Clinical Research Dictionary

Clinical Research Dictionary

(Glossary of Terms and Acronyms)

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T
Targeted Research (in terms of NIH)		Research funded as a result of the National Institutes of Health setting aside of dollars for a specific scientific area.
Telecommunication Standardization Sector of the International Telecommunications Union	ITU-T	The ITU Telecommunication Standardization Sector (ITU-T) is one of the three Sectors of the International Telecommunication Union (ITU). ITU-T's mission is to ensure an efficient and on-time production of high quality standards (Recommendations) covering all fields of telecommunications.	http://www.itu.int/ITU-T/
Telemedicine		Professional services given to a patient through an interactive telecommunications system by a practitioner at a distant site.
Telephone Report		1.) Notification via telephone to the FDA of unexpected fatal or life threatening advent associated with a clinical study. 2.) Documentation of a telephone contact in clinical trials, e.g., between a CRA and study coordinator regarding the eligibility of a subject. 3.) May also refer to the expedited reporting of an unexpected, fatal, or life-threatening experience associated with the use of the drug in a clinical study.
Teletypewriter	TTY	A TTY is a communication device used by people who are deaf, hard of hearing, or have a severe-speech impairment. A TTY consists of a keyboard, display screen, and modem. Messages travel over regular telephone lines. People who don’t have a TTY can communicate with a TTY user through a message relay center (MRC). An MRC has TTY operators available to send and interpret TTY messages.
Temporal Association		Connected in time. Temporal association can exist between any two or more occurrences linked in time. As it relates to adverse event assessment, it strengthens proof of causality.
Terms and Conditions		Legal terminology contained in a contract that controls various aspects of the performance of the University and the sponsor.
Test		A statistical test used to compare the means of two groups of test data.
Test Article		1.) Another term for an investigational product being tested in a clinical trial. 2.) (US) Any drug, device or biologic experimentally employed in human subjects participating in a clinical investigation. 3.) (UK) See Trial Medication
Test Procedure		Any investigational method (other than test articles) being developed, tested and evaluated, designed to develop or contribute to generalizable knowledge. Examples include surgical techniques and psychological therapy.
Therapeutic Intent		Intent to provide some benefit to improving a subject's condition (e.g., prolongation of life, shrinkage of tumor, or improved quality of life) even though cure or dramatic improvement cannot necessarily be effected (e.g., Phase 1 drug studies in which potentially toxic drugs are given to an individual with the hope of inducing some improvement in the patient's condition as well as assessing the safety and pharmacology of a drug).
Therapeutic Area		A grouping of indications or treatment areas that are defined by the drug sponsor (e.g., oncology, cardiovascular, anti-inflammatory, etc.).
Therapeutic Ratio		The minimum effective dose divided by the maximum safe dose. An ideal drug has a therapeutic ratio approaching zero; that is, a very small amount of the drug would be effective, but even large doses would be safe.
Therapeutic Research		Interventions that are designed to determine the efficacy and safety of a therapeutic or diagnostic method, and are not applied solely to enhance the well being of the individual research participant (not patient) who is sick.
Therapy		The treatment of disease or disorder by various methods
Thought Leader		See Opinion Leader
Thousands of bits per second	Kbps	data transmission
tmax		The time after dosing when Cmax occurs
Total Development Spending		The total amount spent by a sponsor in all pre-clinical and clinical (Phases I-IV) development and testing.
Total Grant Budget		The amount spent during the course of entire protocol on payments to investigators and clinical laboratories to conduct each protocol.
Total Patients		The number of patients or subjects enrolled over the course of an entire study, (i.e., all enrolled subjects regardless of whether all the subjects completed the study).
Total Sites		The total number of investigational sites at which at least one subject was enrolled during the course of the protocol. Sites which were closed or terminated are included, provided at least one subject had been enrolled.
Toxicity		An adverse effect of an intervention. If toxicity prevents people from taking more of an experimental drug, the toxicity is called dose limiting. See also adverse event.
