Clinical Research Dictionary

Clinical Research Dictionary

(Glossary of Terms and Acronyms)

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Cache		Storage area on a computer’s hard drive where the browser stores (for a limited time) Web pages and/or graphic elements.
Cadaver		The body of a deceased person.
Cadaveric Transplant		The surgical procedure of excising a kidney from a deceased individual and implanting it into a suitable recipient.
Canadian Association of Pharmaceutical Regulatory Affairs	CAPRA	The CAPRA is the premier pharmaceutical regulatory affairs organization in Canada. It is non-profit and non-aligned, meaning it does not lobby. It was founded in 1982, and incorporated in 2004, to provide a forum in which pharmaceutical regulatory affairs professionals could interact and keep abreast of the ever-changing regulatory environment in Canada. Likewise, its mission has expanded to include both federal and provincial regulatory affairs for pharmaceuticals, biologicals, medical devices, herbals, veterinary medicines, and radio-pharmaceuticals.	http://www.capra.ca/
Cancer Clinical Trial		An organized study conducted in subjects with cancer to answer specific questions about a new treatment or a new way of using an existing treatment.
Capacity in terms of Consent)		The ability to understand the purpose, procedures, risks, benefits of and alternatives (including non participation) to a research study, including the ability to express a choice about participation and to understand that a refusal to participate involves no penalty or loss of benefits to which the person is otherwise entitled.
Caregiver		Person who provides one or more of the following support: emotional, financial, medical and daily assistance (e.g., hands-on help) with various activities to a family member, friend, client or neighbor.
Carry-Over Effect		Effects of treatment that persist after treatment has been stopped, sometimes beyond the time of a medication’s known biological activity.
Case Control Study		A type of retrospective study comparing persons with a given condition or disease (the cases) and persons without the condition or disease (the controls) with respect to antecedent factors.
Case Management		A process used by a doctor, nurse, or other health professional to manage your health care. Case managers make sure that you get needed services, and track your use of facilities and resources.
Case Manager		A nurse, doctor, or social worker who arranges all services that are needed to give proper health care to a patient or group of patients.
Case History Record		The hospital chart or medical office file containing all medical and demographic information on the study subject.
Case Report Form	CRF	1. ICH: A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject. 2.A record of data and other information collected on each subject during a clinical study as defined by the clinical protocol.	ICH E6 1.11
Case Record Form	CRF	See Case Report Form
Case Study Form		See Case Report Form
Catastrophic Illness		A very serious and costly health problem that could be life threatening or cause life-long disability. The cost of medical services alone for this type of serious condition could cause you financial hardships.
Catastrophic Limit		The highest amount of money you have to pay out of your pocket during a certain period of time for certain covered charges. Setting a maximum amount you will have to pay protects you.
Categorical Data		Data evaluated by sorting values (for example, severe, moderate, and mild) into various categories.
Causality (in relation to adverse events)		Determination of a reasonable possibility that the product or procedure caused or contributed to an adverse event. Common examples include: unknown, not related, possible, probable, definite.
Causality Assessment		Determining whether there is a reasonable possibility that the drug caused or contributed to an adverse event. It includes assessing temporal relationships, dechallenge / rechallenge information, association (or lack of association) with underlying disease, and the presence (or absence) of a more likely cause.
Cause		An assessment made by the investigator and/or sponsor regarding the proper attribution of an adverse event Examples: Study intervention (e.g. drug, device, or therapy); Concurrent non-research therapy; Disease progression; Other or unknown source. See also Attribution and Relatedness
Center (in relation to clinical trial)		See Site
Center for Advancement of Clinical Research	CACR	See Michigan Institute for Clinical and Health Research
Center for Biologics Evaluation and Research	CBER	The Center within the FDA responsible for ensuring the safety and efficacy of blood and blood products, vaccines, allergenics, and biological therapeutics.	http://www.fda.gov/cber/
Center for Clinical Investigations and Therapeutics	CCIT	Former name of the Center for Advancement of Clinical Research. Currently called Michigan Institute for Clinical and Health Research .
Center for Devices and Radiological Health	CDRH	The Center within the FDA responsible for ensuring the safety and efficacy of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational, and consumer products.	http://www.fda.gov/cdrh/index.html
Centers for Disease Control and Prevention	CDC	The lead United States agency that protects the health and safety of people - at home and abroad, provides credible information to enhance health decisions, and promotes health through strong partnerships.	http://www.cdc.gov/
Center for Drug Evaluation and Research	CDER	The Center within the FDA responsible for ensuring the safety and efficacy of drug products including drug development and review, generic drug review, over-the-counter drug review, and post drug approval activities.	http://www.fda.gov/cder/
Center for Food Safety and Applied Nutrition	CFSAN	The Center within the FDA responsible for ensuring that imported and domestic food supplies are safe, sanitary, wholesome, and honestly labeled and that cosmetic products are safe and properly labeled.	http://vm.cfsan.fda.gov/list.html
Center For Healthcare Information Management	CHIM	A health information technology industry association.
