CAB Glossary

The build-up or increase in the number of participants in a clinical trial.

Final and most severe stage of disease due to infection with the human immunodeficiency virus (HIV). 

Acute HIV infection: (Also known as primary HIV infection). The period of rapid HIV replication (increasing amount of virus in the body) that occurs shortly after becoming infected with HIV.

Taking the correct dose of a medicine at the correct time.

One of two main studies being conducted within the PHACS network. This study is designed to look at how HIV infection and antiretroviral therapy affects children and teens with perinatal HIV infection.

An unwanted symptom or medical problem caused by a medicine.

To study data (information) to determine clinical trial results.

Nameless or unidentified.

A protein produced by the immune system that recognizes and fights infectious organisms that enter the body. Each antibody is specific to a particular infectious organism (such as HIV antibodies or measles antibodies).

Any substance that can stimulate the body to produce antibodies (Example: HIV can be an antigen).

An anti-HIV medicine (See Antiretroviral therapy).

A treatment developed to suppress a retrovirus, such as Human immunodeficiency virus (HIV).  It is a course of treatment with anti-HIV medicine or medicines.  

The treatment or placebo group in a clinical trial may be referred to as an “arm” of the study.

Having no signs or symptoms of disease.

A survey system administered on a laptop computer, designed for participants to privately answer sensitive questions to reduce discomfort at answering questions of a personal or illegal nature. 

Information gathered about the participant before study treatment begins. To study the effect of a treatment, baseline information is compared with information gathered later in the trial.

A good, positive, or useful effect.

Unfair favoring or unfair judgment. A point of view that is not impartial.

The person responsible for all or a subset of statistical design, statistical monitoring, analysis, and presentation of a study. 

Neither the participants nor the investigators know to which group a participant is assigned.

A form used to collect clinical trial or protocol-required data. 

An indirect way to measure how much damage has been done to the immune system by HIV.

In the context of a proposal for a clinical trial, a capsule is a brief outline of a proposed study.

The record that tells something unusual about what has happened with a patient. Case reports led doctors to identify AIDS and later, HIV.

nsible for promoting health by preventing and controlling disease, injury, and disability.

A formal explanation of a particular protocol section/issue.

A group of medicines that work in the same way to treat a disease or health problem. There are 5 classes of anti-HIV medicines.

In a research trial, a clinical endpoint refers to a disease, symptom, or sign that is one of the indicators of whether or not a treatment is safe and effective. 

The occurrence or recurrence of HIV-related infections or a decline in physical health despite taking anti-HIV medicines. Clinical failure may occur because of immunologic or virologic failure.

The committee of clinical site investigators, who meet to discuss study implementation, collaborate on site issues, and provide feedback to network leadership. 

The facility and staff where you go for your visit.

Resaerch involving people (See Clinical Trial).

A study designed to determine the potential beneficial effects and/or determine the safety and efficacy of a drug, biologic or device in human subjects. 

A group of hospitals and clinics in different locations that cooperate to develop and conduct clinical trials related to preventing or treating a specific health problem. Participants from many different locations may enter the same clinical trial.

A protocol is closed to accrual when the last subject has been enrolled.

Participating in more than one clinical trial at the same time.

A group of nonscientific community members who give input and act as liaisons between researchers and the local community where they live and work. 

A problem resulting from the disease or its treatment.

A brief proposal for a research study or clinical trial.

Keeping personal information private. Personal information collected during a clinical trial is not recorded or transmitted by name, date of birth, or other types of personal information.

Any characteristic other than the treatment that might affect the results of a clinical trial.

In most comparison clinical trials, one group of participants receives the experimental medicine while another group of participants receives the standard treatment. 

In PHACS, the institution responsible for funding the participation of scientific consultants, and the administrative management of many PHACS committees as well as any potential substudies. The CC for PHACS is Tulane University. 

Information, especially facts or numbers, collected within a protocol for examination and consideration.

Studying the information collected during a clinical trial to determine the results of the trial.

The institution within PHACS primarily responsible for management of the network. Among other duties, this includes selecting, funding, and overseeing the clinical sites; monitoring site performance; organizing semi-annual network meetings; and data analysis.

An edit failure or invalid data for a question.

The act of manually keying data into a database.

A system of data collection and data monitoring, which includes continuously checking for errors and inconsistencies in the data being collected on a study, from the time the study opens until all study data have been received and converted to final analysis.

The institution responsible for managing data entry and database generation and/or maintenance. All sites submit their data to the DMC. The DMC for PHACS is Frontier Science & Technology Research Foundation (FSTRF).

The staff member responsible for data management at a clinical site. 

A CRF that has not been received by the DMC, but is scheduled to have been received according to protocol delinquency report specifications. 

