Clinical
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Clinical
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| J | |||
| Japan Medical Association | JMA | The Japan Medical Association (JMA) was established in 1916, then re-established in 1947 in its current form, which includes the 47 Prefectural Medical Associations. Its mission as a professional society is to promote policies which protect the health of all citizens, and the autonomy of physicians essential to protect the public, at the national level of health care policy planning. The JMA's national impact comes from the high membership rate: its 156,000 members represent about 60% of all physicians licensed in Japan. Of these, 82,000 are self-employed clinical practitioners, and 74,000 are physicians employed by health care facilities such as hospitals. | http://www.med.or.jp/english/ |
| Japan Pharmaceutical Manufacturers Association | JPMA | The Japan Pharmaceutical Manufacturers Association (JPMA) is a voluntary organization of research-based pharmaceutical manufacturers that contribute to society by developing new pharmaceuticals. Member companies maintain appropriate communications with the aims of promoting balanced public understanding of industry issues and finding solutions to such issues in order to support the sound development of the industry. | http://www.jpma.or.jp/12english/ |
| Joint Chiefs of Staff | JCS | The Chairman of the Joint Chiefs of Staff as the senior ranking member of the Armed Forces. | http://www.dtic.mil/jcs/ |
| Joint Commission on Accreditation of Healthcare Organizations | JCAHO | An independent, not-for-profit organization that objectively inspects, evaluates and accredits health care organizations. | http://www.jcaho.org/index.htm |
| Joint Commission for the Accreditation of Hospitals | JCAH | Historical term for the Joint Commission on Accreditation of Healthcare Organizations whose new name was established in 1987. | |
| Journal of the American Medical Association | JAMA | An international peer-reviewed general medical journal | http://jama.ama-assn.org/ |
| Judge Advocate General | JAG | The mission of the Office of the Judge Advocate General (OJAG) is extensive, embraces virtually all aspects of Department of the Navy (DON) activities, and is grounded in both law and regulation. Primary Mission: A staff office within SECNAV, OJAG's primary mission is to support the Judge Advocate General (JAG) in providing legal and policy advice to the Secretary of the Navy. This mission: Extends to all legal matters (except for Board of Contract Appeals and Board for Correction of Naval Records) not under cognizance of the General Counsel. Secondary Mission: OJAG supports JAG in advising and assisting the Chief of Naval Operations (CNO) in formulating and implementing policies and initiatives pertaining to the provision of legal services within the Navy. | http://www.jag.navy.mil/ |
| Justice (in relation to Belmont Report) | The consideration of who ought to receive the benefits of research and bear its burdens, in the sense of "fairness in distribution" or "what is deserved." | ||
| K | |||
| Kefauver-Harris Amendment of 1962 | (US) Legislation requiring proof of effectiveness of a product before it can be marketed, requiring manufacturers to comply with GMP, and making FDA approval of an NDA the prerequisite for marketing. | ||
| Key Personnel (in terms of NIH) | Individuals, including the principal investigator and collaborators, who contribute in a substantive way to the scientific development or execution of a project, whether or not they receive compensation from the grant supporting that project. | ||
| Key Variable | Number of subjects, number of visits, and the primary efficacy or safety outcome data points regarded as critical in the original design, analysis, and decision-making portions of the clinical study. | ||
| L | |||
| Labels (in relation to Investigational Product) | 1.) Document for compliance with applicable labeling regulations and appropriateness of instructions provided to subjects. 2.) Information about medication (amount taken, how often, safety profile, etc.) written on the container, package, or wrapper and approved by regulatory agencies upon review / approval of the registration dossier submission (NDA). |
ICH E6 8.2.13 | |
| Labeling | See Labels (in relation to Investigational Product) | ||
| Laboratory (in terms of CLIA) | Any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health. | ||
| Laboratory Accreditation | 1.) A process resulting in a document issued by government authorized agencies, which indicates that a clinical laboratory's equipment meet certain required standards. 2.) Document on the competence of facility to perform required test(s) and support reliability of results. Examples include, but not limited to: College of American Pathologists, Clinical Laboratory Improvement Act. |
ICH E6 8.2.12 | |
| Laboratory Certification | See Laboratory Accreditation | ICH E6 8.2.12 | |
| Laboratory Data | The results of laboratory tests. | ||