		Grade I: Mild adverse event
		Grade II: Moderately severe adverse event
		Grade III: Severe adverse event
		Grade IV: Life-threatening or disabling adverse event
		Grade V: Death related to adverse event
Toxicity Studies		Studies designed to determine the onset, degree, and duration of adverse effects in animals. Information from these studies is used to predict the likelihood of similar effects in man (i.e., dose response, species response, prior experience of predictability); to correlate with pharmacology information of efficacy and drug metabolism on ADME and kinetics and present to clinicians for use in making benefit-risk and starting dose decisions, and to present to regulatory bodies for same purpose.
Toxicology		The study of the toxic pharmacology of a compound, i.e., the study of the potentially harmful effects of chemicals and physicals agents on living systems. It includes the identification of the stimulating agent and the mechanisms underlying its interactions with biotic systems, the prevention and treatment of negative responses and, in some cases, the recognition of beneficial uses of these interactions.
Toxicokinetics	TK	A subfield of toxicology that studies how toxins are absorbed by, metabolized by, and eliminated from the bodies of living things.
Trademark		A name, word, symbol, or device that allows the trademark owner to dictate its use in identifying a product, e.g., logos and brand names.
Training		Education or instruction in a certain area.
Transaction		The transmission of information between two parties to carry out financial or administrative activities related to health care. It includes the following types of information transmissions: Health care claims or equivalent encounter information. Health care payment and remittance advice. Coordination of benefits. Health care claim status. Enrollment and disenrollment in a health plan. Eligibility for a health plan. Health-plan premium payments. Referral certification and authorization. The HHS Secretary is also required to adopt standards for first report of injury, claims attachments, and other transactions that the HHS Secretary may prescribe by regulation.
Transition Provisions		A section of the Privacy Rule that permits covered entities to rely on express legal permission for use and disclosure of PHI, informed consent, or IRB-approved waiver of informed consent for research, provided the legal permission, informed consent, or IRB-approved waiver was obtained prior to the compliance date.
Transitional Device		A device subject to section 520(l) of the FDC (Act) and which FDA previously regulated as a new drug or an antibiotic drug before May 28, 1976	21 CFR 812.3
Transmission Control Protocol/Internet Protocol	TCP/IP	A protocol for communication between computers, used as a standard for transmitting data over networks and as the basis for standard Internet protocols.
Transplant		The surgical procedure that involves removing a functional organ from either a deceased or living donor and implanting it in a patient needing a functional organ to replace their nonfunctional organ.
Treatment		Medical or surgical management of a patient
Treatment Code		A list of subjects with their coorsponding treatment assignments. To avoid potential bias, the treatment assignment log is typically maintained by trial organizers who are not directly involved in treating and evaluating the subjects. See also Randomization Code
Treatment Duration		The time from a subject's first dosage of study medication to the last dosage. Typically, treatment duration does not include the periods of time the subject was on run-in or wash-out periods.
Treatment Emergent		An adverse event that emerges during treatment in the trial 1.) having been absent before the trial and/or 2.) worsens relative to the subject’s pretreatment state.
Treatment IND		1.) A method by which the FDA allows desperately ill patients to receive promising experimental drugs outside of clinical trials before the drugs are approved. 2.) (US) An FDA procedure for allowing subjects with immediately life-threatening illnesses of serious diseases, which non comparable or satisfactory alternative drug of therapy exists, to receive investigational drugs which are still in clinical development. The drugs must show "sufficient evidence of safety and effectiveness".
Treatment Investigational New Drug Application		A method by which the FDA allows sick patients to receive promising experimental drugs outside of clinical trials before the drugs are approved. The FDA generally approves treatment INDs for patients ineligible for clinical trials, usually during Phase III testing. See also Expanded Access.
Treatment, Payment and Operations (in relation to HIPAA)	TPO	Areas where covered entities may use or disclose protected health information (PHI) without the patient's authorization.
