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Clinical Data Management
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. Role of the clinical data manager in a clinical trial Job profile acceptable in CDM: clinical researcher, clinical research associate, clinical research coordinator etc. The clinical data manager plays a key role in the setup and conduct of a clinical trial. The data collected during a clinical trial forms the basis of subsequent safety a ... [...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] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Data Management
Data management comprises all disciplines related to handling data as a valuable resource. Concept The concept of data management arose in the 1980s as technology moved from sequential processing (first punched cards, then magnetic tape) to random access storage. Since it was now possible to store a discrete fact and quickly access it using random access disk technology, those suggesting that data management was more important than business process management used arguments such as "a customer's home address is stored in 75 (or some other large number) places in our computer systems." However, during this period, random access processing was not competitively fast, so those suggesting "process management" was more important than "data management" used batch processing time as their primary argument. As application software evolved into real-time, interactive usage, it became obvious that both management processes were important. If the data was not well defined, the data wo ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
National Institutes Of Health
The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late 1880s and is now part of the United States Department of Health and Human Services. The majority of NIH facilities are located in Bethesda, Maryland, and other nearby suburbs of the Washington metropolitan area, with other primary facilities in the Research Triangle Park in North Carolina and smaller satellite facilities located around the United States. The NIH conducts its own scientific research through the NIH Intramural Research Program (IRP) and provides major biomedical research funding to non-NIH research facilities through its Extramural Research Program. , the IRP had 1,200 principal investigators and more than 4,000 postdoctoral fellows in basic, translational, and clinical research, being the largest biomedical research instit ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Efficacy
Efficacy is the ability to perform a task to a satisfactory or expected degree. The word comes from the same roots as ''effectiveness'', and it has often been used synonymously, although in pharmacology a pragmatic clinical trial#Efficacy versus effectiveness, distinction is now often made between efficacy and effectiveness. The word ''efficacy'' is used in pharmacology and medicine to refer both to the maximum response achievable from a pharmaceutical drug in research settings, and to the capacity for sufficient therapeutic effect or beneficial change in clinical settings. Pharmacology In pharmacology, efficacy () is the maximum response achievable from an applied or dosed agent, for instance, a small molecule drug. Intrinsic activity is a relative term for a drug's efficacy relative to a drug with the highest observed efficacy. It is a purely descriptive term that has little or no mechanistic interpretation. In order for a drug to have an effect, it needs to bind to its t ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Statistical Analysis
Statistical inference is the process of using data analysis to infer properties of an underlying distribution of probability.Upton, G., Cook, I. (2008) ''Oxford Dictionary of Statistics'', OUP. . Inferential statistical analysis infers properties of a population, for example by testing hypotheses and deriving estimates. It is assumed that the observed data set is sampled from a larger population. Inferential statistics can be contrasted with descriptive statistics. Descriptive statistics is solely concerned with properties of the observed data, and it does not rest on the assumption that the data come from a larger population. In machine learning, the term ''inference'' is sometimes used instead to mean "make a prediction, by evaluating an already trained model"; in this context inferring properties of the model is referred to as ''training'' or ''learning'' (rather than ''inference''), and using a model for prediction is referred to as ''inference'' (instead of ''prediction''); ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Standard Operating Procedure
A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations. Some military services (e.g., in the U.S. and the UK) use the term standing (rather than ''standard'') operating procedure, since a military SOP refers to a unit's unique procedures, which are not necessarily standard to another unit. The word "standard" could suggest that only one (standard) procedure is to be used across all units. The term is sometimes used facetiously to refer to practices that are unconstructive, yet the norm. In the Philippines, for instance, "SOP" is the term for pervasive corruption within the government and its institutions. Clinical research and practice In clinical research, the '' International Council for Harmonisation'' (ICH) defines SOPs as "de ... [...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] |
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] |
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] |
Serious Adverse Event
A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose #Results in death #Is life-threatening #Requires inpatient hospitalization or causes prolongation of existing hospitalization #Results in persistent or significant disability/incapacity #May have caused a congenital anomaly/birth defect #Requires intervention to prevent permanent impairment or damage The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. Adverse events are further defined as “Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.” Research Investigators in human clinical trials are obligated to report these events in ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Control
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): # Elements such as controls, job management, defined and well managed processes, performance and integrity criteria, and identification of records # Competence, such as knowledge, skills, experience, and qualifications # Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships. Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example. History and introduction Ea ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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