Glossary
A | B | C | D | E | F | G | H | I | M | N | O | P | Q | R | S | T | V | W
A
Adverse Drug Reaction (ADR)In the pre-approval clinical experience with a new medicinal product often the therapeutic dose(s) may not being established: all unintended or unexpected responses to the product should be considered an adverse drug reaction. This includes any reaction that cannot be reasonably ruled out as being connected to the medication.
Adverse Event (AE)
An Adverse Event (AE) is any unfavorable or unintended effect (i.e., abnormal laboratory levels) that may or may not have a causal relationship to the study treatment. An adverse event (AE) can therefore be any symptom or disease temporally associated with the use for a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Adverse Event Report
An Adverse Event Report is a mandatory report to appropriate institutional/sponsor officials about adverse events.
Applicable Regulatory Requirement(s)
Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.
Approval (Institutional Review Boards)
The decision of the IRB that a clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.
Approved Drugs
The U.S. Food and Drug Administration (FDA) approves substances as drugs before marketing can take place. The approval process involves pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval of the application. (See Food and Drug Administration).
ARENA
Applied Research Ethics National Association: a membership organization for individuals interested in ethical issues relating to medicine and research.
Assent
An individual who is not competent to give legally valid informed consent (i.e., a minor), can give assent to participate in research.
Assurance
Assurance is the word used in the Federal Policy (Common Rule) for a formal writtenand binding commitment that is submitted to a federal agency. In it an institution promises to comply with regulations governing the protection of human subjects in research.
Audit
Trial related activities and documents are systematically examined by an independent auditor to determine whether the evaluated trial related activities were conducted, and the data was recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs) are evaluated, as is Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
Audit Certificate
The Audit Certificate is an auditor's declaration that confirms that an audit has taken place.
Audit Report
An Audit Report is the written evaluation by the sponsor's auditor containing the results of the audit.
Audit Trail
An Audit Trail is the documentation that makes reconstruction of the course of the audit events possible.
B
Baseline1. Information gathered at the beginning of a study from which variations found during the course of the study are measured. 2. A known value or quantity with which an unknown is compared to measure or assess. 3. The initial point in a clinical trial, just before a participant starts to receive the experimental treatment that is being tested. Monitoring changes from the baseline values often helps determine the safety and efficacy of a drug.
Bias
Bias is a particular point of view, or position, that can prevent impartial judgment of the study subject. In clinical studies, blinding and randomization help to control bias.
Belmont Report
The Belmont Report was issued in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and is a statement of basic ethical principles governing research involving human subjects.
Beneficence
The Belmont Report (see above) discussed the ethical principle of obligation to protect persons from harm. The principle of beneficence can be defined by two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.
Benefit
An advantageous, valued or desired outcome.
Blinding/Masking
Blinding (or Masking) is used to keep certain participants of a study unaware of treatment assignments. In a single-blind study the participant is unaware of the study treatment that he/she receives. In a double-blind study the participant, investigator and sometimes the data analyst are unaware of the treatment assignment.
C
Case Report Form (CRF)A document used to record all of the protocol-required information that is to be reported to the sponsor for every trial participant. Current CRF designs may be printed, optical or electronic documents.
Certificate of Confidentiality
A Certificate of Confidentiality protects the compelled release of identifiable information about research subjects in any legal proceeding. These documents are issued by the DHHS and can be requested for all research, regardless of funding source [42 USC 241(d)].
Children
Persons who are minors as defined by law, i.e. under 18 years of age.
Clinical Trial/Study
In order for a study to be considered a "clinical Trial", the study must involve ALL of the following elements:
- Intervention (either biomedical or behavioral)
- Human Interaction (beyond the informed consent process)
- Outcome Variables (measures safety and effectiveness of intervention)
- Prospective Design (Phases I, II, III, IV)
Registries and retrospective studies do not fit the definition of clinical trial so will be executed through the Grants and Contracts office. The terms clinical trial and clinical study are synonymous.
