Tag Archives: CTSA

CTSA-PCORnet Webinar: A Central IRB Approach

Informed Consent, Institutional review boards, Patient-Centered Outcomes Research, , ,

The webinar copresented on March 2, 2016, by the Clinical and Translational Science Awards (CTSA) program and PCORnet is available as a video and slideset.

Petra Kaufmann, MD, MSc
Director, Office of Rare Diseases Research and Division of Clinical Innovation
National Center for Advancing Translational Sciences
National Institutes of Health

Rachael Fleurence, PhD
Program Director, CER Methods and Infrastructure Program
Patient-Centered Outcomes Research Institute

Sabune J. Winkler, JD
Director, Regulatory Affairs Operations
Harvard Catalyst

Webinar details:
March 2, 2016
3pm - 4pm ET
To join the WebEx, click here: http://bit.ly/1TGRTFS
Call-in number: 1-855-244-8681
Access code: 737 807 582

CTSA Working Group Unveils Accelerated Clinical Trial Agreement

Clinical trials, Regulatory issues, Research tools, , , , , ,

A persistent problem facing the clinical research enterprise is the difficulty of negotiating the terms of contracts under which clinical trials will be performed at individual clinical research sites. For many research centers, the process is complex and protracted, and can often contribute to substantial delay in study start-up.

However, the Clinical and Translational Science Award (CTSA) Master Contracts Working Group has recently developed a possible solution—the Accelerated Clinical Trial Agreement, or ACTA. The ACTA provides a standardized template for contracts between site investigators and study sponsors, one with the potential to expedite contracting and make the start-up process for clinical trials more efficient.

The ACTA, which has already been adopted by more than 50 research centers and individual is available, along with the Accelerated Confidential Disclosure Agreement (ACDA), from the CTSA’s Accelerated Research Agreements Initiative.

For further reading:

CTSA Tools - ACTA

"Use Accelerated Clinical Trial Agreement (ACTA) to Expedite Study Start-Up" (Duke Translational Medicine Institute)

Clinical Trials Transformation Initiative - Site Metrics Project Summary

Cycle time metrics for multisite clinical trials in the United States