Treatment Trial		Clinical trials designed to test new methods for treating medical conditions or diseases
Trial Audit		See Audit
Trial Arm		See Study Arm
Trial Coordinator		See Study Coordinator
Trial Initiation Monitoring Report		Document such that trial procedures were reviewed with investigator and the investigator’s trial staff	ICH E6 8.2.20
Trial Master File		A hard copy of all the documentation relating to a clinical trial. See also Central File
Trial Medication		The medication administered to a subject according to the protocol of a clinical trial. In a comparable trial, this will include both the drug under investigation and the comparator.
Trial Number		See Study Number
Trial Site		The location(s) where trial-related activities are actually conducted.	ICH E6 1.59
Trial Subject		See Subject	ICH E6 1.57
Triple-Blind		1.) Knowledge of the treatment is concealed from the people who organize and analyze the data of a clinical study as well as from subjects and investigators. 2.) The design of a study in which knowledge of the treatment is concealed from those who organize and analyze the data, as well as from subjects and investigators.
Triple Masked		See Triple Blind
Tuberculosis	TB	A usually chronic highly variable disease that is caused by the tubercle bacillus and rarely in the U.S. by a related mycobacterium (Mycobacterium bovis), is usually communicated by inhalation of the airborne causative agent, affects especially the lungs but may spread to other areas (as the kidney or spinal column) from local lesions or by way of the lymph or blood vessels, and is characterized by fever, cough, difficulty in breathing, inflammatory infiltrations, formation of tubercles, caseation, pleural effusion, and fibrosis.
Tufts Center for the Study of Drug Development	Tufts CSDD	The Tufts Center for the Study of Drug Development is an independent, academic, non-profit research group affiliated with Tufts University. Founded in 1976, Tufts CSDD is internationally recognized for its scholarly analyses and thoughtful commentary on pharmaceutical issues. Tufts CSDD's mission is to provide strategic information for drug developers, regulators, and policy makers on improving the quality and efficiency of pharmaceutical development, research, and utilization.	http://csdd.tufts.edu/
Type 1 (or Type I) Error		1.) Error made when a null hypothesis is rejected but is actually true. Also called "false positive". 2.) Statistical term referring to an error made when a correct null hypothesis is not rejected.
Type 2 (or Type II) Error		1.) Error made when an alternative hypothesis is rejected when it is actually uniform resource locator. 2.) Statistical term referring to an error made when a correct null hypothesis is not rejected.
U
Unanticipated Adverse Device Effect		Any serious adverse effect on health or safety, or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or deaht was not previously identified in nature, severity, or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
Unanticipated event		An unanticipated problem may be either an actual harmful or unfavorable occurrence or any development that potentially increased the likelihood of harm occurring in the future.
Uncontrolled Trial		A trial in which no comparison group of subjects is studied.
Underlying condition		A disease or other circumstance affecting the research subject that is not a result of the intervention or experimental design of a research study.
Undue Influence		Unfair measures or influence to enroll persons in research
Unequal Randomization		A technique used to allocate subjects into groups at a differential rate (e.g., three subjects may be assigned to a treatment group for every one assigned to a control group).
Unexpected Adverse Drug Experience		See Unexpected Adverse Drug Reaction
Unexpected Adverse Drug Reaction		ICH Definition: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).	ICH E6 1.60
Unexpected Adverse Event		An experience not previously reported (in nature, severity, or frequency) in the current Investigator's Brochure, in the general investigational plan, or elsewhere.
Unexpected Event		An event or side effect that is not described in the informed consent document (ICD) (for purposes of reporting to the IRBMED). An event is unexpected if not described in the ICD even when the event or effect was foreseen by the investigator or sponsor as a possibility. See also Expected Event and Unexpected Magnitude, Duration or Frequency.