Clinical Trial/Study Report
"A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report" (see the ICH Guideline for Structure and Content of Clinical Study Reports).
Cohort
A group of individuals with some characteristics in common.
Community-Based Clinical Trial (CBCT)
A clinical trial conducted primarily through primary-care physicians rather than academic research facilities.
Coercion
The act of inducing, or pressuring an individual to consent to participate, or stay in research.
Cognitive Impairment
Some disorder that affects cognitive, or emotional functions so much that the capacity for judgment and reasoning are significantly diminished (i.e. a learning disability, or mental retardation).
Common Rule
The short description of the Federal Policy for the Protection of Human Subjects in Research.
Compensation
A form of payment, or other benefits given to subjects who volunteer to participate in research protocols.
Competence
The mental and psychological capacity to understand and analyze information, to fully understand the consequences of acting, or not acting on that information, to act on one's own behalf and to make an informed decision.
Comparator (Product)
An investigational, or marketed product (i.e., active control), or placebo, can be used as a reference in a clinical trial.
Compliance
Full compliance requires to follow all trial-related requirements, Good Clinical Practice (GCP) requirements, and all regulatory requirements.
Confidentiality
Confidentiality requires the protection of a participant's identity, or a sponsor's proprietary information, this information only being viewed by those authorized..
Consent
In a clinical trial, informed consent is an agreement to participate and follow the guidelines of the protocol with the complete understanding of what those guidelines are and of the possible benefits and hazards.
Contract
A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.
Contract Research Organization (CRO)
This may be a commercial, academic, or private organization that is contracted by a study sponsor to perform some, or all of the trail-related duties and functions on the sponsor's behalf.
Contraindication
Under certain circumstances the use of particular treatments could be harmful.
Control
Participants who are not given the treatment under study, or who do not have a given condition, background, or risk factor that is the object of the study are used for comparison.
Coordinating Committee
A committee that a sponsor may organize to coordinate the conduct of a multicenter trial.
Coordinating Investigator
An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicenter trial.
D
Data and Safety Monitoring Board (DSMB)An independent committee that monitors clinical trials and reviews data while a trial is in progress for adverse events and other trends. The Data and Safety Monitoring Board looks for any information that might warrant modification, or termination of a trial due to exposure because of undue risk. The DSMB will notify participants about new information that might affect their willingness to continue in the trial.
Declaration of Helsinki
A code of ethics for clinical research approved by the World Medical Association. The Declaration of Helsinki has been widely adopted by medical associations worldwide.
DHHS – U.S. Department of Health and Human Services
The DHHS is the agency responsible for overseeing the safety and effectiveness of all drugs, biologics, vaccines, and medical devices, including any used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA, in cooperation with the blood banking industry, works to safeguard the nation's blood supply.
Direct Access
Direct access grants permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial by any authorized party. Domestic and foreign regulatory authorities, sponsor's monitors and auditors should take all reasonable precautions to maintain the confidentiality of participants' identities and sponsor's proprietary information and to act within the constraints of applicable regulatory requirements.
Documentation
Documentation consists of all records that describe, or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken. These include and are not limited to written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms.
E
EfficacyDrug efficacy is the maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the procedure mandated by the FDA, Phase II clinical trials gauge efficacy, and Phase III trials confirm it.
Eligibility Criteria
Eligibility criteria include inclusion and exclusion criteria defined by the protocol. All participants must meet the standards as set out in the eligibility criteria in order to participate in a study.
Empirical
Knowledge and evidence that is based on experimental data, not on a theory.
Epidemiology
Epidemiology in medical science deals with the study of incidence and distribution and control of a disease in a population.
Essential Documents
Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
Experiment
An experiment refers to an intervention, or interaction that is unproven and not yet scientifically validated.
Experimental Drug
A drug that is not FDA licensed for use in humans, or as a treatment for a particular condition.
F
FDAThe Food and Drug Administration, is a component of DHHS. This agency is responsible for protecting public health focusing on medical products and devices, the food supply, cosmetics and biological products.
Federal Policy
Another short reference, along with the phrase "Common Rule," for the Federal Policy for the Protection of Human Subjects in Research by the US FDA [56 FR 28003].
Federal Register
A government publication of final and proposed rules or notices.
Fetus
A fetus is a developing mammal after the embryonic stage, but before birth.
Federal Register (FR)
The Federal Register is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents.
Full Board Review
A convened meeting of the IRB, at which a majority of the IRB members are present and review proposed research. At least one member must be included whose primary concerns are nonscientific [45 CFR 46.109; 21 CFR 56.108].
G
GrantTypically financial support provided for a research study designed and proposed by the principal (or primary) investigator, but also can be used to sustain an organization, or higher level of training in an area of interest.
Guardian
A guardian is an individual who is authorized, by law, to give permission on behalf of another person to participate in research.
Good Clinical Practice (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial participants are protected and guided by GCP.
H
Human in Vitro FertilizationAny fertilization involving human sperm and ova that takes place outside of the human body.
Human Subject
An individual who is the object of study in a research project. Under the Federal Policy (Common Rule), "human subject" means a living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information [45 CFR 46.102(f)]. Under FDA regulations, "human subject" means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual, or a patient [21 CFR 50.3(g) and 56.102(e)].
Hypothesis
A hypothesis is a theory, or supposition that is the basis for reasoning, or argument and may be a guide to experimental investigation.
I
Investigational Device Exemption (IDE)Exemptions from certain regulations found in the FDA, Medical Device Amendments that allow shipment of unapproved devices for use in clinical investigations [21 CFR 812.20].
Independent Ethics Committee (ICE)
An independent body constituted of medical professionals and non-medical members,
whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial. To achieve this the ICE will review and approve a trial protocol along with the suitability of the investigators involved, the facilities, and the methods and materials that will be used in the Informed Consent process. The ICE must meet the legal requirements of its locality and should act in accordance with Good Clinical Practice.
Incapacity
A person who is unable by virtue of mental status, or legal classification to understand information presented, to evaluate consequences of action,or inaction, and the ability to make an informed decision or choice.
Inclusion Criteria
The criteria that establish whether a person is eligible to participate in a clinical trial.
Incompetence
An person who is deemed legally incompetent is unable to manage one's own affairs. (See "incapacity" above).
An impartial witness is independent of the study, who cannot be unfairly influenced by people involved with the study. If the participant, or the participant's legal representative cannot read, the impartial witness attends the informed consent process and reads the informed consent form and any other written information supplied to the participant.
Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee)
An independent data-monitoring committee that may be established by the sponsor to assess the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.
Indication
The term indication is used in connection with clinical trials to denote primary diseases, or indications being studied. The indications are used to index studies within the clinical trials registry. Multiple disease, or indication terms can be applied to one trial.
Informed Consent
A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.
Informed Consent Document
The informed consent form presents all of the relevant details to study to a potential study participant. These include possible benefits and risks, length of the study and number and duration of required visits. It also presents what, if any, laboratory tests, or other tests are required. The informed consent describes the responsibilities and rights of both the participant and the study staff. Detailed information regarding confidentiality and the use of a participant's PHI are described. 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.
Inspection
The review of documentation, facilities, medical records and any other resource deemed to be related to a clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization's (CRO's) facilities, or at other establishments deemed appropriate by the regulatory authority overseeing the inspection.
Institution (medical)
The use of "institution" may be any public, or private entity, agency, medical, or dental facility where clinical trials are conducted.
Institutional Review Board (IRB)
An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human participants involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial participants. Federal regulations at 45 CFR Part 46 require that institutions engaging in human subject research funded by the Department of Health and Human Services (DHHS) devise mechanisms for the protection of human subjects.
Interim Clinical Trial Study Report
An interim clinical trial study report reviews intermediate results. The evaluation is based on analyses performed during the course of a trial.
Intervention Type
The type of treatment used in a trial as specified by the protocol, e.g. Drug, Vaccine, Medical Device is the intervention.
Investigational New Drug Application (IND)
IND stands for Investigational New Drug application, which is part of the process to get approval from the FDA for marketing a new prescription drug in the U.S.
Investigational Product
An investigational product is a pharmaceutical form of an active ingredient, or placebo, that has marketing approval, being tested, or used as a reference in a clinical trial when the product is being used or assembled (including formulation and packaging) in a way different from the approved form, or being used for an unapproved indication, or when being used to gain further information about an approved use.
Investigator
Also known as the Principal Investigator this person is responsible for the conduct of the clinical trial at a trial site. When a team of individuals at a site conducts a trial, the investigator is the responsible leader of the team and may be called the principal investigator.
Investigational New Drug Application (IND)
An application to conduct a clinical investigation involving a drug not yet determined by the Food and Drug Administration to be safe and effective for a particular use in the general population and not yet licensed for marketing [21 CFR 312.1].
M
Minimal RiskAs defined by Federal Policy, DHHS Subpart A, and the FDA minimal risk means that the probability and magnitude of harm, or discomfort anticipated in the research will not be greater in and of themselves than those ordinarily encountered in daily life, or during the performance of comparable to routine physical, or psychological examinations or tests [45 CFR 46.102(i); and, 21 CFR 50.3(k) and 56.102(j)].
Monitor
An individual employed by the sponsor to oversee the progress of a clinical trial. The study monitor acts as the point of contact for study staff and makes periodic study-monitoring visits to assure that the protocol criteria are being met and the study is being conducted in accordance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and adheres to regulatory requirements.
Monitoring Report
The study monitor writes a detailed report to the sponsor after each site visit.
Multicenter Trial
A mulitcenter trial is conducted at more than one site with investigator(s) at each site, but in accordance with a single protocol.
N
National Bioethics Advisory Commission (NBAC)A commission made up of Presidential appointees that issues reports and makes recommendations regarding ethical considerations in biomedical research, human subjects in research and other medical ethics issues.
NIH National Institutes of Health
The National Institutes of Health is a part of the DHHS and is the primary agency for medical research in the United States.
Non-Affiliated Member
A non-affiliated IRB member is a person, usually from the local community, who has no ties and who has no family members with ties to the institution.
Non-clinical Study
Biomedical studies not performed on human subjects.
Normal Volunteers
Some studies will have "normal" volunteers, that is, people who do not have the condition that is being studied. "The 1993 Office for Protection from Research Risks (OPRR) Guidebook defines normal volunteers as follows: "Normal" may not mean normal in all respects. For example, patients with broken legs (if not on medication that will affect the results) may serve as normal volunteers in studies of metabolism, cognitive development, and the like. Similarly, patients with heart disease but without diabetes may be the "normal" in a study of diabetes complicated by heart disease". The OPRR has become the OHRP.
Nuremberg Code
The Nuremberg Code was developed during the Nazi war trials in Nuremberg following WWII in order to set a standard of protection for human subjects.
O
Office for Human Research Protections (OHRP)An office within the DHHS that was created in June of 2000. OHRP is responsible for the implementation of the DHHS regulations governing the protection of human subjects in research. Their website offers a comprehensive list of policy guidelines by topic.
Off-Label Use
A drug prescribed for conditions other than those approved by the FDA.
Open-Label Trial
A clinical trial in which doctors and participants know which drug, or vaccine is being used.
Opinion
In relation to an Independent Ethic Committee it is the judgment and/or the advice provided by the IEC following review of a protocol.
Oral Consent
Typically refers to informed consent that is obtained from a participant without use of a written informed consent document.
P
Parental PermissionThe agreement of one or both parents or a guardian of a minor to participate in research.
Peer Review
Experts chosen by the study sponsor review a clinical trial for scientific merit, participant safety and ethical issues.
Pharmacodynamics
Pharmacodynamics is the study of the biochemical and physiologic effects of drugs and the mechanisms by which they work.
