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Electronic Data Capture
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). Typically, EDC systems provide: * a graphical user interface component for data entry * a validation component to check user data * a reporting tool for analysis of the collected data EDC systems are used by life sciences organizations, broadly defined as the pharmaceutical, medical device and biotechnology industries in all aspects of clinical research, but are particularly beneficial for late-phase (phase III-IV) studies and pharmacovigilance and post-market safety surveillance. EDC can increase data accuracy and decrease the time to collect data f ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Data Acquisition
Acquisition or collection of clinical trial data can be achieved through various methods that may include, but are not limited to, any of the following: paper or electronic medical records, paper forms completed at a site, interactive voice response systems, local electronic data capture systems, or central web based systems. There is arguably no more important document than the instrument that is used to acquire the data from the clinical trial with the exception of the protocol, which specifies the conduct of that clinical trial. The quality of the data collected relies first and foremost on the quality of that instrument. No matter how much time and effort go into conducting the clinical trial, if the correct data points were not collected, a meaningful analysis may not be possible. It follows, therefore, that the design, development and quality assurance of such an instrument must be given the utmost attention. The ICH guidelines on good clinical practice (GCP) use the term ‘ ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Thick Client
In computer networking, a rich client (also called heavy, fat or thick client) is a computer (a "client" in client–server network architecture) that typically provides rich functionality independent of the central server. This kind of computer was originally known as just a "client" or "thick client," in contrast with "thin client", which describes a computer heavily dependent on a server's applications. A rich client may be described as having a rich user interaction. While a rich client still requires at least periodic connection to a network or central server , it is often characterised by the ability to perform many functions without a connection. In contrast, a thin client generally does as little processing as possible on the client, relying on access to the server each time input data needs to be processed or validated. Introduction The designer of a client–server application decides which parts of the task should be executed on the client, and which on the server. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Research
Clinical research is a branch of healthcare science that determines the safety and effectiveness ( efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment. Overview The term "clinical research" refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied. In the United States ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Mobile Forms
A mobile form is an electronic or digital form application that functions on a smartphone or tablet device. Mobile forms enable users to collect data using mobile devices, and then to send the results back to the source. Mobile forms exist to replace paper forms as a more productive means of data collection, eliminating the need to transcribe or scan paper data results into a back office system. Depending on the mobile form application provider, some mobile form solutions allow offices to dispatch data to mobile form applications. In addition, other mobile form applications can be connected with various cloud services, servers, and social media platforms. Depending on the business, the motivating factors to deploying mobile forms may vary. Some businesses implement mobile forms to speed up processes, while others institute mobile forms with field users to reduce costs associated with transporting paper forms back and forth. Furthermore, green-minded businesses implement mobile ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Title 21 CFR Part 11
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)). Coverage Practically speaking, Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions. It requires that they implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data that FDA predicate rules require them to maintain. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Electronic Patient-reported Outcome
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. Methods The two main methods currently used for ePRO are computers (including smartphones) and telephone systems. ''Computers'' are most often touch-screen devices, ranging from wearables, hand-held devices and smartphones, through iPads and other Tablet computers. The smaller devices are often used as electronic diaries, designed to be used for symptom reporting on a daily basis. Larger devices are generally used in a clinic setting. Computers generally run dedicated ePRO applications - the use of the web for ePRO is not yet widespread. Typic ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Patient-reported Outcome
A patient-reported outcome (PRO) is a health outcome directly reported by the patient who experienced it. It stands in contrast to an outcome reported by someone else, such as a physician-reported outcome, a nurse-reported outcome, and so on. PRO methods, such as questionnaires, are used in clinical trials or other clinical settings, to help better understand a treatment's efficacy or effectiveness. The use of digitized PROs, or electronic patient-reported outcomes (ePROs), is on the rise in today's health research setting. Terminology PROs should not be confused with PCOs, or '' patient-centered outcomes''. The latter implies the use of a questionnaire covering issues and concerns that are specific to a patient. Instead, ''patient-reported'' outcomes refers to reporting situations in which only the patient provides information related to a specific treatment or condition; this information may or may not be of concern to the patient. Further, PROs should not be confused with PREM ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Remote Data Capture
Remote data capture is the process of automatic collection of scientific data. It is widely used in clinic trials, where it is referred to as electronic data capture. In physical sciences, automatic observation hardware in the field can be linked to an observer in a laboratory through a cellphone or other communication link, for example in hydrology. RDC systems influenced the design of later electronic data capture 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 stre ... (EDC) systems.Aitkendhead, M.J. and Cooper, R.J. 2007. Neural network time series prediction of environmental variables in a small upland headwater in NE Scotland. ''Hydrological Processes'', 22, 3091-310 References Clinical research Telemetry Clinical data management {{Telecomm-stub ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Remote Data Entry
{{Unreferenced, date=December 2009 A remote data entry (RDE) system is a computerized system designed for the collection of data in electronic format. The term is most commonly applied to a class of software used in the life sciences industry for collecting patient data from participants in clinical research studies—research of new drugs and/or medical devices. Typically, RDE systems provide: * a graphical user interface component for data entry * a validation component to check user data * a reporting tool for analysis of the collected data RDE software was started in the mid- to late-1980s as software installed locally on portable computers with modems. It has largely been replaced by a newer generation of software called electronic data capture, or EDC, that provides the same type of functionality over the Internet using web pages. See also * Clinical data acquisition * Electronic data capture An electronic data capture (EDC) system is a computerized system designed for the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Case Report Form
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events. The sponsor of the clinical trial develops the CRF to collect the specific data they need in order to test their hypotheses or answer their research questions. The size of a CRF can range from a handwritten one-time 'snapshot' of a patient's physical condition to hundreds of pages of electronically captured data obtained over a period of weeks or months. (It can also include required check-up visits months after the patient's treatment has stopped.) The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Data Management System
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. Classification The CDMS can be broadly divided into paper-based and electronic data capturing systems. Paper-based systems Case report forms are manually filled at site and mailed to the company for which trial is being performed. The data on forms is transferred to the CDMS tool through data entry. The most popular ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Data Acquisition
Acquisition or collection of clinical trial data can be achieved through various methods that may include, but are not limited to, any of the following: paper or electronic medical records, paper forms completed at a site, interactive voice response systems, local electronic data capture systems, or central web based systems. There is arguably no more important document than the instrument that is used to acquire the data from the clinical trial with the exception of the protocol, which specifies the conduct of that clinical trial. The quality of the data collected relies first and foremost on the quality of that instrument. No matter how much time and effort go into conducting the clinical trial, if the correct data points were not collected, a meaningful analysis may not be possible. It follows, therefore, that the design, development and quality assurance of such an instrument must be given the utmost attention. The ICH guidelines on good clinical practice (GCP) use the term ‘ ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |