Clinical Research Dictionary
(Glossary of Terms and Acronyms)
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D
Data   Generally refers to recorded information regardless of form, and is legally defined according to the institution  
Data and Safety Monitoring Board DSMB See Independent Data Monitoring Committee ICH E6 1.25
Data Archival   The storage of data during and at the end of the trial  
Data Audit Trail   The documentation that tracks the changes that have been made to recorded data (e.g., case report forms) and/or databases  
Database DB A collection of electronic files containing the information recorded on and derived from the data forms (e.g., case report forms [CRFs]).  
Database Closure   A process of closing the database by halting the input of additional data. Database closure occurs when all data collected under a study protocol have been computerized and deficiencies / inconsistencies have been rectified to agreed standards. Generally proceeded by a database finalization process. Also referred to as "database lock".  
Database Finalization   Following the closure of a database, the process at project end which includes the database audit, re-veritification if necessary, and creation of final datasets for analysis. No further changes / additions to the database are permitted. Also referred to as "freezing the database".  
Data Checks   Computerized or manual checks for CRF data discrepancies based on the data review guidelines. Also called "edit checks" or "plausibility checks".  
Data Clarification Form DCF A document that requests additional information and/or clarification of data entered on a specific case report form and with its completion with dated signature(s) serves as confirmation, clarification and/or correction of the original data entry.  
Data Collection   The process of recording the information, usually on a data form, about each subject by an investigator or study coordinator during the course of a trial.  
Data Collection Form   See Case Report Form  
Data Condition   A description of the circumstances in which certain data is required.  
Data Content   Under HIPAA, this is all the data elements and code sets inherent to a transaction, and not related to the format of the transaction.  
Data Coordinating Center DCC See Data Coordination Center  
Data Coordination Center DCC An organization or part of an organization with a centralized function of data management for a clinical study, often, a multicenter study/trial.  
Data Council   A coordinating body within HHS that has high-level responsibility for overseeing the implementation of the A/S provisions of HIPAA  
Data Dictionary   A document or system that characterizes the data content of a system.  
Data Element   Under HIPAA, this is the smallest named unit of information in a transaction.  
Data Encryption Standard DES A widely used method of data encryption using a private (secret) key. Each message uses one of 72 quadrillion or more possible encryption keys that are chosen at random. The sender and receiver must both know and use the same private key. DES applies a 56-bit key to each 64-bit block of data. The U.S. government judged the key so difficult to break that it restricted the key’s export to other countries.  
Data Entry   Process of entering data into a database.  
Data Error   Mistakes occurring in the recording of clinical trial data.  
Data Extract System Access Form   A form that is required for access to the DESY system. This system replaces the Data Support Access Facility (DSAF)  
Data Form   A printed document (e.g., case report form) designed to record all of the protocol-required information on each trial subject.   
Data Handling   Activity relating to all aspects of data management, including quality review for range and logic checks, follow-up of missing data, coding, data coordination between trial center and monitoring center, computer transfer and database management.  
Data Integrity   The accuracy and validity of data.  
Data Interchange Standards Association   A body that provides administrative services to X12 and several other standards-related groups.  
Data Management   The process of handling the data gathered during a clinical trial. May also refer to the department responsible for managing data entry and database generation and/or maintenance.  
Data Manager DM An appropriately trained person responsible for data handling and preparation of computer-generated trial data for statistical analysis.  
Data Mapping   The process of matching one set of data elements or individual code values to their closest equivalents in another set of them. This is sometimes called a cross-walk  
Data Model   A conceptual model of the information needed to support a business function or process.  
Data Monitoring   Process by which case report forms are examined for completeness, consistency, and accuracy.  
Data Monitoring Committee   See Independent Data Monitoring Committee ICH E6 1.25 
Data Point(s)   Any text or numbers that are generated during a clinical trial.  
Data Query   Any question raised during the review of a particular entry on a case report form which is open to different interpretations including various data errors.  
Data Review Guideline   A study-specific guideline used by data management to ensure that data are being collected consistently for all subjects across all sites. This guideline includes information specific to data management, including various data and edit checks, coding, procedures, and procedures for data review (manual versus computerized, etc.).  
Data Safety Committee   See Independent Data Monitoring Committee  
Data Safety Monitoring Plan DSMP The plan that researchers create to monitor the safety of participants during a clinical trial http://www.niams.nih.gov/rtac/clinical
/safe_monitoring_plan.htm
Data Set   A computer file composed of the values of one or more variables for one or more subjects. This collection of data is usually arranged in rectangular form, so that each observation contains one data value for each variable.  
Data Support Access Facility Access Form   A form that is required for access to Leg 1 (Enrollment Database (EDB)) and, Leg 2 (Medicare Provider Analysis and Review(MEDPAR)) of the Data Support Access Facility.  
Data Tracking   A system to monitor data flow of a project - case report form (CRF) receiption, data entry, query generation and resolution, etc.  
Data Transfer   Moving data from one system to another.  
Data Use Agreement (in relation to HIPAA)   A written agreement for research, public, health, or health care operations between two entities that share protected health information (PHI), specifying for what it will be used, and who will be permitted to access it.  
Data Use Checklist   A form used to provide pertinent information about the data request and identifies the identifiable data being processed.  
Data Validation   See Validity of Data  
Data Verification   Process of checking the accuracy of the data for each subject that has been entered into a computer database.  
Dead fetus   A fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord. 45 CFR 46.202(a)
Death   Deaths occurring within 30 days of the last study intervention are reportable events regardless of whether or not the investigators deem the death to be related to the study. If death occurs later than 30 days after the last study intervention AND the subject is still on-study (i.e., subject would have had further follow-up or intervention / interaction had death not occurred), then the death may still be a reportable event. If the subject is NOT still on-study and there is no long-term follow-up, a late death does not need to be reported the IRBMED even if the investigator learns that the subject died. Reports generally refer to the death of a research subject but also death of another (a person not enrolled in the study) that is definitely, probably, or possibly related to the study must be reported (e.g., in a study of anti-psychotic medications, the study drug is found to increase irritability and the research subject commits murder).  
Debrief (in terms of Subject)   Giving participants previously undisclosed information about the research project following completion of their participation in research.  
Deception (in relation to Misconduct)   Intentionally misleading or withholding information.  