| Laboratory Normal Ranges | See Laboratory Reference Ranges | ICH E6 8.2.11 | |
| Laboratory Normal Values | See Laboratory Reference Ranges | ICH E6 8.2.11 | |
| Laboratory Reference Ranges | Reference ranges of a laboratory test covering 95% of a sample population. Normal values obtained by lab personnel when performing assays that the laboratory is qualified to undertake on health individuals. Also referred to as "reference values," "normal laboratory values," or "reference ranges". | ICH E6 8.2.11 | |
| Laboratory Report | Typically a computer generated print-out of the results of the laboratory tests for a specific subject. | ||
| Laboratory Requisition | The request form that must be completed by the investigator or other study personnel to order a laboratory test. | ||
| Lactation | The period of time during which a woman is providing her breast milk to an infant or child. | ||
| Legally Acceptable Representative | ICH Definition: An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial. | ICH E6 1.37 | |
| Legally Authorized Representative | See Legally Acceptable Representative | ||
| Leiter Der Klinischen Prufung | LKP | The investigator required in every clinical trial in Germany. Investigators must be registered MDs, with at least two years of experience in clinical trials. | |
| Lethal Dose | LD | The dosage level of an investigational drug that is deadly. Also known as "acute lethality". | |
| License | Permission granted to an individual or organization by a competent authority, usually public, to engage lawfully in a practice, occupation, or activity. | ||
| Licensure | See License | ||
| Life-threatening | Any adverse drug experience that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction that, had it occurred in a more severe form, might have caused death. | 21 CFR 312.32 | |
| Limited Data Set (in relation to HIPAA) | Refers to PHI (Protected Health Information) that excludes 16 categories of direct identifiers and may be used or disclosed, for purposes of research, public health, or health care operations, without obtaining either an individual's authorization or a waiver of consent or an alteration of authorization for its use and disclosure, with a data use agreement. | ||
| Line Extension | Marketing term generally used to denote additional dosage forms of a particular drug product. | ||
| List (of New Drug Products) | Drug products with effective approvals published in the current edition of FDA's publication "Approved Drug Products with Therapeutic Equivalence Evaluations'' and any current supplement to the publication. | 21 CFR 314.3 | |
| Listed Drug | A new drug product that has an effective approval in the United States. | 21 CFR 314.3 | |
| Local Area Network | LAN | A local computer network for communication between computers; especially a network connecting computers and word processors and other electronic office equipment to create a communication system between offices. OR A data communications network which is geographically limited (typically to a 1 km radius) allowing easy interconnection of terminals, microprocessors and computers within adjacent buildings. Ethernet and FDDI are examples of standard LANs. Because the network is known to cover only a small area, optimizations can be made in the network signal protocols that permit data rates up to 100Mb/s. | |
| LOD Score | An expression of the probability that a gene and a marker are linked. | ||
| Long-Term Care | A variety of services that help people with health or personal needs and activities of daily living over a period of time. Long-term care can be provided at home, in the community, or in various types of facilities, including nursing homes and assisted living facilities. Most long-term care is custodial care. Medicare doesn’t pay for this type of care if this is the only kind of care you need. | ||
| Longitudinal Study | A trial in which data are collected from a number of subjects over a long period of time. | ||
| Lost to Follow-Up (in relation to Subject) | Subject who fails to return for scheduled follow up visit of a trial and never returns for any further evaluation. | ||
| Lot | A batch or or a specific identified portion of a batch having uniform character and quality within specified limits; or, in the case of a drug product produced by continuous process, a specific identified amount produced in a unit of time or quantity in a manner that ensures its having uniform character and quality within specific limits. | ||
| M | |||
| Magnetic Resonance Imaging | MRI | A noninvasive diagnostic technique that produces computerized images of internal body tissues and is based on nuclear magnetic resonance of atoms within the body induced by the application of radio waves. | |
| Malnutrition | A health problem caused by the lack (or too much) of needed nutrients. | ||
| Mammogram | A special x-ray of the breasts. | ||
| Managed Care | Includes Health Maintenance Organizations (HMO), Competitive Medical Plans (CMP), and other plans that provide health services on a prepayment basis, which is based either on cost or risk, depending on the type of contract they have. | ||
