Clinical Research Dictionary

Clinical Research Dictionary

(Glossary of Terms and Acronyms)

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G
Gas Chromatography	GC	A process by which the components of a mix are separated from one another by volatilizing the sample into a carrier gas stream and passing the gas through a column containing a substance that selectively retains (adsorbs) and releases the volatile constituents.
General Accounting Office	GAO	An oversight organization reporting to Congress of the United States
General Assurance		Obsolete term, previously used to denote an institutional assurance covering multiple research projects or multiple project assurances.
General Clinical Research Center	GCRC	One of 79 NIH-funded clinical research centers at leading hospitals throughout the United States located within the University of Michigan Medical Center	http://www.med.umich.edu/gcrc/
General Controls		Certain FDA statutory provisions designed to control the safety of marketed drugs and devices. The general controls include provisions on adulteration, misbranding, banned devices, good manufacturing practices, notification and record keeping, and other sections of the Medical Device Amendments to the Food, Drug and Cosmetic Act.	21 U.S. Code §360(c) (Food, Drug and Cosmetic Act §513)
General Practitioner	GP	A physician or veterinarian whose practice is not limited to a specialty
Generic Drug		Medications with the same active ingredients as brand-name drugs, which are marketed after patents on brand-name drugs have expired. Both brand-name and generic drugs are tested in clinical trials.
Gene Therapy		The treatment of genetic disease accomplished by altering the genetic structure of either somatic (nonreproductive) or germ line (reproductive) cells.
Gene Therapy Patient Tracking SYstem	GTPTS	FDA system for the collection and analysis of information pertinent to the safety of gene therapy recipients	http://www.fda.gov/cber/genetherapy /gttrack.htm
Genetic Screening		Tests to identify persons who have an inherited predisposition to a certain phenotype or who are at risk of producing offspring with inherited diseases or disorders.
Genotype		The genetic constitution of an individual.
Gift		Funds from a private source that do not provide a benefit to the donor, including results from a defined project.
Gigabits or Billions of Bits per Second (data transmission)	Gbps	A unit of information transfer rate equal to one billion bits per second. Note that, while a gigabit is defined as a power of two (2^30 bits), a gigabit per second is defined as a power of ten (10^9 bits per second, which is slightly less) than 2^30).
Good Clinical Practice	GCP	1.) (US) The body of regulations and guidelines specifying the responsibilities of sponsors, investigators, monitorings, and IRBs involved in clinical trials, the purpose of which is: a.) to ensure the protection of the safety, rights, and welfare of the clinical trial subjects; and b.) to ensure the quality and integrity of the clinical data collected. 2.) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. 3.) (EU) A standard by which clinical trials are designed, implemented and reported so that there is a public assurance that the data are credible, and the rights, integrity, and confidentiality of subjects are protected.	ICH E6 1.24
Good Clinical Research Practice	GCRP	See Good Clinical Practice
Good Guidance Practice (in terms of Regulation)	GGP	FDA policies and procedures for developing, issuing and using guidance documents
Good Laboratory Practice	GLP	A standard for the conduct and reporting of non-clinical laboratory studies and are intended to assure the quality and integrity of safety data submitted to regulatory authorities.
Good Manufacturing Practice	GMP	A standard governing the manufacture of human and animal drugs and biologics
Government Printing Office	GPO	GPO is the federal government’s primary centralized resource for gathering, cataloging, producing, providing, authenticating, and preserving published information in all its forms. GPO is responsible for the production and distribution of information products and services for all three branches of the federal government.
Graduate Student Research Assistant	GSRA	An appointment which may be provided to a student in good standing in a University of Michigan graduate degree program who performs personal research (including thesis or dissertation preparation) or who assists others performing research that is relevant to his or her academic goals.
Grant		A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Grantee		The organization or individual awarded a grant or cooperative agreement and is responsible and accountable for the use of the funds provided and for the performance of the grant-supported project or activities.
Gross Domestic Product	GDP	The total dollar value of all goods and services produced in a year in the United States, regardless of who supplies the labor or property.
Group Sequential Design		A trial design that allows a look at the data at particular time points or after a defined number of patients have been entered and followed up based on formulating a stopping rule derived from repeated significance tests.
Guardian		An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care when general medical care includes participation in research.	21 CFR 50.3 45 CFR 46.402 (e)
Guidelines		Guidelines are systematically developed by appropriate groups to assist practitioners and patient decisions about appropriate health care for specific clinical circumstances.
H
Handling Instructions (in relation to Investigational Product)		Document for instructions needed to ensure proper storage, packaging, dispensing and disposition of investigational products.	ICH E6 8.2.14
Handwritten Signature		The scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.	21 CFR 11.3
Harmonized Standard		(EU) A European Norm (EN) that has been accepted by all Member States and published in the Official Journal of the European Communities.
