Comply with ICH E6 (R2)

The ICH E6 (R2) GCP Guideline became final in November 2016. This guidance fundamentally changed the requirements for GCP, which now must include a total quality approach. As noted in the Guideline, since the original ICH E6 (R1) was released, clinical trials were performed in a largely paper-based process. E6 (R2) was developed to address the increased scale, complexity, and cost of clinical trials, and to include the advances that have been made in electronic data recording and reporting technologies, as well as the implementation of other approaches and, in fact,  encourages the implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.

The articles can help ensure your GCP is up to par in the areas included in the ICH E6 (R2).

Endpoint Adjudication and the ICH E6

By Moe Alsumidaie

This articles includes information of the impact of ICH-E6 Addendum Guidelines (Section 5.0 on Quality) on each of the sub-sections on endpoint adjudication in clinical trials.

Building Quality into Study Startup

By Craig Morgan

The ICH-GCP E6(R2) includes a section dedicated to risk-based Quality Management, and states that the sponsor should implement a system to manage quality throughout all stages of the trial process, including the beginning.

Importance of Data Entry Timeliness

By Linda B. Sullivan, Keith W. Dorricott

As organizations implement risk-based quality management systems to focus on monitoring critical data, they should update their site data entry cycle time metric definition to align with ICH E6.

We Need a Next-Generation RBM Approach Today

By Sudeep Pattnaik

The pharma industry needs an improved risk-based management approach to better handle the increased complexity of trials, to improve the quality of studies and to better adhere to new regulatory guidelines.

Does Your CRO Comply with ICH E6?

By Penelope K. Manasco, MD

This article includes RBM questions every sponsor should ask to confirm your CRO complies with new GCP.

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