Optimizing the Use of Clinical Trial Disclosure Systems to Meet Complex and Evolving Global Regulatory Requirements
This Solution Provider Webinar is brought to you by DIA in cooperation with
Regulations related to clinical trial disclosures and transparency are becoming increasingly complex due to recent legislation such as the NIH Final Rule, EU 536/2014 Clinical Trial Regulation, and other regional directives. These pieces of legislation have expanded and enhanced disclosure requirements, mandating that the pharmaceutical industry share an ever-growing set of data in a more transparent fashion. Managing detailed regulatory and content requirements across regions as well as tracking dates for mandatory registrations, study updates, and results posting requires sophisticated tools and systems to ensure compliance, data quality, and reporting efficiency. Systems that can manage complex logic related to regulatory requirements across regions and produce accurate, study-level projections of mandatory activities and associated timelines are becoming increasingly necessary to ensure compliance. These systems also need to have strong content management functionality to enable reuse across registries, the ability to integrate with existing regulatory and clinical data, as well as workflow functionality to facilitate efficient interaction between clinical study teams and disclosures staff throughout the life cycle of the study.
As transparency requirements and outputs grow beyond clinical trial registry databases to include redacted documents, lay summaries, anonymized datasets, and more, disclosures systems need to evolve to support an increasingly complex and multi-faceted environment.
Continuing Education Credits are not available for this event.
- Overview of Current Clinical Trial Disclosure and Transparency Environment
- Content Management Strategies to Optimize Reuse Across Regions
- Integrating and Maintaining Drug and Regulatory Submission Tracking Data to Produce Accurate Disclosure Timelines and Compliance Metrics
- Integrating Master Data to Support Disclosure Workflow
Who should attend?
- Clinical Trial Disclosures/Transparency
- Regulatory Affairs
- Clinical Operations
- Medical Writing
- Regulatory IT
- Regulatory Authorities
- Compliance/Quality Assurance
- Determine key drivers for the use of technology to manage clinical trial disclosures processes
- Implement efficiencies and consistencies gained from enabling reuse of protocol and results summary content across regions
- Understand the importance of integrating drug and submission-level metrics into disclosures systems
- Identify system features and functionality that are key to achieving global compliance
- Recognize the importance of automated workflow management to manage the disclosures life cycle