The Faster Clinical Trials Act would create an FDA Center for Clinical Trial Innovation and aims to cut trial costs and enrollment time by at least 30%.
|Articles|November 30, 2016
CDISC: FDA Binding Guidance In Effect Soon
Advertisement
Austin, TX – The Clinical Data Interchange Standards Consortium (CDISC) would like to remind the clinical research community that the FDA Binding Guidance goes into effect next month. Sponsors whose studies start after December 17, 2016 must submit data in FDA-supported formats listed in the FDA Data Standards Catalog. The current FDA Data Standards Catalog specifies the use of CDISC standards: SDTM, SEND, ADaM and Define-XML as well as Controlled Terminology.
The FDA’s Guidance on Standardized Study Data states... "After the publication of this guidance, all studies with a start date 24 months after the publication date must use the appropriate FDA-supported standards, formats, and terminologies specified in the Catalog (see section II.C) for NDA, ANDA, and certain BLA submissions.”
Implementing CDISC standards offers a number of benefits, including fostering efficiency, improving data quality, enhancing innovation, streamlining processes, increasing the ability to share information among systems and organizations, and reducing costs. Additionally, submitting standardized data helps regulatory reviewers receive, process, review, and archive submissions more effectively.
About CDISC
CDISC is a 501(c)(3) global, non-profit charitable organization that develops clinical research data standards to streamline research and enable connections to healthcare. The CDISC suite of standards supports the complete clinical research lifecycle from protocol through analysis and reporting by allowing data to speak the same language, making the most of the valuable information offered by patients participating in research studies around the globe. Implementing CDISC standards from the start of studies enables Smarter Research to Unlock Cures, saving 70-90% start-up time and ~60% overall in time and resources to conduct clinical research.
CDISC is funded through the generous support of over 400 member organizations, as well as through grants, authorized Education courses and CDISC events. To find out more about how to support CDISC, please visit
Advertisement
Related to this article
Standardized measurement across five oncology centers found that clinical research coordinators rated eSource-enabled workflows positively (Overall Mean Satisfaction 5.79 of 7), with reduced manual entry and electronic data transfer earning strong marks, while perceived reduction in sponsor and monitor queries lagged as the one domain below threshold.
In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, describes the industry’s trajectory toward a unified intelligence orchestration environment—and explains why the future isn’t one model that knows everything, but a trusted system that brings the right evidence to the right human decision.
In today’s ACT Brief, we examine how sites can avoid both fear-driven and overly aggressive AI adoption, why community-based research needs sustained financial investment, and why patient access matters more than organizational size.
Pacing obesity trial enrollment, anchoring eligibility to stable real-world therapies, and building site and physician relationships improve retention and data quality more than aggressive recruitment or restrictive exclusion criteria do.
In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, argues that CROs must act as orchestrators rather than aggregators—and that the real test of any AI ecosystem is whether it reduces sponsor coordination burden or just hands it back to them.
Syneos Health and Optum outline a joint model for trial planning, recruitment and site access, with no financial terms or timelines disclosed.
AstraZeneca and Oracle Outline AI Collaboration for Clinical Trial Recruitment and Safety Monitoring
What sponsors and sites should know about the AstraZeneca-Oracle AI collaboration on trial recruitment, safety monitoring and data governance.
Advertisement
Advertisement
Trending on Applied Clinical Trials Online
1
Where the Industry Is Headed as Clinical, Operational, and Real-World Data Connect
2
Building Standardized Evidence for eSource-Enabled Clinical Trials: Multi-Site Validation of a Clinical Research Coordinator Satisfaction Methodology
3
Where AI Governance in Clinical Development Falls Short
4
Syneos Health, Optum Partner on Adaptive Clinical Development Model
5