Trained personnel: How important are they? Here are excerpts from a few FDA warning letters. After reading them, you may view the importance of training in a different way.

“A July 10, 2006 response from our attorneys of record, [redacted] and [redacted], of [redacted] notes that "Dr. Wolf recognizes and understands that, as Principal Investigator, the Inspectional Observations made by the FDA Investigators and other auditors are his responsibility," and that "responsibilities as Principal Investigator extended beyond simply referring potential study subjects to the research study coordinator."

The response also included a letter to you, dated 7/5/06 from [redacted]. Dean of the [redacted] noted that "you and your research team have inadequate training in clinical research and that one trial was performed in a sloppy, careless, and inconsistent manner." He further recommends that you and your research staff "promptly make arrangements to receive appropriate, thorough training in clinical research."

Please provide us with documentation of the clinical research training that has been or will be undertaken, including the names and titles of all study personnel, a description of the training, and dates that such training has been or will be completed.

Tools For The Study Coordinator - Study Coordinator Value Indicators
One of the top subjects of requested information is the salary survey.

Everyone wants to know what their true value is...Well let’s just say if a coordinator was ever paid her true value, everyone would want to be a coordinator!

Unfortunately, sites do not always realize the functions and value of a study coordinator until they loose one and have to fill the position. So the song lyrics are right...”You don’t know what you’ve got till it’s gone.”

But what if we as coordinators could help in our own evaluation process? Obviously it would do 2 things. 1) It would aid the site by providing an in depth view of the job functions we perform and in that process, it would also 2) Show coordinators our own strengths and weaknesses, thus giving ourselves an opportunity to take action steps on for own improvement.

I’m convinced that PI’s don’t always understand the true value of a well-trained coordinator, just as coordinators don’t always understand the valuable ways to shine.

Join us again for more Tools For The Study Coordinator and learn how to use the tools to help with your own performance evaluation.

Join us again for more Tools For The Study Coordinator.

Study Coordinator Basic or Intermediate Training April Only Special!

Train one staff member at the regular price $1095 and train a second staff member for only $595 at our training center in Novi, MI. Offer good for April dates only.

Don't miss out on the only chance to receive this special savings on training for research personnel this year! Call today for details and to register!

Deadline April 19th.

Read warning letters from the FDA demanding proof of training for research personnel on our resource page...FDA Warning Letters!

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

AUDIT (of a clinical trial) A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial- related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s).

CLINICAL SIGNIFICANCE Change in a subject’s clinical condition regarded as important whether or not due to the test article. Some statistically significant changes (in blood tests, for example) have no clinical significance. The criterion or criteria for clinical significance should be stated in the protocol.

DIRECT ACCESS Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor’s monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subject’s identities and sponsor’s proprietary information.

ELECTRONIC RESEARCH ADMINISTRATION (eRA) The NIH's infrastructure for conducting interactive electronic transactions for the receipt, review, monitoring, and administration of NIH grant awards to biomedical investigators worldwide.

GOOD LABORATORY PRACTICE (GLP) Regulations pertaining to research laboratories. Refer to 21 CFR Part 58.

jstader@ortsedu.com

phone: 419-343-7384