Unexpected Magnitude, Duration or Frequency		An event or occurrence(s) should be reported to the IRBMED according to the Timeline for unexpected events when the intensity (severity), how long the event takes or persists, or the rate of occurrence is different than described in the informed consent document (ICD), even if the event is otherwise described in the ICD. For example, the ICD notes that some subjects experience mild, brief ringing in the ears following an fMRI. If a subject experiences ringing of significant intensity (such that she cannot work or attend classes) or the ringing persists for several weeks, the event would be reportable as an unexpected event. Likewise, if elevated liver enzymes were described in the ICD as expected at statistical rate of 2% but monitoring revealed 10% of subjects experienced such elevations, this should be reported as an unexpected adverse event.
Uniform Anatomical Gift Act		Legislation adopted by all 50 States and the District of Columbia that indicates procedures for donation of all or part of a decedent's body for such activities as medical education, scientific research, and organ transplantation.
Unit for Laboratory Animal Medicine	ULAM	Provides veterinary care for animals on campus; provides animal housing facilities; educates students and faculty on use and care of animals in education and research.	http://www.ulam.umich.edu/
Unplanned Interim Analysis		An analysis which was not described in the study protocol, i.e., the decision to perform the analysis was made after study start.
Unsolicited Research (in terms of NIH)		See Investigator-Initiated Research (in terms of NIH)
Uniform Resource Locator	URL	Address of a Web page—actmagazine.com, for example.
United Kingdom	UK	A monarchy in northwestern Europe occupying most of the British Isles; divided into England and Scotland and Wales and Northern Ireland.
United States Code	USC	A consolidation and codification by subject matter of the general and permanent laws of the United States; is prepared and published by a unit of the United States House of Representatives.
United States Pharmacopeia	USP	1.) A book that is the officially recognized authority and standard on the description of drugs, chemicals, and medicinal preparations in the United States. 2.) (US) An official compendium consisting of two parts: the USP, covering all drug substances and drug products, and the National Formulary (NF), covering pharmaceutical ingredients. Together they are recognized as official compendia and provide the standards for the strength, quality, purity, packaging, and labeling of drugs and related articles.
University Committee for the Use and Care of Animals	UCUCA	Approves all use of vertebrate animals in UM research and education; advises University research officials on matters related to the use of animals in research and education.
University of Michigan	UM	Public university located primarily in Ann Arbor, Flint, and Dearborn, Michigan	http://www.umich.edu/
University of Michigan Health System	UMHS	A large healthcare complex comprised of the University of Michigan Medical School and its Faculty Group Practice, three University of Michigan hospitals, approximately 30 health centers, 120 outpatient clinics, M-CARE HMO and the Michigan Health Corporation	http://www.med.umich.edu/
University of Michigan Medical School	UMMS	Nationally recognized as a premiere site for state-of-the-art research activities, innovative medical education and pioneering clinical care since its inception in 1848.	http://www.med.umich.edu/ medschool/
Unrelated Event		Any adverse event for which there is evidence that it was definitely related to a cause other than the investigational drug/agent/therapy (e.g. disease progression). Investigators must be able to provide such evidence upon request. See also Cause, Attribution and Relatedness
Urgently Needed Care		Care for a sudden illness or injury that needs medical attention right away, but is not life threatening. Your primary care doctor generally provides urgently needed care if you are in a Medicare health plan other than the Original Medicare Plan. If you are out of your plan's service area for a short time and cannot wait until you return home, the health plan must pay for urgently needed care.
US Department of Agriculture	USDA	USDA remains committed to helping America's farmers and ranchers. USDA leads the Federal anti-hunger effort with the Food Stamp, School Lunch, School Breakfast, and the WIC Programs; steward of our nation's 192 million acres of national forests and rangelands; country's largest conservation agency, encouraging voluntary efforts to protect soil, water, and wildlife on the 70 percent of America's lands that are in private hands; brings housing, modern telecommunications, and safe drinking water to rural America; responsible for the safety of meat, poultry, and egg products; research leader in everything from human nutrition to new crop technologies that allow us to grow more food and fiber using less water and pesticides; helps ensure open markets for U.S. agricultural products and provides food aid to needy people overseas.	http://www.usda.gov/wps/portal /usdahome
Use		With respect to individually identifiable health information, the sharing, employment, application, utilization, examination, or analysis of such information within the entity or health care component (for hybrid entities) that maintains such information.
