In this issue: Feature Article ACRP Certification Upcoming Events Glossary Exploration

	Feature Article

FDA grants fast track designation to potential uveitis drug

JERSEY CITY, N.J. — The U.S. Food and Drug Administration has granted fast track designation to Lux Biosciences for LX211, a calcineurin inhibitor being developed as a treatment for both noninfectious posterior and intermediate uveitis and for panuveitis, the company announced in a press release.

The FDA granted LX211 fast track designation because it "is intended for the treatment of a serious or life-threatening condition" and because it "demonstrates the potential to address medical needs unmet by available treatments," the release said.

Lux Biosciences is currently conducting three controlled, double-masked studies intended to support approval of LX211 for treating uveitis. Fast track designation will allow the company to expedite development and review of the drug, the release said.

	ACRP Certifcation

CRC Certification Exam Review Course Outline

Exam Review Objectives

• Examine the origin, purpose, development, and benefits of certification
• Identify exam preparation strategies and resources
• Determine areas of competency to assess strengths and weaknesses
• Diagnostically review critical sections of the exam and help you assess your level of readiness
• Analyze critical pre-study, study conduct, and post-study responsibilities

About Certification

• Purpose, origin, and development of certification
• Benefits of certification
• ACRP CRC job analysis
• Exam content
• Strategies and resources to prepare for the exam

Study Management

• Protocol evaluation
• Site preparation
• Close-out

Project Activities

• Investigational product accountability
• Laboratory issues
• Adverse events
• Responsibilities and obligations

Subject Coordination

• Recruitment
• Informed consent
• Screening/scheduling
• Study conduct

Documentation and Administration

• Case report forms
• Source documentation
• Financial/budgetary issues
• Archiving
• Auditing and inspections

Requirements for Admission to the CCRC Exam

Completion of the CRC certification exam review does not guarantee acceptance to the exam. To be eligible to sit for the CCRC exam, candidates must have accumulated a minimum of two years full-time (40+ hours per week) or four years part-time (more than 20 hours per week) experience by the date of the exam.

To qualify to take the CCRC exam, candidates must perform, at a minimum, subject enrollment, conduct subjects study visits and maintenance of source documents. A résumé or C.V. must be included with the exam application.

For More information on ACRP certification: http://www.acrpnet.org/education/examrev/crccourse.html

	Upcoming Events

Training Seminars:

“On The Road Seminar Series” begins in Chicago on September 28. For more information and to register: http://www.ortsedu.com/ontheroad.htm

Study Coordinator Basic Training A-Z Monday September 17, Novi, Mi

Study Coordinator Intermediate Training A-Z Tuesday September 18, Novi, MI

For more information and to register: http://www.ortsedu.com/calendar.htm

Teleclass Schedule:

Protocol Evaluations, Budget Analysis & Negotiations Skills – Begins September 26

Standard Operating Procedures for the Research Office – Begins October 30

The A-B-C’s of Recruiting – Begins November 26

For more information and to register: http://www.ortsedu.com/calendar.htm

Tools for the Study Coordinator Free Teleclass:

Open Forum – Your questions, concerns and problems addressed. – September 25

Email us your questions prior to September 21 and we’ll address as many as we can in the time allowed. All questions will be answered! All questions will be presented in an anonymous format.

Click here to send us your questions: http://www.ortsedu.com/contact.htm

Can’t make the teleclasses? Don’t worry the classes are recorded and sent to all students who registered for the class!

Coming Soon:

Self-Learning Modules:

Self help information on all the topics you’ve requested including protocol evaluations, analyzing budgets, recruitment, standard operating procedures and many more will be available very soon making it easier than ever to train at your own pace and when time is available for you.

	Glossary Exploration

Each month we’ll help expand your clinical research understanding by exploring the terms and acronyms that we function with everyday. Seems simple right? But, there are so many things that we don’t know and others that we need to know better.

“People do the best with what they know – when they know better they do better!”
- Maya Angelou

NULL HYPOTHESIS: A null hypothesis (for example, “subjects will experience no change in blood pressure as a result of administration of the test product”) is used to rule out every possibility except the one the researcher is trying to prove, an assumption about a research population that may or may not be rejected as a result of testing. Used because most statistical methods are less able to prove something true than to provide strong evidence that it is false.

OPEN LABEL STUDY: A trial in which subjects and investigators know which product each subject is receiving; opposite of double-blind study.

PATIENT PACKAGE INSERT (PPI): A patient package insert contains information for patients' understanding of how to safely use a drug product.

RANDOM ALLOCATION: Assignment of subjects to treatment (or control) groups in an unpredictable way. Assignment sequences are concealed, but available for disclosure in the event a subject has an adverse experience.

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