Health Authority (UK)	HA	The NHS was set up 56 years ago and is now the largest organization in Europe. It is recognized as one of the best health services in the world by the World Health Organization but there need to be improvements to cope with the demands of the 21st century. The NHS is changing the way it works to make sure patients always come first. The information and clickable diagram below shows you how the new structure works in England. For information on the health service in other parts of the UK, please visit the NHS in Northern Ireland, the NHS in Scotland or the NHS in Wales.	http://www.nhs.uk/
Health and Human Services	HHS	See Department of Health and Human Services (DHHS)
Health Care (in relation to HIPAA)		Care, services, or supplies related to the health of an individual, including: 1.) preventive, diagnostic, therapeutic, rehabilitative, maintenance, or palliative care, and counseling, service, assessment, or procedure with respect to the physical or mental condition, or functional status, of an individual that affects the structure or function of the body; and 2.) sale or dispensing of a drug, device, equipment, or other item in accordance with a prescription.
Health Care Agent		Legally authorized representative to whom authority to make health decisions delegate under a health care proxy as authorized by Public Health Law Article 29-C.
Health Care Clearinghouse		A public or private entity, including a billing service, repricing company, community health management information system or community health information system, and "value-added" networks and switches that either process or facilitate the processing of health information received from another entity in a nonstandard format or containing nonstandard data content into standard data elements or a standard transaction, or receive a standard transaction from another entity and process or facilitate the processing of health information into a nonstandard format or nonstandard data content for the receiving entity.
Health Care Financing Administration	HCFA	See Centers for Medicare and Medicaid (CMS)
Health Care Provider (in relation to HIPAA)		Any person, business, or agency that furnishes, or bills or receives payment for health care in the normal course of business.
Health Care Proxy		Document delegating authority to make health care decisions executed in accordance with the requirements of Public Health Law Article 29-C.
Health Industry Manufacturers Association	HIMA	AdvaMed is the world's largest medical technology association representing manufacturers of medical devices, diagnostic products and medical information systems.	http://www.1800miti.com/associations /pagea033himf.html
Health Information		Any information, whether oral or recorded in any form or medium, that: 1.) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and 2.) relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual.
Health Insurance Portability and Accountability Act	HIPAA	Refers to United States legislation of 1996 (privacy rules effective April 14, 2003) that requires health care providers and others to obtain written authorization from patients or their legally authorized representatives before using or disclosing their Protected Health Information (PHI) for many purposes other than treatment, billing, quality assurance, and education. Research is one of the activities for which written authorization is required in most cases.	http://www.hhs.gov/ocr/hipaa/
Health Level 7	HL7	A clinical data interchange messaging system in which messages are structured according to a predefined format and sent from one system to another. The sending system needs to know only how to convert its data into an HL7 message; the receiving system needs to know only how to extract the data.
Health Maintenance Organization	HMO	A medical group practice plan that acts as both an insurer and health care provider. Group participants are entitled to services from participating physicians, clinics and hospitals for a flat monthly or quarterly fee.
Health Plan (in relation to HIPAA)		For the purposes of Title II of HIPAA, an individual or group plan that provides or pays the cost of medical care (section 2791(a)(2) of the PHS Act, 42 U.S.C. 300gg-91(a)(2)) and including entities and government programs listed in the Rule. Health plan excludes: 1.) any policy, plan, or program to the extent that it provides, or pays for the cost of, excepted benefits that are listed in section 2791(c)(1) of the PHS Act, 42 U.S.C. 300gg-91(c)(1); and 2.) a government-funded program (unless otherwise included at section 160.103 of HIPAA) whose principal purpose is other than providing, or paying for the cost of, health care or whose principal activity is the direct provision of health care to persons or the making of grants to fund the direct provision of health care to persons.
Health Protection Branch	HPB	The regulatory branch of the government that regulates clinical investigations in Canada.
Healthcare Common Procedural Coding System	HCPCS	A medical code set that identifies health care procedures, equipment, and supplies for claim submission purposes. It has been selected for use in the HIPAA transactions. HCPCS Level I contains numeric CPT codes which are maintained by the AMA. HCPCS Level II contains alphanumeric codes used to identify various items and services that are not included in the CPT medical code set. These are maintained by HCFA, the BCBSA, and the HIAA. HCPCS Level III contains alphanumeric codes that are assigned by Medicaid state agencies to identify additional items and services not included in levels I or II. These are usually called "local codes", and must have "W", "X", "Y", or "Z" in the first position. HCPCS Procedure Modifier Codes can be used with all three levels, with the WA - ZY range used for locally assigned procedure modifiers.
Healthcare Financial Management Association	HFMA	An organization for the improvement of the financial management of healthcare-related organizations. The HFMA sponsors some HIPAA educational seminars.
Health Services Research	HSR	The multidisciplinary field of scientific investigation that studies how social factors, financing systems, organizational structures and processes, health technologies, and personal behaviors affect access to health care, the quality and cost of health care, and ultimately our health and well-being
Healthy Volunteer		See Subject
Hedis Measures From Encounter Data	HEDIS	Measures from encounter data as opposed to having the plans generate HEDIS measures. HEDIS is a collection of performance measures and their definitions produced by the National Committee for Quality Assurance (NCQA).