Is a cabinet department of the United States government, which oversees several key government organizations including the National Institutes of Health and the Food and Drug Administration. 

A departure from the protocol as written. 

Informing another person or persons of one’s HIV infection status.

Unfair treatment of a person or group based on prejudice.

An area of scientific interest to the study, typically used when a study will explore multiple areas of interest. For example, the SMARTT domains are metabolic and growth, cardiac, neurological, neurodevelopmental, behavior, language, and hearing domains.

The ability of a virus like HIV (or bacteria) to change so that it can continue to reproduce, even in the presence of medicines that would normally kill it.

Useful. Having a positive effect on a condition or disease.

Usefulness in treating or preventing a medical problem.

The subject’s participation in a prior research study, preferred but not necessary for participation in PHACS.  

A measurable change in the condition of a person in a clinical trial that is used to determine whether a therapy is effective. (See Clinical endpoint.) A laboratory endpoint refers to something that can be measured by another blood test (such as a viral load).

The study of when, where, why, and how a disease occurs in a population.

Guides research on fertility, pregnancy, growth, development, and medical rehabilitation and strives to ensure that every child is born healthy and wanted, and grows up free from disease and disability.  NICHD is the lead NIH institute providing funding for PHACS.

The tests or examinations done during the course of a clinical trial to check the health status of participants.

The group responsible for decisions with budgetary and administrative consequences. 

A form that discloses any financial arrangement entered into between the sponsor and the clinical investigator where the compensation to the investigator for conducting the study could be influenced by the outcome of the study (Form FDA 3455 for FDA studies).

urther action that results from and is intended to add to something that was done earlier.

The agency responsible for ensuring the safety and effectiveness of medicines, vaccines, and medical devices licensed in the US.

A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.

Treatment for HIV infection using a combination of ARVs from at least two different classes.

A Westat support function that allows users to call, email, or otherwise communicate with technical staff. The Helpdesk for PHACS deals specifically with questions and concerns regarding the ACASI survey and laptop. 

Human immunodeficiency virus: The virus that causes HIV infection and AIDS.

The blood test used to determine presence or absence of HIV antibodies in the blood. A positive test result in anyone over 18 months of age indicates that the person is infected with HIV.

When a person was in the presence of HIV in a way that makes it possible the virus was transmitted to that person. 

HIV transmission from one person to another, except in the case of mother-to-child transmission (called vertical transmission).

An unproven explanation used as a basis for a clinical trial. 

Protection against or resistance to a disease.

HIV incidence is the rate at which new cases of HIV occur in a population during a specified period of time. For example, the incidence of HIV in country X was 500/100,000 per year.

The process of learning all of the key facts about a clinical trial before deciding whether to participate. The informed consent process continues throughout the study to provide information for participants, some of whom may decide to stop participating.

A document explaining all relevant study information to assist the study volunteer in understanding the expectations and requirements of participating in a clinical trial. This document is presented to the study subject and must be signed if the subject agrees to participate in the study.

An action undertaken in order to change what is happening or might happen, especially to prevent something undesirable. For example, teaching the ABCs of HIV prevention is an intervention designed to reduce the risk of HIV transmission.

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. 

A written description of a formal protocol change.

Person serving as a link or connection between individuals or groups.

A manual comprised of the various policies by which a network is operated. 

A training tool designed to assist clinical site staff in conducting a study. It includes study documentation and project procedures.

Illness

Death

Transmission of HIV infection from mother to infant during pregnancy, labor and delivery, or breastfeeding. Also called vertical transmission.

Provides leadership for a national program in diseases of the heart, blood vessels, lung, and blood; blood resources; and sleep disorders.

Conducts and supports research on the causes, consequences, treatment, and prevention of alcoholism and alcoholism-related problems.

Strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. 

Conducts and supports biomedical research and research training on normal mechanisms as well as diseases and disorders of hearing, balance, smell, taste, voice, speech, and language.

Supports and conducts research on drug abuse and addiction and enhances rapid and effective dissemination of research results to improve drug abuse and addiction prevention, treatment, and policy.

Provides national leadership dedicated to understanding, treating, and preventing mental illnesses through basic research on the brain and behavior, and through clinical, epidemiological, and services research.

Supports and conducts research on the causes, prevention, diagnosis, and treatment of brain and nervous system disorders.

A group of clinical sites brought together to conduct a single or multiple studies.

A meeting, often the entire network, to ensure standardized procedures, particularly in multi-center studies. 

Located within the Office of the Director of NIH, the OAR is responsible for the scientific, budgetary, legislative, and policy elements of the NIH AIDS research program. 

Within the purview of the DHHS, deals with ethical oversight of clinical research conducted by the DHHS, mostly through the National Institutes of Health.

A protocol is open to accrual when the appropriate approvals are granted and the clinical site(s) begins recruiting subjects. 