Centers for Medicare and Medicaid Services	CMS	An HHS agency (formerly known as the Health Care Financing Administration) that has refocused along its three primary lines of service: the Center for Medicare Management, Center for Beneficiary Choices and the Center for Medicaid and State Operations.	http://cms.hhs.gov/default.asp?fromhc fadotgov=true
Center for Scientific Review	CSR	The National Institutes of Health (NIH) component responsible for the receipt and referral of applications to the PHS, as well as the initial review for scientific merit of most applications submitted to the NIH.	http://www.csr.nih.gov/default.htm
Central Data Coordinating Center		See Data Coordination Center
Central Ethics Committee		See Institutional Review Board
Central File		The file that contains all of the key documents relating to a clinical study, usually maintained by the sponsor or sponsor representative (CRO).
Central Institutional Review Board Initiative (in relation to NCI)		A pilot project sponsored by the National Cancer Institute (NCI), in consultation with the DHHS Office of Human Research Protections (OHRP) and created to develop an innovative approach to human subjects protection with the unique feature of its "facilitated review" process that can streamline local IRB review for national multi-center cancer treatment trials.	http://www.ncicirb.org/
Central Laboratory		The laboratory used for the analysis of laboratory samples from more than one study site.
Central Nervous System	CNS	The part of the nervous system which in vertebrates consists of the brain and spinal cord, to which sensory impulses are transmitted and from which motor impulses pass out, and which supervises and coordinates the activity of the entire nervous system.
Central Review Board		See Institutional Review Board
Certificate of Analysis (in relation to Investigational Product)		Document for identity, purity, and strength of investigational product(s) to used in the trial.	ICH E6 8.2.16
Certificate of Confidentiality (in relation to NIH)	COC	A document issued by the NIH, which provides additional protections to data from legal subpoena.
Certified Clinical Research Associate	CCRA	Clinical research associate or monitor with related work experience and with certification earned by passing a required program and written examination from the Association of Clinical Research Professionals (ACRP) or equivalent organization.	http://grants1.nih.gov/grants/policy/coc/
Certified Clinical Research Coordinator	CCRC	Clinical research coordinator or study coordinator with related work experience and with certification earned by passing a required program and written examination from the Association of Clinical Research Professionals (ACRP) or equivalent organization.
Certified Clinical Research Investigator	CCRI	An investigator with related work experience and with certification earned by passing a required program and written examination from the Association of Clinical Research Professionals (ACRP) or equivalent organization.
Certified Clinical Research Professional	CCRP	Clinical research professional (i.e., administrator, coordinator, consultant, educator, or researcher in clinical trial management) with related work experience and with certification earned by passing a required program and written examination from the Society of Clinical Research Associates (SOCRA) or equivalent organization.
Certified IRB Manager	CIM	An IRB professional with related work experience and with certification earned by passing a required program and written examination from the National Association of IRB Managers or equivalent organization.
Certified IRB Professional	CIP	An IRB professional with related work experience and with certification earned by passing a required program and written examination from Applied Research Ethics National Association (ARENA) or equivalent organization.
Certified Nursing Assistant	CNA	CNAs are trained and certified to help nurses by providing non-medical assistance to patients, such as help with bathing, dressing, and using the bathroom.
Certified Registered Nurse Anesthetist		A nurse who is trained and licensed to give anesthesia. Anesthesia is given before and during surgery so that a person does not feel pain. See Anesthesia
Chemistry, Manufacturing and Controls	CMC	A section of the new drug application (NDA) or biological license application (BLA) that fully describes the composition, manufacture, and specifications of the drug/biological substance and the drug/biological product.
Chief Financial Officer	CFO	The corporate executive having financial authority to make appropriations and authorize expenditures for a firm.
Children (in terms of Informed Consent)		Persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted.	21 CFR 50.3 45 CFR 46.402 (a)
CIOMS Form		A form developed by The Council of International Organization of Medical Sciences, and used for reporting to regulatory authorities (usually in an expeditated manner) an individual AE. Since each country has its own standard reporting form for internal use, the CIOMS-I Form is normally only used for AEs occurring in subjects outside the local country. The Council also produces guidelines referred to as CIOMS-II (periodic safety update reports), CIOMS-III (core safety information for product labeling), CIOMS-IV (for risk / benefit assessment), and the new CIOMS-V (signal generation).
Circadian Rhythm		Biological timing and rhythmicity that, in human beings, is characterized by cycles of approximately 24 hours. Synonym: biological clock.
Civilian Health and Medical Program	CHAMPUS	Run by the Department of Defense, in the past CHAMPUS gave medical care to active duty members of the military, military retirees, and their eligible dependents. (This program is now called "TRICARE")
Class 1 Device		One of 3 classifications by the Food and Drug Administration of medical devices according to potential risks or hazards. Examples include elastic bandages, exam gloves, and hand-held surgical instruments.
