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A Practical Approach To Data Management For Clinical Trial Efficiency with ICH GCP E6 (R2) - Webinar

  • ID: 4399550
  • Webinar
  • 90 Minutes
  • Online Compliance Panel
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Clinical Data Management plays a significant role in the performance of clinical trials. ICH GCP E6 R2 reinforces the requirements in regards to electronic systems and the Standard Operating Procedures (SOPs) that govern processes specific to these systems. Being the most significant revision to International GCP, the new addendum ICH GCP E6 (R2) introduced 26 new items concentrated in the areas of data management, sponsor and investigator responsibilities. The new guidelines will have an international effect and everyone involved in clinical trial research will have to comply with the new requirements.

Objectives of the Presentation:
  • Define the recommended SOPs associated with electronic systems used to collect clinical trial data
  • Discuss data integrity issues described in the final guideline
  • List the considerations of risk associated in clinical trial conduct and its connection to Clinical Data Management
  • How to describe how to implement data oversight approaches that will identify systematic data errors using central review approaches
  • Review the principles of quality management as related to clinical trials and the tools utilized to implement a quality approach
  • How to perform a Risk Assessment for a protocol and determine how data systems will be affected
  • Learn how to describe how root cause analysis plays a critical role in Corrective Action Plans
Why Should you Attend?

Since the development of the first ICH GCP Guideline, the way clinical trials are conducted has been significantly affected by the technological advancements, such as the use of electronic data recording and reporting. The addendum updates the guidance by covering Risk Management, Sponsor Oversight and Advances in Clinical Trial technology.

In this webinar, a review of these requirements as well as an examination of the components of quality management is covered. Further, the role that risk has on the overall conduct of clinical trials will be discussed, particularly since this concept will be the standard way forward (rather than an option). We will also review recommended approaches, industry standards/best practices to achieve compliance with the requirements.

Topic Background

The Updated Guideline for good clinical practice (GCP), E6 (R2), was adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on the 15th December 2016. The update came into effect in Europe on 14th June 2017 and it is critically important for organisations running clinical trials to understand the modifications, how these will affect them and what new approaches need to be adopted.

Investigator responsibilities specify that the investigator is entirely accountable for supervising the different individuals or parties that the investigator has delegated trial related responsibilities. In order to secure data credibility the investigator must adopt sufficient documented procedures and ensure that all trial operations are executed with integrity. It is therefore imperative that all procedures are monitored throughout the clinical trial process. Sponsor Responsibilities have been revised to include 16 new items and become the section with the largest alteration. The implementation of a solid management system through the clinical trial process in order to secure quality in all stages is one of the main responsibilities of the Sponsor. This process is vital in ensuring the subject protection and reliability of outcome. A risk based quality management system is expected to be operated by the Sponsor which includes critical processes identification, risk evaluation, risk control, risk communication, risk review and finally risk reporting.

The Sponsor is also expected to oversee any trial-related duties including those subcontracted by a CRO. The Sponsor is also responsible for implementing a root cause analysis and a corrective and preventive strategy for any possible non-compliance that may occur along the process.

Considering all the above it is evident that the ICH-GCP E6 (R2) 2016 addendum is a challenging update that requires the appropriate training of all parties that need to ensure compliance.
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  • Susan Leister Susan Leister,

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  • Clinical Data Managers
  • Clinical Data Scientists
  • Clinical Quality Assurance Professionals
  • Clinical Compliance Personnel
  • Quality Assurance/Quality Control Managers
  • Regulatory/Compliance Staff
  • IT Staff
  • Software Validation Staff
  • Clinical Data Coordinator
  • Clinical Research Coordinator
  • Clinical Research Nurse
  • Clinical Research Scientist
  • CTMS Administrator
  • Data Manager
  • Director or Manager of Clinical Trial Operations
  • Drug Safety Manager
  • Drug Safety Physician
  • Medical Safety Officer
  • Monitor or Clinical Research Associate
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