The Office of Regulatory Support

The Office of Regulatory Support (ORS) has been organized to provide for a range of investigator needs.  Structured to provide a central warehousing of information and to serve as a hub of service referral for the clinical and translational research enterprise, ORS offers the following tools and services:

Customized Action Plan (CAP)

All clinical and translational research investigators are encouraged to create a Customized Action Plan (CAP), to develop a checklist of required approvals and available services, in support of each planned research project. 

The CAP application leads users through a short series of questions, providing sufficient information to support an informed answer.  After providing answers that describe a research project, users are presented with a report that lists the processes that are implicated by their responses.  Descriptions of each service, including timelines, links to required forms and policies as well as opportunities to request assistance are included on each CAP report.  Final CAP reports are stored within the users’ profiles, and can be exported in an electronic form that retains live links. 

Support for FDA Regulatory Compliance

ORS offers services to support clinical and translational research investigators with the navigation of and compliance with specific FDA-regulated processes, including research involving experimental drugs and devices, as well as pre-clinical laboratory studies.

Investigational New Drugs (IND)
Governed by 21 CFR part 312, studies which involve investigational new drugs or off-label use of FDA-approved drugs are required to submit an application to FDA before the study commences.  ORS provides a variety of services to support development of application submission, and provides guidance and assistance throughout the lifecycle of IND-regulated studies.

Investigational Device Exemptions (IDE)
Navigation of the FDA-regulated device processes involves a series of decisions including assessment of the potential risk posed by the device.  Use of investigational devices in clinical research is outlined in 21 CFR part 812, and ORS provides guidance through the various application processes.

Good Laboratory Practice (GLP)
Governed by 21 CFR part 58, researchers conducting pre-clinical laboratory studies that are designed to lay the foundation for translation to FDA-regulated human-subject research are encouraged to request assistance from ORS in establishing compliant practices.  Additionally, ORS houses the Quality Assurance Unit function for system and critical phase auditing.

Research Subject Advocacy

The Research Subject Advocacy (RSA) Program complements the University of Rochester Human Subject Protection Program in support of ensuring the safety of people participating in research.  In addition to serving as a resource for research volunteers who have questions or concerns regarding participation in research, the RSA program provides assistance to investigators and all members of research teams in the following areas:

Support for ClinicalTrials.gov Study Registration

ORS offers services to support research teams with registration and reporting of clinical research trials at ClinicalTrial.gov. ClinicalTrials.gov is a database of clinical research trials conducted in the United States and around the world. Study registration and reporting of results and adverse events are required by federal law for most clinical trials.  Registration is also a requirement for publication in many medical journals.

Guidance on Determination of Registration Requirements
ORS provides guidance in determining whether a clinical research trial must be registered, who is responsible for the registration, whether study results must be reported and the deadlines for registration and results reporting.

Assistance with ClinicalTrials.gov Account Management
ORS coordinates institutional participation in registration and reporting of clinical research studies at ClinicalTrials.gov, provides education regarding requirements and procedures and assists with account creation and management.

Technical Assistance with Entry of Study Information
ORS provides technical assistance with entry of study information, including registration information and reporting of results and adverse events.

Contact

Nancy Needler
Research Subject Advocate
(585) 275-1020
Email Nancy

Joan E. Adamo, PhD
Regulatory Support Analyst
(585) 758-7823
Email Joan

Eric P. Rubinstein, JD, MPH
Director
(585) 758-7802
Email Eric

General Inquiries
Email Regulatory Support