Class 2 Device		One of 3 classifications by the Food and Drug Administration of medical devices according to potential risks or hazards. Examples include powered wheel chairs, infusion pumps, and surgical drapes.
Class 3 Device		One of 3 classifications by the Food and Drug Administration of medical devices according to potential risks or hazards. Examples include replacement heart valves, silicone gel-filled breast implants.
Class Codes		Clinical Trial - 22200: Sponsored projects that includes human clinical trials of an Investigational New Drug (IND) or device as defined by the FDA.
Clean Database (or file)		One from which errors have been eliminated and in which measurements and other values are provided in the same units.
Client		A program that makes a service request of another program (the server) that fulfills the request. Web browsers (such as Netscape Navigator and Microsoft Explorer) are clients that request HTML files from Web servers.
Clinical		Related to observation of and intervention on human participants
Clinical Coordinator		See Study Coordinator
Clinical Data Interchange Standards Committee (DIA)	CDISC	The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.	http://www.cdisc.org/
Clinical Data Management	CDM	General term that covers the procedures for collection of data at clinical sites and the quality control of these data both at a site and after they have been submitted to a central data coordinating center.
Clinical Development Plan	CDP	A written document for the clinical strategy outlining a study or studies to support a project plan for development of an investigational product (e.g., drug, biologic, device).
Clinical Efficacy		See Efficacy
Clinical Endpoints		Generally, clinical events (e.g., death, loss of vision, myocardial infarction, etc.) or measurements (e.g., blodo pressure or antibody count) used to help assess the drug's effectiveness. Endpoints are classified into two groups: primary endpoints and surrogate endpoints.
Clinical Events		Any untoward experiences that happen to a subject during the course of a clinical trial. See Adverse Events.
Clinical Hold		A regulatory procedure used by the FDA to delay or discontinue clinical investigations due to human safety concerns or faulty study design. There is no equivalent EU term.
Clinical Investigation		A systematic study to evaluate a product (drug, device or biologic) using human subjects, in the treatment, prevention, or diagnosis of a disease or condition, as determined by the product's benefits relative to its risks. See also Clinical Study
Clinical Investigation Brochure	CIB	See Investigator’s Brochure
Clinical Investigator (in terms of Financial Disclosure)		Only a listed or identified investigator or sub investigator who is directly involved in the treatment or evaluation of research subjects. The term also includes the spouse and each dependent child of the investigator.	21 CFR 54.3
Clinical Investigator’s Brochure	CIB	See Investigator’s Brochure
Clinical Laboratory		Facility where evaluation and analysis of clinical materials (fluids, tissues, etc.) from patients takes place. Also referred to as diagnostic laboratory.
Clinical Laboratory Improvement Amendments	CLIA	United States law passed in 1988 that established quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.	http://www.fda.gov/CDRH/clia/index.html
Clinical Observations		The noting of clinical signs and symptoms in a subject
Clinical Performance Measure		This is a method or instrument to estimate or monitor the extent to which the actions of a health care practitioner or provider conform to practice guidelines, medical review criteria, or standards of quality.
Clinical Practice Guidelines		Reports written by experts who have carefully studied whether a treatment works and which patients are most likely to be helped by it.
Clinical Pharmacology		The study of the properties and reactions of drugs, especially with relation to their therapeutic value, in humans including the general areas of toxicology/safety, pharmacokinetics (i.e., ADME), and pharmacodynamics.
Clinical Phase (in relation to clinical trials)		The time period between the initiation and completion of a trial at an investigational site.
Clinical Practice Guidelines		Reports written by experts who have carefully studied whether a treatment works and which patients are most likely to be helped by it.
Clinical Protocol		See Protocol
Clinical Research Assistant	CRA	See Monitor
Clinical Research Assistant	CRA	Individual who works under the direction of the investigator and provides assistance to the study coordinator to perform study tasks.
Clinical Research Associate	CRA	See Monitor
Clinical Research Center	CRC	See General Clinical Research Center
Clinical Research Coordinator	CRC	Person who handles most of the administrative responsibilities of a clinical trial; acts as a liasison between the investigative site and sponsor; reviews all data and records before monitor visit. The coordinator is an appropriately experienced person nominated by the investigator to assist the administering the trial at the investigational site. Also called "Study Coordinator" or "Research Nurse".
Clinical Research Curriculum Award (K-30)	CRCA	A National Institutes of Health (NIH) award to institutions and addresses to improve the quality of training in clinical research.
Clinical Research Design and Statistical Analysis Program	CRDSA	See On the Job/On Campus (OJ/OC) (program)
Clinical Research and Development (in relation to investigational product)	CRD	The testing of an investigational product in humans primarily done to determine its safety and efficacy.
Clinical Significance		Change in a subject’s clinical condition regarded as important whether or not due to the test article. Some statistically significant changes (in blood tests, for example) have no clinical significance. The criterion or criteria for clinical significance should be stated in the protocol.
