Compliance with The European Medicines Agency reflection paper on e-source data

Why Should You Attend:The European Medicines Agency (EMA) has adopted a reflection paper on GCP inspectors’ expectations for e-source data (EMA/INS/GCP/454280/2010). The paper, which came into effect on 1 August 2010, outlines the current opinion of the EU GCP Inspectors Working Group on the use of electronic data capture in clinical trials and on related inspections. This reflection paper is very consistent with the FDA‘s most recent guidance on computerized systems. The 12 principles described in the Clinical Data Interchange Standards Consortium (CDISC) e-SDI Group publication ‘CDISC Standards and Electronic Source Data within Clinical Trials are key requirements of the reflection paper.

These enhanced requirements reflected in the reflection paper are part of the strict regulations now in force in the European Community. Attend this session to get an overview of the e-source compliance areas covered by this important document.

Areas Covered in the Seminar:

• Understand the CDISC standards which are internationally applicable and consistent with ICH GCP.
• Review the requirements/protocols for systems used to capture source data.
• Discussion on the requirements form records of change control and validation.
• The general principles outlined for the creation, modification and transfer of data.
• Ensure that data must be time-/date-stamped when they are created or generated.
• Audit Requirement.
• Responsibility of the sponsor.
• Requirements for investigator access.
• How to ensure how the investigator to maintain the original source.
• The source document allows for accurate copies to be made, and that the process should ensure that the copy is precise and preserved for the audit trail.

Who Will Benefit:

• Clinical Research Professionals
• Clinical Research Project Managers
• Study managers
• Quality Assurance Managers
• SOP mangers and co-ordinators
• Investigators and site staff
• Data management staff

Dr Laura Brown, PhD, MBA, Diploma Clinical Sciences is an independent QA and Training Consultant in the Pharmaceutical Industry, and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 17 year’s experience of running clinical trials and clinical quality assurance in the pharmaceutical industry.

Laura Brown has held a number of international and senior management QA positions in the pharmaceutical industry including as an Associate Director with a leading GCP audit consultancy. She has worked for several international companies including GlaxoWellcome, Hoechst Marion Roussel and Phoenix International.

Laura is author of a chapter on “Training QA staff” in the leading GXP book: “Good Clinical, Laboratory and Manufacturing Practices” (2007). She is author of SCRIP’s latest GCP guide and a “Practical Guide to the Clinical Trial Directive. She is also co-author of several books including “Developing the Individual” and “Project Management for the Pharmaceutical Industry”. She has regularly lectured at conferences and on training courses on QA and GCP issues.