Deception Study   A research study that incorporates in the design a technique for intentionally misleading a human subject during the course of the study to obtain certain results, and the subject is debriefed after the study or their participation ends.  
Dechallenge   A method used to determine if an adverse event (AE) causally related to a drug treatment. The drug is stopped and the subject is carefully monitored to observe if the event resolves.  
Decisionally Incapacitated Individual   Individual who is at least 18 years of age, and who cannot give a valid informed consent to participate as the subject of research because the individual cannot sufficiently understand the nature, extent, or probably consequence of the proposed research participation, cannot make a sufficient evaluation of burdens, risks, and benefits of the proposed research participation, or cannot communicate a research participation decision by a court.  
Declaration of Helsinki   The World Medical Association’s set of recommendations or basic principles that guide medical doctors in the conduct of biomedical research involving human subjects. http://www.wma.net/e/policy/pdf/17c.pdf
Defense Advanced Research Projects Agency DARPA DARPA is the central research and development organization for the Department of Defense (DOD). It manages and directs selected basic and applied research and development projects for DoD, and pursues research and technology where risk and payoff are both very high and where success may provide dramatic advances for traditional military roles and missions. http://www.darpa.mil/
Definitely related   An adverse event that is clearly related to the investigational agent(s) or research intervention: the adverse event has a temporal relationship to the administration of the investigational agent(s) or research intervention, follows a known pattern of response, and no alternative cause is present. (NCI/CTC Common Toxicity Criteria v.2.0) See also Cause, Attribution and Relatedness.  
Deidentification (in relation to HIPAA)   Removal of all 18 elements that make data individually identifiable.  
Delegation of Authority Log   Document that details specific clinical trial activities with signatures and/or initials of all persons authorized by the investigator  
Delivery (in terms of Fetus)   Complete separation of the fetus from the woman by expulsion or extraction or any other means. 45 CFR 46.202(b)
Demographic Data   Refers to the characteristics of study subjects, including sex, age, family medical history, and other characteristics relevant to the study in which they are enrolled.  
Demographics   See Demographic Data  
Department of Defense DOD The United States government’s main department that determines the security needs of the nation, and then take courses of action to ensure that they are met. http://www.defenselink.mil/
Department of Energy DOE The Department of Energy's overarching mission is to advance the national, economic and energy security of the United States; to promote scientific and technological innovation in support of that mission; and to ensure the environmental cleanup of the national nuclear weapons complex. http://www.doe.gov
Department of Health, Education, and Welfare DHEW United States federal agency reorganized in 1980 into 2 other departments: the Department of Health and Human Services (DHHS) and the Department of Education.  
Department of Health and Human Services DHHS The United States government’s main agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. http://www.hhs.gov/
Department of Housing and Urban Development HUD HUD's mission is to increase homeownership, support community development and increase access to affordable housing free from discrimination. To fulfill this mission, HUD will embrace high standards of ethics, management and accountability and forge new partnerships--particularly with faith-based and community organizations--that leverage resources and improve HUD's ability to be effective on the community level. http://www.hud.gov/
Department of Transportation DOT The Department of Transportation was established by an act of Congress on October 15, 1966, the Department’s first official day of operation was April 1, 1967. The mission of the Department is to: Serve the United States by ensuring a fast, safe, efficient, accessible and convenient transportation system that meets our vital national interests and enhances the quality of life of the American people, today and into the future. http://www.dot.gov
Department of Veteran Affairs   A division of the executive branch of the United States government concerned with overall planning, promoting, and administering programs pertaining to veterans.  
Dependent Variables   Outcomes that are measured in an experiment. Dependent variables are expected to change as a result of an experimental manipulation of the independent variable(s).  
Descriptive Study   Any study that is not truly experimental (e.g., quasi-experimental studies, correlation studies, record reviews, case histories, and observational studies).  
Descriptor   The text defining a code in a code set  
Designated Record Set   A group of records maintained by or for a covered entity that includes: 1.) medical and billing records about individuals maintained by or for a covered health care provider; 2.) enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; or 3.) used, in whole or in part, by or for the covered entity to make decisions about individuals. A record is any item, collection, or grouping of information that includes PHI and is maintained, collected, used, or disseminated by or for a covered entity.  
Destruction Records (in relation to Investigational Product)   Document for the destruction of unused investigational products by sponsor or at site ICH E6 8.4.2
Device   An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended for use in the diagnosis, cure, treatment or prevention of disease.  
Device (Medical)   See Device  
Development   See Research and Development  
DHHS Protection of Human Subjects Regulations (in regards to HIPAA)   Regulations intended to protect the rights and welfare of human subjects involved in research conducted or supported by HHS. The HHS regulations include the Federal Policy for the Protection of Human Subjects, effective August 19, 1991, and provide additional protections for pregnant women, fetuses, neonates, prisoners, and children involved in research. 45 CFR Part 46
Diagnosis   The name for the health problem that you have.  
Diagnosis Code   The first of these codes is the ICD-9-CM diagnosis code describing the principal diagnosis (i.e., The condition established after study to be chiefly responsible for causing this hospitalization). The remaining codes are the ICD-9-CM diagnosis codes corresponding to additional conditions that coexisted at the time of admission, or developed subsequently, and which had an effect on the treatment received or the length of stay.  
Diagnosis Related Group DSI Any of the payment categories that are used to classify patients and especially Medicare patients for the purpose of reimbursing hospitals for each case in a given category with a fixed fee regardless of the actual costs incurred and that are based especially on the principal diagnosis, surgical procedure used, age of patient, and expected length of stay in the hospital  
Diagnostic   Tests used to identify a disorder or disease in a living person.  
Diary Cards   Forms given to subjects to record the frequency and/or severity of symptoms of their illness on a daily basis.  
Digital signature   An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. 21 CFR 11.3
Direct Access   Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial.  Any party (e.g., domestic and foreign regulatory authorities, sponsors, monitors, and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor's proprietary information. ICH E6 1.21
Direct Data Entry   The process by which investigators and study coordinators use computers at their site to enter clinical data directly into the database without using paper case report forms (CRFs) and to subsequently transfer these data typically across a modem for downloading into the sponsor's computers.  
Direct Costs   Expense items that can be identified and charged to specific cost centers within a project, such as personnel, fringe benefits, consultants, contractual services, travel, equipment, materials, and supplies.  