V
Vaccine		A biologic product generally made from an infectious agent or its components - a virus, bacterium, or other microorganism - that is killed (inactive) or live attenuated (active, although weakened).
Vaccine Adverse Event Reporting System	VAERS	The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). The purpose of VAERS is to detect possible signals of adverse events associated with vaccines. VAERS collects and analyzes information from reports of adverse events (possible side effects) that occur after the administration of US licensed vaccines. Reports are welcome from all concerned individuals: patients, parents, health care providers, pharmacists and vaccine manufacturers.	http://www.fda.gov/cber/ vaers/vaers.htm
Validation		The process by which the integrity and correctness of data are established. Validation processes can occur immediately after a data item is collected or after a complete set of data is collected.
Validity		The accuracy of the relationship between two or more variables.
Validity of Data		The procedures that are undertaken to confirm the authenticity of trial data.
Variable		1.) An element or factor that the research is designed to study, either as an experimental intervention or a possible outcome (or factor affecting the outcome) of that intervention. 2.) An item of data for which values are to be computerized after collection as specified in the study protocol (e.g., weight, age, blood pressure of subjects, etc.).
Variance		1.) A measure of the variability in a sample or population. It is calculated as the mean squared deviation (MSD) of the individual values from their common mean. In calculating the MSD, the divisor n is commonly used for a population variance and the divisor n_1 for a sample variance. 2.) Statistical term referring to the measure of the amount by which a value differs from the mean.
Verification/Validation of Data		THe procedures carried out to ensure that the data contained in the final clinical trial report match original observations. These procedures apply to raw data, hard copy, or electronic CRFs, computer printouts and statistical analyses and tables. See also Data Verification, Audit, and Quality Control
Veteran’s Affairs Ann Arbor Healthcare System	VAAAHS	Department of Veteran Affairs Medical Center that provides high quality, cost effective tertiary care to veterans residing in lower Michigan and northwestern Ohio	http://www.va.gov/sta/guide /facility.asp?ID=7
Veterans Affairs Human Research Protection Accreditation Program		Accreditation program operated by the National Committee for Quality Assurance (NCQA) to ensure that VA medical centers are complying with VA and other relevant federal regulations designed to protect human subjects of research.	http://www.ncqa.org/Programs/QSG /VAHRPAP/vahrpap.htm
Veteran’s Health Administration	VHA	Agency within the United States Department of Veteran Affairs that provides a broad spectrum of medical, surgical, and rehabilitative care to its customers (i.e., war veterans)	http://www.va.gov/health_benefits/
Viable Infant		When referring to a delivered or expelled fetus, the term "viable infant" means likely to survive to the point of sustaining life independently, given the benefit of available medical therapy [45 CFR 46.203(d)]. This judgment is made by a physician. In accordance with DHHS regulations, the Secretary, HHS, may publish guidelines to assist in the determination of viability. Such guidelines were published in 1975, and specify an estimated gestational age of 20 weeks or more and a body weight of 500 grams or more as indices of fetal viability [Federal Register 40 (August 8, 1975): 33552]. These indices depend on the state of present technology and may be revised periodically. See also Nonviable Fetus
Visit Report Form		A detailed report, which documents any new information, gathered by sponsor personnel while visiting a site, pertaining to the capabilities of the study team. The visit report form also establishes a record of all commitments made by and to the study staff, and chart the progress of the study at that site.
Vital Signs		The signs of life, namely pulse, respiration, and temperature.
