Since 2012, the Yale ClinicalTrials.gov (CTgov) team has been housed at the Yale Center for Analytical Sciences (YCAS). Through direct support from the Yale Center for Clinical Investigations (YCCI), the team assists researchers in all facets of using the ClinicalTrials.gov database. In addition, the Yale CTgov team provides guidance to the university with respect to clinical research study registration and results reporting as it pertains to regulatory compliance.
The Yale CTgov Team works with principal investigators and their research teams at Yale to ensure that applicable clinical trials are being kept in compliance with FDAAA Section 801 and/or ICMJE standards. We also monitor the registration of clinical research studies with respect to CMS billing compliance (http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1344.pdf). Our team keeps current with the latest updates and changes to reporting standards and compliance as it relates to clinical trials/ research conducted at academic medical institutions.
We can assist study teams in the following areas:
- Creating usernames and resetting passwords
- Determining if a study is an applicable clinical trial in need of registration and results reporting
- Providing insight, suggestions and training around the areas of registering studies and reporting study results
- Resolving Quality Assurance Review Comments for both protocol registration and results record submissions
We also provide direct services in the areas of:
- Registration of applicable clinical trials using the Protocol Registration System
- Reporting the results of applicable clinical trials using the Protocol Registration System
To contact the Yale CTgov Team, email us at Yale.CTgov@yale.edu.