Clinical Research Professional

ACRP, Where we are and where we are going, 2000 White Paper, Association of Clinical Research Professionals, Alexandria, VA, 2000, www.acrpnet.org/whitepaper2/html/ii. con-tract research organizations.html... 

The book is written with two groups of readers in mind. The first is entry-level professionals in the pharmaceutical, biotechnology, and contract research organization industries and seasoned clinical research professionals who wish to refresh their knowledge in areas outside their immediate area of expertise. The second is students of clinical research, pharmacy, medicine, and allied health professions. 

Clinical research directories/professional organizations that provide listings of clinical research professionals (e.g., ACRP, DIA, RAPS)... 

Today s quality sites often encourage study coordinators to become certified either by the Association of Clinical Research Professionals (ACRP), an international organization with chapters in more than a dozen nations, or the Society of Clinical... 

Research Associates (SoCRA), an organization with chapters in some half-dozen countries. The ACRP certification is known as Certified Clinical Research Coordinator (CCRC), and SoCRA s certification is the Certified Clinical Research Professional (CCRP). 

NCRP Northwest Clinical Research Professionals (Portland, OR)... 

Society for Clinical Research Associates (SoCRA) hosts both an Investigator Program as well as a week-long research seminar, and also hosts a Clinical Research Professional Certification (CCRP) Prep Course and Exam for those who meet the required qualifications. 

The Association of Clinical Research Professionals (ACRP) holds two certification exams, one for Clinical Research Coordinator (CRC), and another for Clinical Research Associate (CRA). 

BATAVIA M (2001) Clinical research for health professionals, Boston, Buherworth Heinemarm. CAMPBELL M j, MACHiN D (1999) Medical statistics, New York, John Wiley Sons, Inc. CHOW s c, LIU j p (1998) Design and analysis of clinical trials. New York, John Wiley Sons, Inc. 

BATAVIA M (2001) Clinical research for health professionals, Boston, Butterworth Heinemaim. 

The data and information about an individual drug developed through Phase I, II, and III studies are extremely important to the medical community. For many drugs Phase I, II, and III data may be all, or nearly all, that is available about the clinical use of the drug at the time the product is marketed. During the time the product is in Phase I, Phase II, and Phase III, some of the compound s product and clinical data may be presented at professional meetings, published in preliminary reports, or otherwise made available to the scientific and business communities. However, it is not uncommon for a drug to be approved by FDA without the presence of its clinical research in the published biomedical literature. 

As soon as fraud is suspected, a series of steps needs to be followed which have been thought out and written down as an SOP before any clinical research commenced. Where possible, additional evidence should be obtained, usually by the use of a competent QA auditor. In the meantime, only the minimum key individuals should be made aware of the problem until sufficient evidence has been obtained to establish the truth. The appropriate authorities such as the national drug industry organisation and the regulatory authorities should be informed if fraud has taken place. Sometimes, other sponsors will have reported additional evidence that fraud is taking place at a particular site. The site will need to be closed if study subjects are still being recruited and a full explanation provided to the authorities. Any clinical data collected will need to be reviewed and a decision made as to whether any of the data can be included in an analysis. To a pharmaceutical physician, fraud is never an easy situation. It usually involves a professional colleague and there is always the worry that the established facts have been misinterpreted. However, a fraudulent individual cannot be tolerated in modern clinical research. 

Clinical protocols and investigator information—detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators—professionals (generally physicians) who oversee the administration of the experimental compound—to assess whether they are qualified to fulfill their clinical trial duties finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an IRB, and to adhere to the IND regulations. 

Hypothermia and Cerebral Ischemia Mechanisms and Clinical Applications is intended to provide a comprehensive review of mild hypothermia s therapeutic potential, its limitations, and recent developments in both basic and clinical research. We hope that this volume serves to educate clinicians, other health professionals, and basic scientists, as well as promote interest in the study and implementation of mild hypothermia for the treatment of stroke and TBI. 

All IRBs are ultimately responsible for the unbiased determination of whether a proposal for clinical research is acceptable in terms of the standards of professional practice, the institution or individual undertaking the research, and the patient population. Therefore, proposals considered for approval at convened meetings must receive approval by the majority of the members present at that meeting. 

There is no standard professional education for QA auditors and, therefore, practical experience is indispensable before embarking on the QA job. Before joining the QA department, the QA candidate may have worked in clinical monitoring, data management, pharmacovigilance, regulatory affairs, training and other areas of clinical research. 

Pharmacotherapy is the specialty responsible for ensuring the safe, appropriate, and economical use of drugs in patient care. The pharmacotherapy specialist has responsibility for direct patient care and often functions as a member of a multidisciplinary treatment team. These specialists may conduct clinical research and are frequently primary sources of drug information for other health care professionals. 

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