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s3uf0c99 · Posted: Tue 10:19, 18 Jan 2011 Post subject: J. X. Thomas

If you have been employed in the clinical research industry for a decade or more, chances are your training and education were minimal when you first entered into your new job. It was standard to be given a job description and expected to jump right into your new role. If you were lucky, you had a mentor to work with for a limited time or a book of standard operating procedures to review. Michelle Pearsall, BA, CCRA, who started her career as a clinical research coordinator conducting in-home sleep studies confirms this experience in her article, “The Evolution of a Clinical Research Trainer”; she states; “As I was certainly not experienced, I needed guidance that was not available to me. Luckily, I was blessed with a couple of supportive clinical research associates (CRA’s) who mentored me in my role as a study coordinator and challenged me to learn more about the industry.”1Thankfully, over the past few years we have seen a new emphasis being put on education and training in our industry. There are hundreds of education and training programs available which are targeted to various professions in our industry, such as clinical research coordinators,[link widoczny dla zalogowanych], clinical research associates and principal investigators. These programs however, are not required, they are optional.Many industries have standard education fulfillment requirements and/or certification expectations however, in the clinical research industry there are no such requirements. Although education and training has been in the forefront over the past few years, there are still many individuals who remain in need of education in our industry.Clinical Research Consulting, Inc. (CRCI), a Clinical Research Organization in Boston, MA consisting of over fifty clinical research consultants across the U.S., has a large presence in the clinical monitoring arena. CRCI consultants are witness to the continuing need for support and endorsement of clinical research education and training. CRCI consultant, Linda Martini states; “I continue to experience numerous coordinators and investigators working in their roles without the proper education and training. At least half of the clinical research coordinators I work with have never received formal education or training. This lack of education and training seems to be especially evident in the areas of regulatory requirements and FDA regulations. When I recommend an education program targeting these areas, they express great interest however, their respective organizations do not offer reimbursement for education and training and it continues to be put on the back burner.”2Unfortunately, too often organizations do not fully recognize the importance and value education and training brings to the new or existing clinical research professional. Candy Pewanick, Director of Clinical Research at Anchor Research Center in Naples, FL states, “Ongoing education for research professionals is very important. For new employees it gives them a basic understanding of regulations and terminology unique to this industry. There is nothing worse than being a new coordinator thrown into the land of research acronyms without any preparation. Those of us that have worked in the industry for many years can still benefit for continuing education to keep up with new regulations and reminders on previously learned information.”Ms. Pewanick continues, “The str[link widoczny dla zalogowanych]le with education is the costs versus the budget versus management. When things get tight,[link widoczny dla zalogowanych], education costs seem to be the first item we are asked to cut from the budget. Part of the problem is that administrators who are only peripherally involved in the department really do not understand how complex research is and how difficult it is to stay on top of changes without continuing education.” 3There continues to be an obvious need for entry education and training, but many clinical research institutions appear to be resistant in reimbursing for such programs despite proven research that education and training directly benefits performance. Nagel, et al.4 conducted a study to determine if attendance at an audit preparation class would help institutional CRA’s prepare for an audit and impact the audit results. The outcome of this study showed a clear trend of improved audit preparation and outcome for those CRA’s who attended the audit preparation class. Further,[link widoczny dla zalogowanych], Sherman, et al.5 found that pediatric residents who participated in a formal education process on the topic of informed consent in their residency education program positively affected residents’ knowledge and attitudes about the processes and issues involving informed consent.The clinical research industry is credited for a new and increasing awareness and emphasis on the need for education and training. However, although the industry may be observing an upward trend in support of such, it is obvious that resistance remains. Until the clinical research industry requires and/or standardizes such training and education, it remains optional to those coming into our industry and we will continue to see many who are uneducated and lack the necessary skills to fulfill their defined roles. Further, until organizations are required to formally educate their clinical research personnel, it remains optional and unsupported by many.As an industry,[link widoczny dla zalogowanych], education and training standards should be raised. The industry should require that professionals in this industry be trained and educated to perform the roles expected of them. As professionals, we need to communicate and rally for such a requirement.References:1. M. Pearsall, “The Evolution of a Clinical Research Trainer,[link widoczny dla zalogowanych],” The Monitor, 20 (5) (2005).2. L. Martini, “Personal Communication,” March 9, 2007.3. C. Pewanick, “Personal Communication,” March 22, 2007.4. K. Nagel, S. Devine, M. Krailo, L. Benson, S. Caso,[link widoczny dla zalogowanych], “Audit Preparation Class: Does it Really Help CRAs,” Applied Clinical Trials, 15 (6), (2006).5. H. B. Sherman,[link widoczny dla zalogowanych], W. C. McGaghie, S. M. Unti, J. X. Thomas, “Teaching Pediatrics Residents how to Obtain Informed Consent,” Academic Medicine,[link widoczny dla zalogowanych], 80 (10): S10-3 (2005).
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