3 Day Workshop

Research Subjects
Review Board

"... to protect the rights and welfare of human research subjects at the University of Rochester. To accomplish this, we review, approve the initiation of, and conduct periodic review of research involving human subjects."

Research Education
and Training

GCP Training - offered on-line through CITI...

ROSS Training ....
RSRB ROSS training 3rd Monday of every month from 2pm to 3pm. Please Click HERE to sign up.

Quality Improvement

"To assess and assist the Investigator (PI) in assuring the rights and wellbeing of human subjects are protected and that the study is being conducted in accordance with IRB requirements, the approved protocol, applicable Federal regulations, U of R policies and best practice (GCP) standards."

Training

Throughout the year, the Office for Human Subject Protection offers a 3 - day workshop entitled "Conducting Clinical Trials". The next workshop is scheduled for fall. Below is a brief description of the program:

What You Will Learn

The federal regulations and guidance that are a part of Good Clinical Practice required to conduct clinical studies.
How to conduct a study from preparation to final report.
Standards for conducting high quality clinical research at your site.

Who Should Attend

New clinical research coordinators who want to learn how to conduct clinical studies properly.
Experienced coordinators who are interested in updating their knowledge regarding GCPs and eager to learn the most up-to-date methods for the conduct of clinical research to the highest standard.

Practical Hands-On Workshop Experience

Managing regulatory documentation
IRB interaction
Interacting with sponsors
Obtaining informed consent
Completing source documents and CRFs accurately
Maintaining accurate drug/device accountability

Course Director: Deborah L. Rosenbaum, CCRA, CCRC, CCRP

Deborah Rosenbaum, lead consultant for Sarrison Clinical Research LLC, has over 30 years experience in research. Ms. Rosenbaum is certified by ACRP as a CRA and CRC. She is a credentialed Clinical Research Trainer (CCRT) by ACRP, and a certified Training Generalist by Langevin Learning Services. Her experience includes conducting preclinical research, clinical research scientist for industry (Burroughs Wellcome and Hoffmann LaRoche), and clinical research coordinator (Bowman Gray School of Medicine).
Ms. Rosenbaum develops and presents customized training programs for industry sponsors and research institutions.
Additionally, Ms. Rosenbaum has published three books on clinical research entitled, "The Practical Clinical Trial Series."

Course Outline

Day 1:
- Overview of Clinical Research
  - General aspects of conducting clinical trials
  - Preclinical drug development concept
  - Clinical study design
  - Protocol development
  - The Role of the FDA and other Regulatory Agencies
- The Federal Regulations: FDA and HHS
  - Sorting out the differences
  - Navigating the regulations
  - Obligations of the investigator
  - Obligations of the sponsor
  - Investigator initiated studies
  - IRB regulations and role of the IRB
  - Required elements of informed consent, additional elements
  - Other pertinent regulatory documents
- Video: The Belmont Report
- The Informed Consent Process
  - Regulatory Aspects
  - Writing the informed consent document
  - Presenting informed consent
  - Proper informed consent
  - Tissue Banking and consent
- Informed Consent Workshop
- Study Logistics
  - Definition of Roles
  - PI Oversight
  - Site selection
  - Study planning and feasibility
  - Study start-up: Study approval, what's next?
  - Study coordination strategies and tools
  - Impact of noncompliance
- Study File Workshop
Day 2:
- Subject Recruitment and Retention
  - Subject recruitment plan
  - Subject enrollment
  - Making participation attractive
  - Subject retention and compliance
- Site Visit Overview
  - Study initiation
  - Periodic monitoring
  - Monitoring of Investigator initiated studies
  - Study termination and final report
- Data Management
  - Source Documents
  - CRFs
- Data Management Workshop
Day 3:
- Adverse Events
  - Assessing adverse event information
  - UPIRTSOs
  - FDA definition of serious adverse events
  - FDA reporting requirements for serious adverse events
- Serious Adverse Events Workshop
- Investigational Agent Management
  - Packaging and shipping of investigational agents and supplies
  - Drug accountability
- Compliance in Clinical Research
  - Types of compliance: FDA, OHRP, IRBs, Institution
  - Self-audit tools
  - Preparation for an FDA inspection
  - Outcomes and consequences of the inspection

Registration Information - Download Registration Form

The next workshop is scheduled for fall.

$800.00* 3- day workshop fee

Fee includes workshop manual and CD, all workshop materials, and refreshment breaks

* Non-University of Rochester employees can attend the course for $1000.00.

For additional information and dates of future workshops, call:

Phone: (585) 273-4127
Fax: (585) 273-1174
email:janice_taylor@urmc.rochester.edu

Ethics Certification

Seminars

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Research Subjects Review Board

Research Education and Training