A volunteer enrolled in a clinical trial.

The number assigned to a participant in a clinical trial in order to maintain the confidentiality (privacy) of the personal information collected during the trial (data) Information about the participant is identified by a number, rather than by name.

A network designed to address two critical pediatric HIV research questions: the long-term safety of fetal and infant exposure to preventative antiretroviral therapy, and the effects of perinatally acquired HIV infection in adolescents. 

A person who provides information and training to a person with a similar background or characteristic.

Around the time of pregnancy, birth, and breastfeeding.

Anti-HIV medicine given to help prevent HIV infection after a high-risk exposure to HIV (such as injury from a contaminated needle, or sexual assault).

After birth

After birth

Before birth

Refers to the proportion of the population affected by a disease at a particular point in time (like a camera snapshot). For example, in 2003, 25% of the adults in country Y were HIV-infected.

Intervention to stop the passing of HIV from an infected mother to her infant during pregnancy, labor and delivery, or breastfeeding.

A medical professional under whose direction a clinical trial is conducted at a research site. A principal investigator is responsible for the overall conduct of the clinical trial at his/her site.

Treatment to prevent a particular disease or to prevent recurrence of an ongoing infection that has been brought under control.

A major category of anti-HIV medicines that block the action of the enzyme protease, which is needed for the virus to make more HIV.

A detailed plan that sets forth the objectives, study design, and methodology for a clinical trial. A study protocol must be approved by an IRB before implementation.

The individual who has the leadership role on the team that develops the protocol and is responsible for oversight of the conduct of the protocol.  

A brief summary of a proposed study or substudy, which must be approved prior to further development. 

An elongated summary of a proposed study or substudy, which must be approved prior to protocol development. 

The protocol-specific documents a site must have on file to register for participation in a clinical trial protocol. Protocol registration must be approved prior to study implementation and is required for each protocol the site conducts. 

The team who develops the protocol and is responsible for oversight of its conduct.

All the planned and systematic activities performed by personnel that are implemented within a quality system, and demonstrated as needed, to provide adequate confidence that an entity will fulfill requirements for quality.

A specific plan for implementing and maintaining quality at a clinical site.  

The function/department within a regulated industry that involves compliance with government regulations and interaction with government regulatory agencies.

A scientist who helps to develop, manage, and analyze results of a clinical trial.

A scientist who provides expertise in a specific area that may be used as part of the protocol team and/or to provide advice on a particular subject.

The PHACS committee responsible for scientific oversight of the network. 

Unintended effects of a medicine.

The site-specific (rather than protocol-specific) documents a site must have on file prior to registering to participate in a clinical trial protocol. Once approved, this “establishes” the site as qualified. 

The person who reviews study records to make sure a study meets protocol, network, and government standards.

All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents.

The document where information regarding a subject is first recorded.  This is the written proof that the subject exists and satisfies the protocol requirements for enrollment.  Investigator patient files or hospital records generally are the basis of source data.

An essential element of Good Clinical Practice.  This includes verifying that 1) all subjects enrolled in the study actually exist and are able to participate for the duration of the study; 2) source documents actually exist for each subject.

The entity that initiates a clinical investigation, but does not actually conduct the investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. 

A treatment plan that experts agree is appropriate, accepted, and widely used for a given disease or condition.

Written documents that describe in detail how a procedure should be done.

A scientific specialist responsible for analyzing all of the data collected in a clinical trial to determine trial results. Statisticians are part of the protocol team, and are important in designing clinical trials.

Disapproval associated with a particular circumstance, quality, or person.

The staff member at the clinical site who serves as the primary contact and ensures that the studies are conducted appropriately.

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions.

A person who participates in an investigation, who may be a healthy human or a patient with a disease.

One of two main protocols being conducted within the PHACS network. This study is designed to estimate the incidence of conditions and diagnoses potentially related to in utero exposure to antiretroviral therapy and/or exposure in the first two months of pregnancy.

A type of white blood cell in the immune system that helps to protect the body from infections. Destruction of CD4 cells by HIV harms the immune system, which leaves the person at higher risk of serious infection or disease.

Ability to poison or otherwise harm the body.

A clinical or laboratory result, which falls outside a predetermined acceptable limit. This result is said to “trigger” additional testing. 

A viral load test result showing that the amount of virus in the blood sample is too low to be detected by the laboratory. An undetectable viral load usually shows that treatment is effective and/or that the person is at low risk of disease progression.

Sexual intercourse without the use of a condom.

Transmission of HIV from mother to infant during pregnancy, labor and delivery, or breastfeeding.

Within PHACS, a group of scientists, clinicians, and community members that reviews the data, monitor triggers, and develops conference and publication materials in a particular area of interest.