Direct-To-Consumer DTC Drug Advertising  
Disabling / Incapacitating   An experience that results in a permanent and/or substantial disruption of the subject's abilty to carry out normal life function.  
Disability   A substantial disruption of a person's ability to conduct normal life functions. 21 CFR 312.32
Discharge Planning   A process used to decide what a patient needs for a smooth move from one level of care to another. This is done by a social worker or other health care professional. It includes moves from a hospital to a nursing home or to home care. Discharge planning may also include the services of home health agencies to help with the patient's home care  
Disclosure (in relation to HIPAA)   Release of divulgence of information by an entity to persons or organizations outside of that entity.  
Disclosure History   Under HIPAA this is a list of any entities that have received personally identifiable health care information for uses unrelated to treatment and payment.  
Discovery (in relation to
Research)		   The early phases of the overall development process of an investigational products/devices dealing with the synthesis of/search for products/devices and the screening processes developed to identify "lead" products/devices.  
Distribution (in relation to Pharmacokinetics)   The pharmacokinetic (PK) process that controls transfer of a drug from the site of measurement to its target and other tissues.  
Division of Research Development and Administration DRDA A University of Michigan department that assists faculty and staff members in all aspects of externally funded research projects and other scholarly activities; from the identification of a potential sponsor and the preparation of a proposal, through various administrative problems (related to budgets, personnel, space, sub-contracts, reporting and accountability, patents, negotiations with the sponsor) during the course of the project, to the submission of the documents required to close out the project. http://www.research.umich.edu/contacts
/drda/drda_contact.html
Division of Research Grants (NIH) DRG CSR organizes the peer review groups that evaluate the majority (70%) of the research grant applications sent to NIH. The Center also receives all grant applications for NIH, as well as for some other components of the U.S. Department of Health and Human Services. Our primary goal is to see that NIH applications receive fair, independent, expert, and timely reviews -- free from inappropriate influences -- so NIH can fund the most promising research. http://www.drg.nih.gov/
Division of Scientific Investigations (FDA) DSI The DSI has two major goals: To verify the integrity of efficacy and safety data submitted to the FDA in support of new drug applications; and To assure that the rights and welfare of human research subjects are protected. http://www.fda.gov/cder/Offices/DSI/
Doctor of Medicine MD A person who has received the degree of doctor of medicine following successful completion of a prescribed course of study in medicine and surgery in an accredited medical school.  
Doctor of Osteopathy DO A person who has received the degree of doctor of osteopathy following completion of a prescribed course of study in osteopathy in an accredited osteopathic school.  
Document Type Definition DTD For Electronic Interchange  
Documentation   All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records; and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken. ICH E6 1.22
Domain Name   The way a particular Web server is identified on the Internet. For example, www.tripod.com names the World Wide Web (www) server for Tripod (tripod), which is a commercial (com) entity.  
Dosage Form   The "delivery system" for a drug product (e.g., tablet, capsule, IV solution).  
Dosage Regimen   1.) The number of doses per given time period; 2.) the time that elapses between doses or the time that the doses are to be given; or 3.) the amount of a medicine to be given at each specific dosing time.  
Dose   The amount of drug administered to a subject. Also referred to as Dosage.  
Dose-Comparison Control (in terms of Subject)   Subjects who are randomly assigned to at least one of two doses of study drug.  
Dose-Escalation Studies   Observations carried out in early phase trials on human volunteers in which subjects are given the same sequence of increasing drug doses. The goal is to establish the optimal dose for safety and/or efficacy. Also called "dose-ranging" or "dose response studies".  
Dose Range Finding Study   See Dose-Ranging Study  
Dose-Ranging Study   A clinical trial to compare two or more doses of the same drug.  
Dose Titration   A method of adjusting drug dose based on the subject's response to the treatment.  
Dosing Schedule   See Dosage Regimen  
Double Blind DB Neither the subject(s) nor the investigator(s) know which treatment a subject is receiving in a clinical trial.  
Double Data Entry   Common procedure for 2 different persons to enter the same data from a clinical trial into a database at separate times for the purpose of reducing data entry errors.  
Double Dummy   A technique that enables a trial comparing two different dose forms (e.g., tablets and capsules) to be conducted in a double blind manner. A subject usually receives both dosage forms at the same time whereby one dosage form is a placebo.  
Double Masked   See Double Blind  
Draft Package Labeling   The first proposed labeling for a new pharmaceutical which is submitted as part of the original NDA.  
Drop Out   A subject who does not complete the protocol requirements of a clinical trial.  
Dropped Subject   A subject whose participation in the trial is discontinued by the investigator.  
Drug   As defined by the Food, Drug and Cosmetic Act (FDC), "articles (other than food) intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, or to affect the structure or any function of the body of man or other animals".  
Drug Abuse Warning Network DAWN The Drug Abuse Warning Network (DAWN) is a public health surveillance system that monitors: Drug-related visits to hospital emergency departments (EDs); and Drug-related deaths investigated by medical examiners and coroners (ME/Cs). In 2003, a new, redesigned DAWN expanded beyond drug abuse. New DAWN helps communities and member facilities identify emerging problems, improve patient care, and manage resources. http://dawninfo.samhsa.gov/
Drug Accountability   See Accountability (in relation to Investigational Product)  
Drug Classification System   (US) A system established by the FDA designed to assist the agency in prioritizing its reviewing assignments in order to help expedite the evaluation of drugs that offer potentially significant therapeutic gains over exisiting treatments.  
Drug Development   All activities and decision making processes which must be completed in a program meant to discover a new investigational product/device and progress it through approval by the regulatory authorities for marketing it.  
Drug Efficacy Study Implementation notice DESI FDA, to evaluate drugs in use before 1962.  
Drug Enforcement Administration DEA An agency within the Department of Justice that enforces the controlled substance laws and regulations of the United States. http://www.usdoj.gov/dea/
Drug Establishment Registration   (US) The submission of a facility's name and address, and the identification of the facility's owner/operators. The information identified for the FDA those companies and facilities actively involved in manufacturing or processing pharmaceuticals.  
Drug Experience Reveiw Committee   (US) A committee convened to ensure subject protection and safety in the use of marketed products.  
Drug Exports Amendments Act of 1986   (US) This legislation reformed US drug export law to allow US drug makers, for the first time, to export certain drugs not yet approved by the FDA to 21 different countries judged to have adequate drug regulatory systems.  
Drug Information Association DIA An international member-driven organization that encompasses the full continuum of disciplines in the pharmaceutical and related industries and serves as a professional development authority. http://www.diahome.org/docs/index.cfm
Drug Inventory   See Drug Accountability  
Drug Level   The amount of drug that is found  or deposited in various bodily tissues (e.g., blood, serum, plasma, urine, feces).  
Drug Master File DMF