Vocational Rehabilitation		The process of facilitating an individual in the choice of or return to a suitable vocation. When necessary, assisting the patient to obtain training for such a vocation. Vocational rehabilitation can also mean to preparing an individual regardless of age, status (whether U.S. citizen or immigrant) or physical condition to cope emotionally, psychologically, and physically with changing circumstances in life, including remaining at school or returning to school, work, or work equivalent (homemaker).
Voluntary (in terms of Informed Consent)		Free of coercion, duress, or undue inducement.
Voluntary Action Indicated	VAI	FDA inspection classification indicating that the site inspected has violations that do not immediately jeopardize subject safety, corrective action is required in a formal response to FDA, and follow-up inspection may be possible
Volunteer		See Healthy Volunteer
Vulnerable Populations		See Vulnerable Subjects
Vulnerable Subjects		ICH Definition: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.	ICH E6 1.61
W
Waiver		1.) The act of voluntarily giving up a right, claim or privilege. 2.) A written agreement by the regulatory authorities (FDA) to accept some deviation from applicable guidelines. In a clinical trial, waivers should be obtained before the study starts.
Waiver of Authorization (in relation to HIPAA)		A waiver of the requirement to obtain patient authorization prior to the use of disclosure of protected health information (PHI) for research purposes.
Waiver of Informed Consent (in relation to IRBs)		An action taken by the IRB permitting the investigator to pursue research involving human subjects without obtaining informed consent
Ward		A child who is placed in the legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State, or local law.	21 CFR 50.3
Warning Letter	WL	A written communication from FDA notifying an individual or firm that the agency considers one or more products, practices, processes, or other activities to be in violation of the Federal FD&C Act, or other acts, and that failure of the responsible party to take appropriate and prompt action to correct and prevent any future repeat of the violation may result in administrative and/or regulatory enforcement action without further notice. (FDA)	http://www.fda.gov/foi/ warning.htm
Washout Period		A period in the clinical study during which subjects receive no treatment for the indication under study and the effects of a previous treatment are eliminated (or assumed to be eliminated).
Web Browser		A computer program that interprets HTML and other Internet languages and protocols and displays Web pages on your computer monitor.
Web Server		A computer program that delivers HTML pages or files. Sometimes the computer on which a server program runs is also referred to as a server.
Web Site		A collection of Web pages and other files. A site can consist of a single Web page, thousands of pages, or custom created pages that draw on a database associated with the site.
Weighting		An adjustment in a value on the basis of a judgment by the investigator. (statistics)
Well-being (of the trial subjects)		ICH Definition: The physical and mental integrity of the subjects participating in a clinical trial.	ICH E6 1.62
Wide Area Network	WAN	A computer network that spans a wider area than does a local area network.
Withdrawal (in terms of Subject)		Subject who are taken off a clinical trial by the investigator for any number of reasons (e.g., serious adverse event, lack of efficacy, poor compliance with protocol)
Withdrawn IND Status		(US) The sponsor of an IND can withdraw an IND at any time and for any reason. When a sponsor withdraws an IND, all clinical investigations being conducted under the IND must be ended, all investigators notified, and all stocks of the drug returned to the sponsor or otherwise disposed of at the request of the sponsor.
Within-Subject (Patient) Differences		In a crossover trial, variability in each patient is used to assess treatment differences. (statistics)
Witness (with regards to Informed Consent)		See Impartial Witness
Whistleblower (in terms of Misconduct)		A person who makes an allegation of scientific misconduct
Women of Child-Bearing Potential		Generally considered to be females of 12 years of age (or younger, depending on sexual maturation) and older who have not undergone menopause or surgical sterilization. Post-menopausal women are considered of child-bearing potential until they have not had any menstrual bleeding for two or more years.
Workforce		Employees, volunteers, trainees, and other persons whose conduct, in the performance of work for a covered entity, is under the direct control of the covered entity, whether or not they are paid by the covered entity.
Workers Compensation		Insurance that employers are required to have to cover employees who get sick or injured on the job.
Workgroup For Electronic Data Interchange		A health care industry group that has a formal consultative role under the HIPAA legislation (also sponsors SNIP).
