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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 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] |
Adverse Event
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. AEs in patients participating in clinical trials must be reported to the study sponsor and if required could be reported to the local ethics committee. Adverse events categorized as "serious" (results in death, illness requiring hospitalization, events deemed life-threatening, results in persistent or significant incapacity, a congenital anomaly, birth defect or medically important condition) must be reported to the regulatory authorities immediately, whereas non-serious adverse events are ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Statistics
Statistics (from German language, German: ''wikt:Statistik#German, Statistik'', "description of a State (polity), state, a country") is the discipline that concerns the collection, organization, analysis, interpretation, and presentation of data. In applying statistics to a scientific, industrial, or social problem, it is conventional to begin with a statistical population or a statistical model to be studied. Populations can be diverse groups of people or objects such as "all people living in a country" or "every atom composing a crystal". Statistics deals with every aspect of data, including the planning of data collection in terms of the design of statistical survey, surveys and experimental design, experiments.Dodge, Y. (2006) ''The Oxford Dictionary of Statistical Terms'', Oxford University Press. When census data cannot be collected, statisticians collect data by developing specific experiment designs and survey sample (statistics), samples. Representative sampling as ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Institutional Review Board
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical. Such boards are formally designated to approve (or reject), monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be conducted. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. Along with developed countries, many developing countries have established national, regional or local Institutional Review Boards in order to safeguard ethical conduct of research concerning both national and international norms, regulations or codes. A key goal of IRBs is to protect human subjects ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Study Report
{{Short description, Document providing much detail about the methods and results of a trialIn medicine, a clinical study report (CSR) on a clinical trial is a document, typically very long, providing much detail about the methods and results of a trial. A CSR is a scientific document addressing efficacy and safety, not a sales or marketing tool; its content is similar to that of a peer-review Peer review is the evaluation of work by one or more people with similar competencies as the producers of the work ( peers). It functions as a form of self-regulation by qualified members of a profession within the relevant field. Peer revie ...ed academic paper. Results of trials are usually reported in a briefer academic journal paper, but methodological flaws are often glossed over in the briefer paper.Ben Goldacre">Ben Goldacre, Statins have no side effects? This is what our study really found …, Guardian newspaper, 15 March 2014/ref> The International Conference on Harmonisation ... [...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] |
Clinical Research Associate
A clinical research associate (CRA), also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials. Clinical research associates work in various settings, such as pharmaceutical companies, medical research institutes and government agencies. Depending on the jurisdiction, different education and certification requirements may be necessary to practice as a clinical research associate. The main tasks of the CRA are defined by good clinical practice guidelines for monitoring clinical trials, such as those elaborated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. A CRA would subsequently grow into a Feasibility Leader, Study Start up Leader, Project Manager, and Project Director at a Pharmaceutical company or a contract research organization. A CRA is usually required to possess an academic degree in Life Sciences and needs ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial Protocol
In natural and social science research, a protocol is most commonly a predefined procedural method in the design and implementation of an experiment. Protocols are written whenever it is desirable to standardize a laboratory method to ensure successful replication of results by others in the same laboratory or by other laboratories. Additionally, and by extension, protocols have the advantage of facilitating the assessment of experimental results through peer review. In addition to detailed procedures, equipment, and instruments, protocols will also contain study objectives, reasoning for experimental design, reasoning for chosen sample sizes, safety precautions, and how results were calculated and reported, including statistical analysis and any rules for predefining and documenting excluded data to avoid bias. Similarly, a protocol may refer to the procedural methods of health organizations, commercial laboratories, manufacturing plants, etc. to ensure their activities (e.g., b ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Data Clarification Form
A data clarification form (DCF) or data query form is a questionnaire specifically used in clinical research. The DCF is the primary data clarification tool from the trial sponsor or contract research organization (CRO) towards the investigator to clarify discrepancies and ask the investigator for clarification. The DCF is part of the data validation process in a clinical trial. See also * Case report form * Clinical data acquisition * Clinical research associate (CRA) * Clinical trial * Clinical trial protocol * Drug development * Electronic data capture * 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 m ... References * Celine Clive (2004), ''Handbook of SOPs for Good Clinical Practice'', CRC, {{ISBN, 0-8493-2181-6 External links DCF entry in Clini ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Data Collection System
Data collection system (DCS) is a computer application that facilitates the process of data collection, allowing specific, structured information to be gathered in a systematic fashion, subsequently enabling data analysis to be performed on the information. Typically a DCS displays a form that accepts data input from a user and then validates that input prior to committing the data to persistent storage such as a database. Many computer systems implement data entry forms, but data collection systems tend to be more complex, with possibly many related forms containing detailed user input fields, data validations, and navigation links among the forms. DCSs can be considered a specialized form of content management system (CMS), particularly when they allow the information being gathered to be published, edited, modified, deleted, and maintained. Some general-purpose CMSs include features of DCSs. Importance Accurate data collection is essential to many business processes, to the ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Development
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug. The entire process – from concept through preclinical testing in the laboratory to clinical trial development, including Phase I–III trials – to approved vaccine or drug typically takes more than a decade. New chemical entity development Broadly, the process of drug development can be divided into preclinical and clinical work. Pre-clinical New chemical entities (NCEs, also known as new molecular entities or NMEs) are compounds that emerge from the process of drug discovery. Th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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] |
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