1. (US) A voluntary filling with the FDA submitted by a manufacturer of an active ingredient, usually in bulk, an excipient, flavor, or coloring materials, or a pharmaceutical packaging facility. The information contained in the DMF is kept confidential by the FDA to be referenced only in connection with another company's FDA filing.

2. A submission to a regulatory authority that may be used to provide confidential, detailed information about facilities, processes or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

 21 CFR 314.420
Drug Metabolism DM See Metabolism (in relation to pharmacokinetics)  
Drug Price Competition & Patent Term Restoration Act of 1984   (US) Legislation expanding the Abbreviated New Drug Application (ANDA) process to include the eligibility of drugs approved after 1962. This law was designed, in part, to increase pricing competition upon a product's patent expiration.  
Drug Product   A finished dosage form (e.g., tablet, capsule, or solution) that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients. 21 CFR 314.3
Drug Reconciliation   Process of comparing dispensing records, CRFs, and source documentation to ensure that all records are accurate and drug has been disposed of properly.  
Drug Substance   An active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates use in the synthesis of such ingredient. 21 CFR 314.3
Due Diligence   A measure of activity expected from a reasonable and prudent person under a particular circumstance.  
Duration (in terms of treatment)   The treatment period for each subject in the trial  
Durable Medical Equipment DME Purchased or rented items such as hospital beds, iron lungs, oxygen equipment, seat lift equipment, wheelchairs, and other medically necessary equipment prescribed by a health care provider to be used in a patient's home which are covered by insurance.  
Durable Power Of Attorney   A legal document that enables you to designate another person, called the attorney-in-fact, to act on your behalf, in the event you become disabled or incapacitated.  
Durham-Humphrey Amendments of 1951   (US) Legislation that created a statute declaring which drugs required labeling for prescription use.  
Dynamic HTML DHTML Collective term for a combination of new tags and options, style sheets, and programming that lets you create Web pages in Hypertext Mark-up Language (HTML) that are more responsive to user interaction than previous versions of HTML.  
E
Eastern Cooperative Oncology Group (U.S.) ECOG The ECOG was established as one of the first cooperative groups launched to perform multi-center cancer clinical trials. Funded primarily by the NCI, ECOG has evolved from a five member consortium of institutions on the East Coast to one of the largest clinical cancer research organizations in the U.S. with almost 6000 physicians, nurses, pharmacists, statisticians, and clinical research associates (CRAs) from the U.S., Canada, and South Africa. These institutions work toward the common goal of controlling, effectively treating, and ultimately curing cancer. Research results are provided to the world-wide medical community through scientific publications and professional meetings. http://ecog.dfci.harvard.edu/
Edit Checks   Tools used by data management to validate clinical data. These are generally automated (computerized) and are used to detect inconsistencies in the data (i.e., illogical entries, value inconsistencies, and out of range values).  
Effectiveness (in relation to Drug Product)   The desired measure of a drug's influence on a disease condition as proved by substantial evidence from adequate and well-controlled investigations such as clinical trials.  
Effective Dose   The dose of an investigational product that produces the outcome of "effectiveness" (e.g., cure of the disease in question or simply the mitigation of symptoms), as defined in the study protocol.  
Efficacy   A product's ability to produce beneficial effects on the course or duration of a disease.  
Effort Certification   Employees appointed directly to a sponsored project sign an annual certification that the distribution of effort on their appointment form is correct.  
Eldercare   Public, private, formal, and informal programs and support systems, government laws, and finding ways to meet the needs of the elderly, including: housing, home care, pensions, Social Security, long-term care, health insurance, and elder law.  
Electronic Data Interchange EDI The exchange of standardized document forms between computer systems for business use. EDI is part of electronic commerce. EDI is most often used between different companies ("trading partners") and uses some variation of the ANSI X12 standard (USA) or EDIFACT (UN sponsored global standard).  
Electronic Form (in relation to
HIPAA)		   Using electronic media such as internet, extranet, telephone lines (e.g., facsimile), private networks, and electronic media moved physically from one location to another (e.g., magnetic tape, disk, CD).  
Electronic Funds Transfer EFT Transfer of money initiated through electronic terminal, automated teller machine, computer, telephone, or magnetic tape. In the late 1990s, this increasingly includes transfer initiated via the WWW. The term also applies to credit card and automated bill payments.  
Electronic Mail Service EMS or Email A system for sending and receiving messages electronically over a computer network, as between personal computers.  
Electronic Research Administration ERA In the generic sense, is simply doing research administration electronically. It encompasses everything from using EDI to submit grant proposals to creating a word template to print a funding agency's form. ERA is building a home page for a sponsored research office or utilizing the web to find out about a grant application. ERA incorporates listservs, searching for funding opportunities, making publications available electronically, and faculty profile databases.  
Electronic Record   Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. 21 CFR 11.3
Electronic Regulatory Submission ERS The electronic equivalent or version of a marketing application (e.g., NDA)  
Electronic Signature   A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. 21 CFR 11.3
Electronic Transaction (in relation to HIPAA)   See Electronic Form (in relation of HIPAA)  
Eligibility (in relation to subjects)   Subjects who meet inclusion and exclusion criteria identified by the protocol.  
Elimination (in relation to Pharmacokinetics)   See Excretion  
Emancipated Minor   A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law (for such purposes as consenting to medical care), but who are entitled to treatment as if they had by virtue of assuming adult responsibilities such as being self-supporting and not living at home, marriage, or procreation.  
Embryo  