Pharmacokinetics
Pharmacokinetics is the study of the metabolism and action of drugs. Particular attention is paid to the time required for absorption, duration of action, and distribution in the body and method of excretion.
Phases of a clinical trial
Clinical trials are usually conducted in phases. Preclinical trials are early experiments performed in the lab prior to being tested in humans. This early research helps to identify potential treatments that are unsafe, or ineffective.
Phase I trials are the first step in testing a new approach in humans. In these studies, researchers evaluate what dose is safe, how a new agent should be given (by mouth, injected into a vein, or injected into the muscle, for example), and how often. Researchers watch closely for any harmful side effects. Phase I trials usually enroll a small number of patients and take place at only a few locations.
Phase II trials study the safety and effectiveness of an agent or intervention, and evaluate how it affects the human body. Phase II studies usually focus on a particular medical condition.
Phase III trials compare a new agent, or intervention (or new use of a standard one) with a current standard therapy. Participants are randomly assigned to the standard group. This randomization helps to avoid bias and ensures that human choices, or other factors do not affect the study's results. In most cases, studies move into phase III testing only after they have shown promise in phases I and II. Phase III trials may include hundreds of people across the country.
Phase IV trials are conducted to further evaluate the long-term safety and effectiveness of a treatment. They usually take place after the treatment has been approved for standard use. Several hundred to several thousand people may take part in a phase IV study.
Placebo
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, placebos are used in comparison to the experimental treatment to assess the treatment's effectiveness.
Placebo Effect
A physical or emotional change, occurring after a substance is taken or administered, that cannot be attributed to the substance. The expectations of both the participant and the study staff may be reflected in the reported change.
Principal Investigator (PI)
The PI is the person with primary responsibility for all aspects of the study at a site.
Protected Health Information (PHI)
Defined by the NIH, "the Privacy Rule defines PHI as individually identifiable health information held, or maintained by a covered entity, or its business associates acting for the covered entity, that is transmitted or maintained in any form, or medium (including the individually identifiable health information of non-U.S. citizens). This includes identifiable demographic and other information relating to the past, present, or future physical or mental health, or condition of an individual, or the provision, or payment of health care to an individual that is created, or received by a health care provider, health plan, employer, or health care clearinghouse. For purposes of the Privacy Rule, genetic information is considered to be health information."
Protocol
The objective(s), design, methodology, statistical considerations, and organization of a trial. A protocol document may also give the background and rationale for the trial. The protocol dictates the actions of the study staff and is the basis for answers to any questions that come up throughout the course of the study.
Protocol Amendment
Any change to a protocol, or any clarification of a protocol item must be written as an amendment to the protocol.
Public Health Service (PHS)
A division within the DHHS. PHS agencies include the National Institutes of Health, Centers for Disease Control, the Indian Health Service, and the Substance Abuse and Mental Health Services Administration.
Public Responsibility in Medicine and Research (PRIM&R)
A non-profit organization that organizes conferences, workshops, and other activities to further the protection of human subjects in research.
Q
Quality Assurance (QA)Quality assurance is achieved through planned and systematic actions that are established to ensure that the trial is performed and the data are generated and recorded, in compliance with Good Clinical Practice (GCP) and meet regulatory requirements.
Quality Control (QC)
Within the quality assurance system, quality control operational techniques and activities are undertaken to verify that the quality requirements for the trial-related activities are fulfilled.
R
RandomizationRandomization assigns study participants to a treatment group, or control group by random chance in order to reduce bias.
Randomized Trial
A study in which participants are randomly (i.e., by chance) assigned treatment groups, or "arms" of a study. Placebos may be utilized in one group/arm.
Regulatory Authorities
Regulatory authorities have the power to set regulation requirement by which clinical studies must abide. These are sometimes referred to as competent authorities.
Risk
Risk is assessed as the probability of harm, or injury occurring as a result of participation in a research study.
Risk-Benefit Ratio<
The risk-benefit ratio is the comparison of possible risks to possible benefits for any study participant. The risk-benefit ratio is assessed for each study.