| Managed Care Organization | MCO | The term generally includes HMOs, PPOs, and Point of Service plans. These organizations include Federally Qualified Health Centers, integrated delivery systems, and public health clinics. | |
| Manual of Policy and Procedures | MAPP | See Standard Operating Procedures | |
| Marketed Product | A compound which has received regulatory approval and been made available commercially. | ||
| Marketing Application | An application for a new drug or a biologics license application for a biological product. | ||
| Marketing Application (as FDA Form) | The official form identified as 356H and used for an application (e.g., New Drug Application, Product License Application) or written request made by a sponsor-investigator to FDA for approval to market a new drug, biologic, or antibiotic to humans in the United States. | ||
| Marketing Authorization Application | MAA | (EU) Documentation necessary to obtain marketing approval for a new pharmaceutical product in Europe (c.f. NDA in US). The MAA consists of 4 Sections - Part I (Summary of Dossier), Part II (Chemical, Pharmaceutical & Biological Documentation), Part III (Pharmaco-Toxicological Documentation), and Part IV (Clinical Documentation). MAA is also used as a generic term for submissions requesting marketing approval. | |
| Marketing Studies | Studies (e.g., Phase 4) that are conducted to provide additional data to help promote an investigational product with an approved marketing application (e.g., New Drug Application) in the market place. | ||
| Masked Study Design | See Blinded Study Design | ||
| Masking | See Blinding | ICH E6 1.10 | |
| Mass Immunization Center | A location where providers administer pneumococcal pneumonia and influenza virus vaccination and submit these services as electronic media claims, paper claims, or using the roster billing method. This generally takes place in a mass immunization setting, such as a public health center, pharmacy, or mall but may include a physician's office setting. | 4408.8, Part 3 of MCM | |
| Master File (in relation to devices) | A reference source that a person submits to FDA which may contain detailed information on a specific manufacturing facility, process, methodology, or component used in the manufacture, processing, or packaging of a medical device. | 21 CFR 814.3 | |
| Master Patient Log | MPL | See Subject Identification Code List, Subject Enrollment Log, and/or Subject Screening Log | |
| Master Randomization List | Document for method of randomization of trial population | ICH E6 8.2.18 | |
| Master Subject Log | See Subject Identification Code List, Subject Enrollment Log, and/or Subject Screening Log | ||
| Mature Minor | Someone who has not reached adulthood (as defined by state law) but who may be treated as an adult for certain purposes (e.g., consenting to medical care). Note that a mature minor is not necessarily an emancipated minor. | ||
| Matched Pair (in relation to clinical trials) | A type of parallel trial design in which investigators identify pairs of subjects who are identical with respect to relevant factors, then randomize them so that one receives a treatment and the other receives another treatment. | ||
| Matching | A selectrion process used in case-control studies to ensure that control subjects are similar to the cases in specific characteristics that could influence study outcomes. Commonly used matching variables are age, sex, race, and socio-economic status. | ||
| Material Transfer Agreements and Evaluation Agreements | MTA | Agreements that authorize companies to use or evaluate chemical compounds, prototypes, biological materials and software programs within specific limits. | http://www.research.umich.edu/projects /transfers/materials_transfer.html |
| Material Transfer Form | MTF | Form for agreements that govern terms of use of materials provided to another investigator; should be considered a research contract; may cover intellectual property rights, publication, warranties, confidentiality and other topics. See: Materials Transfer Agreements. Forms can be downloaded from the UM Forms page. | |
| Maximum Tolerated Dose | MTD | 1.) The highest dose deemed tolerable by a subject, assessed according to predetermined and detailed safety assessments and observations in the clinical protocol. The MTD is generally determined during a dose escalation study. 2.) Dose that produces grade 3 (severe) or grade 4 (life-threatening) toxicity in 30% or fewer of the patients tested. |
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| Mean Value | The sum of the values of all observations or data points divided by the number of observations, an arithmetical average. | ||
| Measurement | The systematic process of data collection, repeated over time or at a single point in time. | ||
| Mechanism of Action | The
mechanism by which a pharmacologically active
substance produces an effect on a living organism or in a biochemical system.