Early stages of a developing organism, broadly used to refer to stages immediately following fertilization of an egg through implantation and very early pregnancy (i.e., from conception to the eighth week of pregnancy).

See also Fetus

  
Emergency Use   The use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval. 21 CFR 56.102
Emergency and/or Urgent Treatment (for purposes of adverse event reporting)   An event that was not life-threatening but still warranted urgent professional treatment for physical or psychological trauma or injury such as treatment in an emergency room, urgent care center, psychiatrist’s office, psychologist office, or other facility providing immediate care (e.g., battered women’s shelter).  
Emergency Care   Care given for a medical emergency when you believe that your health is in serious danger when every second counts.  
Emergency Room (Hospital)   A portion of the hospital where emergency diagnosis and treatment of illness or injury is provided.  
Emergency Use Application (in relation to IRBMED)   An application specific to the IRBMED process at the University of Michigan  
End-of-Phase II Meetings   Meetings held with regulatory officials to determine the safety of proceeding to Phase III, to evaluate Phase III plan and protocols, and to identify any additional information necessary to support a marketing application for the uses under investigation.  
End-of-Review Conference   (US) A conference offered to all applicants after the FDA has issued either an approvable or not-approvable letter with respect to the NDA, during which FDA officials discuss steps the sponsor must take before the application can be approved.  
End-of-Study Visit Report   See Final Trial Close-Out Monitoring Report  
Endpoint   An outcome or medical event that a clinical trial monitors. Common endpoints include death or need for hospitalization. For example, a clinical trial studying a new cancer drug might use death as an endpoint to determine if people getting the drug lived longer than those who did not get the drug.  
Enrollment   The process of registering subjects who have been recruited for participation for participation in a clinical trials.  
Entry Criteria   See Exclusion Criteria AND Inclusion Criteria  
Epidemiology   The study of the patterns of determinants and antecedents of disease in human populations utilizing biology, clinical medicine, and statistics in an effort to understand the etiology (causes) of illness and/or disease.  
Equipoise  

1. A state in which an investigator is uncertain about which arm of a clinical trial would be therapeutically superior for a patient.

2. When an investigator is uncertain about which arm of a clinical trial would be therapeutically superior for a subject. An investigator who has a treatment preference or finds out that one arm of a comparative trial offers a clinically therapeutic advantage should disclose this information to subjects participating in the trial.