Helsinki Declaration		See Declaration of Helsinki
Hematocrit		A measure of red blood cell volume in the blood.
Hemodiafiltration		Simultaneous hemodialysis and hemofiltration which involves the removal of large volumes of fluid and fluid replacement to maintain hemodynamic stability. It requires the use of ultra pure dialysate or intravenous fluid for volume replacement. Also called high flux hemodiafiltration and double high flux hemodiafiltration.
Hemodialysis	HD	This treatment is usually done in a dialysis facility but can be done at home with the proper training and supplies. HD uses a special filter (called a dialyzer or artificial kidney) to clean your blood. The filter connects to a machine. During treatment, your blood flows through tubes into the filter to clean out wastes and extra fluids. Then the newly cleaned blood flows through another set of tubes and back into your body (See dialysis and peritoneal dialysis.).
Hemofiltration		Fluid removal.
Heterologous		Consisting of different elements, or of elements in differing proportions.
High Performance Liquid Chromatography	HPLC	Liquid chromatography in which the degree of separation is increased by forcing a solvent under pressure through a densely packed adsorbent
HIPAA Authorization Form		An entity may not use or disclose protected health information (PHI) with a valid authorization, which may be part of the consent form or a separate document presented as an attachment to the consent form.
Historical Control (in terms of Subject)		Subjects (followed at some time in the past or for whom data are available through records) who are used for comparison with subjects being treated concurrently
Home Patients		Medically-able individuals, who have their own dialysis equipment at home and after proper training, perform their own dialysis treatment alone or with the assistance of a helper.
Homebound		Normally unable to leave home unassisted. To be homebound means that leaving home takes considerable and taxing effort. A person may leave home for medical treatment or short, infrequent absences for non-medical reasons, such as a trip to the barber or to attend religious service. A need for adult day care doesn't keep you from getting home health care.
Hospice		Hospice is a special way of caring for people who are terminally ill, and for their family. This care includes physical care and counseling. Hospice care is covered under Medicare Part A (Hospital Insurance).
Hospice Care		A special way of caring for people who are terminally ill, and for their family. This care includes physical care and counseling. Hospice care is covered under Medicare Part A (Hospital Insurance).
Hospital		An institution whose primary function is to provide inpatient diagnostic and therapeutic services for a variety of medical conditions, both surgical and nonsurgical.
Hospitalist		A doctor who primarily takes care of patients when they are in the hospital. This doctor will take over your care from your primary doctor when you are in the hospital, keep your primary doctor informed about your progress, and will return you to the care of your primary doctor when you leave the hospital.
Hospitalization		Typically, the term 'hospitalization' refers to the admission of a
Human Experimentation Committee		See Institutional Review Board
Human In Vitro Fertilization		Any fertilization involving human sperm and ova that occurs outside the human body.
Human Protections Administrator (in relation to OHRP)		The primary contact person for human subjects protection issues at a United States institution (e.g., university) filing for a Federal Wide Assurance (FWA).
Human Research Coordinating Council	HRCC	A University of Michigan committee under the jurisdiction of the Office of the Vice President for Research (OVPR) that oversees campus-wide policies, programs and initiatives related to the protection of human subjects including IRBs.	http://www.research.umich.edu /policies/um/HRCC.html
Human Research Ethics Committee	HREC	See Independent Ethics Committee
Human Research Protection Program		The systematic and comprehensive approach by an organization to ensure human subject protection in all research in its setting and to implement any part of the approach by delegation to specific committees within the organization.
Human Subject		See Subject
Human Subjects Research Advisory Committee	HSRAC	A committee working under the direction of the Office of Human Subjects Research (OHSR) in the National Institutes of Health (NIH) that advises the NIH Deputy Director for Intramural Research on policies and procedures regarding the conduct of human subjects research in the Intramural Research Program (IRP)	http://206.102.88.10/ohsrsite /human/human.html
Human Subject Review Committee	HSRC	See Institutional Review Board
Humanitarian Device Exemption	HDE	Pre-market approval application that seeks exemption for a humanitarian use device from the effectiveness requirements	21 CFR 814.3
Humanitarian Use Device	HUD	Medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.	21 CFR 814.3
Huriet Law		France’s regulations covering the initiation and conduct of clinical trials.
Hybrid Entity		A single legal entity that is a covered entity, performs business activities that include both covered and non-covered functions, and designates its health care components as provided in the Privacy Rule. If a covered entity is a hybrid entity, the Privacy Rule generally applies only to its designated health care components. However, non-health care components of a hybrid entity may be business associates of one or more of its health care components, depending on the nature of their relationship.
Hydration		This is the level of fluid in the body. The loss of fluid, or dehydration, occurs when you lose more water or fluid than you take in. Your body cannot keep adequate blood pressure, get enough oxygen and nutrients to the cells, or get rid of wastes if it has too little fluid.
