An electronic portfolio is a collection of electronic evidence assembled and managed by a user, usually on the Web. Such electronic evidence may include input text, electronic files, images, multimedia, blog entries, and hyperlinks. E-portfolios are both demonstrations of the user's abilities and platforms for self-expression. If they are online, users can maintain them dynamically over time.
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
Electronic assessment, also known as digital assessment, e-assessment, online assessment or computer-based assessment, is the use of information technology in assessment such as educational assessment, health assessment, psychiatric assessment, and psychological assessment. This covers a wide range of activity ranging from the use of a word processor for assignments to on-screen testing. Specific types of e-assessment include multiple choice, online/electronic submission, computerized adaptive testing such as the Frankfurt Adaptive Concentration Test, and computerized classification testing.
A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing to post-marketing activities, and for safety information data entry, retrieval, evaluation, and presentation. Also, it is the adverse event classification dictionary.
The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States and beyond.
Medical practice management software (PMS) is a category of healthcare software that deals with the day-to-day operations of a medical practice including veterinarians. Such software frequently allows users to capture patient demographics, schedule appointments, maintain lists of insurance payors, perform billing tasks, and generate reports.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration.
Abstract management is the process of accepting and preparing abstracts for presentation at an academic conference. The process consists of either invited or proffered submissions of the abstract or summary of work. The abstract typically states the hypothesis, tools used in research or investigation, data collected, and a summary or interpretation of the data.
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group.
Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF. However, the document provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Typically, a drug master file is filed when two or more firms work in partnership on developing or manufacturing a drug product. The DMF filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details.
Interactive customer evaluation (ICE) is commonly implemented in web-based applications. Its purpose is to provide feedback. The term does not refer to a commercial application.
The following outline is provided as an overview of and topical guide to clinical research:
Regulated Product Submission (RPS) is a Health Level Seven (HL7) standard designed to facilitate the processing and review of regulated product information. RPS is being developed in response to performance goals that the U.S. Food and Drug Administration (FDA) is to achieve by 2012, as outlined in the Prescription Drug User Fee Act (PDUFA). In addition to the U.S., regulatory agencies from Europe, Canada, and Japan are at varying levels of interest and participation. Currently, the second release of RPS is in development.
An electronic submission refers to a manuscript submitted by electronic means: that is, via e-mail or a web form on the Internet, or on an electronic medium such as a compact disc, a hard disk or a USB flash drive. Traditionally, a manuscript referred to anything that was explicitly "written by hand". However, in popular usage and especially in the context of computers and the Internet, the term "manuscript" may even refer to documents typed out or prepared on typewriters and computers and can be extended to digital photographs and videos, and online surveys too. In other words, any manuscript prepared and submitted online can be considered to be an electronic submission.
A submission management system is a software system, also known as submission processing, that streamlines and eases out the collection, tracking and management of electronic submissions. Information can be received, authenticated, tracked, stored, and distributed electronically. Submission management systems can be web-based system operating in a browser environment, a COTS based product, or may also be in the form of a desktop application. Submissions are completed electronically creating an efficient real-time process that saves time for both the submitter and recipient. Usually a submission management system can take in a high volume of data at fast rate.
Banking business process outsourcing or banking BPO is a highly specialized sourcing strategy used by banks and lending institutions to support the business acquisition and account servicing activities associated with the customer lending lifecycle. These specific BPO services are usually offered through multi-year service-level agreements for all or portions of the credit card lending, consumer lending or commercial lending segments of the financial services market. Some larger financial services organizations choose to extend their sourcing strategy to include other outsourced services such as ITO systems and software, human resources outsourcing and benefits services, finance and accounting outsourcing (FAO) services, procurement or training outsourcing.
In order to comply with government regulatory requirements pertinent to clinical trials, every organization involved in clinical trials must maintain and store certain documents, images and content related to the clinical trial. Depending on the regulatory jurisdiction, this information may be stored in the trial master file or TMF, which today takes the form of an electronic trial master file (eTMF). The International Conference on Harmonization (ICH) published a consolidated guidance for industry on Good Clinical Practice in 1996 with the objective of providing a unified standard for the European Union, Japan, and the United States of America to facilitate mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. This guidance document established the requirement across all ICH regions to establish trial master files containing essential documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.[2] In some jurisdictions, for example the USA, there is no specific requirement for a trial master file. However, if the regulatory authority requires ICH GCP to be followed, then there is consequently a requirement to create and maintain a trial master file.[2]
A virtual learning environment (VLE) in educational technology is a web-based platform for the digital aspects of courses of study, usually within educational institutions. They present resources, activities, and interactions within a course structure and provide for the different stages of assessment. VLEs also usually report on participation and have some level of integration with other institutional systems. In North America, VLE's are often referred to as Learning Management Systems (LMS).
Diary studies is a research method that collects qualitative information by having participants record entries about their everyday lives in a log, diary or journal about the activity or experience being studied. This collection of data uses a longitudinal technique, meaning participants are studied over a period of time. This research tool, although not being able to provide results as detailed as a true field study, can still offer a vast amount of contextual information without the costs of a true field study. Diary studies are also known as experience sampling or ecological momentary assessment (EMA) methodology.
Grievance Redressal is a management- and governance-related process used commonly in India. While the term "Grievance Redressal" primarily covers the receipt and processing of complaints from citizens and consumers, a wider definition includes actions taken on any issue raised by them to avail services more effectively.