 
Equitable (in terms of Recruitment)   Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed.  
Error   A deviation from truth or accuracy. A disprepancy between a data field and the coorsponding data recorded on the CRF.  
Error Rate   The number of incorrect items in a dataset or in a database expressed as a percentage of the total number of completed items in the database or dataset.  
Essential Documents   ICH Definition: Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. ICH E6 1.23
Essential Requirements ER (EU) The requirements set forth in Annex 1 of the Medical Device Directives (MDD), which any device must fulfill before a CE marking may be affixed. Compliance with most ERs is presumed when the company is deemed in compliance with certain harmonized standards.  
Establishment Inspection Report EIR A compilation of documents issued by FDA after the completion of an site inspection as defined by subchapter 590 of the Investigations Operations Manual.  
Establishment License Application ELA Historical term for an application for a new biological product submitted to the FDA, specifically CBER, under the Public Health Service Act for review and approval prior to marketing in interstate commerce.  
Ethical Committee EC See Independent Ethics Committee  
Ethics Advisory Board   See Independent Ethics Committee  
Ethics Committee EC See Independent Ethics Committee  
Ethics Review Board ERB See Independent Ethics Committee  
Ethics Review Committee ERC See Independent Ethics Committee  
Ethnographic Research   Fieldwork, that involves observation of and interaction with the persons or group being studied in the group's own environment, often for long periods of time.  
European Community EC Historical term for European Union  
European Currency Unit ECU A weighted index of the currencies of ten European Economic Community members. For bonds denominated in ECUs, U.S. investors risk not only the possibility of interest-rate increases but also the chance that the dollar will rise relative to the ECU (that is, one ECU will buy fewer dollars). On the plus side, these securities provide investors with the opportunity of overseas diversification without reliance on the currency of a single country.  
European Economic Community EEC Historical term for European Union  
European Federation of Pharmaceutical Industries Association EFPIA An organization that represents the pharmaceutical industry in Europe. http://www.efpia.org/
European Forum for Good Clinical Practices EFGCP Europe's leading think-tank that consider the ethical, regulatory, and scientific framework of clinical research in Europe. http://www.efgcp.org/
European Free Trade Association EFTA An international organization promoting free trade and economic integration with and within its membership, primarily European states. http://www.efta.int/
European Medicines Evaluation Agency EMEA The Agency within the European Union that coordinates scientific resources existing from EU member states to evaluate, supervise, and provide opinions on marketing authorization of medicinal products for both human and veterinary use. http://www.emea.eu.int/
European Union EU Organization of European countries dedicated to increasing economic integration and strengthening cooperation among its members. It is composed of the following countries: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, and the United Kingdom. http://europa.eu.int/index_en.htm
Evaluable (in relation to subjects)   A subject in a clinical trial who has satisfied all of the protocol requirements and may be evaluated for safety and efficacy in the final data analysis and report.  
Evaluable for Efficacy (in relation to subjects)   A subgroup of intent-to-treat subjects who satisfy the criteria for efficacy evaluation as set forth in the protocol's statistical plan.  
Every day event   As used in the context of particular subject populations, this term refers to the magnitude or frequency of events that would be expected in that population (i.e., broken hips in geriatric population).  
Every day life   As used in the reporting of mild adverse events only, this term refers to the magnitude or frequency of an otherwise mild untoward occurrence (e.g., a headache) that is outside the expected norm for subjects in the study.  
Exclusion Criteria   Refers to the characteristics that would prevent a subject from participating in a clinical trial, as outlined in the study protocol.  
Excretion (in relation to Pharmacokinetics)   The pharmacokinetic (PK) process of eliminating drug from the body.  
Exemptions (in terms of Human Research Protection Programs)   Research falling under 1 of 6 exemptions noted in 45 CFR 46.101(b) is not required to undergo IRB review and the investigator is not required to abide by the requirements for obtaining informed consent.  
Expanded access   The ways that the FDA allows patients to get experimental medications outside of clinical trials before the drugs are approved. Compassionate use is one form of expanded access.  
Expanded Availability   Policy and procedure that permits individuals who have serious or life-threatening diseases for which there are no alternative therapies to have access to investigational drugs and devices that may be beneficial to them.  
Expected Event   An adverse event described in the informed consent document. Other reporting entities (sponsors or the FDA) may require an assessment of expectedness based on the Investigator’s Brochure or protocol, but for IRBMED reporting, look to the consent document.  
Expedited Reporting   A report of serious adverse event (SAE) that is submitted to a health authority in an expedited manner, (e.g., the FDA, as a three-day and/or ten-day report).  
Expedited Review (in terms of IRBs)   Review for certain types of research involving no more than minimal risk and for minor changes in approved research which may be done solely by the IRB chair or designee using criteria set by federal regulations.  
Experimental   Term often used to denote a therapy (drug, device, procedure) that is unproven or not yet scientifically validated with respect to safety and efficacy. A procedure may be considered "experimental" without necessarily being part of a formal study (research) to evaluate its usefulness.  
Experimental Drug   See Investigational New Drug  
Experimental Study   A study in which subjects are randomly assigned to groups that experience carefully controlled interventions manipulated by the experimenter according to a strict logic allowing causal inference about the effects of the interventions under investigation.  
Expert Report   (EU) A critique required by the regulatory authorities of the European Union (EU) regarding each section of a pharmaceutical marketing application.  
Explanatory Trial  

Term used to describe a clinical study designed to demonstrate the efficacy of a product.

See also Pragmatic Trial

  
Extended Care Services   In the context of this report, an alternate name for "skilled nursing facility services".  
Extensible Markup Language XML An initiative from the World-Wide Web Consortium defining an "extremely simple" dialect of standardized markup language suitable for use on the World-Wide Web.  
External Consistency   The consistency of a procedure between sets of data.  
External Quality Review Organization EQRO Typically the EQRO is a peer review organization. It may conduct focused medical record reviews (i.e., Reviews targeted at a particular clinical condition) or broader analyses on quality. While most EQRO contractors rely on medical records as the primary source of information, they may also use eligibility data and claims/encounter data to conduct specific analyses.  
Extramural Research (in terms of NIH)   Research supported by the National Institutes of Health (NIH) through a grant, contract, or cooperative agreement to researchers and organizations outside the NIH.  
F
FDA Action Letter   (US) The means through which the FDA communicates its official decision on an NDA. There are three types of "action letters": approval, approvaable, and non-approvable.  
FDA FORM-356H   (US) The form which accompanies a new drug application (NDA) and is signed by the sponsor.  
FDA FORM-1571   (US) The cover sheet submitted with an IND. The FDA Form-1571 summarizes all information required in the IND: sponsor identification, name of the drug, indication, phase of clinical investigation, safety protocol, the drug's chemical composition, manufacture and labeling, and non-clinical and clinical experience.  
FDA FORM-1572   (US) See Statement of Investigator  
FDA Oversight   The FDA has oversight over clinical trials involving investigational drugs, devices, and biologics, and some trials involving approved drugs, devices and biologics. Contact the IRBMED Office or the UMHS Office of General Counsel for guidance if there is any question regarding whether FDA oversight of a clinical trial is required.  
FDA Protection of Human Subjects Regulations   Regulations intended to protect the rights, safety, and welfare of participants involved in studies subject to FDA jurisdiction. The FDA Protection of Human Subjects Regulations can be found at Title 21 Code of Federal Regulations, Parts 50 and 56.  
Fabrication (in terms of
Misconduct)		   Making up data or results and recording or reporting them.    
Facilities and Administrative (Costs) F&A

The costs of operations which generally cannot be assigned to specific projects, such as electricity and central administrative services; sometimes referred to as "overhead" (called Indirect costs at the UM).

