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Female Overactive Bladder Study
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
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An unintended reaction to a drug taken at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. In clinical trials, an ADR would include any injuries by overdosing, abuse/dependence, and unintended interactions with other medicinal products. |
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Adverse Event |
Any change in health that occurs in a person after he or she enrolls in a clinical trial. Not every adverse event is related to the treatment or test being studied, but researchers must report all adverse events to the Food and Drug Administration (FDA). See also serious adverse event. |
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Approved Drugs
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In the U.S., the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application (See Food and Drug Administration). |
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Arm |
Any of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more (See Randomized Trial). |
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1. Information gathered at the beginning of a study from which variations found in the study are measured. 2. A known value or quantity with which an unknown is compared when measured or assessed. 3. The initial time point in a clinical trial, just before a participant starts to receive the experimental treatment which is being tested. At this reference point, measurable values such as CD4 count are recorded. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values. |
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Bias |
When a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, bias is controlled by blinding and randomization |
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Blind |
A randomized trial is "Blind" if the participant is not told which arm of the trial he is on. A clinical trial is "Blind" if participants are unaware on whether they are in the experimental or control arm of the study; also called masked. |
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A record of pertinent information collected on each subject during a clinical trial, as outlined in the study protocol. |
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Clinical Investigator |
A medical researcher in charge of carrying out a clinical trial's protocol. |
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Clinical Research Associate (CRA) Back to Top |
Person employed by the study sponsor or CRO to monitor a clinical study at all participating sites. See also, monitor. |
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Clinical Research Coordinator (CRC) |
Site administer for the clinical study. Duties are delegated by the investigator. Also called research, study or healthcare coordinator, and data manager, research nurse or protocol nurse. |
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Clinical Study Materials |
Study supplies (i.e., study test article, laboratory supplies, case report forms) provided by the study sponsor to the investigator. |
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Clinical Trial
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A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. (See Phase I, II, III, IV trials) |
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Compassionate Use |
A method of providing experimental therapeutics prior to final FDA approval for use in humans. This procedure is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained from the FDA for "compassionate use" of a drug or therapy. |
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Confidentiality for Trial Participants |
Refers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial participants' consent to the use of records for data verification purposes should be obtained prior to the trial and assurance must be given that confidentiality will be maintained. |
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Consent Form |
A document explaining all relevant study information to assist the study volunteer in understanding the expectations and requirements of participation in a clinical trial. This document is presented to and signed by the study subject. |
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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 study-related duties and functions. |
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Control |
A control is the nature of the intervention control. |
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Control Group |
The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo (See Placebo and Standard Treatment); A comparison group of study subjects who are not treated with the investigational agent. The subjects in this group may receive no therapy, a different therapy, or a placebo. |
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Controlled Trials |
Control is a standard against which experimental observations may be evaluated. In clinical trials, one group of participants is given an experimental drug, while another group (i.e., the control group) is given either a standard treatment for the disease or a placebo. |
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This term is legally defined according to the institution. It generally refers to recorded information regardless of form. Most institutions hold title to data while researchers have rights to access the data. |
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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. A device does not achieve its intended purpose through chemical action in the body and is not dependent upon being metabolized to achieve its purpose. |
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Diagnostic Trials |
Refers to trials that are conducted to find better tests or procedures for diagnosing a particular disease or condition. Diagnostic trials usually include people who have signs or symptoms of the disease or condition being studied. |
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Documentation |
All forms of records that describe or document study methods, conduct and results, including any adverse events and actions taken. |
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Dose Ranging Study |
A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is least harmful. |
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Double Blind Study
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A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study. |
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Drug |
As defined by the Food, Drug and Cosmetic Act, drugs are "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." |
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Drug or Device Accountability Records (DAR) |
Required documentation for material accountability, quantity used and left over, and date of disposal. |
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Drug Product |
A finished dosage form (e.g. tablet, capsule, or solution) that contains the active drug ingredient usually combined with inactive ingredients. |
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The dose of an investigational agent that produces the outcome considered "effective," as defined in the study protocol. This could mean a cure of the disease in question or simply the mitigation of symptoms. |
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Efficacy |
A product's ability to produce beneficial effects on the duration or course of a disease. Efficacy is measured by evaluating the clinical and statistical results of clinical tests. |
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Endpoint |
Overall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death. |
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Ethics Committee |
An independent group of both medical and non-medical professionals who are responsible for verifying the integrity of a study and ensuring the safety, integrity, and human rights of the study participants. |
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Exclusion Criteria |
Refers to the characteristics that would prevent a subject from participating in a clinical trial, as outlined in the study protocol. |
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A list of commitments and requirements by the FDA for each investigator performing drug/biologics studies. Also referred to as a statement of the investigator. |
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FDA See Food and Drug Administration |
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Food and Drug Administration
