![](https://www.transceleratebiopharmainc.com/wp-content/uploads/2020/09/tim-mossholder-H6eaxcGNQbU-unsplash-scaled.jpg)
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
TransCelerate is thrilled to announce the launch of the Digital Data Flow Initiative’s Study Definition Repository Reference Implementation (SDR RI) Minimal Viable Product (MVP). The SDR RI is a model implementation of a repository that uses a Unified Study Definitions Model to facilitate data exchange. The source code and configurations are available by means of…
History converged with the future at DIA’s 60th-anniversary Global Annual Meeting. The conference’s theme—Charting New Horizons—fit the mood perfectly. The palpable energy and high attendance levels were reminiscent of pre-pandemic times; it felt like we finally put COVID-19 behind us. Still, underlying this return to “normal” was an eagerness not to forget the lessons of…
Diversity, Equity, and Inclusion (DE&I) and drug safety in clinical trials teams may not have established relationships within an organization. Yet, these two areas of focus have more similarities than one might think. In our next installment of our series on our Interpretation of Pharmacovigilance Guidances and Regulations Initiative (IGR PV), we are exploring this…