New Clinical Trial Guideline Encourages Risk-Based Approach and Greater Use of Technology

15 November 2016


For the first time in two decades, significant updates to the international guideline for clinical trials will soon be released. Slated for November 2016, the revised Good Clinical Practice (GCP) guideline from the International Conference on Harmonization (ICH) has major implications for stakeholders, reflecting the industry’s growing emphasis on risk-based quality management supported by expanded use of innovative technologies.

The guideline, known as ICH-GCP E6(R2),[1] highlights the increasing complexity of clinical trials and how the ongoing evolution in technology creates opportunity for increased efficiency in quality management. Specifically, the guideline describes quality management as multifaceted, with emphasis on re-imagining protocol design to minimize complexity, unnecessary procedures and related data collection as key to better decision making. Intralinks is making these process changes possible through solutions that enable remote monitoring, collaborative site-engagement platforms, and site-controlled virtual workspaces, none of which existed when the first ICH-GCP guideline launched in 1996.[2]

There are changes throughout the new guideline, but the big ones appear in Section 5 – Quality Management – which details steps needed to build a risk-based approach, namely:

  • Critical processes and data identification
  • Risk identification
  • Risk evaluation
  • Risk control
  • Risk communication
  • Risk review
  • Risk reporting

Here are a few examples of what risk-based methodology entails: Risk identification refers to identifying risk linked to critical study processes and data at both the system and clinical trial levels. Risks at the system level include facilities, standard operating procedures, computerized systems, personnel and vendors. Risks at the clinical trial level are related to trial design, data collection and the investigational product. Another factor, risk control, involves the sponsor identifying risks that are either acceptable or should be reduced through mitigating actions incorporated into monitoring plans and protocol design. Moreover, the updated guideline cites the sponsor as responsible for oversight of any trial-related duties and functions carried out on its behalf, such as those performed by contract research organizations.

Investigative sites also have expanded responsibilities under the new guideline. Section 8.1 states that the site should have control of all essential documents and records generated by the site before, during and after the trial. As part of this effort, the sponsor should ensure that the investigator maintains control and has continuous access to the case report form data reported to the sponsor. And, importantly, the sponsor is not to have exclusive control of those data. Intralinks’ site-controlled virtual workspaces enable these functionalities as studies unfold, enabling remote monitoring of site-based documents, including remote source document verification (rSDV).

Given the new emphasis on a risk-based approach to quality management, greater use of disruptive technologies designed to address the issues addressed in the guideline are essential for improved efficiency and compliance.

[1] Integrated addendum to ICH E6(R1): guideline for good clinical practice E6(R2). Integrated conference on harmonisation harmonised guideline. June 11, 2015. Accessed October 8, 2016.

[2] Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance. International Conference on Harmonisation. 1996. Accessed October 10, 2016.


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