Scope of the Clinical Research Information System


This essay aims at critically discussing the Clinical Research Information System as one of the technological innovations that are used in NIH Clinical Center by providing a brief overview of this organization, the various roles of preceptors involved in this organization, review of CRIS, discussion of various technical aspects of this system and recommend some multiple ways that can be part of the plan of involving the students in learning how to successfully use this system within the clinical centers.

Information about the Agency

Brief Background

Since the time it was established in 1953, the American-based clinical research hospital known as National Institute of Health (NIH) Clinical Center remains committed into undertaking clinical research that has seen the organization make significant medical discoveries and milestones(Flowers, 2011). They include the invention of gene therapy, first cure of a solid tumor through using chemotherapy, successful replacement of a mitral valve in the heart and use of AZT to treat a deadly disease known as AIDS(Daviglus et al., 2010). Through the help of well-trained staff, the NIH Clinical Center focuses of advancing medical knowledge that can lead to new cures, therapies, and treatments to the different diseases that affect the health status of the human beings(Gallin & Ognibene, 2012). More than 1500 clinical research studies are already in progress in this organization. Majority of these research studies are clinical trials that are predominantly in Phase I and Phase II and which involve conducting the first test of therapies and new drugs on people to establish effectiveness and safety (Gallin & Ognibene, 2012).

Roles of Preceptor

There are various roles that an instructor or preceptor in the Department of Clinical Research Informatics which is within the NIH Clinical Center undertakes in the attempt of promoting clinical research efforts within this organization(De Mul et al., 2012). Firstly, the preceptor who must always have a clinical background in nursing or pharmacy and experienced user of the clinical research information system works in collaboration with the system training team to provide education and training to all the CRIS users before they are permitted to access and use this system (Ganz et al., 2012).

The preceptor also helps in keeping all the educational materials up to date and conducts advanced system training for the savvy users of this organization. The preceptor also develops customized and in-house courses for the mandatory and role-based CRIS training, offer CRIS e-learning options that are available in the organization’s Learning Management System and provide online reference materials and videos that further boost the training process(Klobas& McGill, 2010). The preceptor ensures that healthcare and governance mandates are well incorporated into the various clinical documents during the process of implementing standardization measures (Ganz et al., 2012). The instructor also creates and configures clinical documentation that allows the existing clinicians access valuable data that may be needed to make informed clinical decisions in the delivery of safe and efficient patient care and at the same time electronically document patients information at the point of care delivery (Ganz et al., 2012).

System Information

Clinical Research Information System (CRIS) is one of the applications and information technology used during the clinical research that is monitored and managed by the Department of Clinical Research Informatics (DCRI)(Hsieh, Lee & Chen, 2013). The primary users of the clinical research informatics include the physicians, nurses, the clinical information systems staff and administrative employees while they are performing various duties that aim at supporting effective delivery of patient care (Hsieh, Lee & Chen, 2013). By being based on the Allscripts Sunrise Acute Care Manager 5.5 SP1, CRIS is a computer information system that is used within the clinical settings to undertake various functions such as conducting administrative activities in the Clinical Center and supports patient care (Hsieh, Lee & Chen, 2013).

Moreover, the clinical research information system helps its users in undertaking various tasks such as managing patient registration process, facilitating the flow of information related to admissions, transfers, and discharges of patients and maintaining patient demographic data that is crucial when making informed decisions during care delivery (Hsieh, Lee & Chen, 2013). CRIS is also used in keeping patient protocol information, electronically writing all medical orders made by the patients and acts as an excellent way of facilitating bed management within the hospitals thus ensuring proper allocation of beds to the patients (Hsieh, Lee & Chen, 2013). Furthermore, the clinical research information system enhances effective retrieval of laboratory and radiology results, helps in attributing various medical activities such as making appointments, orders and documentation to a particular research protocol, helps in the documentation of patient care plans and medication administration(Nadkarni, Kemp & Parikh, 2011). The above functions that CRIS facilitates within the clinical centers form part of the main challenges or problems that have been facing the health care sector in the United States and across the world.

