In this issue: In The News Upcoming Events Glossary Exploration

	Feature Article

Domain Name Registration Fees to Increase October 14

Back in April 2007, ICANN and Verisign announced that the domain name registration and renewal fees would increase by 7% on October 14, 2007. It's expected that all domain registrars will pass this cost increase on to their customers.

However, if you renew your domain registration before October 14 (even if it's not due to be renewed yet), you can lock in the current fee rate for as many years as the registrar will allow. For instance, GoDaddy's current domain name registration fee for .COM names is $8.99 per year, and they will allow you to register that domain for up to 10 years at a discounted $8.49 per year rate.

Here are two things to do before October 14:

1. Look at your existing domains and determine which ones you want to keep/renew before the price increase.

2. Decide if you are comfortable with your current domain registrar's prices. Some companies are offering a great deal on "transfers" of an existing domain from your old registrar to a new registrar.

It pays to do some shopping around. While GoDaddy's domain name registration fee starts at $8.99 a year, Register.com's registration rate is $35.00 a year.

Let's put this price difference in perspective. If you own, oh let's say 15 domain names: 

• If you were to renew with GoDaddy, it would cost a total of $134.85 per year.

• If you were to renew with Register.com, it would cost a total of $525.00 per year.

That's a steep price difference, especially when in research we try to keep our expenses down.

Even if you only have one domain, but wish to lock it in for up to 10 years, that could be a savings of up to $260.00

If you don't have a website, but are considering it in the near future, now is a great time to secure your domain name before the fees rise!

FDA Launches New Drug Safety Newsletter

On September 18 the FDA launched it's Drug Safety Newsletter for the first time.

This publication provides post-marketing information to healthcare professionals to enhance communication of new drug safety information, raise awareness of reported adverse events, and stimulate additional adverse event reporting.
 

To learn more about it click here:

http://www.fda.gov/cder/dsn/default.htm

Behind Every Great Principle Investigator...

The October issue of ACRP The Monitor is focused on “Clinical Trials:

The Investigator’s Perspective.” I could discuss the importance of the investigator’s level of involvement in trials in relation to the on-time, on-budget delivery of quality data in an environment that maintains the volunteer’s safety as the highest priority. Of course, such expectations are familiar to, and should be highly valued by, any principal investigator (PI), but we all know that meeting them would not be possible were it not for another pivotal person on the clinical research team—the clinical
research coordinator (CRC).

From beginning to end, the CRC is often charged with ensuring that attention
is paid to all of the aforementioned factors in a successful study, and so much
more, be it an industry-sponsored or investigator-initiated one. Certainly,
from the PI’s perspective, the CRC is the life blood of any study. If you don’t
believe me, ask any study coordinator why a study isn’t enrolling and you’ll
learn the real story.            

Read the complete article here:                   

http://www.ortsedu.com/Articles/BehindeverygreatPI....pdf

The Study Budget...

The October issue of ACRP The Monitor is focused on “Clinical Trials:

Producing a sound budget is a major responsibility for any principal investigator
(PI). Just as accurate budgeting contributes to a sponsor’s success in
bringing a product to market, financial accountability is a significant factor in
the success of every individual clinical trial site. It is therefore vital to ascertain
that budgetary expertise is not ignored during the initial planning stage for the
study. Developing a site budget specifically for an individual study demands the
same careful analysis as review of the study protocol. Creation and supervision
of this financial tool is a necessary function of the PI, but is rarely addressed in
the formal medical and regulatory training that brings an individual to his or
her role in research.

Many platforms exist for the performance of clinical research. These include
full-time, freestanding research centers, university-based research sites, and
individual or group private practice settings. The following will outline a decision-
making process from the perspective of a private practice setting, but will
refer whenever possible to the other venues.

Read the complete article here: 

http://www.ortsedu.com/Articles/TheStudyBudget.pdf

Negotiation is key!

Here is a transcript of a segment that was aired on ABC's Good Morning America

on Sept. 26th. Although the article is focused how men and women view negotiation of salary, it's still an interesting view that rolls over into how we negotiate our clinical research budgets.

Read the complete transcript here:

http://www.ortsedu.com/Articles/MenvsWomenattheBargainingTable.pdf

These skills and so many more can make a huge difference in what you receive in your research budget.

Don't think you have the skills? Our Protocol Evaluations, Budget Analysis and Negotiation Skills Teleclass and soon to be released self learning module can help fill in the blanks for you and your staff.

Or, join us in one of our "On The Road Seminars" and receive all the tools and templates and inside secrets of negotiating better budgets and so much more!

The above articles in ACRP The Monitor express the continued need for trained personnel in clinical research. Both the Principle Investigator and the Study Coordinator benefit from basic training to in depth training specific to their needs.

Ophthalmic Research Training Services offers On Site Training in your office for the entire research team, or we provide training seminars as listed below.

	Fall Upcoming Events

Training Seminars

Study Coordinator Basic Training A-Z

Study Coordinator Intermediate Training A-Z

Click here for more information: http://www.ortsedu.com/course-descriptions.htm

Click here for dates, locations or to register: http://www.ortsedu.com/calendar.htm

On The Road Seminar Series - Select Dates & Locations

Successful Clinical Research - A Hands On Approach To Making Your Clinical Research A Success! 

Click here for more information: http://www.ortsedu.com/ontheroad.htm

Click here for dates, locations, or to register: http://www.ortsedu.com/calendar.htm 

(If the above dates are not convenient for your office please contact us at       419-343-7384, we will be happy to set up a date that fits your schedule!)

Teleclasses

Standard Operating Procedures for the Research Office Teleclass

This teleclass series shows you samples of different types of SOPs including the pitfalls of too much or too little information. Don't let this important part of the research practice go undeveloped.

Standard Operating Procedures not only act as guidance for the sponsor, but for the investigative site as well. SOPs detail the work processes that are conducted in the research practice. When used as part of the training and direction for new employees, or as performance evaluations, or guidance on office policies, SOPs are an important part of any practice and shouldn’t be overlooked.

Ultimately, the value of SOPs is a reduced work effort along with improved data comparability as well as creditability and legal defensibility. This teleclass is designed to provide you with the tools needed to start preparing your own SOP's!

Click here for more information: http://www.ortsedu.com/calendar.htm 

The ABC's of Recruiting Teleclass

Recruiting isn’t just one part of a research practice; it’s the MAIN part.

Today, more and more contracts are stipulating that payment is dependent on recruitment. Therefore how well you perform in this area greatly determines how much you can make. So it’s extremely important that there is a complete understanding of what is involved and what tools will aid your success.

Learn how to design a multiple layered marketing and recruiting program that not only promotes positive research, but your practice as well.

Click here for more information: http://www.ortsedu.com/calendar.htm 

Website Changes

Our website will be undergoing some exciting changes as we strive to make your information collecting process even easier to navigate!

Soon our Learning Center and our new Course Catalog will be available for instant download.

Additionally, we'll also have our self learning modules available on your most requested topics.

Research Success Alliance

Currently, we are very busy with 'behind the scenes' work on our new service the Research Success Alliance, which is a program developed to offer more information, support and resources for real success with your clinical research efforts.

Here's a sample of the benefits included:

• Research Rolodex -  A comprehensive list of important names, contacts and resources important to clinical research

• Monthly teleclasses held after office hours for your convenience

• Monthly Top Topic calls covering all the latest information items

• Unlimited email access

• Message board

• Discounts on all our training services and self learning products

And so much more, so watch for our upcoming announcement for the launch date of the Research Success Alliance.

	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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