Clinical
Research Dictionary
(Glossary
of Terms and Acronyms)
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Clinical
Research Dictionary
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(Glossary
of Terms and Acronyms)
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| Radioactive Biological Product | See Radioactive Drug | ||
| Radioactive Drug | Any substance defined as a drug in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any nonradioactive reagent kit ornuclide generator which is intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radio nuclides. | 21 CFR 310.3 (n) | |
| Radioactive Drug Research Committee | RDRC | An institutional committee responsible for the use of radioactive drugs in human subjects for research purposes. | 21 CFR 361.1(c) |
| Radio pharmaceuticals | Drugs (compounds or materials) that may be labeled or tagged with a radioisotope. | ||
| Radiopaque Contrast Agents | Materials that stop or attenuate radiation that is passed through the body, creating an outline on film of the organ(s) being examined. Contrast agents, sometimes called "dyes," do not contain radioisotopes. When such agents are used, exposure to radiation results only from the X-ray equipment used in the examination. The chemical structure of radiopaque contrast agents can produce a variety of adverse reactions, some of which may be severe — and possibly life-threatening — in certain individuals. | ||
| Radiopharmaceuticals | Drugs (compounds or materials) that may be labeled or tagged with a radioisotope. These materials are largely physiological or subpharmacological in action, and, in many cases, function much like materials found in the body. The principal risk associated with these materials is the consequent radiation exposure to the body or to specific organ systems when they are injected into the body. | ||
| Random | See Randomization | ||
| Random Allocation | The process of assigning subjects to treatment (or control) groups in an unpredictable way. Assignment sequences are concealed but available for disclosure in the event a subject has an adverse event. | ||
| Random Assignment | See Randomization | ||
| Random Number Table | Table of numbers with no apparent pattern used in the selection of random samples for clinical trials. | ||
| Random Sample | Members of a population selected by a method designed to ensure that each person in the target group has an equal chance of selection. | ||
| Random Selection | A method of selecting sample units such that each possible sample has a fixed probability of selection; unbiased sampling. | ||
| Randomization (or Randomized) | 1.) The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. 2.) A method to assign participants to various groups or arms of a study based on chance. Researchers have no say in who gets assigned to the different arms of the study. This leads to groups that are generally comparable, and it minimizes bias. Randomized trials may compare one medical intervention to another intervention, to a control group, or to both. |
ICH E6 1.48 | |
| Randomization Code | A list, pattern, or record of the treatment assignments for all subjects in a particular randomized study. | ||
| Randomized | See Randomization | ||
| Randomized Control Trial | RCT | Studies that randomly assign individuals to an intervention group or to a control group, in order to measure the effects of the intervention. | |
| Randomized Controlled Study | Any comparative study in which subject allocation to treatment groups is unpredictable and is achieved through a systematic randomization scheme. | ||
| Range (in relation to Data) | The numerical difference between the highest and lowest observation and/or data point | ||
| Rarional Drug Design | A process of drug research focusing on the physiological basis of disease and finding or creating new therapeutic agents that alter the course of disease at the molecular level. | ||
| Raw Data | Records or certified copies of the original clinical and laboratory findings from the trial. See also Source Data |
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| Rechallenge | A method used to determine if a drug treatment is causally related to an adverse event. The subject takes the drug suspected of causing the adverse event, and is carefully monitored to observe if the event occurs. | ||
| Recombinant DNA | In the context of the NIH Guidelines, recombinant DNA molecules are defined as either: i.) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell; or ii.) molecules that result from the replication of those described in (i) above. (NIH guidelines including OBA and Recombinant DNA Advisory Committee (RAC)). | ||
| Recombinant DNA Advisory | RAC | An National Institutes of Health (NIH) advisory committee whose principal role is to provide advice and recommendations to the NIH Director on 1.) the conduct and oversight of research involving recombinant DNA, including the content and implementation of the NIH Guidelines; and 2.) other NIH activities pertinent to recombinant DNA technology. | http://www4.od.nih.gov/oba/rac /aboutrdagt.htm |
| Records Retention | 1.) The storage and retention of project documents and database after completion of the project. 2.) Length of time, typically defined by regulatory authorities, that clinical trial records must be maintained and saved. |