See Indirect Costs

  
Factorial Design   A trial design which allows the evaluation of the efficacy of two treatments with the same number of subjects as would be required to evaluate either one alone.  
False Negatives   Occur when the medical record contains evidence of a service that does not exist in the encounter data. This is the most common problem in partially or fully capitated plans because the provider does not need to submit an encounter in order to receive payment for the service, and therefore may have a weaker incentive to conform to data collection standards.  
False Positives   Occurs when the encounter data contain evidence of a service that is not documented in the patient's medical record. If we assume that the medical record contains complete information on the patients medical history, a false positive may be considered a fraudulent service. In a fully capitated environment, however, the provider would receive no additional reimbursement for the submission of a false positive encounter.  
Falsification (in terms of
Misconduct)		   Manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record.  
Family Member   Any one of the following legally competent persons: spouse; parents; children (including adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the subject is the equivalent of a family relationship. 21 CFR 50.3
Familial/social relations   Relationships of significance in the life of the research subject such as parent-child, spousal, employer-employee relations. Harms to these relationships (associated with the research study) are adverse events. When relevant, the study protocol or DSMP should address protection of such relations (e.g., in a genetic study, a plan for how discovery of non-paternity of the assumed father would be handled by the researchers).  
Family Educational Rights and Privacy Act FERPA Covers rights of parents of school children regarding reviewing, amending and disclosing educational records. http://www.ed.gov/policy/gen/guid/fpco
/ferpa/index.html
FastLane   NSF's program for ERA; electronic proposal submission is now functional through this system. http://www.fastlane.nsf.gov/
Fatal Event   The subject’s life ended in conjunction with the event (FDA). A fatal event is considered Grade V using NCI/CTC Common Toxicity Criteria (v. 2.0). See also Death and Severity.  
Federal Accounting Standards Advisory Board FASAB The mission of the FASAB is to promulgate federal accounting standards after considering the financial and budgetary information needs of citizens, congressional oversight groups, executive agencies, and the needs of other users of federal financial information. Accounting and financial reporting standards are essential for public accountability and for an efficient and effective functioning of our democratic system of government.  
Federal Communications Commission FCC The Federal Communications Commission (FCC) is an independent United States government agency, directly responsible to Congress. The FCC was established by the Communications Act of 1934 and is charged with regulating interstate and international communications by radio, television, wire, satellite and cable. The FCC's jurisdiction covers the 50 states, the District of Columbia, and U.S. possessions. http://www.fcc.gov/
Federal Demonstration Partnership FDP The Federal Demonstration Partnership (FDP) is an association of federal agencies, academic research institutions with administrative, faculty and technical representation, and research policy organizations that work to streamline the administration of federally sponsored research. FDP members of all sectors cooperate in identifying, testing, and implementing new, more effective ways of managing the more than $15 Billion in federal research grants. The goal of improving the productivity of research without compromising its stewardship has benefits for the entire nation. http://thefdp.org/
Federal Emergency Management Agency FEMA The Federal Emergency Management Agency - a former independent agency that became part of the new Department of Homeland Security in March 2003 - is tasked with responding to, planning for, recovering from and mitigating against disasters. FEMA can trace its beginnings to the Congressional Act of 1803. This act, generally considered the first piece of disaster legislation, provided assistance to a New Hampshire town following an extensive fire. In the century that followed, ad hoc legislation was passed more than 100 times in response to hurricanes, earthquakes, floods and other natural disasters. http://www.fema.gov/
Federal Insurance Contributions Act FICA Provision authorizing taxes on the wages of employed persons to provide for the OASDI and HI programs. Covered workers and their employers pay the tax in equal amounts.  

Federal Policy (The)