World Health Organization	WHO	The World Health Organization is the United Nations specialized agency for health. It was established on 7 April 1948. WHO's objective, as set out in its Constitution, is the attainment by all peoples of the highest possible level of health. Health is defined in WHO's Constitution as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.	http://www.who.int/en/
World Trade Organization	WTO	The World Trade Organization (WTO) is the only global international organization dealing with the rules of trade between nations. At its heart are the WTO agreements, negotiated and signed by the bulk of the world’s trading nations and ratified in their parliaments. The goal is to help producers of goods and services, exporters, and importers conduct their business.	http://www.wto.org/
World Wide Web	WWW	All the resources and users on the Internet that are using HTTP protocols. Also called the Web.
Writer's Guide		A guide to the style, content, and format of a company document (usually the protocol or final report). It is used by a document author to ensure consistency of all similar documents.
Other Acronym Lists and Glossaries
ACP Journal Club http://www.acpjc.org/shared/glossary.htm
Acronym Finder (Acronyms): http://www.acronymfinder.com/
Applied Clinical Trials (ACT) (Glossary): http://www.actmagazine.com/appliedclinicaltrials/data/articlestandard /appliedclinicaltrials/012002/42076/article.pdf
Biomedical Research Alliance of New York (BRANY) (Glossary): Biomedical Research Alliance of New York (BRANY) Institutional Review Board Guidebook (Glossary): http://www.brany.com/Glossary.shtml
Center for Devices and Radiological Health (CDRH) (Glossary): http://www.fda.gov/cdrh/devadvice/ide/index.shtml
Centers for Medicare and Medicaid Services (CMS) (Glossary): http://www.cms.gov/glossary/
Centerwatch (Glossary): http://www.centerwatch.com/patient/glossary.html
Department of Health and Human Services (DHHS) (Acronyms): http://aspe.hhs.gov/daltcp/acronym.shtml
Department of Health and Human Services (DHHS) (Glossary): http://aspe.hhs.gov/daltcp/diction.shtml#RN
Department of Health and Human Services Health Insurance Portability and Accountability Act (DHHS HIPAA) Privacy Rule (Glossary): http://privacyruleandresearch.nih.gov/pr_12.asp
Division of Research and Development Administration (DRDA) (Acronyms): http://www.research.umich.edu/aids/acronyms_glossary/acronyms.html
Division of Research and Development Administration (DRDA) (Glossary): http://www.research.umich.edu/aids/acronyms_glossary/acronyms.html
Food and Drug Administration (FDA) (Index): http://www.fda.gov/opacom/hpchoice.html
Food and Drug Law Institute (FDLI) (Acronyms): http://www.fdli.org/acronyms/
HIPAA Advisory (Acronyms): http://www.hipaadvisory.com/action/faqs/glossary.htm
IRB Forum (Acronyms): http://www.irbforum.com/forum/read/6/50/50
National Institutes of Health (NIH) (Acronyms): http://grants1.nih.gov/grants/acronym_list.htm
National Institutes of Health (NIH) (Glossary): http://grants1.nih.gov/grants/glossary.htm
Office of Human Research Protection (OHRP) IRB Guidebook (Glossary): http://www.hhs.gov/ohrp/irb/irb_glossary.htm
Office of Technology and Transfer (OTT) (Glossary): http://www.techtransfer.umich.edu/index/glossary.html
Research at Clemson University (Glossary): http://www.clemson.edu/research/orcSite/orcIRB_DefsA.htm
University of Michigan IRBMED (Glossary): http://www.med.umich.edu/irbmed/ae/glossary.htm
University of Michigan Medical School (Acronyms): http://www.med.umich.edu/medschool/staff/handbook/acronyms.html
WebMD (Glossary): http://my.webmd.com/content/pages/13/65826.htm?lastselectedguid={5FE84E90-BC77-4056-A91C-9531713CA348

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