Webinar Duration: 3 hours
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Amer Alghabban
Clinical trials’ data gives an accurate representation of what we measure to evaluate effects of the treatments under comparison. The clinical data recording process, however, as inspected/audited by inspectors/auditors is initiated with the recorded data, either in the Case Report Form, or in some other system, or in an electronic database.
From there, the data subjected to the process of data management is repeatedly inspected to ensure that the data that finally appear in the report are identical to the original, i.e. nothing untoward has happened on the way.
In clinical trials, usually large amount of data is collected, and this data is more and more electronically recorded and processed. The check of the integrity of data is mandatory and is usually performed by the clinical monitor who, in the past, preferentially reviewed only the documentation, but not the history of data entries.
Why should you Attend: This course has been planned to provide you with understanding of Principles of Research Data Integrity and the essential skills and tools to evaluate the potential impact of compromised data integrity. It provides an outline of: ways for detecting issues with clinical data quality and integrity, the QA supports for data integrity and quality Lessons learnt.
Areas Covered in the Session:
– Principles of Research Data Integrity
– Potential impact of compromised data integrity
– Detecting issues with clinical data quality and integrity
– QA supports for data integrity and quality
– Lessons learnt
Who Will Benefit:
– Employees involved in Designing, Conducting, Evaluating, and Documenting of Clinical Trials
– Clinical Monitors, Study Nurses and Investigators
– Validation Managers
– QA Managers, Project Managers
– Data Managers and Statisticians
– Pharmaceutical Companies, Sponsors, Contractors (for example CROs, analytical labs) and Vendors for Electronic Systems (including hosting partner)
– Inspectors Responsible for Performing GCP Inspections and Needing to understand and Assess Data Integrity
Amer Alghabban is currently the Managing Director of GxP Compliance and Training Partners (GCTP) helping pharmaceutical companies to achieve compliance with GCP, GVP, GCLP and GLP. Amer has over 27 years’ experience in the pharmaceutical industry. He has been an invited speaker at over 110 international congresses. Mr. Alghabban has published reference books, The Pharmaceutical Medicine Dictionary and The Dictionary of Pharmacovigilance and other publications. He was Assistant Editor for 11 medical journals and an invited Course Director for Pharmacovigilance Auditing at the UK RQA. As part of his current role as QA Expert, he is serving as GxP QA adviser for Allecra Therapeutics SAS and has served as VP of GxP Quality Assurance, Compliance at Karyopharm Therapeutics Inc. and similarly as the Senior QA representatives of Biotech companies in Switzerland and the U.K. Prior to GCTP, he was Global Director, Head of Quality Assurance & Audit Management at Merck Serono, Geneva, Switzerland.
His other previous positions included Global Head of GxP Quality Assurance at Arpida Ag., Switzerland, Senior International Clinical Quality Assurance Audit Manager at Novartis Headquarters, Basel, Switzerland and he was the first Pharmacovigilance Compliance Officer of the MHRA in the UK.