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FOOD AND DRUG ADMINISTRATION (FDA): The U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices, including those used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA also works with the blood banking industry to safeguard the nation's blood supply. Internet address: http://www.fda.gov/. |
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Formulation |
The mixture of chemicals and/or biological substances used to prepare dosage forms. |
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A medicinal product with the same active ingredient, but not necessarily the same inactive ingredients as a brand-name drug. A generic drug may only be marketed after the original drug's patent has expired. |
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Good Clinical Practice (GCP) |
International ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting studies. Insures that the data reported is credible and accurate, and that subject's rights and confidentiality are protected. |
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A patient or healthy individual participating in a research study. A living individual about whom an investigator obtains private information or data through intervention or interaction. |
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Non-clinical testing conducted in an artificial environment such as a test tube or culture medium. |
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Inclusion Criteria |
A list of criteria that must be met by all study subjects. |
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Informed Consent
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A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time. |
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Institution |
Location of research. Retains ultimate responsibility for human subject regulation compliance. |
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Institutional Review Board (IRB) |
An independent group of professionals designated to review and approve the clinical protocol, informed consent forms, study advertisements, and patient brochures, to ensure that the study is safe and effective for human participation. It is also the IRB's responsibility to ensure that the study adheres to the FDA's regulations. |
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Intervention Name |
The generic name of the precise intervention being studied. |
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Interventions |
Primary interventions being studied: types of interventions are Drug, Gene Transfer, Vaccine, Behavior, Device, or Procedure. |
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Investigational Device Exemption (IDE) |
Exemption from FD & C Act to study investigational medical devices. |
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Investigational New Drug Application (IND) |
The petition through which a drug sponsor requests the FDA to allow human testing of its drug product. |
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Investigator
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A medical professional, usually a physician but may also be a nurse, pharmacist or other health care professional, under whose direction an investigational drug is administered or dispensed. A principal investigator is responsible for the overall conduct of the clinical trial at his/her site. |
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Investigator's Brochure |
Relevant clinical and non-clinical data compiled on the investigational drug, biologic or device being studied. |
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A study conducted over a long period of time. |
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An FDA program designed to monitor adverse events (AE) from drugs marketed in the U.S. Through the MedWatch program, health professionals may report AEs voluntarily to the FDA. Drug manufacturers are required to report all AEs brought to their attention. |
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Monitor |
Person employed by the sponsor or CRO who reviews study records to determine that a study is being conducted in accordance with the protocol. A monitor's duties may include, but are not limited to, helping to plan and initiate a study, and assessing the conduct of studies. Monitors work with the clinical research coordinator to check all data and documentation from the study. See also CRA. |
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Monitoring |
Reviewing a clinical study, ensuring conduct, proper records and reports are performed as stated in the clinical protocol, standard operating procedures, GCP and by regulatory requirements. |
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Multiple Project Assurance |
Permit given to institution for multiple federally funded research grants for a specified period of time. States institution retains responsibility for all research involving humans and that the institution must have an established IRB. |
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Agency within DHHS that provides funding for research, conducts studies and funds multi-site national studies. |
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National Research Act
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Act created by the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research in 1974 and mandated review of studies by institutional review boards and subject protection by informed consent. |
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New Drug Application (NDA) |
The compilation of all non-clinical, clinical, pharmacological, pharmacokinetic and stability information required about a drug by the FDA in order to approve the drug for marketing in the U.S. |
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The unauthorized use of a drug for a purpose other than that approved of by the FDA. |
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Office for Human Research Protection (OHRP) |
A federal government agency that issues Assurances and overseas compliance of regulatory guidelines by research institutions. |
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Open-Label Study
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A study in which all parties, (patient, physician and study coordinator) are informed of the drug and dose being administered. In an open-label study, none of the participants are given placebos. These are usually conducted with Phase I & II studies. |
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Orphan Drug
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A designation of the FDA to indicate a therapy developed to treat a rare disease (one which afflicts a U.S. population of less than 200,000 people). Because there are few financial incentives for drug companies to develop therapies for diseases that afflict so few people, the U.S. government offers additional incentives to drug companies (i.e. tax advantages and extended marketing exclusivity) that develop these drugs. |
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Over-the-Counter (OTC) |
Drugs available for purchase without a physician's prescription. |
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Individual seeking medical care. |
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Pharmacoeconomics |
The study of cost-benefit ratios of drugs with other therapies or with similar drugs. Pharmacoeconomic studies compare various treatment options in terms of their cost, both financial and quality-of-life. Also referred to as "outcomes research". |
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Phase I Study |
The first of four phases of clinical trials, Phase I studies are designed to establish the effects of a new drug in humans. These studies are usually conducted on small populations of healthy humans to specifically determine a drug's toxicity, absorption, distribution and metabolism. |
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Phase II Study |
After the successful completion of phase I trials, a drug is then tested for safety and efficacy in a slightly larger population of individuals who are afflicted with the disease or condition for which the drug was developed. |
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Phase III Study |
The third and last pre-approval round of testing of a drug is conducted on large populations of afflicted patients. Phase III studies usually test the new drug in comparison with the standard therapy currently being used for the disease in question. The results of these trials usually provide the information that is included in the package insert and labeling. |
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Phase IV Study |
After a drug has been approved by the FDA, phase IV studies are conducted to compare the drug to a competitor, explore additional patient populations, or to further study any adverse events. |
