Oracle Clinical

Last updated

Oracle Clinical or OC is a database management system designed by Oracle to provide data management, data entry and data validation functionalities to support Clinical Trial operations. [1]

The Major Functions Supported by Oracle Clinical are:

Related Research Articles

<span class="mw-page-title-main">Outline of academic disciplines</span> Overviews of and topical guides to academic disciplines

An academic discipline or field of study is a branch of knowledge, taught and researched as part of higher education. A scholar's discipline is commonly defined by the university faculties and learned societies to which they belong and the academic journals in which they publish research.

<span class="mw-page-title-main">Health informatics</span> Applications of information processing concepts and machinery in medicine

Health informatics is the field of science and engineering that aims at developing methods and technologies for the acquisition, processing, and study of patient data, which can come from different sources and modalities, such as electronic health records, diagnostic test results, medical scans. The health domain provides an extremely wide variety of problems that can be tackled using computational techniques.

Health Level Seven or HL7 refers to a set of international standards for transfer of clinical and administrative data between software applications used by various healthcare providers. These standards focus on the application layer, which is "layer 7" in the OSI model. The HL7 standards are produced by Health Level Seven International, an international standards organization, and are adopted by other standards issuing bodies such as American National Standards Institute and International Organization for Standardization.

<span class="mw-page-title-main">Laboratory information management system</span> Software infrastructure for improving research and storing data

A laboratory information management system (LIMS), sometimes referred to as a laboratory information system (LIS) or laboratory management system (LMS), is a software-based solution with features that support a modern laboratory's operations. Key features include—but are not limited to—workflow and data tracking support, flexible architecture, and data exchange interfaces, which fully "support its use in regulated environments". The features and uses of a LIMS have evolved over the years from simple sample tracking to an enterprise resource planning tool that manages multiple aspects of laboratory informatics.

A data dictionary, or metadata repository, as defined in the IBM Dictionary of Computing, is a "centralized repository of information about data such as meaning, relationships to other data, origin, usage, and format". Oracle defines it as a collection of tables with metadata. The term can have one of several closely related meanings pertaining to databases and database management systems (DBMS):

<span class="mw-page-title-main">Electronic health record</span> Digital collection of patient and population electronically stored health information

An electronic health record (EHR) is the systematized collection of patient and population electronically stored health information in a digital format. These records can be shared across different health care settings. Records are shared through network-connected, enterprise-wide information systems or other information networks and exchanges. EHRs may include a range of data, including demographics, medical history, medication and allergies, immunization status, laboratory test results, radiology images, vital signs, personal statistics like age and weight, and billing information.

The Composite Health Care System (CHCS) is a medical informatics system designed by Science Applications International Corporation (SAIC) and used by all United States and OCONUS military health care centers. In 1988, SAIC won a competition for the original $1.02 billion contract to design, develop, and implement CHCS.

A database trigger is procedural code that is automatically executed in response to certain events on a particular table or view in a database. The trigger is mostly used for maintaining the integrity of the information on the database. For example, when a new record is added to the employees table, new records should also be created in the tables of the taxes, vacations and salaries. Triggers can also be used to log historical data, for example to keep track of employees' previous salaries.

An electronic lab notebook is a computer program designed to replace paper laboratory notebooks. Lab notebooks in general are used by scientists, engineers, and technicians to document research, experiments, and procedures performed in a laboratory. A lab notebook is often maintained to be a legal document and may be used in a court of law as evidence. Similar to an inventor's notebook, the lab notebook is also often referred to in patent prosecution and intellectual property litigation.

In online transaction processing (OLTP), information systems typically facilitate and manage transaction-oriented applications. This is contrasted with online analytical processing.

An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. EDC solutions are widely adopted by pharmaceutical companies and contract research organizations (CRO).

Entity–attribute–value model (EAV) is a data model to encode, in a space-efficient manner, entities where the number of attributes that can be used to describe them is potentially vast, but the number that will actually apply to a given entity is relatively modest. Such entities correspond to the mathematical notion of a sparse matrix.

A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data. Systems for clinical data management can be self-contained or part of the functionality of a CTMS. A CTMS with clinical data management functionality can help with the validation of clinical data as well as helps the site employ for other important activities like building patient registries and assist in patient recruitment efforts.

Database administration is the function of managing and maintaining database management systems (DBMS) software. Mainstream DBMS software such as Oracle, IBM Db2 and Microsoft SQL Server need ongoing management. As such, corporations that use DBMS software often hire specialized information technology personnel called database administrators or DBAs.

<span class="mw-page-title-main">First Databank</span>

First Databank (FDB) is a major provider of drug and medical device databases that help inform healthcare professionals to make decisions. FDB partners with information system developers to deliver useful medication- and medical device-related information to clinicians, business associates, and patients. FDB is part of Hearst and the Hearst Health network.

Caisis is an open-source, web-based, patient data management system that integrates research with patient care. The system is freely distributed to promote the collection of standard, well structured data suitable for research and multi-institution collaboration.

An electronic patient-reported outcome (ePRO) is a patient-reported outcome that is collected by electronic methods. ePRO methods are most commonly used in clinical trials, but they are also used elsewhere in health care. As a function of the regulatory process, a majority of ePRO questionnaires undergo the linguistic validation process. When the data is captured for a clinical trial, the data is considered a form of Electronic Source Data.

AHLTA is a global Electronic Health Record (EHR) system used by U.S. Department of Defense (DoD). It was implemented at Army, Navy and Air Force Military Treatment Facilities (MTF) around the world between January 2003 and January 2006. It is a services-wide medical and dental information management system. What made AHLTA unique was its implementation date, its Central Data Repository, its use in operational medicine and its global implementation. There is nothing like it in the private sector.

Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management ensures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). The ultimate goal of CDM is to ensure that conclusions drawn from research are well supported by the data. Achieving this goal protects public health and increases confidence in marketed therapeutics.

<span class="mw-page-title-main">BioPharm Systems</span>

BioPharm Systems is an American privately owned IT consulting and managed services provider (MSP) headquartered in San Mateo, California that focuses on the life sciences industry. The company specializes in the implementation, integration, migration, upgrade, and private cloud hosting of Oracle's clinical trial management system, drug safety and pharmacovigilance, clinical data warehousing and analytics, clinical data management, and electronic data capture systems.

References

  1. Chow, Sheiu-Chung (2003). Encyclopedia of Biopharmaceutical Statistics. Informa Health Care. pp. 397–401. ISBN   0-8247-4261-3.