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| Recruitment (in relation to investigators) | The process used by the sponsor to select investigators for a clinical study. See also Investigator Recruitment |
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| Recruitment (in relation to subjects) | 1.) The process of identifying and screening potential subjects for trial enrollment. 2.) Process used by investigators to enroll appropriate subjects in a clinical trial. |
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| Recruitment Period | 1.) Time period during which investigators must complete enrollment of their quota of subjects for a trial. 2.) The time period during which subjects can be entered into a clinical study. |
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| Recruitment Plan | A summary of the steps to be taken to ensure recruitment of adequate numbers of subjects within the target time frame. This might include, for example, pre-study chart review to identify potential subjects, early development and IEC/IRB approval of advertisements, or other permissible techniques to optimize recruitment. | ||
| Recruitment Strategy | A statement routinely included in the clinical plan which addresses the anticipated ease or difficulty in recruiting subjects for protocol, and the strategy to be adopted if recruitment targets are not being met. | ||
| Recruitment Target | 1.) The minimum number of subjects who must be recruited to provide the number of evaluable subjects required for statistical signficance after dropout loss. 2.) Number of subjects that must be recruited into a trial to meet the requirements of the protocol. |
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| Reference Ranges | Laboratory test values typical of specific subject populations used for comparison and evaluation of actual test results. | ||
| References (in relation to Trial) | A list of relevant literature which is usually noted in a variety of study documents (e.g., protocol, reports, publications). | ||
| Reference Listed Drug | The listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its abbreviated application. | 21 CFR 314.3 | |
| Refuse To File (Letter) | RTF | A formal letter from FDA (e.g., CDER) to the applicant of a New Drug Application that is incomplete detailing the decision and the deficiencies that form its basis of its non-acceptance by the agency. | |
| Registered Nurse | RN | A nurse who has graduated from a formal program of nursing education and has been licensed by an appropriate state authority. | |
| Registered Pharmacist | See Pharmacist | ||
| Registration Dossier | See Registration Submission | ||
| Registration Strategy | See Regulatory Strategy | ||
| Registration Submission | The vehicle through which drug sponsors formally request that a regulatory agency approve a new pharmaceutical for marketing. | ||
| Regulation | A governmental order with the force of the law. | ||
| Regulatory Affairs | 1.) The function/department within a regulated industry that involves compliance with government regulations and interaction with government regulatory agencies. 2.) The department or function that is responsible for ensuring compliance with government regulations and interacts with the regulatory agencies |
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| Regulatory Affairs Professional Society | RAPS | A primary resource and international association for regulatory affairs professionals | http://www.raps.org/ |
| Regulatory Agencies | See Regulatory Authorities | ||
| Regulatory Approval | Usually refers to affirmation or positive decision by a government agency (i.e., regulatory authority) with jurisdiction over requested process or document (e.g., Investigational New Drug applications and updates) | ||
| Regulatory Compliance | Following the rules set by a governing body. | ||
| Regulatory Authorities | 1.) Government organizations responsible for promulgating and enforcing regulations. These organizations are authorized by the government of a single country, such as the US Food and Drug Administration (FDA), or by a group of countries such as the European Economic Community Committee for Proprietary Medicinal Products (CPMP). 2.) ICH Definition: Bodies having the power to regulate. In the ICH GCP guideline the expression “regulatory authorities” includes the authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are sometimes referred to as competent authorities. |
ICH E6 1.49 | |
| Regulatory Compliance | An operating condition in which work practices ensure compliance with government regulations. | ||
| Regulatory Letter | RL | FDA post-audit letter | |
| Regulatory Requirements | Any law(s), regulation(s), and guidelines addressing the conduct of clinical trials of investigational products. | ||
| Regulatory Strategy | A plan describing the steps that should be taken to gain regulatory approval. The strategy generally includes a non-clinical, clinical, and manufacturing section, including estimates of the time and costs associated with implementation. | ||
| Rehabilitation | Rehabilitative services are ordered by your doctor to help you recover from an illness or injury. These services are given by nurses and physical, occupational, and speech therapists. Examples include working with a physical therapist to help you walk and with an occupational therapist to help you get dressed. | ||