Hypertext		Links in a document that permit you to jump immediately to another document. In most Web browsers links are displayed as colored, underlined text.
Hypertext Markup Language	HTML	A set of codes that describe the way type, graphics, and other elements are displayed on a Web page.
Hypertext Transfer Protocol	HTTP	A protocol (utilizing TCP) to transfer hypertext requests and information between servers and browsers
Hypothesis Testing		A scientific method which begins with the statement of a null and an alternate hypothesis, the choice of the level of statistical significance (critical region), computation of test statistic, and conclusion (rejection of null hypothesis) if the value of the test statistic falls in the critical region.
I
Immunosuppressive Drugs		Transplant drugs used to reduce the risk of rejecting the new organ after transplant. Transplant patients will need to take these drugs for the rest of their lives.
Impartial Witness		A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.	ICH E6 1.26
Implant		A device that is placed into a surgically or naturally formed cavity of the human body and is intended to remain there for a period of 30 days or more
In vitro		Literally, "in glass" or "test tube"; used to refer to processes that are carried out outside the living body, usually in the laboratory, as distinguished from in vivo.
In Vitro Fertilization	IVF	Fertilization of an egg in a laboratory dish or test tube; specifically: mixture usually in a laboratory dish of sperm with eggs which have been surgically removed from an ovary that is followed by implantation of one or more of the resulting fertilized eggs into a female's uterus
In Vitro Fertilization / Embryo Transfer	IVF/ET	Fertilization of an egg in a laboratory dish or test tube; specifically: mixture usually in a laboratory dish of sperm with eggs which have been surgically removed from an ovary that is followed by implantation of one or more of the resulting fertilized eggs into a female's uterus.
In Vitro Testing		Non-clinical testing conducted in an artificial environment such as a test tube or culture medium.
In vivo		Literally, "in the living body"; processes, such as the absorption of a drug by the human body, carried out in the living body rather than in a laboratory (in vitro).
In Vivo Testing		Testing conducted in living animal and human systems.
Inactive IND Status		(US) An IND on inactive status is one under which clinical investigations are not being conducted.
Incapacity (in terms of Subject)		Refers to a person's mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice
Incidence/Frequency		How often an event or effect occurred in a population.
Inclusion Criteria		Refers to the characteristics that would allow a subject to participate in a clinical trial, as outlined in the study protocol.
Incompetence (in terms of Subject)		See Incapacity (in terms of subject)
Indemnification		A legal statement or document indicating protection or exemption from liability for compensation or damages from a third party
Independent Consent Monitor		Disinterested adult who is designated by an Institutional Review Board, to monitor the informed consent process when a legally authorized representative is considering whether to give informed consent to the participation by decisional incapacitated individuals in research
Independent Data Monitoring Committee	IDMC	An independent data monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.	ICH E6 1.25
Independent Data and Safety Monitoring Board		See Independent Data Monitoring Committee
Independent Ethics Committee	IEC	An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical/scientific professionals and nonmedical/nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The legal status, composition, function, operations, and regulatory requirements pertaining to Independent Ethics Committees may differ among countries.	ICH E6 1.27
Independent Laboratory		A freestanding clinical laboratory meeting conditions for participation in the Medicare program and billing through a carrier. OR, A laboratory certified to perform diagnostic and/or clinical tests independent of an institution or a physician's office.
Independent Variables		The conditions of an experiment that are systematically manipulated by the investigator.
Indication		1.) The basis for initiation of a treatment for a disease or of a diagnostic test 2.) The defined disease, syndrome, or clinical condition for which an investigational product may be given under a clinical protocol and for which it may, after regulatory approval, be prescribed under approved labeling.
Indirect Costs	IDC	Also known as Facilities and Administrative Costs. The costs of operations which generally cannot be assigned to specific projects, such as electricity and central administrative services; sometimes referred to as "overhead."
Individually Identifiable Health Information (in terms of HIPAA)		Information that is a subset of health information, including demographic information collected from an individual, and 1.) is created or received by a health care provider, health plan, employer, or health care clearinghouse; and 2.) relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and a.) that identifies the individual; or b.) with respect to which there is a reasonable basis to believe the information can be used to identify the individual.
Individual Investigator Award		Generally a single project or series of closely related projects under the direction of a single investigator.
Industrial Affiliates		Programs authorized within the University to encourage interactions with business and industry; in return for fees, members receive general benefits.
Ineligibility (in relation to subjects)		Subjects who do not meet one or more inclusion and exclusion criteria identified by the protocol
Information Technology	IT	The development, installation, and implementation of computer systems and applications. Applied computer systems - both hardware and software, and often including networking and telecommunications, usually in the context of a business or other enterprise. Often the name of the part of an enterprise that deals with all things electronic. The term "computer science" is usually reserved for the more theoretical, academic aspects of computing, while the vaguer terms "information systems" (IS) or "information services" may include more of the human activities and non-computerized business processes like knowledge management. Others say that IT includes computer science.