The mechanism of action is usually considered to include an identification
of the specific molecular targets to which a pharmacologically active substance
binds or whose biochemical action it influences. A general recognition of
the broad biochemical pathways (such as DNA synthesis, protein synthesis,
cholesterol synthesis) which are inhibited or affected by a substance is
termed its mode of action. |
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| Med Watch Form (as FDA Form) | (US) The official “Medical Products Reporting Program” form completed by sponsors, user facilities, distributors, importers, applicants, and manufacturers for mandatory reporting of adverse events especially serious ones and product problems as designated by applicable United States laws and FDA regulations. | http://www.fda.gov/medwatch/ | |
| Median | The middle value in a data set when they are arranged in order of magnitude. That is, just as many values are greater than the median and lower than the median value (with an even number of values, the conventional median is halfway between the two middle values). | ||
| Mediate | To settle differences between two parties. | ||
| Medical Advisor | See Medical Monitor | ||
| Medical Device | See Device | ||
| Medical Device Amendments | MDA | Amendments to the Federal Food, Drug and Cosmetic Act passed in 1976 to regulate the distribution of medical devices and diagnostic products. | |
| Medical Device Reporting (in relation to FDA) | MDR | The mechanism for the Food and Drug Administration to receive significant medical device adverse events information from manufacturers, importers and user facilities, so they can be detected and corrected quickly. | http://www.fda.gov/cdrh/mdr/ |
| Medical Dictionary for Regulatory Activities | MedDRA | A standardized dictionary of medical terminology initiated by the International Conference on Harmonization. | |
| Medical Director | Typically the physician who heads medical or clinical development groups in industry situations (e.g., pharmaceutical, medical device, biotechnology companies). | ||
| Medical Doctor | MD | See Doctor of Medicine | |
| Medical Education Scholars Program | MESP | University of Michigan program is designed to prepare Medical School faculty members for leadership roles in medical education. | http://www.med.umich.edu/meded/MESP/ |
| Medical History | Information gathered about the subject’s general health status and problems experienced during his/her lifetime at the time of enrollment into a trial. | ||
| Medical License | A document issued by a State Board of Medicine that certifies that a physician is allowed to practice medicine in that state. | ||
| Medical Monitor | 1.) An individual at the sponsor company (or CRO), usually a physician, who is responsible for the clinical development of a product and the conduct and progress of a clinical trial(s). 2.) Physician who has medical authority for clinical trial. |
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| Medical Practice Computer System | A PC- or network-based computer system used to manage electronic patient files. Defined by the European Forum for GCP, such a system is neither sponsor-supplied nor trial specific. | ||
| Medical Records | MR | See Source Documents | |
| Medical Records Institute | An organization that promotes the development and acceptance of electronic health care record systems. | ||
| Medical Review / Utilization Review | Contractor reviews of insurance claims to ensure that the service was necessary and appropriate. | ||
| Medical School Grants Office | University of Michigan office reviews all proposals and material transfers with external funding/provider sources. | http://www.med.umich.edu/medschool /grants/index.html |
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| Medical School Institutional Review Board | IRBMED | See Institutional Review Boards of the Medical School | |
| Medical Underwriting | The process that an insurance company uses to decide, based on your medical history, whether or not to take your application for insurance, whether or not to add a waiting period for pre-existing conditions (if your State law allows it), and how much to charge you for that insurance. | ||
| Medically Necessary | Services or supplies that: are proper and needed for the diagnosis or treatment of your medical condition, are provided for the diagnosis, direct care, and treatment of your medical condition, meet the standards of good medical practice in the local area, and aren’t mainly for the convenience of you or your doctor. | ||
| Medically Responsible Clinician | A licensed medical doctor or other practitioner skilled and knowledgeable about caring for persons with the kinds of conditions / disease represented by the specific study population, who is designated by an investigator and approved by and IRB to evaluate whether decisionally incapable subjects' continued participation is appropriate in research that presents a minor increase over minimal risk is more than a minor increase over minimal risk. | ||
| Medicare | The federal health insurance program for: people 65 years of age or older, certain younger people with disabilities. | ||