| Related Drug | Other brands, potencies, dosage forms, salts, and esters of the same drug moiety, including articles prepared or manufactured by other manufacturers: and any other drug containing a component so related by chemical structure or known pharmacological properties that, in the opinion of experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, it is prudent to assume or ascertain the liability of similar side effects and contraindications. | 21 CFR 310.3 (k) | |
| Related Event | Any adverse event that has a temporal relationship to the administration of the investigational drug or research intervention, follows a known or suspected pattern of response, and for which an alternative cause may not be present, is definitely, probably, or possibly associated with the investigational drug/agent. Investigator needs to judge relatedness and be prepared to justify the judgment. See also Relatedness and Cause |
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| Relatedness | Definitely Related: The adverse event 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. | ||
| Possibly Related: The adverse event may be related to the investigational agent(s) or intervention: the adverse event has a temporal relationship to the administration of the investigational agent(s) or research intervention, follows a suspected pattern of response, but an alternative cause is present. | |||
| Probably Related: The adverse event is likely related to the investigational agent(s) or intervention: the adverse event has a temporal relationship to the administration of the investigational agent(s) or research intervention, follows a known or suspected pattern of response, but an alternative cause may be present. | |||
| Unlikely to be related: The adverse event is doubtfully related to the investigational agent(s) or intervention: the adverse event has a temporal relationship to the administration of the investigational agent(s) or research intervention, but follows no known or suspected pattern of response, and an alternative cause is present. | |||
| Unrelated (or Not Related): The adverse event is clearly NOT related to the investigational agent(s) or intervention: the adverse event has no temporal relationship to the administration of the investigational agent(s) or research intervention, follows no known or suspected pattern of response, and an alternative cause is present. | |||
| Remission | A period in which the signs and symptoms of a disease are diminished or in abeyance. The term "remission" is used when one cannot say with confidence that the disease has been cured. | ||
| Remote Data Entry | RDE | 1.) Systems for directly entering data from investigational sites into the study databases by electronic means (rather than by physical transfer of data on paper CRFs from the site to the database location for entry). 2.) The process by which investigators and study coordinators use computers at their site to enter clinical data from the case report forms (CRFs) directly and transfer these data typically across a modem for downloading into the sponsor's computers. |
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| Remuneration | Payment for participation in research. | ||
| Representative | See Legally Acceptable Representative | ||
| Request for Application (in relation to NIH) | RFA | Official statement that invites grant or cooperative agreement applications to accomplish a specific program purpose; indicates the amount of funds set aside for the competition; and, generally identifies a single application receipt date | |
| Request for Proposal (in relation to NIH) | RFP | Name used for application guidelines for a grant program which contain project specifications and application procedures | |
| Request for Quotation | RFQ | Contract announcement distributed by a contracting agency to potential respondents defining in a general way the type of goods or services needed | |
| Research | A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. This includes the development of research repositories and databases for research. | ||
| Research Collaboration Agreements | Most university technologies are early stage and often additional research and evaluation is required to move the technology toward commercialization. If the prospective licensee can't do that research "in-house," the university inventors may be asked to do it under a sponsored research agreement with the company. The Division of Research Development and Administration (DRDA) negotiates such agreements, with input from OTT as appropriate. | ||
| Research and Development | R&D | Discovering new knowledge about products, processes, and services, and then applying that knowledge to create new and improved products, processes, and services that fill market needs. | |
| Research Assistant | RA | Another common job family term used for study coordinator roles at the University of Michigan | |
| Research Associate | RA | Most common job family name (includes levels 1 and 2) for study coordinator role at University of Michigan | |
| Research Coordinator | See Study Coordinator | ||
| Research Ethics Board | See Independent Ethics Committee | ||
| Research Hypothesis | The research hypothesis is the conclusion a study sets out to support (or disprove); for example, “blood pressure will be lowered by [specific endpoint] in subjects who receive the test product.” See also Null Hypothesis |