Informed Consent	IC	1.) ICH Definition: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form. 2.) The voluntary confirmation of a subject's willingness to participate in a particular trial, and the documentation thereof. This confirmation should only be sought after information has been given about the trial including an explanation of its objectiveness, potential benefits, and risks and inconveniences, and of the subject's rights and responsibilities in accordance with the current revision of the Declaration of Helsinki.	ICH E6 1.28
Informed Consent Document	ICD	See Informed Consent Form
Informed Consent Form	ICF	1.) A document of information given to trial subject(s) that documents the informed consent process. 2.) The form prepared by the investigator and/or the sponsor, and approved by the IEC/IRB, which must be signed by the subject before entry in a clinical trial. It is the legal written record that the subject, or his/her representative, agrees to voluntarily participate in the investigation. Also referred to as "consent form" or "subject consent form".	ICH E6 8.2.3
Infusion Pumps		Pumps for giving fluid or medication into your vein at a specific rate or over a set amount of time.
Initial Visit		1.) The first routine monitoring visit that is conducted after the first few subjects have been enrolled. The initial visit is a unique oportunity for the CRA to determine whether the study staff understands the protocol and the study procedures. 2.) May also refer to a clinical subject's first office visit in a clinical trial.
Initiative (in terms of NIH)		A request for applications (RFA), request for proposals (RFP), or program announcement (PA) stating the National Institutes of Health’s interest in receiving research applications in a given area because of a programmatic need or scientific opportunity.
In-Kind Contribution		Non-monetary cost sharing, often consisting of equipment which is donated or loaned for a project.
Innovative Therapy		When a clinician departs in a significant way from standard or accepted practice entirely for the benefit of a particular individual patient, and with consent. It need not constitute research, though it may be described as an experiment in the sense that it is novel and invalidated, but extension of such an experiment into wider use of general application should be regarded as research.
Inpatient Care		Health care that you get when you are admitted to a hospital.
Inpatient Hospital		A facility, other than psychiatric, which primarily provides diagnostic, therapeutic (both surgical and non-surgical) and rehabilitation services by or under the supervision of physicians, to patients admitted for a variety of medical conditions.
Inpatient Hospital Services		These services include bed and board, nursing services, diagnostic or therapeutic services, and medical or surgical services.
Inpatient Psychiatric Facility		A facility that provides inpatient psychiatric services for the diagnosis and treatment of mental illness on a 24-hour basis, by or under the supervision of a physician.
Inspection		1.) The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization's (CRO's) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). 2.) An official audit conducted by relevant authorities at the site of the investigation and/or at the sponsor, in order to verify adherence to Good Clinical Practice (GCP).	ICH E6 1.29
Inspectional Observations (as FDA Form)		Official FDA inspection form, also known as 482, completed by FDA investigators which note deviations, if any, and presented to the most responsible person (e.g., investigator) at the inspected site at the end of the inspection
Inspector General	IG	The mission of the Office of Inspector General, as mandated by Public Law 95-452 (as amended), is to protect the integrity of Department of Health and Human Services (HHS) programs, as well as the health and welfare of the beneficiaries of those programs. The OIG has a responsibility to report both to the Secretary and to the Congress program and management problems and recommendations to correct them. The OIG's duties are carried out through a nationwide network of audits, investigations, inspections and other mission-related functions performed by OIG components.	http://www.oig.hhs.gov/
Institute of Clinical Research	ICR	Formerly Association for Clinical Research in the Pharmaceutical Industry (ACRPI). The Vision of ICS is to be internationally recognized as the premier organization for clinical research respected as a key influencer, promoting knowledge and understanding by engaging the healthcare community and the general public.	http://www.instituteofclinicalresearch.org/
Institute of Electrical and Electronic Engineers, Inc.	IEEE	IEEE’s Vision: To advance global prosperity by fostering technological innovation, enabling members' careers and promoting community world-wide. The Mission: The IEEE promotes the engineering process of creating, developing, integrating, sharing, and applying knowledge about electro and information technologies and sciences for the benefit of humanity and the profession.	http://www.ieee.org/portal/site
IOM		The nation turns to the IOM of the National Academies for science-based advice on matters of biomedical science, medicine, and health. A nonprofit organization specifically created for this purpose as well as an honorific membership organization, the IOM was chartered in 1970 as a component of the National Academy of Sciences. The Institute provides a vital service by working outside the framework of government to ensure scientifically informed analysis and independent guidance. The IOM's mission is to serve as adviser to the nation to improve health. The Institute provides unbiased, evidence-based, and authoritative information and advice concerning health and science policy to policy-makers, professionals, leaders in every sector of society, and the public at large.	http://www.iom.edu/
Institute for Social Research	ISR	An academic survey and social research organization at the University of Michigan that is dedicated to social science in the public interest,advancing public understanding of human behavior through empirical research.	http://www.isr.umich.edu/index-ns4.html
Institution (Medical)		Any public or private entity or agency or medical or dental facility where clinical trials are conducted.	ICH E6 1.30
Institutional Animal Care and Use Committee	IACUC	According to U.S. federal law, institutions that use laboratory animals for research or instructional purposes must establish an Institutional Animal Care and Use Committee (IACUC) to oversee and evaluate all aspects of the institution's animal care and use program.	http://www.iacuc.org/
Institutional Biosafety Committee	IBC	The Institutional Biosafety Committee which oversees recombinant DNA research at the University of Michigan. The UM adheres to the NIH Guidelines for Research Involving Recombinant DNA Molecules with regard to all uses of recombinant DNA at the University. The UM requires that all use of recombinant DNA at the University be registered with the Institutional Biosafety Committee even if such use is exempt from the requirements of the NIH Guidelines.	http://www.research.umich.edu/policies /um/committees/BRRC/BRRC.html
Institutionalized (in terms of Subject)		Confined, either voluntarily or involuntarily, in a facility for the care of the mentally or otherwise disabled (e.g., a psychiatric hospital, home or school for the retarded).
