeping and record retention requirements
Areas Covered in the Conference:
• EHRs & EDC Systems
• Types of EHRs
• Applicability of FDA recommendations RE: EHR & Clinical Investigations
• Advantages of EHR & Clinical Investigations
• Interoperability between EHR & EDC Systems including Advantages & Challenges
• ALCOA - Data Quality of EHRs as Clinical Source Data
• ONC Health IT Certification of EHR technology, Alternative Controls or Risk Analysis & Regulatory Implications
• Data Management Plan
• EHR Data Changes
• Audit Trails
• Informed Consent
• Privacy & Security Safeguards
• Inspection, Record Keeping & Retention
• Refresher of key requirements for computer systems used in clinical investigations
Who will Benefit:
• Sponsors of clinical trials (drug, biologic, medical device & combination product manufacturers)
• Pharma, Biotech Medical Device manufacturers including start-up CEOs, Product Managers, COOs, Founders, Co-Founders, Executive & Management Staff
• Clinical Investigators (physicians)
• Contract Research Organizations (CROs)
• Institutional Review Boards (IRB) / Ethics Review Boards (ERB) / Research Ethics Boards (REB)
• Clinical Research Associates
• Project Managers
• Principal Investigators
• Clinical Research Coordinators
• Regulatory Affairs, Quality Assurance, Clinical Trial Professionals
• Academic Medical Center and Research Institution Professionals supporting clinical research
• Personnel responsible for ensuring compliance with GCP regulations