Performance of clinical trials according to the Good Clinical Practice (GCP) standard has been introduced as a European regulatory requirement for clinical trials with medicines but as this is a globally agreed best practice standard for clinical research involving human subjects, it is an ethical obligation for clinical researchers to apply this standard to all type of studies to ensure optimal protection of participants and generation of reliable results. It is the basis for enabling funding, acceptance of publications and for patients’ access to new treatments. This standard has implications for all stakeholders and processes in clinical trials. However, despite overall commitment and best intentions to apply to these requirements, monitoring, audits and inspections regularly find deficiencies of different levels of severity.
In this interactive 3 lunchtime lectures current experience and requirements of GCP-conform set-up and performance of clinical studies will be presented, practical implications and examples discussed and pragmatic solutions for your daily practice elaborated.
13:00 Welcome and Introduction
13:05 Ethical Principles in the Declaration of Helsinki, Questions & Answers
13:30 ICH-E6(R2): Good Clinical Practice Principles and Guideline Content, Questions & Answers
14:15 The Informed Consent Process, Questions & Answers
14:35 Ethical Aspects in Recruitment, Questions & Answers
15:00 End of Part 1
13:00 Welcome and Introduction
13:05 Set-up of a Clinical Trial at the Site, Questions & Answers
13:30 Compliance in Document Management, Questions & Answers
14:20 Critical Elements in Conducting Clinical Trials, Questions & Answers
14:35 PI’s responsibilities in Safety Reporting in Clinical Trials, Questions & Answers
15:00 End of Part 2
13:00 Welcome and Introduction
13:05 Risk-adapted Management of Clinical Trials, Questions & Answers
13:45 Exercise: Critical Review of GCP Conditions Presented in a Publication
14:20 Multiple Choice Test
15:00 End of Part 3
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