Clinical Study		Any investigation in human subjects intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.	ICH E6 1.12
Clinical Study Agreement	CSA	A document signed and dated by the investigator and sponsor that delineates agreements on liability (i.e., indemnification) and financial matters and on the delegation/distribution of responsibilities.
Clinical Study Information		Any information or data derived from studies in humans. This includes, but is not limited to: tabulations, listings, assay results, pharmacokinetic analyses, statistical analyses, and cross-study summaries.
Clinical Study Report	CSR	1.) A complete and comprehensive description of the trial after its completion including a description of experimental (including statistical) methods and materials, a presentation and a critical statistical and clinical appraisal. 2.) ICH: A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report.	ICH E6 1.13
Clinical Supplies		The investigational agents used in a clinical study. This may include active drug or placebo.
Clinical Team		Generally refers to a multi-disciplinary work group consisting of staff representing various departments such as Biostatistics, Data Management, and Clinical Research. The Team is responsible for planning and executing each clinical trial. May also include investigators, site staff, CRO personnel, and any other staff assisting in the execution of a clinical trial.
Clinical Therapeutics Evaluation Program (NCI)	CTEP	The mission of the CTEP is to improve the lives of cancer patients by finding better ways to treat, control and cure cancer. CTEP accomplishes this mission by funding an extensive national program of cancer research and by sponsoring clinical trials to evaluate new anti-cancer agents, with a particular emphasis on translational research to elucidate molecular targets and mechanisms of drug effects.	http://ctep.cancer.gov/
Clinical Trial		See Clinical Study	ICH E6 1.12
Clinical Trial Agreement	CTA	See Clinical Study Agreement
Clinical Trial Certificate	CTC	(UK) A document filed with the regulatory authorities in the UK before initiation of clinical trials. It is much like an MAA and contains complete research reports and expert reports on pharmaceutical, toxicological and clinical data provided by the sponsor. Today's sponsors file a shorter version of the CTC, the Clinical Trial Exemption.
Clinical Trial Coordinator (in relation to Sponsor)		See Monitor
Clinical Trial Coordinator (in relation to Investigator)		See Study Coordinator
Clinical Trial Exemption	CTX	A scheme that allows sponsors to apply for approval for each clinical study in turn, submitting supporting data to the Medicines Control Agency (MCA), which approves or rejects the application (generally within 35 working days). Approval means that the company is exempt from the requirement to hold a clinical trial certificate (CTC).
Clinical Trial Materials	CTM	Complete set of supplies (e.g., documents, laboratory, investigational product) provided to an investigator.
Clinical Trial Office		A department or centralized function that handles many administrative functions for clinical trials within an institution.
Clinical Trial Report		See Clinical Study Report	ICH E6 1.13
Closed System		An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.	21 CFR 11.3
Close relative		Any person, eighteen years of age or older who is related to the prospective subject and has maintained such regular contact with the prospective subject to be familiar with his or her activities, health, and religious or moral beliefs.
Code of Federal Regulations	CFR	The Code of Federal Regulations is an annual codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. The CFR is divided into 50 titles representing broad areas subject to Federal regulation. Each Title is divided into chapters that are assigned to agencies issuing regulations pertaining to that broad subject area. Each chapter is divided into parts and each part is then divided into sections -- the basic unit of the CFR. The purpose of the CFR is to present the official and complete text of agency regulations in one organized publication and to provide a comprehensive and convenient reference for all those who may need to know the text of general and permanent Federal regulations.	http://www.gpoaccess.gov/cfr/index.html
Code Set (in relation to HIPAA)		Any set of codes used to encode data elements, such as tables of relation, medical concepts, medical diagnostic codes, or medical procedure codes including their descriptions.
Coding		The process of assigning data to categories for analysis.
Coding (in relation to Clinical Trials)		In Clinical Trials, the process of assigning CRF data to categories for analysis; the process of transcribing CRF entries into computer-readable variables.
Coding Symbols for Thesaurus of Adverse Reaction Terms	COSTART	The terminology developed and used by the Food and Drug Administration (FDA) for the coding, filing and retrieving of post marketing adverse reaction reports.
Coercion (in relation to Subject Recruitment)		Pertaining to unacceptable participant recruitment methods, which involve duress, undue inducement or indirect pressure.
Cognitive Impairment		See Cognitively Impaired
Cognitively Impaired (in terms of Subject)		Having either a psychiatric or a developmental disorder that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished.
Cohort		A group of subjects initially identified as having one or more characteristics in common who are followed over time. In social science research, this term may refer to any group of persons who are born at about the same time and share common historical or cultural experiences.
Cohort Study		An observational study with more than one group of subjects.
Co-Investigator		Ambiguous term (i.e., not a regulatory term) for 1.) individual who shares responsibility with the investigator for a clinical trial or; 2.) synonym for sub investigator.