S
Serious Adverse Event (SAE), or Serious Adverse Drug Reaction (Serious ADR)Any medical occurrence that at any dose:
- results in death,
- is life-threatening,
- requires inpatient hospitalization, or prolongation of existing hospitalization,
- results in persistent, or significant disability/incapacity, or
- is a congenital anomaly/birth defect.
Side Effects
All experimental drugs are evaluated for immediate and long-term side effects. During a study any undesired effects, such as headache, nausea, or rash, to name a few, must be reported as side effects.
Site Visit
Federal regulatory agencies may visit a study site to be sure that an institution is operating in compliance with federal regulations.
Source Data
Any information included in the original participant records, or certified copies of original records of clinical findings, observations, or other activities in a clinical trial are considered source data. Source documents contain source data.
Source Documents
Any original documents, data, and records are considered source documents. Source documents can be hospital records, clinical and office charts, laboratory notes, memoranda, participants' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, participant files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial.
Sponsor
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
Sponsor-Investigator
A sponsor-investigator is responsible for the obligations of both the sponsor and the investigator. In this case the investigator initiates and conducts, alone or with staff, a clinical trial, and under his/her immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term refers only to an individual and does not include a corporation, or an agency.
Standards of Care
Standards of care are medical, or psychological treatment guidelines. These medical management, or treatment regimens are based on state of the art participant care.
Standard Operating Procedures (SOPs)
Detailed written instructions which describe functions and achieve uniformity in a clinical trial.
Statistical Significance
A conclusion that an "intervention" has a true effect. This conclusion is based upon observed differences in outcomes between the treatment and control groups that are large enough so that it can be concluded that these differences are unlikely to have occurred due to chance.
Sub investigator
A sub investigator is designated to perform trial related procedures and can make trial related decisions under the overall supervision of the primary investigator (PI).
Subject Identification Code
A subject identification code is a unique identifier assigned to each trial participant, but is so unique in fact that this code would not reveal the participants identity to anyone uninvolved in the study. This code helps to protect the participant's identity and is used in lieu of the participant's name trial related data.
Subject/Trial Participant
A trial participant is an individual who participates in a clinical trial also known as a "human subject".
Surveys
Studies designed to obtain information from human subjects through written
questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.
Suspension
Certain agencies, such as the Office for Human Research Protections (OHRP) have the authority to suspend an Assurance thus preventing an institution from conducting studies supported by federal funds.
T
Test Article"Any drug, biological product for human use, medical device for human use, human food additive, color additive, electronic product subject to FDA regulations under 42 USC 262, 263b-263N [21 CFR 50.3(j) and 56.102(e)]."
Toxicity
Toxicity may cause an adverse effect that is detrimental to the participant's health produced by a drug. The level of toxicity associated with a drug will vary depending on the condition for which the drug is being used.
Trial Site
A trial site is the location where trial-related activities are conducted.
Trial Status
The trial status is reflected in the stage that the trail is in:
- Planned: participants are not yet being recruited, or enrolled
- Recruiting: participants are currently being recruited and enrolled
- No longer recruiting: trial is under way and new participants are no longer being recruited or enrolled
- Completed: The data collection for the trial is completed.
V
VoluntaryVoluntary participation in a clinical trial is when a participant agrees to take part free of coercion, duress, or undue influence.
Vulnerable Subjects
Individuals whose decision to volunteer in a clinical trial who feels pressured to do so because they believe they will benefit from participation, or be penalized due to lack of participation are considered vulnerable subjects. These people could be anyone within a hierarchical structure such as subordinate hospital staff, students, members of the armed forces, or detainees. Other types of vulnerable subjects include: patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, homeless persons, refugees, minors, and those incapable of giving consent.
W
Waiver of Informed ConsentUnder certain conditions outlined by the FDA and OHRP an IRB may permit an investigator to pursue research involving human subjects without obtaining informed consent [45 CFR 46.116(d)].
Well-being
The well-being of the trial subjects is the physical and mental integrity of the subjects participating in a clinical trial.
