Overview
Timely and accurate safety reporting is critically important in clinical research.
CTTI’s work will help you improve the quality and efficiency of safety reporting, reduce irrelevant reports, and increase adherence to FDA requirements for clinical trials conducted under an investigational new drug application (IND). Three sets of recommendations are available to help you to:
- Develop approaches for better assessment and communication of IND safety issues, implement safety assessments, and adopt aggregate reporting to enhance efficiency and interpretability.
- Use electronic portals for expedited safety reporting.
- Improve reporting of unexpected serious adverse events (SAEs) to IND investigators.
Solutions
Search AllRecommendation Summary
Recommendations
- Recommendations for Improving Reporting of Unexpected Serious Adverse Events (SAEs) to Investigation New Drug (IND) Investigators
- Recommendations for IND Safety Assessment and Communication
- Recommendations for Desired Attributes of Electronic Portals for Expedited Safety Reporting
Resources
Related Items
- Sponsors’ and investigative staffs’ perceptions of the current investigational new drug safety reporting process in oncology trials
- Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project
- IND Safety Reporting: final results and best practices from the Clinical Trials Transformation Initiative IND Safety Advancement Project
- Case Studies on Expedited IND Safety Reporting
- The FDA’s Final Rule on Expedited Safety Reporting: Statistical Considerations
- Expert Meeting: CTTI IND Safety Advancement Project
- Clinical Trial Sponsors Fail to Report Results to Participants, Public
- Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND
- Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule
- Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application
- Clinical Trials: Do Participants Feel Safe?
- Participants’ Perspectives on Safety Monitoring in Clinical Trials
- Expert Meeting: IND Safety Assessment and Communication
- Results and Recommendations: New Recommendations from Public-Private Partnership Aim to Improve Clinical Trial Quality and Safety
- Expert Meeting: Adverse Event Reporting
News
- CTTI Publishes Findings on Stakeholder Perceptions of IND Reporting Process in Oncology TrialsCTTI has published its findings on remaining barriers and potential solutions to full implementation of the FDA final rule on IND safety reporting by investigators, clinical research staff, and sponsors. In 2010, the ...