College of American Pathologists	CAP	A medical society composed exclusively of pathologists that serves its physician members and the laboratory community throughout the world and provides laboratory quality improvement programs (i.e., certification/accreditation).	http://www.cap.org/
College of Healthcare Information Management Executives		To serve the professional needs of healthcare Chief Information Officers; and to advance the strategic application of information technology in innovative ways aimed at improving the effectiveness of healthcare delivery.	http://www.cio-chime.org/index.asp
Commission on Office Laboratory Accreditation	COLA	A nonprofit organization working to promote excellence in the healthcare industry through programs of voluntary education, consultation, and accreditation.	http://www.cola.org/
Committee for Protection of Human Subjects		See Independent Ethics Committee
Committee on Clinical Investigations		See Institutional Review Board
Committee on Human Research		See Institutional Review Board
Committee for Proprietary Medicinal Products	CPMP	(EU) The body set up to facilitate the adoption of a common position by members of the European Union about the issue of marketing authorizations, thereby promoting free movement of proprietary medicinal products.
Common Rule		1991 United States agreement to cover all federal-sponsored research by a common set of regulations.
Communications		See Correspondence
Community of Science	COS	Database of funding opportunities and faculty profiles.
Comparative Study		A trial in which the investigational product is compared against another investigational and/or marketed product.
Comparator (Product)		An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.	ICH E6 1.14
Comparison Group		Individuals whose characteristics (e.g., race/ethnicity, gender, and age) are similar to those of one's trial participants.
Compassionate Use		Circumstances under which FDA regulations may allow use of the investigational product in selected subject(s) for whom a beneficial effect may be realized but who normally would be ineligible for enrollment in a clinical trial, which typically requires a unique written protocol.
Compensation (in terms of Subject)		Payment or medical care provided to subjects injured in research; does not refer to payment (remuneration) for participation in research.
Compensation Affected by the Outcome of Clinical Studies		Compensation that could be higher for a favorable outcome than for an unfavorable outcome, such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.	21 CFR 54.2
Competence (in terms of Subject)		Technically, a legal term, used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice.
Competent Authority	CA	(EU) Regulatory body charged with monitoring compliance with European Union member state national statutes and regulations.
Complementary medicine		A group of approaches to healing not normally used in conventional (or allopathic) medicine, such as chiropractic, acupuncture, and herbs. Other terms include alternative and integrative medicine.
Completed Subject		A subject having completed all requirements in an entire clinical study as defined in the protocol, or a subject having terminated from a study and a case report forms reflecting the time period the subject was enrolled in the study are complete.
Compliance (in relation to subjects)		A measure of how well subjects have taken the study medications in the prescribed frequency and/or followed protocol required tests and visit schedules.
Compliance (in relation to clinical trials)		Adherence to all the trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements.	ICH E6 1.15
Compliance Date		The date by which a covered entity must comply with a standard, implementation specification, requirement, or modification adopted under the Privacy Rule. With the exception of small health plans, which have an extra year to comply, covered entities must complete implementation of, and be in compliance with, the Privacy Rule by April 14, 2003.
Compliance Policy Guide	CPG	Level 1 guidance document that explains policy on regulatory issues directly related to the FDA laws or regulations.
Compliance Program Guidance Manual (in relation to BIMO)	CPGM	Manuals that provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans regarding specific program areas.	http://www.fda.gov/ora/cpgm/default.htm
Comprehensive Inpatient Rehabilitation Facility		A facility that provides comprehensive rehabilitation services under the supervision of a physician to inpatients with physical disabilities. Services include physical therapy, occupational therapy, speech pathology, social or psychological services, and orthotics and prosthetics services.
Comprehensive Outpatient Rehabilitation Facility	CORF	A facility that provides a variety of services including physicians' services, physical therapy, social or psychological services, and outpatient rehabilitation.
Computer-Assisted New Drug Application	CANDA	A provision (to the FDA) by a sponsor of a new drug application to submit its entire clinical database and possibly, its animal toxicology database in electronic computer files with the needed equipment to use these databases.
Computer-Assisted Product License Application	CAPLA	A provision (to the FDA) by a sponsor of a biologic product application to submit its entire clinical database and possibly, its animal toxicology database in electronic computer files with the needed equipment to use these databases.
Computer Retrieval of Information on Scientific Projects	CRISP	A searchable biomedical database of federally supported proposed research conducted at universities, hospitals, and other research institutions.	http://crisp.cit.nih.gov/
Computer Matching Agreement		Any computerized comparison of two or more systems of records or a system of records of non-Federal records for the purpose of (1) establishments or verifying eligibility or compliance with law and regulations of applicants or recipients/beneficiaries, or (2) recouping payments or overpayments.
Computer-Based Patient Record Institute-Healthcare Open Systems and Trials		An industry organization that promotes the use of healthcare information systems, including electronic healthcare records.
Computer Validation		Ongoing process of evaluation and documentation of the hardware and software of a system during acquisition, implementation, and use to ensure accurate and reliable compliance with user requirements.
Computerized Axial Tomography Scan	CAT Scan	Abbreviation for Computerized Axial Tomography, an X-ray technique for producing images of internal bodily structures through the assistance of a computer.
