Regulatoryscientific

The Regulatory Core offers regulatory and quality assurance support in all aspects of clinical research from preclinical requirements to first-in-human studies and beyond. The goal is to provide the NJ ACTS community with the tools, training and support needed to navigate the complex regulatory pathways that accompany translational research.

Human Subject Project Lifecycle

I Activities for Preparatory Research
II Feasibility
III Getting Started: Building the IRB Protocol
IV Choose Appropriate IRB Application
V Consider Special Study Requirements
VI Study Personnel and Training
VII Recruitment Materials and Informed Consent Documents
VIII Plan for IRB Review
IX Confidential Disclosure and Clinical Trial Agreements
X Clinical Trials.gov
XI Study Closure and Data Retention