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 December 1 - 3, 2009.  Below is a brief description of the program:

What You Will Learn

1. The federal regulations and guidance that are a part of Good Clinical Practice required to conduct clinical studies.
2. How to conduct a study from preparation to final report.
3. 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

Deborah Rosenbaum, lead consultant for Sarrison Clinical Research LLC, has over 23 years experience in research. Ms. Rosenbaum is certified by ACRP as a CRA and CRC. She is accredentialed 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 completed three books on clinical research entitled, "The Practical Clinical Trial Series."

Course Outline

Day 1 :

Overview of Clinical Research

• General aspects of drug development
• Preclinical drug development concept
• Clinical study design
• Protocol development
• New Drug Application to the FDA

The Federal Regulations

• History of regulatory development
• Obligations of the investigator
• Obligations of the sponsor
• IRB regulations
• 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

Informed Consent Workshop

Study Logistics

• Definition of Roles
• Site selection
• Study planning
• Study start-up
• Study coordination strategies and tools

Study Files 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
• Study termination

Data Management

• Source Documents
• CRFs

Data Management Workshop

Day 3:

Adverse Events

• Assessing adverse event information
• 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

Inspections by the FDA

• Types of FDA inspection
• Preparation for an FDA inspection
• Outcomes and consequences of the inspection

Inspection Workshop

Registration Information - Download Brochure (PDF format)

The next workshop is scheduled for December 1 - 3, 2009.

$900.00* 3- day workshop fee

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

* Since the workshop is supported by a grant from the University of Rochester Office for Human Subject Protection, University of Rochester employees can attend the course for $600.00.

For additional information and dates of future workshops, call:

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

Department Training

The Office for Human Subject Protection (OHSP) holds departmental training sessions on a monthly basis. Each month the OHSP schedules a training session with a department involved in conducting clinical research. These sessions focus on presenting to the clinical research investigators issues relating to their roles and responsibilities in conducting clinical trials. Topics discussed include; federal and state regulations, University policies and procedures pertinent to human clinical research, and Good Clinical Practices (GCPs).