Concentration maximum	cmax	Used in pharmacokinetics and bioequivalence to indicate maximum plasma concentration for a drug
Concomitant Medication		Medication taken by a subject, in addition to the trial medication(s).
Concomitant Treatment		Treatment (e.g., diet, therapy) taken by a subject in addition to the trial medication.
Concurrent Control (in terms of Subject)		See Control
Concurrent Illness		An illness experienced by a subject in a clinical study other than the illness or condition being treated in the study.
Concurrent Standard Therapy		Treatment (e.g., surgery, drug) a subject is receiving while participating in a research study that is not the treatment under investigation; treatment the subject would be offered even if not enrolled in the research study. For example, in a comparison study of two anti-nausea drugs in cancer patients, the chemotherapy would be the “concurrent standard therapy” and the anti-nausea drugs would be the “investigational therapy."
Concurrent Study		A study being conducted at the same time as another, generally operating under the same protocol.
Concurrently		Reporting should occur simultaneously or in parallel to all oversight bodies (at the same time as).
Conflict of Interest	COI	Refers to a situation when someone an individual has competing professional or personal obligations or personal or financial interests that would make it difficult to fulfill his duties fairly.
Confidential Research Information Act	CRIA	Complement to FOIA which exempts proprietary information held by university personnel if certain conditions are met.
Confidentiality		Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity.	ICH E6 1.16
Confidentiality Agreement		A document between 2 parties which ensures the confidentiality of information provided by one party to the other.
Confidentiality Statement (in relation to Informed Consent Form)		Statement included in the informed consent form such that records (including publication of trial results) identifying a subject will be kept confidential and to the extent permitted by applicable federal laws and regulations will not be made publicly available.
Conformity Assessment		The process by which compliance with the Essential Requirements (ERs) is assessed. See also Notified Body.
Consent		See Informed Consent
Consent Form		See Informed Consent Form
Consistency Checks		Computerized checks of data in a clinical trial. See Plausibility Checks
Consolidated Omnibus Budget Reconciliation Act	COBRA	A law that lets some people keep their employer group health plan coverage for a period of time after: the death of your spouse, losing your job, having your working hours reduced, leaving your job voluntarily, or getting a divorce. You may have to pay both your share and the employer’s share of the premium. Generally, you also have to pay an administrative fee.
Consortium		Generally an agreement between university and corporate partners entered into for a specific research project or program.
Consortium for Health Outcomes, Innovations, and Cost Effectiveness Studies	CHOICES	A University of Michigan group that facilitates collaboration and fosters relationships that results in an increase in the quality and quantity of health services research undertaken in the University of Michigan Health System.	http://www.med.umich.edu/choices /default.htm
Consultant		A participant, either internal or external to the University, whose participation does not require a sub-account or sub-contract, and who is paid via a personal service agreement.
Consulting Agreement		Arrangements between inventors and licensees designed to facilitate product development, the most important phase of the technology transfer process.
Consumer Assessment of Health Plans Study	CAHPS	An annual nationwide survey that is used to report information on Medicare beneficiaries' experiences with managed care plans. The results are shared with Medicare beneficiaries and the public.
Consumer Price Index		A measure of the average change in prices over time in a fixed group of goods and services. In this report, all references to the CPI relate to the CPI for Urban Wage Earners and Clerical Workers (CPI-W).
Consumer Product Safety Commission (U.S.)	CPSC	The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of serious injury or death from more than 15,000 types of consumer products under the agency's jurisdiction. Deaths, injuries and property damage from consumer product incidents cost the nation more than $700 billion annually. The CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard or can injure children. The CPSC's work to ensure the safety of consumer products - such as toys, cribs, power tools, cigarette lighters, and household chemicals - contributed significantly to the 30 percent decline in the rate of deaths and injuries associated with consumer products over the past 30 years.
Consumer Safety Officer	CSO	An FDA position with duties that may include: investigating complaints of injury, illness, or death caused by an FDA-regulated product, initiating actions against violators, advising industry, state and local officials and consumers on enforcement, policies, methods, and interpretation of regulations, planning and directing regulatory programs, developing inspection procedures and techniques, coordinating the review process of New Drug Applications (NDAs).
Consumer Self-Report Data		Data collected through survey or focus group. Surveys may include Medicaid beneficiaries currently or previously enrolled in a MCO or PHP. The survey may be conducted by the State or a contractor to the State.
Consumer Survey Data		Data collected through a survey of those Medicaid beneficiaries who are enrolled in the program and have used the services. The survey may be conducted by the State or by the managed care entity (if the managed care entity reports the results to the State).
Continuation (in relation to IRB approval)		See Annual Review (in relation to IRBs)
Continuing Education Unit	CEU	Amount of time spent in Continuing Medical Education activities. Each CEU is determined by the Continuing Medical Education Office. Typically 1 unit = 1 hour.
Continuing Medical Education	CME	Medical and Nursing staff are required to take numerous CEUs each year to maintain their certifications.
