
Sep 15
11/10/2020
The Clinical Content & Reuse (CC&R) initiative aims to enhance clinical trial processes by providing harmonized structure and proposed model content within clinical trial documents (e.g., Common Protocol Template, Statistical Analysis Plan, and Clinical Study Report) that can be reused throughout the project lifecycle to enable digitization and traceability through automation. The initiative’s guiding principles include a streamlined and consistent structure and content that can be used across multiple documents and processes, and is aligned with Good Clinical Practice (GCP), ICH and EU requirements, with elements drawn from Clarity and Openness in Reporting (CORE) Reference.
Our annual release continues to provide benefits to regulators, investigator sites, patients, and research sponsors.
This year, the team is also excited to present an updated graphic that illustrates the interconnectedness, continued growth and development of the CC&R Initiative. Presented as three interconnected triangles, the image denotes the close relationships among the clinical template suite, harmonized model content and reuse capabilities. The initiative is grounded by its guiding principles and flexible implementation options.
Looking ahead, the team anticipates a busy 2021 as they will continue to make content enhancements, including enhancing eTemplates to minimize adoption barriers. They are also assessing adoption of new automation technologies, including a clinical trial registration tool and a ClinicalTrials.gov export profile.
We welcome you to visit our updated CC&R initiative website and solutions page to learn more and we invite you to share your feedback on the Clinical Template Suite.
By Mark Makurath, Head of GCD Standards & Training Excellence at Merck
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