Funded by: NIH | NCRR | CTSA

• Regulatory & Ethics Support & Knowledge (RESK)
• Online Ethics Center
• Office of Clinical Research
• Accomplishments
  • Reciprocity
  • Electronic Conflict of Interest System
  • FDA IND and IDE Activities
  • Value Stream Analysis
• Health Services Research

The Research Administrative offices of both Emory University and Morehouse School of Medicine developed support for Investigational New Drug (IND) applications and Investigational Device Exemptions (IDE) for investigator-initiated studies at their respective institutions. An Adverse Event Reporting System will assist investigators in that aspect of required IND reporting requirements. The Emory Clinical Trial Audit and Compliance (CTAC) and CIN Quality Core also include IND filing and reporting requirements in their list of clinical trial and regulatory documents that are reviewed in routine audits to assist investigators in ensuring regulatory compliance with sponsor reporting requirements.

Emory Clinical Trials Summit

In recognition of the critically important role that clinical trials play in clinical and translational research, the ACTSI co-sponsored a Clinical Trials Summit at Emory University in October 2009. The summit included faculty, staff, and leadership representatives from research administration and the Emory Woodruff Health Sciences Center and was tasked with identifying areas required to improve and facilitate the safe conduct of clinical trials.

A Clinical Trials Task Force was organized to delve deeper into each area and to provide recommendations to the Clinical Trials Executive Committee (formed in January  2010) of the Emory Woodruff Health Sciences Center. Beginning in January 2010, the Clinical Trials Task Force studied the issues regarding each of these areas and developed recommendations. Over the course of six months, the Clinical Trials Task Force conducted a multi-pronged approach for gathering relevant information for final recommendations that included the formation of individual subcommittees to address each of the priority areas identified during the Clinical Trials Summit; the conduct of individual interviews with leadership and surveys of both leadership and Task Force membership; reviews of benchmark institutions through national CTSA resources; and sponsored visits from benchmark institution leaders including those from Duke University, University of Washington, and City of Hope.