University of Rochester

OHSP Library

The OHSP office has a number of educational and training materials available for loan.

1. "A Guide to Patient Recruitment and Retention"Written by Diana L. Anderson, Ph.D, Copyright 2004 by CenterWatch, a division of Thomson Healthcare, Inc.
2. "Good Clinical Practice: A Question and Answer Reference Guide June 2008" Douglas Mackintosh, DrPH, MBA, GCPA; Vernette Molloy, MBA, RN, GCPA
3. "ICH Guidelines Guidance for Industry E6: Good Clinical Practice: Consolidated Guidance"
4. "University of Rochester Requirements for Shipping Biological Materials and Dry Ice."
5. "Clinical Research Coordinator Activity Guide" by Research Dynamics Consulting Group, Ltd.
   This book will guide CRC's through their daily clinical research activities while improving efficiency and GCP compliance. The guide includes over 140 pages of chronological step-by-step checklists from first receipt of a protocol to study closeout as well as important reference information.
6. "Clinical Research Associate Activity Guide" by Research Dynamics Consulting Group, Ltd.
   This book will guide CRA's through their daily clinical research activities while improving GCP compliance. The guide includes over 130 pages of chronological step-by-step checklists from first receipt of a protocol to study closeout as well as important reference information.
7. "The CRC's Guide to Prepare for the Cerfification Exam" 2009 Edition by ACRP
8. "Information Sheet Guidance For IRB's Clinical Investigators, and Sponsors" FDA Inspections of CLinical Investigators - US Department of Health and Human Services Food and Drug Administration, 2006
9. "GCP Flash Cards" by The Ran Institute
   A set of high quality flash cards that help study coordinators study for their certification exam. These cards provide specific source references, questions on the front and answers on the back, and they're color-coded to identify different sections of the regulations/requirements.
10. "Investigator 101" by PRIM&R
    This 3 hour CD has two presentations: Part 1: The History and Ethics of Human Subject Research with Dr. Jeffrey Cooper
    Part 2: The Top 10 Responsibilities of Investigators with Ms. Ada Sue Selwitz
11. "Practical Strategies for De-Identifying Patient Data" by Melamedia LLC
12. "The CRCs Guide to Coordinating Clinical Research" written by Karen E. Woodin, Ph.D., is designed as a training resource for investigative site staff. This guidebook is filled with valuable information on the role and responsibilities of a clinical research coordinator (CRC) and explains in detail the research process from the site and CRC perspective.
13. "The CRA's Guide to Monitoring Clinical Research" written by Karen E. Woodin, Ph.D., and John C. Schneider. This guidebook explains the role and responsibilities of a CRA, informs readers of the history of the regulations, explains in detail the research process and describes the regulations and GCPs that govern clinical research.

Please call the OHSP office at 273-4127 to request these materials.

Ethics Certification

• Greater Than Minimal Risk Research (HSPP)
• Minimal Risk Research (EPRP)
• Certification Renewal

Seminars

• Seminar Materials
• Upcoming Seminars

ROSS Training

• Investigator & Coordinator
• Board Member
• Department Review
• Ancillary Committee
• Other Materials

Investigator Education

• Listserv Signup
• Basic Guidelines
• Investigator Responsibilities
• IND Information for Investigators
• Statistics and Study Design

Coordinator Education

• Listserv Signup
• Professional Certification
• 3-day Workshop
• Advanced Workshops
• Study Self Audit Tools
• SCORE Group
• Shipping Biologicals and Hazardous Materials
• Library