   The federal policy that provides regulations for the involvement of human subjects in research. The Policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the Policy applicable to such research. Currently, sixteen federal agencies have adopted the Federal Policy. Also known as the "Common Rule."  
Federal Register FR The official daily publication for rules, proposed rules, and notices of Federal (i.e., United States) agencies and organizations, as well as executive orders and other presidential documents. http://www.gpoaccess.gov/fr/index.html
Federal Trade Commission FTC (US) The Federal Trade Commission (FTC) works to ensure that the nation’s markets are vigorous, efficient and free of restrictions that harm consumers. Experience demonstrates that competition among firms yields products at the lowest prices, spurs innovation and strengthens the economy. Markets also work best when consumers can make informed choices based on accurate information. http://www.ftc.gov/
Federal Wide Assurance FWA An assurance of compliance approved by the Office for Human Research Protections (OHRP) and obtained by every institution engaged in human subjects research supported or conducted by DHHS that should 1) create a new registry of IRBs; and 2) streamline the assurance process to significantly reduce the administrative burden on individual institutions, other federal departments and agencies, and OHRP. http://ohrp.osophs.dhhs.gov/humansubjects
/assurance/fwas.htm
Federation of American Societies for Experimental Biology FASEB The mission of FASEB is to enhance the ability of biomedical and life scientists to improve, through their research, the health, well-being, and productivity of all people. FASEB is a coalition of independent Member Societies that serve the interests of biomedical and life scientists, particularly those related to public policy issues. FASEB facilitates coalition activities among Member Societies and disseminates information on biological research through scientific conferences and publications. FASEB also offers Member Societies headquarters facilities, and operational and logistic support. http://www.faseb.org/
Fetal Material   The placenta, amniotic fluid, fetal membranes, and umbilical cord.  
Fetus   The product of conception from the time of implantation until delivery. If the delivered or expelled fetus is viable, it is designated an infant [45 CFR 46.203(c)]. The term "fetus" generally refers to later phases of development; the term "embryo" is usually used for earlier phases of development. See also Embryo. 45 CFR 46.202(c)
Field   An element in a database record in which one piece of information from a CRF, either derived or copied directly, is stored.  
Fieldwork   Behavioral, social, or anthropological research involving the study of persons or groups in their own environment and without manipulation for research purposes (distinguished from laboratory or controlled settings).  
Fifteen-Day Alert Reports   (US) A type of expedited AE reporting. The FDA's alert reporting provisions state that a drug manufacturer must alert the FDA within 15 calendar days to, "all adverse drug experiences that are both serious and unexpected; and any significant increase in frequency of an adverse drug experience that is both serious and expected."  
File Transfer Protocol FTP A standard protocol for exchanging files between computers on the Internet. Used to transfer Web page files to the computer that acts as a server for everyone on the Internet. Also commonly used to download programs and other files to your computer from other servers. FTP is usually one of the programs that come with TCP/IP.  
Final Printed Label FPL All labeling which will appear on or accompany the package or container of an approved drug.  
Final Report (in relation to IRBs)   Document for the completion of the trial  
Final Trial Close-Out Monitoring Report   Document such that all activities required for trial closeout are completed, and copies of all documents are held in the appropriate files. ICH E6 8.4.5
Financial Agreement   A document detailing all financial arrangements entered into between the sponsor and the investigational site.  
Financial Disclosure (as FDA Forms) FDF See Financial Disclosure Questionnaire 21 CFR 54
Official legal document formally titled Form FDA 3454: Certification: Financial Interests and Arrangements of Clinical Investigators that is completed by sponsors to certify the absence of any financial arrangement between an investigator and the applicant for marketing application of a new investigational product in the United States.
Official legal document formally titled Form FDA 3455: Disclosure: Financial Interests and Arrangements of Clinical Investigators that is completed by sponsors to detail the specific status of any financial arrangement between an investigator or investigators and the applicant for the marketing application a new investigational product in the United States.
Financial Disclosure Questionnaire (in relation to investigator) FDQ Form required in the United States and completed by investigators, sub investigators, their spouses, and their dependents to disclose legally required financial arrangements with the sponsors of their clinical study.  
Firewall   A set of related programs, located at a network gateway server, that protects a private computer network from users from other networks. Also the security policy that is used with the programs.  
First-In-Humans Study   The first Phase 1 study in which the test product is administered to human beings.  
First-In-Man Study   See first-in-humans study.  
Follow up report   A supplemental report from a sponsor or investigator providing additional information, clarification, or corrections to a previously reported (to IRBMED) adverse event.  
Food and Drug Administration FDA (US) An agency in the U.S. Department of Health and Human Services that regulates drugs, vaccines, medical devices, and blood transfusions. The FDA is responsible for ensuring that all medical products, both new and old, are safe and work well. http://www.fda.gov/
Food and Drug Administration Modernization Act FDAMA Major legislation in the United States (in 1997) that focused on reforming the regulation of food, medical products, and cosmetics that included: Prescription Drug User Fees FDA Initiatives and Programs Information on Off-label Use and Drug Economics Pharmacy Compounding Risk-based Regulation of Medical Devices Food Safety and Labeling Standards for Medical Products. http://www.fda.gov/oc/reform/fdama2
/fdama.htm
Food and Drug Law Institute FDLI Forum for the Food and Drug Administration (FDA), other government agencies and the legal, business, academic and consumer communities to engage in the exchange of information and perspectives on optimizing public policy, law and regulation relating to products subject to FDA jurisdiction. http://www.fdli.org/
Food Drug and Cosmetic (Act) FDC

Major legislation in the United States (in 1938) that extensively revised the 1906 Food and Drug Law with provisions that: 1.) Required new drugs to be shown safe before marketing them. 2) Eliminated the Sherley Amendment. 3.) Extended control to cosmetics and therapeutic devices. 4.) Set safe tolerances for unavoidable poisonous substances. 5.) Authorized factory inspections. 6.) Added remedy of court injunctions to previous penalties of seizures and prosecutions.

  
For Cause Audit   Conducted when a regulatory agency suspects that there are problems with regard to scientific integrity or protection of subject welfare.  
Forced Titration Design   A study in which all subjects move through a series of rising doses. This is similar in concept and limitations to a randomized multiple crossover dose-response study, except that assignment to dose levels is ordered, not random.  
Form G   Covers rights of parents of school children regarding reviewing, amending and disclosing educational records.  
Form G-2   Form used to pay independent consultants (not if they have IRS employer ID number)  
Form G-Q   Form used to pay independent consultants (not if they have IRS employer ID number)  
Format   In data management, the 'display' or 'image' of a variable whether in the database or on printouts, e.g., date variable with the format 'DD-MMM-YY'.  
Formulary   A list of certain drugs and their proper dosages. In some health plans, doctors must order or use only drugs listed on the health plan's formulary.  
Formulary Drugs   Listing of prescription medications which are approved for use and/or coverage by the plan and which will be dispensed through participating pharmacies to covered enrollees.  
Formulation   The mixture of chemicals and/or biological substances and excipients used to prepare dosage forms.  
Freedom of Information Act FOIA

1.) (US) Law which allows public access to certain information in government files, including information regarding clinical trials.

2.) The United States statute that provides access to federal agency records except to the extent that such records (or portions thereof) are protected from disclosure by any of the nine exemptions and three special law enforcement record exclusions in the act.

 http://www.hhs.gov/foia/
Frequency  

1.) In statistics, the number of occurrences of a given type of event, or the number of times an event or value falls into a given class.

2.) May also refer to the number of times medications are given in a specified time period.

  
Frequency Distribution   A descriptive statistic illustrating the degree to which quanitative and qualitative responses are present in treatment groups.  
Full Board Review (in terms of IRBs)   Review of proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas.  
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