Institutionalized Cognitively Impaired		Persons who are confined, either voluntarily or involuntarily, in a facility for the care of the mentally or otherwise disabled (e.g., a psychiatric hospital, home, or school for the retarded).
Institutional Review Board	IRB	An independent body constituted of medical, scientific, and nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trials, of protocols and amendments, and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.	ICH E6 1.31
Institutional Review Board Approval		The determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements.	21 CFR 56.102
Institutional Review Boards of the Medical School	IRBMED	The University of Michigan’s four Institutional Review Boards of the Medical School, collectively known as IRBMED fulfill a federal mandate to protect human volunteers participating as subjects in research conducted at or by the University of Michigan Health System or involving faculty of the Medical School or patient of the University of Michigan Health System.
Institutional Review Committee	IRC	See Institutional Review Board
Insulin-Dependent Diabetes Mellitus	IDDM	Diabetes of a form that usually develops during childhood or adolescence and is characterized by a severe deficiency of insulin secretion resulting from atrophy of the islets of Langerhans and causing hyperglycemia and a marked tendency toward ketoacidosis
Insurance Statement		Statement in information given to trial subject(s) such that compensation to subject(s) for trial-related injury will be available, where required	ICH E6 8.2.5
Integrated Clinical / Statistical Report	ICS or ICSS	The final integrated clinical and statistical report, based on complete analysis of the data generated in a clinical trial or trials, including both statistical and medical input and review. Prepared for submission to a regulatory authorities in a marketing application. See also Clinical Study Report
Integrated Efficacy Summary		A complete summary of all efficacy data accumulated on an investgational agent compiled by the sponsor for submission to a regulatory agency.
Integrated Safety Summary		A complete summary of all safety data accumulated on an investgational agent compiled by the sponsor for submission to a regulatory agency.
Integrated Services Digital Network	ISDN	ISDN is comprised of digital telephony and data-transport services offered by regional telephone carriers. ISDN involves the digitization of the telephone network, which permits voice, data, text, graphics, music, video, and other source material to be transmitted over existing telephone wires. The emergence of ISDN represents an effort to standardize subscriber services, user/network interfaces, and network and internet work capabilities. ISDN applications include high-speed image applications (such as Group IV facsimile), additional telephone lines in homes to serve the telecommuting industry, high-speed file transfer, and videoconferencing. Voice service is also an application for ISDN. This chapter summarizes the underlying technologies and services associated with ISDN.
Integrated Summary of Efficacy	ISE	A major section of an NDA (New Drug Application) that summarizes the data demonstrating substantial evidence of effectiveness of a new drug for the claimed indications.	21 CFR 314.50
Integrated Summary of Safety	ISS	A major section of an NDA (New Drug Application) that summarizes all available information about the safety of the drug product, including pertinent animal data, demonstrated or potential adverse effects of the drug, clinically significant drug/drug interactions, and other safety considerations, such as data from epidemiological studies of related drugs	21 CFR 314.50
Integrity (in terms of Data)		See Data Integrity
Intent-To-Treat	ITT	A method of analyzing the results of clinical trials where participants are included in the treatment group to which they were originally assigned, even if they eventually received a different, including no, treatment.
Interaction		The situation in which a treatment contrast (e.g., difference between investigational product and control) is dependent on another factor (e.g., site)
Interactive Voice Response	IVR	A software application that accepts a combination of voice telephone input and touch-tone keypad selection and provides appropriate responses in the form of voice, fax, callback, e-mail and perhaps other media often used as a randomization and/or tracking tool on clinical trials.
Interactivity		1.) Interactions in cyberspace with other people, information, and computers. 2.) The extent to which something is interactive; the extent to which a computer program and human being may have a dialog.
Interim Analysis		Typically planned statistical data analysis performed before all subjects have completed the trial.