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| Research Integrity Officer | The institutional official responsible for assessing allegations of scientific misconduct and determining when such allegations warrant inquiries and for overseeing inquiries and investigations | ||
| Research Misconduct | See Misconduct (in terms of Research) | ||
| Research Nurse | A nurse who serves the function of a study coordinator | ||
| Research Projects (in terms of NIH) | Primarily investigator-initiated, basic scientific research. | ||
| Research Protocol | A document that outlines a strong research design, which clearly states the objectives, background, methods and the significance of the study being proposed. | ||
| Research Record | Any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research | ||
| Research Subject | See Subject | ||
| Research Subject Advocate (in relation to GCRC) | RSA | A required position within NIH-sponsored General Clinical Research Centers (GCRCs) which ensure that the IRB- and GCRC Advisory Committee (GAC)-approved data and safety monitoring plan is fully implemented and that the protocol carried out at the GCRC complies with the IRB- and GAC-approved protocol. | |
| Residential Substance Abuse Treatment Facility | A facility which provides treatment for substance (alcohol and drug) abuse to live-in residents who do not require acute medical care. Services include individual and group therapy and counseling, family counseling, laboratory tests, drugs and supplies, psychological testing, and room and board. | ||
| Respect for Persons (in relation to Belmont Report) | An ethical principle that divides into two separate moral requirements: 1.) the requirement to acknowledge autonomy of an individual, and; 2.) the requirement to protect those individuals with diminished autonomy. | ||
| Respite Care | Temporary or periodic care provided in a nursing home, assisted living residence, or other type of long-term care program so that the usual caregiver can rest or take some time off. | ||
| Responder | A patient who successfully responds to product (e.g., medication) or procedure given. | ||
| Responsible Conduct of Research | RCR | General term previously promoted by the United States Public Health Service, specifically, the Office of Research Integrity (ORI) for educational purposes | http://ori.dhhs.gov/html/programs /finalpolicy.asp#definitions |
| Restraints | Physical restraints are any manual method or physical or mechanical device, material, or equipment attached to or adjacent to the resident’s body that the individual cannot remove easily which restricts freedom of movement or normal access to ones body. Chemical restraints are any drug used for discipline or convenience and not required to treat medical symptoms. | ||
| Retest Date (Clinical Supplies) | The date on which an investigational drug is tested to determine whether it may still be used for a clinical study. Testing is done when there is a sufficient amount of drug available for use. | ||
| Retrospective Study | A trial where an investigator goes back through the medical records and chooses subjects satisfying certain criteria and determines protocol specific outcomes. | ||
| Review of Research (in relation to IRBs) | The concurrent oversight of research on a periodic basis by an IRB. | ||
| Revised Protocol | A complete re-issue of a protocol to replace a protocol which has already been approved. | ||
| Right of Reference or Use | The authority to rely upon, and otherwise use, an investigation for the purpose of obtaining approval of an application, including the ability to make available the underlying raw data from the investigation for FDA audit, if necessary. | 21 CFR 314.3 | |
| Risk | 1.) In clinical trials, the probablility of harm or discomfort for subjects. The level of acceptable risk varies depending on the condition for which a product is being tested. 2.) A factor, element, or course of action involving an uncertain, potentially negative outcome |
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| Risk (in relation to trials) | The probability of harm or discomfort for subjects | ||
| Risk-Benefit Analysis | See Risk-Benefit Ratio | ||
| Risk-Benefit Balance | See Risk-Benefit Ratio | ||
| Risk-Benefit Ratio | An individual's comparison of the risks that a clinical trial poses to its possible benefits. Because people weigh risks and benefits differently, the risk-benefit ratio for a clinical trial will vary from person to person. | ||
| Roentgen Equivalent in Man | REM | The unit of measurement for a dose of an ionizing radiation that produces the same biological effect as a unit of absorbed does (1 rad) of ordinary X-rays. One millirem is equal to 1/1000 of a rem. | |
| Route of Administration | How investigational product is being delivered into the subject | ||
| Routine Monitoring | See also Monitoring | ||
| Routine Monitoring Visit | A site visit conducted periodically throughout the study by sponsor representatives, to evaluate how well the study staff is conducting the study and to audit the quality of the data entered on the CRFs. Also called "Routine Visit." See also Monitoring Visit |
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| Run-In Period | The time between subject recruitment and allocation to treatment when pre-trial measurements can be taken. | ||
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