Today, thousands of users have access to CRIS within their respective clinical centers through the use of standard clinical desktops, sunray workstations, and remote computers hence positively transforming how they provide care services to the patients (Nadkarni, Kemp & Parikh, 2011). The primary mission of the National Institute of Health Clinical Center is to give hope to the patients through pioneering clinical research that aims at improving human health(Daviglus et al.,2010). The clinical research information system perfectly fits in the NIH Clinical Center’s mission through the way it enhances detailed clinical research (Nadkarni, Kemp & Parikh, 2011). For instance, through the help of CRIS, it is now possible for information to efficiently flow from the research laboratories and other departments hence facilitating informed decision making during care delivery (Nadkarni, Kemp & Parikh, 2011). Moreover, by collaborating with the Radiology Information Systems that are present in NIH Clinical Center, users are able to receive and send results to the concerned departments through the help of the clinical research information system (CRIS) as it integrates of all the clinical information systems that are present in a hospital (Hsieh, Lee & Chen, 2013). CRIS makes it possible for the researchers to access all the relevant clinical information that is present in different information systems such as electronic health record system and radiology information system among others by creating a single online system that is accessible all the time (Hsieh, Lee & Chen, 2013). Additionally, through using the Medical Archival Retrieval System (MARS), CRIS enables clinical researchers to identify anonymized potential research subjects or records and allows the clinical researchers to obtain relevant data and analysis tools from the existing databases (Hsieh, Lee & Chen, 2013).

Major Technical Aspects of the System

Almost everyone at the clinical center is virtually touched or associated with the clinical research information system in one way or another. In the effort of assisting the National Institute of Health to achieve its mission of improving health across the nations, majority of the staff members use the clinical research information system to access clinical research information that is related to current health trends, retrieval of past medical data and documenting patient care information(Kovačević, et al., 2011). A clinical research information system is responsible for generating approximately 90% of the medical records content within a clinical center (Kovačević et al., 2011). The remaining 10% is attributed to the handwritten progress notes that can be obtained in the outpatient clinic areas and the Institute and Center (IC) systems which are yet to be integrated to the clinical research information system (Kovačević et al., 2011). The initial structure of CRIS during its invention was primarily based on the CRIS flower Diagram that had been proposed by Doctor Rosenfield (Kovačević et al., 2011).

Figure 1: CRIS Flower Diagram

Source: (Kovačević et al., 2011).

The above diagram illustrates the different interconnected key systems that represent various effective patient care delivery requirements within a clinical setting.The above figure shows the database and network of the clinical information system. With the continued advancement in the Electronic Health Records technology, the Clinical Research Information System has proven to be most effective in meeting the changes that have occurred due to its ability to electronically interface with other clinical systems that exist in the clinical center (Kovačević et al., 2011). As illustrated in the above figure, it is now easy for the clinical researchers to efficiently pull out data from other databases that are located in the mainframe hospital information system(Kuperman, Gardner & Pryor, 2013).

Moreover, both bi-directional interfaces such as Health Level Seven (HL7) and uni-directional interfaces are used within a clinical center to enhance the flow of data between CRIS and the different clinical information systems (Dong, 2012). These interfaces help in ensuring that the right users have access to research information and clinical data on time by creating shared boundaries which more than one separate components of a computer system can easily exchange clinical data within a clinical center (Dong, 2012).

Plan for Student’s Involvement

During the training process of the students who ultimately become the end users of the clinical research information system, it is essential for the preceptors or instructors to make sure that the students are actively involved in using this system though remotely to ensure that the operations of this system are not affected in case of a wrong move or act by the student during the training process (Nadkarni, Kemp & Parikh, 2011). Thus, active involvement and interaction of the students with the CRIS in various training sessions can significantly help in improving the level of understanding and knowledge regarding how this system is practically used within a clinical center.

Moreover, during the training sessions, the instructor should try to frequently incorporate a graphical review of various issues that are taught such as vital signs, how to make orders, review clinical laboratory values and monitor medication administration events(Gallin & Ognibene, 2012). The preceptor should also engage the students in on-job training as one of the techniques of ensuring that the students have gained enough skills on how to operate this system and understand how CRIS is integrated with other information systems that are found in a clinical setting (Gallin & Ognibene, 2012). Lastly, the progress made by students as they learn how to use clinical research information system in advancing their clinical research activities can be monitored using regular tests that should be administered in different periods of the training process (Gallin & Ognibene, 2012). Incorporating all these elements as part of the plan of increasing student involvement in clinical research using CRIS can help in promoting discovery of new treatments and ways of dealing

with the medical challenges that are currently facing healthcare sector.


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