Interim Clinical Study Report		A report of intermediate results and their evaluation based on analyses performed during the course of a trial.	ICH E6 1.32
Interim Clinical Trial Report		See Interim Clinical Study Report	ICH E6 1.32
Interim Report (in relation to IRBs)		Intermediate summary reports provided to IRB	ICH E6 8.3.19
Internal Consistency		1.) A property of data that does not contradict itself. 2.) The consistency of a procedure within a set of data.
International Classification of Diseases	ICD	A medical code set maintained by the World Health Organization (WHO). The primary purpose of this code set was to classify causes of death. A US extension, maintained by the NCHS within the CDC, identifies morbidity factors, or diagnoses. The ICD9 CM codes have been selected for use in the HIPAA transactions. See also MedDRA.
International Conference on Harmonization	ICH	A joint initiative involving both regulators and industry from Japan, European Union, and United States as equal partners in the scientific and technical discussions of the testing procedures, which are required to ensure and assess the safety, quality and efficacy of medicines.	http://www.ich.org/
International Federation of Associations of Pharmaceutical Physicians	IFAPP	The Federation is a non-profit organization, has existed since 1975 and has 29 Member Associations world-wide. The aim of the Organization is to act as an international forum for all the organizations of Pharmaceutical Physicians world-wide by dealing with matters brought to its attention by its National Member Associations. The IFAPP fosters the development and international recognition of Pharmaceutical Medicine as a medical specialty and the development of training and continuing education programs in pharmaceutical medicine. It stimulates a closer relationship between the Member Associations and an improved understanding between the Associations and the medical and allied professionals, regulatory authorities etc.	http://www.ifapp.org/pub/
International Federation of Pharmaceutical Manufacturers Association	IFPMA	An international non-profit, non-governmental organization that represents the worldwide research-based pharmaceutical industry and manufacturers of prescription medicines.	http://www.ifpma.org/
International Organization for Standardization	ISO	ISO (International Organization for Standardization) is the world's largest developer of standards. Although ISO's principal activity is the development of technical standards, ISO standards also have important economic and social repercussions. ISO standards make a positive difference, not just to engineers and manufacturers for whom they solve basic problems in production and distribution, but to society as a whole.	http://www.iso.org/iso/en/ISOOnline .frontpage
Internet		A global system of computer networks that provides the infrastructure for email, the World Wide Web, and other online activities.
Internet Service Provider	ISP	A company that provides access to the Internet for individuals and organizations. ISPs range in size from small local services to huge national providers, like Netcom and AT&T, and international full-service providers like America Online (AOL).
Internist		A doctor who finds and treats health problems in adults.
Interval Data		Data which consists of measurements on an interval scale
Interval Scale		Measurements made in definite units (e.g., height in inches)
Intervention		An investigational product, practice, or application that is tested in a clinical trial and/or used to treat illness or injury.
Intramural Research (in terms of NIH)		Research conducted by, or in support of, employees of the National Institutes of Health
Invasive (in relation to devices or procedures)		Any procedure or surgery which involves the insertion of a piece of equipment or apparatus into a subject to take readings, to undertake assessments or to sample biological fluids.
Invention		A new and useful process, device, article of manufacture, or composition of matter, or new or useful improvement upon one of these.
Invention Disclosure		Written notification to the OTT that an invention has been made. This form is an important step to protecting the invention.
Inventor for Materials:		Where no patent rights are involved, OTT interprets the Policy on Intellectual Properties to hold that the "inventor" of a material is the person that: a.) takes part in the conception of the idea of the specific material that is to be made; and/or b.) actually makes the material but only where making the material was not a routine or known practice. (Thus, in theory, for a given material there could be an inventor under both a and b.) If no such person can be identified, then the file will be treated as having no inventor share of revenues. Absent a written agreement, generally UM employees (or third parties) providing material(s) to a person that uses the material(s) to make a new material will not be considered an inventor. As provided in the Policy on Intellectual Properties, those persons who perform specifically assigned tasks (even if they meet one of the criteria described above) will normally not participate as inventors in the royalty/equity revenue distribution plan.
Inventory (in relation to Investigational Product)		See Accountability (in relation to Investigational Product)
Interim Analysis		Statistical evaluation of the data undertaken while the trial is in progress.
Investigational Agent		See Investigational Product, Investigational Drug, Investigational Device
Investigational Device		A device, including a transitional device that is the object of an investigation.	21 CFR 812.3
Investigational Device Exemption	IDE	1.) (US) The document through which a sponsor notifies the FDA of its plans to test a device in human clinical trials. If the FDA does not contact the sponsor within 30 days of receipt of the submission, the trial may commence. The IDE remains in effect throughout the period of clinical trials. 2.) Refers to the FDA regulations under 21 CFR 812 for which an approved IDE means that the IRB (and FDA for significant risk devices) has approved the sponsor’s study application and all the requirements under 21CFR 812 are met.
