If sunlight, water, nutrient rich soil and care are necessary for a seedling to flourish into a strong healthy plant, what’s needed to ensure a Study Coordinator is strong, confident, and performing to the maximum level possible? The answer is TRAINING!

Study Coordinators need training, knowledge, understanding and skills to perform at peak levels. Well-trained Study Coordinators are the lifeline of any clinical research project. Obtain the training, knowledge and skills with the Study Coordinator Basic Training A-Z Seminar, or the Study Coordinator Intermediate Training A-Z Seminar.

Our Study Coordinator Basic Training A-Z offers personnel the foundational support to start participation in clinical research.

Our Study Coordinator Intermediate Training A-Z is designed for personnel who have a year or more experience and are ready to refine their understanding and skills.

Register today to receive the special savings offered in our Annual Spring Special for March 22 & 23 seminar dates at our training center in Novi, MI.

Registration must be made by March 14 for savings of $100 per person on each seminar.
Now $995

Offices that register 2 or more by March 14 will save $200 per person per seminar.
Now $895

Call 866-773-6787 today to receive these savings or more details.

Straight Talk About Electronic Signatures And Office Security

by Jacqueline Stader

While conducting training, I’ve encountered an alarming number of comments in regards to electronic signatures and overall security attitudes in the workplace. The horrific tales that are shared with me are no doubt true. What concerns me is the seemingly lack of concern in regards to your own safety, so lets start with a little review session.

Following are guidance points provided by the FDA’s Guidance for Industry Computerized Systems Used in Clinical Trials specifically regarding Data Entry and Electronic Signatures.

To ensure that individuals have the authority to proceed with data entry, the data entry system should be designed so that individuals need to enter electronic signatures, such as combined identification codes/passwords or biometric-based electronic signatures, at the start of a data entry session.

The data entry system should also be designed to ensure it's attributable. Therefore, each entry to an electronic record, including any change, should be made under the electronic signature of the individual making that entry. However, this does not necessarily mean a separate electronic signature for each entry or change. For example, a single electronic signature may cover multiple entries or changes.

The printed name of the individual who enters data should be displayed by the data entry screen throughout the data entry session. This is intended to preclude the possibility of a different individual inadvertently entering data under someone elses name.

If the name displayed by the screen during a data entry session is not that of the person entering the data, then that individual should log on under his or her own name before continuing.

Individuals should only work under their own passwords or other access keys and should not share these with others. Individuals should not log on to the system in order to provide another person access to the system.

Passwords or other access keys should be changed at established intervals.

When someone leaves a workstation, the person should log off the system. Failing this, an automatic log off may be appropriate for long idle periods. For short periods of inactivity, there should be some kind of automatic protection against unauthorized data entry. An example could be an automatic screen saver that prevents data entry until a password is entered.

I’ve trained large institutions and small private offices and it happens in both settings. Situations have been shared with me that indicate there is serious need to reread the above guidelines by both the PI’s, Monitors and Study Coordinators.

These are straight forward easy to follow guidelines, so the questions are why do we violate them? And why do we feel it’s safe to share our information with co-workers, or are we even aware we’re being violated?

Tools For The Study Coordinator - Security Tips & Tools

March 28, 2007

Identity theft in the news on a daily basis. Maybe you've even become a victim of it. Electronic security in clinical research is more important than ever!

Learn more about the resources and tools available that will enable you to protect your office, your data, and yourself while participating in clinical research.

Join us again in our Free Telelclass Series -

Tools For The Study Coordinator - Security Tips & Tools

Unsure if you can make the class? Register and you'll receive the teleclass recording!

The first question of many FDA audits begins with..."Can I see your SOP's?" Be prepared for this question with Standard Operating Procedures in your office.

Too frequently this question is answered with a deer in the headlights look. Prevent problems before they occur with careful SOP preparation. Poorly written, SOPs are of little value. SOPs that are well written but not followed by all members of the staff, well, they fall into the same category as poorly written SOPs.

Whether you choose an in depth detailed version or a generalized format, just make sure you have all the bases covered.

This teleclass series shows you samples of each including the pitfalls of too much or too little information.

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

Off-label
The use of an approved drug to treat conditions other than those approved by the FDA.

Protocol
A detailed plan that outlines the objectives, procedures, interventions, and eligibility criteria for a clinical trial. The full protocol must be completed and approved before a clinical trial can begin.

Research Misconduct
Fabrication, falsification, or plagiarism in proposing, performing, or reporting research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. The term does not include honest error or honest differences of opinion.

Vulnerable subjects
Groups of people who could be particularly pressured to join a clinical trial. The groups include people with limited ability to make informed decisions (such as children and individuals with mental illness) or people in sensitive situations (such as a researcher's employees or students).

jstader@ortsedu.com

phone: 866-773-6787