| Medication | See Drug or Biological Product | ||
| Medicines Control Agency | MCA | (UK) The regulatory agency whose primary objective is to safeguard public health by ensuring that all medicines on the UK market meet appropriate standards of safety, quality, and efficacy. This agency approves or rejects CTX/CTC and PL applications. | |
| Mega trials | Massive randomized clinical trials that test the advantages of marginally effective investigational products by enrolling 10,000 or more subjects. | ||
| Member (in relation to IRBs) | A person who is listed on the roster of an IRB as a voting participant in IRB deliberations and actions. | ||
| Member State | (EU) Refers to member states of the Europeon Union: the United Kingdom, Germany, France, Italy, Spain, Portugal, Ireland, Belgium, the Netherlands, Denmark, Greece, Luxembourg, Finland, Austria, Sweden. | ||
| Memorandum of Understanding | MOU | A formal written agreement which sets forth the working arrangements between two groups (e.g., agencies, governments). | |
| Mentally Disabled (in terms of Subject) | See Cognitively Impaired (in terms of Subject) | ||
| Meta-Analysis | A statistical process for pooling data from many clinical trials and summarizing it through formal statistical means. Also called overview. | ||
| Metabolism (of a drug) | The manner in which a drug is acted upon (taken up, converted to other substances, and excreted) by various organs of the body. | ||
| Metabolism (in relation to pharmacokinetics) | The sum of the pharmacokinetic (PK) processes by which a substance is handled in the living body. | ||
| Methodology | The process by which something is conducted every time. | ||
| Mee-Too Drug | A new chemical entity (NCE) that is similar, but not identical, in molecular structure and mechanism of action to a pioneer NCE. | ||
| Michigan Institute for Clinical and Health Research | MICHR | A leading academic clinical research unit that strives to improve the quality and quantity of clinical research being performed at The University of Michigan, with particular attention focused on increasing federally funded clinical research. Formally called Center for the Advancement of Clinical Research. | http://www.michr.umich.edu/ |
| MIchigan Research LibrarY Network | MIRLYN | The library catalog of the University of Michigan. | http://www.lib.umich.edu/libhome/mirlyn /mirlynpage.html |
| Microfiche | A sheet of film, about the size of an index card, on which study documents may be transferred in a miniaturize form for archival purposes. | ||
| Mild Adverse Event | An event which does not pose any significant or permanent risk of harm to the subject. A mild adverse event is considered Grade I using CTC Common Toxicity Criteria (v 2.0). See also Severity |
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| Milestones | Explicit goals to be achieved at designated points of time. | ||
| Minimum Necessary | The least information reasonably necessary to accomplish the intended purpose of the use, disclosure, or request. Unless an exception applies, this standard applies to a covered entity when using or disclosing PHI or when requesting PHI from another covered entity. A covered entity that is using or disclosing PHI for research without Authorization must make reasonable efforts to limit PHI to the minimum necessary. A covered entity may rely, if reasonable under the circumstances, on documentation of IRB or Privacy Board approval or other appropriate representations and documentation under section 164.512(i) as establishing that the request for protected health information for the research meets the minimum necessary requirements. | ||
| Minimal Risk | The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. | 21 CFR 56.102 | |
| Minimum Scope of Disclosure (in relation to HIPAA) | The principle that, to the extent practical, individually identifiable health information should only be disclosed to the extent needed to support the purpose of the disclosure. | ||
| Minor (in terms of Subject) | A person who has not attained the legal age for consent to treatment or procedures involved in research under the applicable law of the jurisdiction in which the research will be conducted (e.g., 18 years in the state of Florida). | ||
| Minor Increase of Minimal Risk | The probability and magnitude of harm or discomfort anticipated in the research, including psychological harm and loss of privacy or other aspects of personal dignity, are only slightly greater in and of themselves that those ordinarily encountered during the performance if routine physical or psychological examination or tests. | ||
| Misconduct (in terms of Research) | Fabrication, falsification, or plagiarism in proposing, performing, or reporting research, or in reporting research results. | ||
| Misconduct in Science | See Misconduct (in terms of Research) | ||
| Modification (to the Protocol) | See Protocol Amendment | ||
| Mode | The value that is possessed by the greatest number of members of a population. The most frequently occurring value in a data set. | ||
| Modem | From modulator/demodulator. A device that converts the digital data that your computer uses into analog data that can travel on telephone lines. | ||