Continuing Review (in terms of IRBs)		Periodic review by the Institutional Review Board (IRB) of active research for the purpose of re-approving, requiring modifications, disapproving, terminating or suspending the study.
Continuous Quality Improvement	CQI	See Quality Improvement
Contract		1. A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract. 2. ICH Definition: A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.	ICH E6 1.17
Contract IEC		An Independent Ethics Committee (formerly an Ethics Review Committee (ERC)) which is not affiliated to a medical instituion and charges a fee for reviewing protocols, e.g., European Ethical Review Committee (EERC).
Contract Research Organization	CRO	A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions.	ICH E6 1.20
Contraindicated		Disadvantageous, perhaps dangerous; a treatment that should not be used in certain individuals or conditions due to risks (e.g., a drug may be contraindicated for pregnant women and persons with high blood pressure).
Contraindication		A condition in which it is recommended that a drug/medication not be administered as related to current medications and/or conditions of the subject.
Control		A comparison treatment with the investigational product, so that the effect of the investigational product can be determined and distinguished from other influences (e.g., spontaneous change, placebo effects, concomitant therapy, or observer expectations). Examples include: placebo concurrent control, dose comparison concurrent control, no-treatment concurrent control, active treatment concurrent control, and historical control.
Control Group		A comparison group of study subjects who are not treated with the investigational agent (i.e., no therapy, a different therapy, or a placebo).
Control Subject		Study subject who is not treated with the investigational agent (i.e., no therapy, a different therapy, or a placebo).
Controlled Study		A trial in which an investigational product is compared with a treatment that has known effects.
Cooperative Agreement		Funding mechanism like a grant except there is substantial programmatic involvement of the sponsor.
Cooperative Project Assurance	CPA	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 a specialized document for use to assure compliance by institutions when involved in certain types of cooperative research (i.e., an OHRP-approved Cooperative Protocol Research Program [CPRP]), which is often designed to be both multi-site and multi-protocol in nature. A Federal Wide Assurance will replace it.
Cooperative Protocol Research Program (in relation to OHRP)	CPRP	A research program often designed to be both multi-site and multi-protocol in nature to bring high-risk clinical research to the subjects by distributing protocols widely and pooling resultant data to hasten conclusions and publication of findings.
Cooperative Research and Development Agreement (with NIH)	CRADA	Mechanism for collaboration between government and outside scientists that legally defines intellectual property rights and financial and other responsibilities. See also technology transfer.
Cooperative Studies Program		A clinical research program in which investigators from two or more medical centers agree to study collectively a selected problem in a uniform manner, using a common protocol with central coordination.
Coordinating Center		See Data Coordinating Center
Coordinating Committee		A committee that a sponsor may organize to coordinate the conduct of a multi center trial.	ICH E6 1.18
Coordinating Investigator		An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multi center trial.	ICH E6 1.19
Coordinator		See Study Coordinator
Co-Principal Investigator	Co-PI	Individual who shares clinical trial responsibility with the principal investigator.
Copyright		Ability to exclude others for a limited period of time from using original works of authorship fixed in any tangible medium of expression which can be perceived, reproduced or otherwise communicated, either directly or with the aid of a machine or device (typically used for texts, software and visual and audio materials).
Coronary Artery Disease	CAD	A condition (as sclerosis or thrombosis) that reduces the blood flow through the coronary arteries to the heart muscle.
Correlation		The relationship of one variable to another
Correlation Coefficient		A statistical index of the degree of relationship between two variables. Values of correlation coefficients range from -1.00 through zero to +1.00. A correlation coefficient of 0.00 indicates no relationship between the variables. Correlations approaching -1.00 or +1.00 indicate strong relationships between the variables. However, causal inferences about the relationship between two variables can never be made on the basis of correlation coefficients, no matter how strong a relationship is indicated.
Correspondence		Documents for any agreements or significant discussions between involved parties. Examples include: letters, e-mails, faxes, telephone call reports.	ICH E6 8.3.11
Cost Accounting Standards	CAS	Specific rules promulgated by the federal government to achieve consistent accounting practices for sponsored projects.
Cost Accounting Standards Board	CASB	The Cost Accounting Standards Board (CASB) was established by Congress in 1970 and currently operates as an independent board within the Office of Federal Procurement Policy of the Office of Management and Budget. Between 1970 and 1980, the Board formulated nineteen cost accounting standards to govern the measurement, assignment, and allocation of costs to federal contracts awarded to all private and non profit organizations that meet the $10 million threshold in terms of annual government contracts.
Cost Benefit Analysis		An attempt to quantify in monetary terms the benefits associated with the use of a particular medication or procedure where no direct savings are immediately apparent.
Cost Benefit Study		A financial analysis of the cost of using a product, compared to the benefits (also measured in monetary terms) of using that product. Benefits are measured in financial terms as well as therapeutic benefits, including any value the product has to a society or system. Benefits are all given monetary values and are compared to the total financial cost of buying and administering the subject drug. These studies often take place during Phase IV trials.
