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Key Terms and Definitions

Key Terms and Defintions

  • AAHRPP

    Association for the Accreditation of Human Research Protection Programs

  • Biobanking

    Collection of biospecimens (blood, DNA, tissue, biopsy specimens, etc) with corresponding patient data such as genetic profile, medical history and lifestyle information

  • CDC

    Center for Disease Control and Prevention

  • CFR

    Code of Federal Regulations

  • COI

    Conflict of Interest, a situation in which financial or personal interest may compromise or appear to compromise one's professional judgement.

  • CRA

    Clinical Research Associate, a specially trained research staff member who works with a Principal Investigator (PI) and Clinical Research Coordinator (CRC) to support, facilitate and coordinate clinical trials.

  • CRC

    Clinical Research Coordinator, a specially trained coordinator works with a Principal Investigator (PI) to support, facilitate and coordinate clinical trials.

  • CRN

    Clinical Research Nurse, a specially trained nurse works with a Principal Investigator (PI) to support, facilitate and coordinate clinical trials.

  • DHHS

    Department of Health and Human Services

  • Good Clinical Practice, regulations and requirements that must be complied with while conducting a clinical study. These regulations apply to manufacturers, sponsors, clinical investigators, institutional review boards, etc. The primary regulations that govern the conduct of clinical studies are included in the Code of Federal Regulations, Title 21.

  • HDE

    Humanitarian Device Exemption, an application submitted to the FDA to obtain approval for a Humanitarian Use Device. Unlike other device applications, it is not required to contain the results of clinical investigations demonstrating that the device is effective for its intended purpose. The application contains information indicating the probable benefit outweighs the risk of injury or illness from its use. It must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that the device would not otherwise be available for market.

  • HUD

    Humanitarian Use Device, a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals per year. The HUD provision provides an incentive for the development of devices for use in the small populations.

  • Human Research Protection Program

    A committee responsible for reviewing research involving human subjects. It is also referred to as an Institutional Review Board or IRB.

  • ICF

    Informed Consent Form, the document that is part of the process of letting participants know what is involved/required of them if they are to take part in a study.

  • IDE

    Investigational Device Exemption, allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Federal Food Drug and Cosmetic Act that would apply to devices in commercial distribution.

  • IND

    Investigational New Drug, an application submitted to the FDA for safety review prior to any clinic trial activities beginning.

  • Industry Sponsored Research

    Research in which an industry sponsor (e.g. device or drug company) designs a research protocol and is responisible for mitigating, managing, and/or financing the study.

  • Investigator Initiated Research

    Research which is designed by the investigator who is planning to carry out the research; the investigator is responsible for mitigating, managing, and/or financing the study.

  • Multi-center Research

    Research is conducted at more than one hospital or clinic. These studies typically include a large number of patients in different geographical locations to increase generalizability of the study.

  • NIH

    National Institute of Health

  • Phase I Trial

    Represents a new potential treatment that has not yet been tested. Researchers are trying to determine dosing and evaluating safety. Usually involves healthy volunteers and between 20-80 participants.

  • Phase II Trial

    Typically building from Phase I trials, assessing the effectiveness and gather further safety data of a particular therapy in a disease. Usually involves 100-300 participants who have the disease or condition they are looking to treat.

  • Phase III Trial

    If a treatment has shown activity against a particular disease, it is then compared to standard of care or added to existing therapies continuing to look at efficacy, side effects and how it compares to standard of care. This phase usually involves 1,000-3,000 participants who have the disease or condition they are looking to treat.

  • Phase IV Trial

    Conducted after a product has been approved, looking to gather long-term information regarding risks and benefits of the treatment.

  • Prospective Study

    A study designed to observe the outcomes or events that occur subsequent to the identification of subjects.

  • Randomized

    A study design used for testing the effectiveness of a new drug, device, or therapeutic procedure. Subjects are assigned randomly to a treatment group (e.g. experimental or control) and the outcomes are compared.

  • Registry

    A study designed to observe subjects with certain shared characteristics. On going data is collected over time for analysis and reporting.

  • Retrospective Study

    A study designed to look backward in time. These studies typically use old medical records or interviews with subjects who already have a specific disease. Past events are reviewed.

  • Study Protocol

    The overall plan for conducting a study.

    The overall plan for conducting a study.

    The overall plan for conducting a study.