Clinical Research Associate

The Changing Role of Clinical Research Associates Patient Recruitment Reduced Time to Database Lock Management of Geographically Diverse Studies... 

Study monitors or clinical research associates (CRAs) can be employed by the study sponsor, CRO, or independently contracted for a specific study and, according to the International Committee on Harmonisation (ICH) and formalized by FDA in the Guidance for Industry Good Clinical Practice (GCP), the purpose of a CRA is to ... 

Clinical research associates who coordinate and monitor the phase 1, 2, and 3 studies and ensure that the appropriate documents, such as case report forms, are correctly prepared... 

Jose Santos earned his doctorate in medicine from the Classic University of Lisbon in 1984. He has been a Clinical Research Associate at Lab. Servier and Associate Medical Director at Lab. Pfizer. Since 1992, Dr. Santos has been Medical Director at OM Portuguesa, S.A. He has also been serving ad Medical Rapporteur in the Commission of Revision of Pharmaceutical Products (CREF of the National Institute of Pharmacy and Medicines (INFARMED) since 1995. He is a member of the Portuguese Medical Association of the Pharmaceutical Industry and the Ordem dos Medicos and is a faculty member in pharmaceutical medicine at the Royal College of Physicians in the United Kingdom. 

One of the most important means of quality control of a clinical study is managed by frequent and thorough monitoring. A monitor s aim is first to protect the agenda of the sponsor/CRO who employs him/her. Monitors (often referred to as CRAs or Clinical Research Associates or Assistants in the pharmaceutical industry) must ensure maintenance of proper standards, compliance with the protocol, accurate and complete data capture and standardization across sites in a multicenter study. Basically, monitors will undertake the review noted in Table 12.8. 

Once a potential investigator has been identified, the sponsor company will continue to be in contact with the investigator and the site to make ad ditional assessments of their continued interest and capabilities to participate in the clinical program. This responsibility is assigned to personnel within sponsor companies that carry many different titles. Site managers (SMs), medical research associates (MRAs), clinical research associates (CRAs), and clinical research monitors (CRMs) are among the names used. For the purpose of this chapter, personnel with these responsibilities will be called monitors. 

Persons authorized to make the requested use or disclosure of this information. The drug sponsor should assure that this disclosure extends to all authorized parties involved in the clinical trial assessment, including Clinical Research Associates, Clinical Research Or-ganizations, other consultants, etc. 

ACP Associates of Clinical Pharmacology (USA), a group that certifies clinical research associates (CRAs) and clinical research coordinators (CRCs)... 

CCRA Certified Clinical Research Associate. See also AC P. 

The organizational purpose of a trial is also essential. The activities of a great many persons (trial physician, trial nurse, trial logistics, clinical research associates and monitors, database managers, regulatory personnel, statisticians and so on) have to be coordinated in order to bring the trial to a successful conclusion. The trial protocol is not the only document used in this, but it is the prime medium of communication. 

A web-based approach to data access can be considered and issues such as access control, security, and levels of access must be addressed (24). Scalability and back-up capabilities are among the issues that may influence decisions at this level. Further guidance from the Society of Clinical Research Associates and published literature (25) can assist with system documentation, system and database security, maintenance of data integrity, regulatory, and compliance issues (23). 

Pharmaceutical medicine is a medical specialty in which both physicians and non-physicians take part. This is not unusual. For example, various medical specialties require specialist nurses, nuclear medicine requires physicists, pathology requires histologists, and venereology requires contact tracers. In our case, pharmaceutical medicine requires pharmacists, clinical research associates, statisticians, administrators, and financiers. Interaction with a diverse set of other types of professional can be one of the most rewarding (and educational) aspects of a career in pharmaceutical medicine. 

Key personnel briefly describe the training and experience required for key positions that will be involved in the present study (e.g. project manager, medical director, clinical research associate, data administration manager, database administrator, programmer, statistician, medical writer, and regulatory affairs manager) and provide resumes of typical personnel in these positions. 

The CRO has a responsibility to staff the study with adequate numbers of competent, well-managed personnel. This can present a challenge, especially in areas prone to high turnover, such as clinical research associates (CRAs). The CRO must have an adequate training and evaluation program to ensure staff performance and must not promote inexperienced personnel to critical positions, such as project manager. It is the CRO s responsibility to conduct the study activities as prescribed in the study specifications and spon-sor-CRO agreement. 

An alternative approach was taken by Hasel (1999, 2001), who developed materials capable of being placed through a hypodermic syringe, from 25 to 16 gauge needles (0.260 to 1.194 mm internal diameter) (Fig. 9.4). Retaining the monomer system used with conventional materials, these new systems initially contained less filler content. This filler also included colloidal silica of particle size 0.04 yum. These are termed flowable composites , and are now widely available (Clinical Research Associates, 2002). Recent generations of flowable composites have been introduced that are at or above conventional paste filler rates (e.g. up to 80wt%). This advance may open up the use and applications of flowables to any situation where conventional paste composites have been used. 

Clinical Research Associates (2002) Flowable resins. Comparison of 33 brands. CRA Newsletter, 26, 3—4. 

Welch Allyn, Inc., Skaneateles Falls, New York, and The Society of Clinical Research Associates, Chalfont, Pennsylvania, USA... 

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. 

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