| Moderate Adverse Event | An event which does not pose any significant or permanent risk of harm to the subject. A mild adverse event is considered Grade I using CTC Common Toxicity Criteria (v 2.0). See also Severity |
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| Modified Total Direct Costs | MTDC | The basis on which most UM indirect costs are calculated. Calculated as total costs minus equipment, tuition, patient care costs, and the portion of a sub-contract in excess of $25,000. | |
| Monitor | Person employed by the sponsor or CRO who is responsible for determining that a trial is being conducted in accordance with the protocol. A monitor’s duties may include, but are not limited to, helping to plan and initiate a trial, assessing the conduct of trials, and assisting in data analysis, interpretation, and extrapolation. Monitors work with the clinical research coordinator to check all data and documentation from the trial. See also clinical research associate. | EU GCP | |
| Monitor Report | See Monitoring Report | ||
| Monitor Visit Report | See Monitoring Report | ||
| Monitoring | ICH Definition: The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s). | ICH E6 1.38 | |
| Monitoring Committee | See Independent Data Monitoring Committee | ICH E6 1.25 | |
| Monitoring Manual | Study-specific manual designed to help CRAs monitor the study. The manual generally includes items like the protocol, recent amendments, information about the protocol, therapeutic indication, completed "mock" CRFs with data field completion instructions, data entry and study conventions, SAE routing information (sponsor contact log), etc. The manual is also often given to study coordinators to aid them in study conduct. Also referred to as "CRA Manual", "CRF monitoring guidelines" or "CRF completion guidelines". |
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| Monitoring Report | ICH Definition: A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs. | ICH E6 1.39 | |
| Monitoring Strategy | A plan, particularly for a multi-center clinical study, that documents the monitoring strategy (e.g., frequency of monitoring, identification of source documents, percentage of source document vertification, etc.). The monitoring stretegy is usually included in the monitoring manual. | ||
| Monitoring Visit | A periodic visit by a CRA to an investigational site conducted to assess the progress of a clinical study, verify adherence to the protocol, and check the data quality, safety of human subjects, and the overall compliance with regulatory requirements. | ||
| Monitoring Visit Log | See Site Visit Log | ||
| Monitoring Visit Report | See Monitoring Report | ||
| Monitoring Visit Report Form | A sponsor-specific form used by a CRA to document activities conducted during a routine monitoring visit to an investigational site, including issues discussed and issues requiring follow-up. | ||
| Monthly Index of Medical Specialties | MIMS | (UK) A monthly list of all proprietaries (by trade name, and in pharmaceutical categories) currently available for the National Health Service (UK) or private prescribing. | |
| Morbidity | A diseased state, often used in the context of a "morbidity rate" (i.e., The rate of disease or proportion of diseased people in a population). In common clinical usage, any disease state, including diagnosis and complications is referred to as morbidity. | ||
| Morbidity Rate | The rate of illness in a population. The number of people ill during a time period divided by the number of people in the total population. | ||
| Mortality Rate | The death rate often made explicit for a particular characteristic (e.g., gender, sex, or specific cause of death). Mortality rate contains three essential elements: the number of people in a population exposed to the risk of death (denominator), a time factor, and the number of deaths occurring in the exposed population during a certain time period (the numerator). | ||
| Multi Center Trial | A clinical trial conducted according to a single protocol but at more than one site, and, therefore, carried out by more than one investigator. | ICH E6 1.40 | |
| Multiple Crossover Design | In a multiple crossover study design, multiple interventions (both control and test articles) are independantly administered to each subject group more than one time. Each switch to a treatment is called a period. This design is useful in identifying period effects. | ||
| Multiple Project Assurance | MPA | A document approved by OHRP from a prospective awardee or other institutional performance site to be engaged in Department of Health and Human Services conducted or supported research that assures institutional compliance with and implementation of regulations (i.e., 45 CFR Part 46) for the protection of human subjects. It is initially approved for three year periods and renewed for five-year intervals and will be replaced by a Federal Wide Assurance. | http://ohrp.osophs.dhhs.gov/humansubjects /assurance/asur.htm |
| Multiple-Source Drug | A drug product not protected by patents or other exclusive marketing rights and marketed by more than one company. | ||
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