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Pivotal Study |
Usually a phase III study which presents the data that the FDA uses to decide whether or not to approve a drug. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind. |
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Placebo |
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment. No sick participant receives a placebo if there is a known beneficial treatment. |
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Placebo Controlled Study |
A method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition. |
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Placebo Effect |
A physical or emotional change, occurring after a substance is taken or administered, that is not the result of any special property of the substance. The change may be beneficial, reflecting the expectations of the participant and, often, the expectations of the person giving the substance. |
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Pre-Clinical Testing |
Before a drug may be tested on humans, pre-clinical studies must be conducted either in vitro but usually in vivo on animals to determine that the drug is safe. |
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Prevention Trials |
Refers to trials to find better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes. |
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Protection of Pupil Rights Amendment (PPRA) |
Department of Education regulation that states that surveys, questionnaires and instructional materials for school children must be inspected by parents/guardians. |
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Protocol
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A study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment |
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Protocol Amendment |
Changes or clarifications made in writing to the original protocol. |
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Systems and procedures designed to ensure that a study is being performed in compliance with Good Clinical Practice (GCP) guidelines and that the data being generated is accurate. |
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Quality of Life Trials |
Refers to trials that explore ways to improve comfort and quality of life for individuals with a chronic illness. |
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A method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. From what is known at the time, any one of the treatments chosen could be of benefit to the participant (See Arm). |
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Randomized Trials |
A study in which participants are randomly (i.e., by chance) assigned to one of two or more treatment arms of a clinical trial. Occasionally placebos are utilized. (See Arm and Placebo). |
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Recruitment |
Act of enrolling subjects with the proper inclusion criteria. |
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Time allowed to recruit all subjects for a study. |
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Regulatory Affairs |
In clinical trials, the department or function that is responsible for ensuring compliance with government regulations and interacts with the regulatory agencies. Each drug sponsor has a regulatory affairs department that manages the entire drug approval process. |
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Research Team |
Investigator, sub-investigator and clinical research coordinator involved with study. |
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Risk-Benefit Ratio |
Risk to individual subject vs. potential benefits. Also called Risk-Benefit Analysis. |
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FDA report required by investigator for any serious and unexpected adverse experience. |
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Serious Adverse Event (SAE) |
Any adverse event (AE) that is fatal, life-threatening, permanently disabling, or which results in hospitalization, initial or prolonged. |
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Side Effects |
Any undesired actions or effects of a drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects (See Adverse Reaction). |
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Single Blind Study |
A study in which one party, either the investigator or participant, is unaware of what medication the participant is taking; also called single-masked study. (See Blind and Double-Blind Study). |
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Single Project Assurance |
Permit given to institution for single grant in compliance with government standards. See "assurance." |
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Source Data |
All information contained in original records and certified copies of results, observations or other facets required for the reconstruction and evaluation of the study that is contained in source documents. |
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Source Documentation |
Location where information is first recorded including original documents, data and records. |
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Sponsor |
Individual, company, institution or organization taking responsibility for initiation, management and financing of study. |
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Standard Operating Procedure (SOP) |
Official, detailed, written instructions for the management of clinical trials. SOPs ensure that all the functions and activities of a clinical trial are carried out in a consistent and efficient manner. |
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Standard Treatment
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The currently accepted treatment or intervention considered to be effective in the treatment of a specific disease or condition. |
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Statistical Significance |
The probability that an event or difference occurred by chance alone. In clinical trials, the level of statistical significance depends on the number of participants studied and the observations made, as well as the magnitude of differences observed. |
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Study Coordinator |
The person at a medical center or research facility who manages the daily activities of the study, including coordinating the treatment or testing of participants. |
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Study Endpoint |
A primary or secondary outcome used to judge the effectiveness of a treatment. |
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Study Type |
The primary investigative techniques used in an observational protocol; types are Purpose, Duration, Selection, and Timing. |
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Sub-investigator |
Helps design and conduct investigation at a study site. |
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Subject/Study Subject |
Participant in a study. See "Human Subject." |
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Notification via telephone to the FDA of unexpected fatal or life threatening advent associated with a clinical study. |
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Toxicity |
An adverse effect produced by a drug that is detrimental to the participant's health. The level of toxicity associated with a drug will vary depending on the condition which the drug is used to treat. |
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Treatment Group |
The group of participants that receives an experimental treatment. See also control group, standard treatment. |
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Treatment IND
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A method through which the FDA allows seriously ill patients with no acceptable therapeutic alternative to access promising investigational drugs still in clinical development. The drug must show "sufficient evidence of safety and effectiveness." In recent decades many AIDs patients have been able to access unapproved therapies through this program. |
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A reaction that is not consistent in nature or severity with study application. |
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Group/individual that cannot give informed consent because of limited autonomy (e.g., children, mentally ill and prisoners). Also refers to subjects who may be unduly influenced to participate (e.g., students, subordinates and patients). |
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Subject's physical and mental soundness. |
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Withdrawal Application |
Investigator/sponsor letter to FDA requesting application withdrawal when no additional work is envisioned. |