Cost Effectiveness Analysis		An attempt to quantify outputs in terms of the most convenient natural units (e.g., years of life gained”) associated with the use of a particular medication or procedure.
Cost Sharing		When the full stated cost of a project is provided by both the sponsor and the University; the University's formal commitment to fund a portion of a sponsored project is referred to as cost sharing.
Cost Utility Analysis		An attempt to quantify the number of life years gained as a result of treatment adjusted by a series of utility weights that reflect the relative values that subjects place on different states of health.
Council for Certification of IRB professionals	CCIP	An Applied Research Ethics National Association (ARENA) program that has established certification standards and mechanisms with the input from a group of experts representing the broad diversity of practice and experience in the field of human subjects protection.	http://www.primr.org/arena.html
Council for International Organizations of Medical Sciences	CIOMS	An international, non-governmental, non-profit organization established to facilitate and promote international activities in the field of biomedical sciences, especially when the participation of several international associations and national institutions is deemed necessary; to maintain collaborative relations with the United Nations and its specialized agencies, in particular with WHO and UNESCO; and to serve the scientific interests of the international biomedical community in general.	http://www.cioms.ch/
Council of Public Representatives (in relation to NIH)	COPR	A United States advisory committee, made up of members of the public, that advises the National Institutes of Health Director on issues related to: 1.) Public input and participation in NIH activities; 2.) Public input and participation in the NIH research priority setting process; and 3.) NIH outreach programs and efforts	http://copr.nih.gov/index.asp
Covered Clinical Study (in terms of Financial Disclosure)		Any study of a drug or device in humans submitted in a marketing application or reclassification petition subject to this part that the applicant or FDA relies on to establish that the product is effective (including studies that show equivalence to an effective product) or any study in which a single investigator makes a significant contribution to the demonstration of safety. This would, in general, not include phase l tolerance studies or pharmacokinetic studies, most clinical pharmacology studies (unless they are critical to an efficacy determination), large open safety studies conducted at multiple sites, treatment protocols, and parallel track protocols.	21 CFR 54.3
Covered Entity (in relation to HIPAA)	CE	Refers to three types of entities that must comply with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule: (1) health care providers; (2) health plans; and (3) health care clearinghouses.
Covered Function (in relation to HIPAA)		Functions that make a covered entity a health plan, a health care provider, or a health care clearinghouse.
Covered Transaction (in relation to HIPAA)		Transactions for which the Secretary of Health and Human Services has adopted standards.
CRA Manual		Also referred to as "CRF monitoring guidelines" and "CRF completion guidelines". See also Monitoring Manual
CRF Design		The process of translating protocol objectives and activities into data collection documents.
CRF Review Guidelines		Study-specific guidelines, often prepared by a CRA, project manager, CRA trainer, or medical writer, that describe, in detail, the way the CRFs should be reviewed and completed. Also referred to as "CRA Manual", "CRF monitoring guidelines" or "CRF completion guidelines".
Critical Access Hospital		A small facility that gives limited outpatient and inpatient hospital services to people in rural areas.
Critical Document Binder		See Investigator's Study File.
Critical Variable		Data that are necessary to answer the objectives of a study (e.g., treatment and its duration, evaluability information, termination profile, primary efficacy and safety variables). Variables for which the computerization of an incorrect value could fundamentally affect the conclusions drawn from the results of the study. See Key Variable
Crossover (in relation to clinical trials)		A trial design for which subjects function as their own control and are assigned to receive investigational product and controls in an order determined by randomizations typically with a washout period between the two products.
Crossover Design		See Crossover (in relation to trials)
Current Dental Terminology		A medical code set of dental procedures, maintained and copyrighted by the American Dental Association (ADA), and adopted by the Secretary of HHS as the standard for reporting dental services on standard transactions.
Current Good Manufacturing Practice	CGMP	(US) FDA regulations intended to ensure the quality of drug products by requiring appropriate control of operations which have potential to directly affect product quality including the manufacturing, testing, packaging, and distribution of active ingredients and finished drug products. These regulations include specific areas that are considered critical to the control of the final product quality, but do not describe how and to what degree they must be considered for a given process of product. Note: The European Union and other countries may have their own GMPS which address these somewhat differently depending on the country(s) involved.
Current Procedural Terminology		A medical code set of physician and other services, maintained and copyrighted by the American Medical Association (AMA), and adopted by the Secretary of HHS as the standard for reporting physician and other services on standard transactions.
Current Good Manufacturing Practices	CGMP	See Good Manufacturing Practices
Curriculum Vitae	CV	Document for the qualifications and eligibility of investigator(s) and/or team members to conduct trial and/or provide medical supervision of subjects.
Custodial Care		Nonskilled, personal care, such as help with activities of daily living like bathing, dressing, eating, getting in or out of a bed or chair, moving round, and using the bathroom. It may also include care that most people do themselves, like using eye drops. In most cases, Medicare doesn’t pay for custodial care.
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