CTTI is pleased to present recommendations addressing two important issues central to the conduct of clinical research: (1) how clinical trials are monitored to ensure that participants are protected and results are reliable, and (2) changes to the systems in place for reporting unexpected serious adverse events for investigational new drugs.

These recommendations have evolved out of CTTI’s initial projects, each of which included a research component as well as input from a broad group of stakeholders who, in the context of expert meetings, considered the research results and developed proposed recommendations.

The recommendations describe important general principles and represent a direction in which CTTI thinks the sector should move to see improvements in the quality and efficiency of trials. Additional work is now underway to gain a more in-depth understanding of specific actions that can be taken in the spirit of the recommendations.

 
Effective and Efficient Monitoring as a Component of Quality Assurance in the Conduct of Clinical Trials

Recommendations

Project overview

Improving Unexpected SAE Reporting to IND Investigators

Recommendations

Project overview

 
Press Release