Investigational Drug		See Investigational New Drug	21 CFR 312.3
Investigational Drug Brochure	IDB	See Investigator’s Brochure
Investigational Drug Services	IDS	A centralized service provided by the Department of Pharmacy Services and supported by the University of Michigan Hospitals and Health Centers and Medical School, that must assist investigators in the coordination of investigational drug studies in accordance with state and federal regulations.	http://ummcpharmweb.med.umich.edu /policies/investigatedrug/ IDS_scope_and_responsibilities.pdf
Investigational Medical Device		See Investigational Device
Investigational New Device	IND	See Investigational Device
Investigational New Drug	IND	1.) A drug never before approved for marketing by the FDA or an approved drug being tested for a new indication, a new condition of use (dosage, route of administration), or inclusion in a new combination of two or more drugs. Testing in humans involving interstate shipment of the study drug cannot proceed without filing an IND. 2.) A new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms "investigational drug'' and "investigational new drug'' are deemed to be synonymous.	21 CFR 312.3
Investigational New Drug Annual Report	INDAR	See Annual Report (in relation to INDs)
Investigational New Drug Application (as FDA Form)		Official FDA document used for the application or written request made by a sponsor-investigator to the FDA for authorization to administer an investigational drug or biological product to humans
Investigational New Drug / Device Safety Report		(US) A sponsor's written or telephone notification to the FDA by the sponsor of a clinical trial of any adverse experience associated with the use of the drug/device that is both serious and unexpected. A written IND safety report should be filed as soon as possible and in no event later than 15 calendar days after the sponsor's intitial receipt of the information. A telephone report, describing an unexpected, fatal or life-threatening event must be made to the FDA no later than 7 calendar days after the receipt of the information.
Investigational New Drug / Device Termination		(US) An FDA order to halt all research conducted under an IND. See also Clinical Hold
Investigational Material		See Investigational Product
Investigational Pharmacy		A specialized pharmacy which coordinates receipt, storage, preparation, and distribution of investigational drugs.
Investigational Plan		See Protocol
Investigational Product		A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.	ICH E6 1.33
Investigational Site		See Site
Investigator		1.) One or more persons responsible for the practical performance of a trial and for the integrity, health, and welfare of the subjects during the clinical study. The individual(s) who actually conducts the clinical investigation and under whose immediate direction drug is administered or dispersed to a subject. 2.) A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.	ICH E6 1.34
Investigator Agreement		A formal document signed by investigators which describes their roles, responsibilities and obligations in conducting the clinical study in accordance with the principles of Good Clinical Practice (GCP).
Investigator Files		A collection of required documents located at or stored with the investigator (includes institution and related departments) for daily management of clinical research at site and, when needed, for review by government agencies (e.g., FDA, NIH) and/or sponsors/contract research organizations
Investigator-Initiated Research (in terms of NIH)		Original research funded as a result of an investigator, on his or her own, submitting a research application.
Investigator/Institution		An expression meaning “the investigator and/or institution, where required by the applicable regulatory requirements”.	ICH E6 1.35
Investigator Meeting		1.) A meeting held either prior to the start of, or during a clinical trial, attended by sponsors, and/or their representatives, and preferable all participating investigators. Sponsors generally hold three kinds of meetings with investigators for the purpose of: a.) providing input and feedback at the stage of protocol development; b.) to help insure consistency of procedures across study sites; and c.) to show appreciation to investigators and study staff for their work/progress in a clinical trial. 2.) A pre-study meeting which may be attended by all investigators and study coordinators who have agreed to participate in a multicenter trial usually to inform them about the pharmacology of the investigational product/device; to provide up to date clinical information concerning the safety and efficacy of the investigational product/device; to review in-depth the protocol and trial procedures (e.g., data collection) and any external services (e.g., central laboratory) associated with the trial.
Investigator Recruitment		Process of interviewing and selecting a potential investigator for a clinical trial by having an in-depth discussion primarily about the aims of the trial; the number and types of subjects to be recruited, overall time frames for trial conduct and completion and available financial funding.
Investigator Selection		See Investigator Recruitment
Investigator's Brochure	IB	1.) A collection of data including all relevant information known prior to the onset of a clinical study, including chemical and pharmaceutical data, toxicological, pharmacokinetic, pharmadynamic data, and the results of earlier clinical trials. Sponsors are required to annually update the Investigator's Brochure. 2.) A document with a current compilation of the clinical and nonclinical data (i.e., scientific information) on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects.	ICH E6 1.36 ICH E6 8.2.1
Investigator's Drug Brochure		See Investigator's Brochure
Investigator's Study File		The file located at the investigator's study site containing all relevant GCP and regulatory documents, including, but not limited to, a sample case report form, protocol/amendments, curriculum vitae of the investigator/sub-investigators, EC/IRB-approved informed consent form, laboratory certification, sponsor coorspondence, etc. This file is maintained and updated by the investigator and must be retained for at least two years after submission of the final discontinuation of the product development. See IRB Approval / IEC/IRB Approval
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